OZEMPIC is indicated:

{ "type": "p", "children": [], "text": "OZEMPIC is indicated:" }

{ "type": "", "children": [], "text": "" }

Recommended Initiation Dosage

Initiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.7), Adverse Reactions (6.1)].

After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.

Recommended Maintenance and Maximum Dosages for Glycemic Control

The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.

If additional glycemic control is needed after at least 4 weeks on the:

The maximum recommended dosage is 2 mg once weekly.

Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease

Increase the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.

Injection: clear, colorless solution available in 3 prefilled, disposable, single-patient-use pens:

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<div class="scrollingtable"><table width="100%"> <col width="17%"/> <col width="21%"/> <col width="18%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Dose per Injection</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Total Strength per Total Volume</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Strength per mL</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">0.25 mg</p> <p>0.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 mg / 3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.68 mg/mL</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">1 mg </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4 mg / 3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.34 mg/mL</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 mg </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8 mg / 3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.68 mg/mL</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"17%\"/>\n<col width=\"21%\"/>\n<col width=\"18%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Dose per Injection</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Total Strength per Total Volume</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Strength per mL</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0.25 mg</p>\n<p>0.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">2 mg / 3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">0.68 mg/mL</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">1 mg </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">4 mg / 3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">1.34 mg/mL</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">2 mg </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">8 mg / 3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">2.68 mg/mL</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.

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OZEMPIC is contraindicated in patients with:

{ "type": "p", "children": [], "text": "OZEMPIC is contraindicated in patients with:" }

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In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide [see Adverse Reactions (6.1)].

After initiation of OZEMPIC, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue OZEMPIC and initiate appropriate management.

In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with OZEMPIC (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (OZEMPIC 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (OZEMPIC 0.7%, placebo 0.4%).

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.

Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions (6.1), Drug Interactions (7)].

The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)]. Monitor renal function in patients reporting adverse reactions to OZEMPIC that could lead to volume depletion, especially during dosage initiation and escalation of OZEMPIC.

Use of OZEMPIC has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6.1)]. In OZEMPIC clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving OZEMPIC (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%).

OZEMPIC is not recommended in patients with severe gastroparesis.

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with OZEMPIC. If hypersensitivity reactions occur, discontinue use of OZEMPIC; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity to OZEMPIC [see Contraindications (4), Adverse Reactions (6.2)].

Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC.

Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

OZEMPIC delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pool of Placebo-Controlled Trials

The data in Table 1 are derived from 2 placebo-controlled trials (1 monotherapy trial and 1 trial in combination with basal insulin) in patients with type 2 diabetes [see Clinical Studies (14)]. These data reflect exposure of 521 patients to OZEMPIC and a mean duration of exposure to OZEMPIC of 32.9 weeks. Across the treatment arms, the mean age of patients was 56 years, 3.4% were 75 years or older and 55% were male. In these trials 71% were White, 7% were Black or African American, and 19% were Asian; 21% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.8 years and had a mean HbA1c of 8.2%. At baseline, 8.9% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m2) in 57.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m2) in 35.9% and moderately impaired (eGFR 30 to 60 mL/min/1.73m2) in 6.9% of patients.

Pool of Placebo- and Active-Controlled Trials

The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes

participating in 7 placebo- and active-controlled glycemic control trials [see Clinical Studies (14)] including two trials in Japanese patients evaluating the use of OZEMPIC as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3150 patients with type 2 diabetes were treated with OZEMPIC for a mean duration of 44.9 weeks. Across the treatment arms, the mean age of patients was 57 years, 3.2% were 75 years or older and 57% were male. In these trials, 60% were White, 6% were Black or African American, and 31% were Asian; 16% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.2 years and had a mean HbA1c of 8.2%. At baseline, 7.8% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m2) in 63.1%, mildly impaired (eGFR 60 to 90 mL/min/1.73m2) in 34.3%, and moderately impaired (eGFR 30 to 60 mL/min/1.73m2) in 2.5% of the patients.

Common Adverse Reactions

Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.

Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus

<div class="scrollingtable"><table width="100%"> <col width="25%"/> <col width="26%"/> <col width="26%"/> <col width="25%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Adverse Reaction</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=262)</span> </p> <p> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">OZEMPIC 0.5 mg</span> </p> <p> <span class="Bold">(N=260)</span> </p> <p> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">OZEMPIC 1 mg</span> </p> <p> <span class="Bold">(N=261)</span> </p> <p> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nausea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15.8 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">20.3 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Vomiting</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2.3 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9.2 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Diarrhea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.9 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.5 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.8 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Abdominal pain</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.7</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Constipation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.5 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5 </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.1 </p> </td> </tr> </tbody> </table></div>

In the pool of placebo- and active-controlled trials and in the 2-year cardiovascular outcomes trial, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1.

In a clinical trial with 959 patients treated with OZEMPIC 1 mg or OZEMPIC 2 mg once weekly as add-on to metformin with or without sulfonylurea treatment for 40 weeks, no new safety signals were identified.

In the FLOW trial [see Clinical Studies 14.3] in patients with type 2 diabetes mellitus and chronic kidney disease, safety data collection was limited to serious adverse events and selected predefined categories of adverse events regardless of seriousness. There were no new serious or severe adverse reactions identified in this trial.

Gastrointestinal Adverse Reactions

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC than placebo (placebo 15.3%, OZEMPIC 0.5 mg 32.7%, OZEMPIC 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation. More patients receiving OZEMPIC 0.5 mg (3.1%) and OZEMPIC 1 mg (3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).

In the trial with OZEMPIC 1 mg and 2 mg, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC 2 mg (34%) vs OZEMPIC 1 mg (30.8%).

Other Adverse Reactions

Hypoglycemia

Table 2 summarizes the incidence of events related to hypoglycemia by various definitions in the placebo-controlled trials.

Table 2. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus

<div class="scrollingtable"><table width="100%"> <col width="28%"/> <col width="24%"/> <col width="24%"/> <col width="23%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">OZEMPIC 0.5 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">OZEMPIC 1 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Monotherapy </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">(30 weeks)</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=129</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=127</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=130</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Severe<span class="Sup">†</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Documented symptomatic (≤70 mg/dL glucose threshold)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.6%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3.8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Severe<span class="Sup">†</span> or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold) </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.6%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Add-on to Basal Insulin with or without Metformin</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">(30 weeks)</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=132</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=132</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=131</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Severe<span class="Sup">†</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1.5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Documented symptomatic (≤70 mg/dL glucose threshold)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15.2%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">16.7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">29.8%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Severe<span class="Sup">†</span> or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold) </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5.3%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.3%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10.7%</p> </td> </tr> <tr class="Last"> <td colspan="4" valign="top"> <p class="First"> <span class="Sup">†</span> “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person.</p> </td> </tr> </tbody> </table></div>

Hypoglycemia was more frequent when OZEMPIC was used in combination with a sulfonylurea [see Warnings and Precautions (5.5), Clinical Studies (14)]. Severe hypoglycemia occurred in 0.8% and 1.2% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 17.3% and 24.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea. Severe or blood glucose confirmed symptomatic hypoglycemia occurred in 6.5% and 10.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea.

Injection Site Reactions

In placebo-controlled trials, injection site reactions (e.g., injection-site discomfort, erythema) were reported in 0.2% of OZEMPIC-treated patients.

Increases in Amylase and Lipase

In placebo-controlled trials, patients exposed to OZEMPIC had a mean increase from baseline in amylase of 13% and lipase of 22%. These changes were not observed in placebo-treated patients.

Acute Pancreatitis

In glycemic control trials, acute pancreatitis was confirmed by adjudication in 7 OZEMPIC-treated patients (0.3 cases per 100 patient years) versus 3 in comparator-treated patients (0.2 cases per 100 patient years).

Cholelithiasis

In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients.

Increases in Heart Rate

In placebo-controlled trials, OZEMPIC 0.5 mg and 1 mg resulted in a mean increase in heart rate of 2 to 3 beats per minute. There was a mean decrease in heart rate of 0.3 beats per minute in placebo-treated patients.

Fatigue, Dysgeusia and Dizziness

Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC include fatigue, dysgeusia and dizziness.

The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of OZEMPIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: Ileus

Hypersensitivity: anaphylaxis, angioedema, rash, urticaria.

Hepatobiliary: cholecystitis, cholecystectomy

Neurologic: dysesthesia

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

Skin and Subcutaneous Tissue: alopecia.

OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.

When initiating OZEMPIC, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.5), Adverse Reactions (6)].

OZEMPIC causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree [see Clinical Pharmacology (12.3)]. Nonetheless, caution should be exercised when oral medications are concomitantly administered with OZEMPIC.

Risk Summary

There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. OZEMPIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal clinical exposure based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/fetal Risk

Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

Data

Animal Data

In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.

In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.02-, 0.2-, and 1.2-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures.

In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.5-, 3-, and 8-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥3X human exposure).

In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.3-, 2-, and 4-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥2X human exposure).

Risk Summary

There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.

Data

In lactating rats, semaglutide was detected in milk at levels 3- to 12- fold lower than in maternal plasma.

Discontinue OZEMPIC in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations (8.1)].

Safety and efficacy of OZEMPIC have not been established in pediatric patients.

In the pool of placebo- and active-controlled glycemic control trials, 744 (23.6%) OZEMPIC-treated patients were 65 years of age and over and 102 OZEMPIC-treated patients (3.2%) patients were 75 years of age and over. In SUSTAIN 6, the cardiovascular outcome trial, 788 (48%) OZEMPIC-treated patients were 65 years of age and over and 157 OZEMPIC-treated patients (9.6%) patients were 75 years of age and over.

No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

No dose adjustment of OZEMPIC is recommended for patients with renal impairment. In subjects with renal impairment including kidney failure, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].

No dose adjustment of OZEMPIC is recommended for patients with hepatic impairment. In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of OZEMPIC of approximately 1 week.

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OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.

{ "type": "p", "children": [], "text": "OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol." }

Structural formula:

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OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL prefilled single-patient use pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1 mL of OZEMPIC solution also contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL prefilled single-patient use pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1 mL of OZEMPIC solution also contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc." }

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.

GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.

The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.

Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

The mechanism of kidney-related risk reduction has not been established.

Semaglutide lowers fasting and postprandial blood glucose and reduces body weight. All pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose escalation) at steady state with semaglutide 1 mg.

Fasting and Postprandial Glucose

Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes, treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose, and 30 mg/dL (22%) for mean 24-hour glucose concentration (see Figure 1).

Figure 1. Mean 24-hour Plasma Glucose Profiles (standardized meals) in Patients with Type 2 Diabetes before (Baseline) and after 12 Weeks of Treatment with Semaglutide or Placebo

Insulin Secretion

Both first-and second-phase insulin secretion are increased in patients with type 2 diabetes treated with OZEMPIC compared with placebo.

Glucagon Secretion

Semaglutide lowers the fasting and postprandial glucagon concentrations. In patients with type 2 diabetes, treatment with semaglutide resulted in the following relative reductions in glucagon compared to placebo, fasting glucagon (8%), postprandial glucagon response (14 to 15%), and mean 24-hour glucagon concentration (12%).

Glucose dependent insulin and glucagon secretion

Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. With semaglutide, the insulin secretion rate in patients with type 2 diabetes was similar to that of healthy subjects (see Figure 2).

Figure 2. Mean Insulin Secretion Rate Versus Glucose Concentration in Patients with Type 2 Diabetes during Graded Glucose Infusion before (Baseline) and after 12 Weeks of Treatment with Semaglutide or Placebo and in Untreated Healthy Subjects

During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes.

Gastric emptying

Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.

Cardiac electrophysiology (QTc)

The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial. Semaglutide does not prolong QTc intervals at doses up to 1.5 mg at steady-state.

Absorption

Absolute bioavailability of semaglutide is 89%. Maximum concentration of semaglutide is reached 1 to 3 days post dose.

Similar exposure is achieved with subcutaneous administration of semaglutide in the abdomen, thigh, or upper arm.

In patients with type 2 diabetes, semaglutide exposure increases in a dose-proportional manner for once-weekly doses of 0.5 mg, 1 mg and 2 mg. Steady-state exposure is achieved following 4 to 5 weeks of once-weekly administration. In patients with type 2 diabetes, the mean population-PK estimated steady-state concentrations following once weekly subcutaneous administration of 0.5 mg and 1 mg semaglutide were approximately 65 ng/mL and 123 ng/mL, respectively. In the trial comparing semaglutide 1 mg and 2 mg, the mean steady state concentrations were 111.1 ng/mL and 222.1 ng/mL, respectively.

Distribution

The mean apparent volume of distribution of semaglutide following subcutaneous administration in patients with type 2 diabetes is approximately 12.5L. Semaglutide is extensively bound to plasma albumin (>99%).

Elimination

The apparent clearance of semaglutide in patients with type 2 diabetes is approximately 0.05 L/h. With an elimination half-life of approximately 1 week, semaglutide will be present in the circulation for about 5 weeks after the last dose.

Metabolism

The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain.

Excretion

The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the dose is excreted in the urine as intact semaglutide.

Specific Populations

Based on a population pharmacokinetic analysis, age, sex, race, and ethnicity, and renal impairment do not have a clinically meaningful effect on the pharmacokinetics of semaglutide. The exposure of semaglutide decreases with an increase in body weight. However, semaglutide doses of 0.5 mg and 1 mg provide adequate systemic exposure over the body weight range of 40 to 198 kg evaluated in the clinical trials. The effects of intrinsic factors on the pharmacokinetics of semaglutide are shown in Figure 3.

Figure 3. Impact of Intrinsic Factors on Semaglutide Exposure

Patients with Renal impairment - Renal impairment does not impact the pharmacokinetics of semaglutide in a clinically relevant manner. This was shown in a study with a single dose of 0.5 mg semaglutide in patients with different degrees of renal impairment (mild, moderate, severe, or kidney failure) compared with subjects with normal renal function. This was also shown for subjects with both type 2 diabetes and renal impairment based on data from clinical studies (Figure 3).

Patients with Hepatic impairment - Hepatic impairment does not have any impact on the exposure of semaglutide. The pharmacokinetics of semaglutide were evaluated in patients with different degrees of hepatic impairment (mild, moderate, severe) compared with subjects with normal hepatic function in a study with a single-dose of 0.5 mg semaglutide.

Pediatric Patients- Semaglutide has not been studied in pediatric patients.

Drug Interaction Studies

In vitro studies have shown very low potential for semaglutide to inhibit or induce CYP enzymes, and to inhibit drug transporters.

The delay of gastric emptying with semaglutide may influence the absorption of concomitantly administered oral medicinal products [see Drug Interactions (7.2)]. The potential effect of semaglutide on the absorption of co-administered oral medications was studied in trials at semaglutide 1 mg steady-state exposure.

No clinically relevant drug-drug interaction with semaglutide (Figure 4) was observed based on the evaluated medications; therefore, no dose adjustment is required when co-administered with semaglutide. In a separate study, no apparent effect on the rate of gastric emptying was observed with semaglutide 2.4 mg.

Figure 4. Impact of Semaglutide on the Exposure of Co-administered Oral Medications

Relative exposure in terms of AUC and Cmax for each medication when given with semaglutide compared to without semaglutide. Metformin and oral contraceptive drug (ethinylestradiol/levonorgestrel) were assessed at steady state. Warfarin (S-warfarin/R-warfarin), digoxin and atorvastatin were assessed after a single dose.

Abbreviations: AUC: area under the curve. Cmax: maximum concentration. CI: confidence interval.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADAs) in the studies described below with the incidence of ADAs in other studies, including those of semaglutide or of other semaglutide products.

Across the placebo- and active-controlled glycemic control trials, 32 out of 3,150 (1%) OZEMPIC-treated patients developed ADAs to the active ingredient in OZEMPIC (i.e., semaglutide). Of the 32 semaglutide- treated patients that developed semaglutide ADAs, 19 patients (0.6% of the overall population) developed antibodies cross-reacting with native GLP-1. The in vitro neutralizing activity of the antibodies is uncertain at this time.

In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [2-, 11-, and 30-fold the maximum recommended human dose (MRHD) of 2 mg/week, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (1-, 2-, and 7-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at clinically relevant exposures.

Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning, Warnings and Precautions (5.1)].

Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).

In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight.

OZEMPIC has been studied as monotherapy and in combination with metformin, metformin and sulfonylureas, metformin and/or thiazolidinedione, and basal insulin in patients with type 2 diabetes mellitus. The efficacy of OZEMPIC was compared with placebo, sitagliptin, exenatide extended-release (ER), and insulin glargine.

Most trials evaluated the use of OZEMPIC 0.5 mg, and 1 mg, with the exception of the trial comparing OZEMPIC and exenatide ER where only the 1 mg dose was studied. One trial evaluated the use of OZEMPIC 2 mg once weekly.

In patients with type 2 diabetes mellitus, OZEMPIC produced clinically relevant reduction from baseline in HbA1c compared with placebo.

The efficacy of OZEMPIC was not impacted by age, gender, race, ethnicity, BMI at baseline, body weight (kg) at baseline, diabetes duration and level of renal function impairment.

Monotherapy Use of OZEMPIC in Adults with Type 2 Diabetes Mellitus

In a 30-week double-blind trial (NCT02054897), 388 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized to OZEMPIC 0.5 mg or OZEMPIC 1 mg once weekly or placebo. Patients had a mean age of 54 years and 54% were men. The mean duration of type 2 diabetes was 4.2 years, and the mean BMI was 33 kg/m2. Overall, 64% were White, 8% were Black or African American, and 21% were Asian; 30% identified as Hispanic or Latino ethnicity.

Monotherapy with OZEMPIC 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 3).

Table 3. Results at Week 30 in a Trial of OZEMPIC as Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

<div class="scrollingtable"><table cellpadding="0pt" width="100%"> <col width="39%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Placebo</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>0.5 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>1 mg</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>129</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>128</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>130</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>HbA<span class="Sup">1c</span> (%)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.1</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.1</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.1</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.4</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.6</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b</span> [95%</dd> <dt> </dt> <dd>CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.2 [-1.5, -0.9]<span class="Sup">c</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.4 [-1.7, -1.1]<span class="Sup">c</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>28</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>73</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>70</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>FPG (mg/dL)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>174</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>174</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>179</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-15</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-41</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-44</dd> </dl> </td> </tr> </tbody> </table></div>

The mean baseline body weight was 89.1 kg, 89.8 kg, 96.9 kg in the placebo, OZEMPIC 0.5 mg, and OZEMPIC 1 mg arms, respectively. The mean changes from baseline to week 30 were -1.2 kg, -3.8 kg and -4.7 kg in the placebo, OZEMPIC 0.5 mg, and OZEMPIC 1 mg arms, respectively. The difference from placebo (95% CI) for OZEMPIC 0.5 mg was -2.6 kg (-3.8, -1.5), and for OZEMPIC 1 mg was -3.5 kg (-4.8, -2.2).

Combination Therapy Use of OZEMPIC in Adults with Type 2 Diabetes Mellitus

Combination with metformin and/or thiazolidinediones

In a 56-week, double-blind trial (NCT01930188), 1231 patients with type 2 diabetes mellitus were randomized to OZEMPIC 0.5 mg once weekly, OZEMPIC 1 mg once weekly, or sitagliptin 100 mg once daily, all in combination with metformin (94%) and/or thiazolidinediones (6%). Patients had a mean age of 55 years and 51% were men. The mean duration of type 2 diabetes was 6.6 years, and the mean BMI was 32 kg/m2. Overall, 68% were White, 5% were Black or African American, and 25% were Asian; 17% identified as Hispanic or Latino ethnicity.

Treatment with OZEMPIC 0.5 mg and 1 mg once weekly for 56 weeks resulted in a statistically significant reduction in HbA1c compared to sitagliptin (see Table 4 and Figure 5).

Table 4. Results at Week 56 in a Trial of OZEMPIC Compared to Sitagliptin in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin and/or Thiazolidinediones

<div class="scrollingtable"><table width="100%"> <col width="39%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">OZEMPIC</p> <p>0.5 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">OZEMPIC</p> <p>1 mg</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Sitagliptin</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">409</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">409</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">407</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 56<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from sitagliptin<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.6 </p> <p>[-0.7, -0.4]<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.8</p> <p>[-0.9, -0.6]<span class="Sup">c</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%<span class="Sup"></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">66</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">73</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">40</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">168</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">167</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">173</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 56<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-35</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-43</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-23</p> </td> </tr> </tbody> </table></div>

The mean baseline body weight was 89.9 kg, 89.2 kg, 89.3 kg in the OZEMPIC 0.5 mg, OZEMPIC 1 mg, and sitagliptin arms, respectively. The mean changes from baseline to week 56 were -4.2 kg, -5.5 kg, and -1.7 kg for the OZEMPIC 0.5 mg, OZEMPIC 1 mg, and sitagliptin arms, respectively. The difference from sitagliptin (95% CI) for OZEMPIC 0.5 mg was -2.5 kg (-3.2, -1.8), and for OZEMPIC 1 mg was -3.8 kg (-4.5, -3.1).

Figure 5. Mean HbA1c (%) Over Time - Baseline to Week 56

Combination with metformin or metformin with sulfonylurea

In a 56-week, open-label trial (NCT01885208), 813 patients with type 2 diabetes mellitus on metformin alone (49%), metformin with sulfonylurea (45%), or other (6%) were randomized to OZEMPIC 1 mg once weekly or exenatide 2 mg once weekly. Patients had a mean age of 57 years and 55% were men. The mean duration of type 2 diabetes was 9 years, and the mean BMI was 34 kg/m2. Overall, 84% were White, 7% were Black or African American, and 2% were Asian; 24% identified as Hispanic or Latino ethnicity.

Treatment with OZEMPIC 1 mg once weekly for 56 weeks resulted in a statistically significant reduction in HbA1c compared to exenatide 2 mg once weekly (see Table 5).

Table 5. Results at Week 56 in a Trial of OZEMPIC Compared to Exenatide 2 mg Once Weekly in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with Sulfonylurea

<div class="scrollingtable"><table cellpadding="0pt" width="536.45pt"> <col width="45%"/> <col width="27%"/> <col width="27%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>1 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Exenatide ER 2 mg</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>404</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>405</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>HbA<span class="Sub">1c</span> (%)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 56<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.9</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Difference from exenatide<span class="Sup">b</span> [95% CI]</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.5</p> <p>[-0.7, -0.3]c</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">62</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">40</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>FPG (mg/dL)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">191</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">188</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 56<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-44</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-34</p> </td> </tr> </tbody> </table></div>

The mean baseline body weight was 96.2 kg and 95.4 kg in the OZEMPIC 1 mg and exenatide ER arms, respectively. The mean changes from baseline to week 56 were -4.8 kg and -2 kg in the OZEMPIC 1 mg and exenatide ER arms, respectively. The difference from exenatide ER (95% CI) for OZEMPIC 1 mg was -2.9 kg (-3.6, -2.1).

Combination with metformin or metformin with sulfonylurea

In a 30-week, open-label trial (NCT02128932), 1089 patients with type 2 diabetes mellitus were randomized to OZEMPIC 0.5 mg once weekly, OZEMPIC 1 mg once weekly, or insulin glargine once daily on a background of metformin (48%) or metformin and sulfonylurea (51%). Patients had a mean age of 57 years and 53% were men. The mean duration of type 2 diabetes was 8.6 years, and the mean BMI was 33 kg/m2. Overall, 77% were White, 9% were Black or African American, and 11% were Asian; 20% identified as Hispanic or Latino ethnicity.

Patients assigned to insulin glargine had a baseline mean HbA1c of 8.1% and were started on a dose of 10 U once daily. Insulin glargine dose adjustments occurred throughout the trial period based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In addition, investigators could titrate insulin glargine at their discretion between study visits. Only 26% of patients had been titrated to goal by the primary endpoint at week 30, at which time the mean daily insulin dose was 29 U per day.

Treatment with OZEMPIC 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statistically significant reduction in HbA1c compared with the insulin glargine titration implemented in this study protocol (see Table 6).

Table 6. Results at Week 30 in a Trial of OZEMPIC Compared to Insulin Glargine in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with Sulfonylurea

<div class="scrollingtable"><table cellpadding="0pt" width="539.65pt"> <col width="39%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>0.5 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>1 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Insulin Glargine</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>362</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>360</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>360</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>HbA<span class="Sub">1c</span> (%)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.1</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.2</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.1</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.2</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.5</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.9</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from insulin glargine<span class="Sup">b</span> [95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.3</dd> <dt> </dt> <dd>[-0.5, -0.1]<span class="Sup">c</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.6</dd> <dt> </dt> <dd>[-0.8, -0.4]<span class="Sup">c</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>55</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>66</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>40</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>FPG (mg/dL)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>172</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>179</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>174</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-35</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-46</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-37</dd> </dl> </td> </tr> </tbody> </table></div>

Table 7. Results at Week 40 in a Trial of OZEMPIC 2 mg Compared to OZEMPIC 1 mg in Adult Patients with Type 2 Diabetes Mellitus in Combination With Metformin or Metformin with Sulfonylurea

<div class="scrollingtable"><table cellpadding="0pt" width="100%"> <col width="43%"/> <col width="23%"/> <col width="25%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC 1 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC 2 mg</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>481</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>480</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>HbA<span class="Sub">1c</span> (%)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.8</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.9</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 40<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.9</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-2.1</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from OZEMPIC 1 mg</dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.2</dd> <dt> </dt> <dd>[-0.31 ; -0.04]<span class="Sup">c</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>56</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>64</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>FPG (mg/dL)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>196</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>193</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 40<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-55</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-59</dd> </dl> </td> </tr> </tbody> </table></div>

The mean baseline body weight was 98.6 kg and 100.1 kg in the OZEMPIC 1 mg and OZEMPIC 2 mg arms, respectively. The mean changes from baseline to week 40 were -5.6 kg and -6.4 kg in the OZEMPIC 1 mg and OZEMPIC 2 mg arms, respectively. The difference between treatment arms in body weight change from baseline at week 40 was not statistically significant.

Combination with basal insulin

In a 30-week, double-blind trial (NCT02305381), 397 patients with type 2 diabetes mellitus inadequately controlled with basal insulin, with or without metformin, were randomized to OZEMPIC 0.5 mg once weekly, OZEMPIC 1 mg once weekly, or placebo. Patients with HbA1c ≤8.0% at screening reduced their insulin dose by 20% at start of the trial to reduce the risk of hypoglycemia. Patients had a mean age of 59 years and 56% were men. The mean duration of type 2 diabetes was 13 years, and the mean BMI was 32 kg/m2. Overall, 78% were White, 5% were Black or African American, and 17% were Asian; 12% identified as Hispanic or Latino ethnicity.

Treatment with OZEMPIC resulted in a statistically significant reduction in HbA1c after 30 weeks of treatment compared to placebo (see Table 8).

Table 8. Results at Week 30 in a Trial of OZEMPIC in Adult Patients with Type 2 Diabetes Mellitus in Combination with Basal Insulin with or without Metformin

<div class="scrollingtable"><table cellpadding="0pt" width="539.6pt"> <col width="39%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Placebo</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>0.5 mg</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>OZEMPIC</dd> <dt> </dt> <dd>1 mg</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>133</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>132</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>131</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>HbA<span class="Sub">1c</span> (%)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.4</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.4</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>8.3</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-0.2</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.3</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.7</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.1</dd> <dt> </dt> <dd>[-1.4, -0.8]<span class="Sup">c</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-1.6</dd> <dt> </dt> <dd>[-1.8, -1.3]<span class="Sup">c</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>13</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>56</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>73</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>FPG (mg/dL)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>154</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>161</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>153</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 30<span class="Sup">b</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-8</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-28</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>-39</dd> </dl> </td> </tr> </tbody> </table></div>

The mean baseline body weight was 89.9 kg, 92.7 kg, and 92.5 kg in the placebo, OZEMPIC 0.5 mg, and OZEMPIC 1 mg arms, respectively. The mean changes from baseline to week 30 were -1.2 kg, -3.5 kg, and -6 kg in the placebo, OZEMPIC 0.5 mg, and OZEMPIC 1 mg arms, respectively. The difference from placebo (95% CI) for OZEMPIC 0.5 mg was -2.2 kg (-3.4, -1.1), and for OZEMPIC 1 mg was -4.7 kg (-5.8, -3.6).

SUSTAIN 6 (NCT01720446) was a multi-center, multi-national, placebo-controlled, double-blind cardiovascular outcomes trial. In this trial, 3,297 patients with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease were randomized to OZEMPIC (0.5 mg or 1 mg) once weekly or placebo for a minimum observation time of 2 years. The trial compared the risk of Major Adverse Cardiovascular Event (MACE) between semaglutide and placebo when these were added to and used concomitantly with standard of care treatments for diabetes and cardiovascular disease. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

Patients eligible to enter the trial were; 50 years of age or older and had established, stable, cardiovascular, cerebrovascular, peripheral artery disease, chronic kidney disease or NYHA class II and III heart failure or were 60 years of age or older and had other specified risk factors for cardiovascular disease. In total, 1,940 patients (58.8%) had established cardiovascular disease without chronic kidney disease, 353 (10.7%) had chronic kidney disease only, and 442 (13.4%) had both cardiovascular disease and kidney disease; 562 patients (17%) had cardiovascular risk factors without established cardiovascular disease or chronic kidney disease. In the trial 453 patients (13.7%) had peripheral artery disease. The mean age at baseline was 65 years, and 61% were men. The mean duration of diabetes was 13.9 years, and mean BMI was 33 kg/m2. Overall, 83% were White, 7% were Black or African American, and 8% were Asian; 16% identified as Hispanic or Latino ethnicity. Concomitant diseases of patients in this trial included, but were not limited to, heart failure (24%), hypertension (93%), history of ischemic stroke (12%) and history of a myocardial infarction (33%). In total, 98.0% of the patients completed the trial and the vital status was known at the end of the trial for 99.6%.

For the primary analysis, a Cox proportional hazards model was used to test for non-inferiority of OZEMPIC to placebo for time to first MACE using a risk margin of 1.3. The statistical analysis plan pre specified that the 0.5 mg and 1 mg doses would be combined. Type-1 error was controlled across multiple tests using a hierarchical testing strategy.

OZEMPIC significantly reduced the occurrence of MACE. The estimated hazard ratio for time to first MACE

was 0.74 (95% CI: 0.58, 0.95). Refer to Figure 6 and Table 9.

Figure 6. Kaplan-Meier: Time to First Occurrence of a MACE in the SUSTAIN 6 Trial

The treatment effect for the primary composite endpoint and its components in the SUSTAIN 6 trial is shown in Table 9.

Table 9. Treatment Effect for MACE and its Components, Median Study Observation Time of 2.1 Years

<div class="scrollingtable"><table cellpadding="0pt" width="550.6pt"> <col width="42%"/> <col width="19%"/> <col width="19%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">Placebo N=1649 (%)</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">OZEMPIC N=1648 (%)</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">Hazard ratio vs Placebo (95% CI)</span><span class="Sup">a</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal</dd> <dt> </dt> <dd>stroke (time to first occurrence)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>146 (8.9)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>108 (6.6)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.74 (0.58, 0.95)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Non-fatal Myocardial Infarction</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>64 (3.9)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>47 (2.9)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.74 (0.51, 1.08)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Non-fatal Stroke</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>44 (2.7)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>27 (1.6)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.61 (0.38, 0.99)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Cardiovascular Death</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>46 (2.8)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>44 (2.7)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.98 (0.65, 1.48)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Fatal or Non-fatal Myocardial Infarction</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>67 (4.1)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>54 (3.3)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.81 (0.57, 1.16)</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Fatal or Non-fatal Stroke</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>46 (2.8)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>30 (1.8)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.65 (0.41, 1.03)</dd> </dl> </td> </tr> </tbody> </table></div>

a Cox-proportional hazards models with treatment as factor and stratified by evidence of cardiovascular disease, insulin treatment and renal impairment.

FLOW (NCT03819153) was a randomized, double-blind, placebo-controlled, event driven trial in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR 25 to 75 mL/min/1.73 m2 with urine albumin-to- creatinine ratio [UACR] >100 mg/g and <5000 mg/g). All patients needed to have an HbA1c ≤10% at screening and be receiving standard of care background therapy, including a maximum tolerated labeled dose of a renin- angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment was contraindicated or not tolerated. The trial excluded patients with congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.

A total of 3,533 patients were randomized to receive OZEMPIC 1 mg once weekly or placebo and were followed for a median of 41 months. The mean age of the study population was 67 years, and 70% of patients were male. Approximately 66% of the trial population was White, 24% Asian, and 5% Black or African American. At baseline, the mean eGFR was 47 mL/min/1.73m2, with 11% of patients having an eGFR <30 mL/min/1.73m2. Median baseline UACR was 568 mg/g with 69% of patients with a UACR >300 mg/g. At baseline, 95% of patients were treated with an ACE inhibitor or ARB, 16% were on sodium-glucose cotransporter 2 (SGLT2) inhibitors, 76% were on a statin, and 50% were on an antiplatelet agent.

OZEMPIC was superior to placebo in reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR <15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, CV death (HR 0.76 [95% CI 0.66, 0.88], p=0.0003) as shown in Table 10 and Figure 7. The treatment effect reflected a reduction in a sustained decline in eGFR of ≥50%, progression to kidney failure and CV death. There were few renal deaths during the trial.

OZEMPIC also reduced the annual rate of change in eGFR (Figure 9), the incidence of a composite cardiovascular endpoint, consisting of non-fatal myocardial infarction (MI), non-fatal stroke, and cardiovascular death, and the incidence of all-cause death (Table 10 and Figure 8).

The treatment effect on the primary composite endpoint was generally consistent across the pre-specified subgroups examined, including age, biological sex, eGFR and UACR. The treatment benefit on the primary composite endpoint was not evident in patients taking SGLT2 inhibitors at baseline, but there were few events in these patients.

Table 10: Analyses of the Primary and Secondary Endpoints and their Individual Components in FLOW Trial

<div class="scrollingtable"><table cellpadding="0pt" width="555.5pt"> <col width="34%"/> <col width="21%"/> <col width="13%"/> <col width="13%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">Placebo</span> </dd> <dt> </dt> <dd> <span class="Bold">N=1766 (%)</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">OZEMPIC</span> </dd> <dt> </dt> <dd> <span class="Bold">1 mg N=1767 (%)</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">Hazard ratio vs placebo (95% CI)1</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">p-value2</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">Number of Patients</span> </dd> <dt> </dt> <dd> <span class="Bold">(%)</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Composite Endpoint (≥ 50% sustained eGFR decline, sustained eGFR &lt; 15 mL/min/1.73 m<span class="Sup">2</span>, chronic renal replacement therapy, or renal or cardiovascular death (time to first occurrence)<span class="Sup">3</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>410 (23.2)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>331 (18.7)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.76 (0.66,</dd> <dt> </dt> <dd>0.88)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.0003</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>≥ 50% sustained eGFR decline<span class="Sup">3</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>213 (12.1)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>165 (9.3)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.73 (0.59,</dd> <dt> </dt> <dd>0.89)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Sustained eGFR</dd> <dt> </dt> <dd>&lt;15mL/min/1.73 <span class="Sub">m2 3</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>110 (6.2)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>92 (5.2)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.80 (0.61,</dd> <dt> </dt> <dd>1.06)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Chronic renal replacement therapy</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>100 (5.7)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>87 (4.9)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.84 (0.63,</dd> <dt> </dt> <dd>1.12)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Renal death</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>5 (0.3)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>5 (0.3)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.97 (0.27,</dd> <dt> </dt> <dd>3.49)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Cardiovascular death</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>169 (9.6)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>123 (7.0)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.71 (0.56,</dd> <dt> </dt> <dd>0.89)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke (time to first occurrence)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>254 (14.4)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>212 (12.0)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.82 (0.68,</dd> <dt> </dt> <dd>0.98)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.0289</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>All-cause death</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>279 (15.8)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>227 (12.8)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>0.80 (0.67,</dd> <dt> </dt> <dd>0.95)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0.0104</p> </td> </tr> </tbody> </table></div>

1 Cox proportional hazards model with treatment as factor and stratified by baseline use of SGLT2-inhibitor at baseline (yes or no).

2 Two-sided p-value for the test of no difference. The significance level was 0.03224.

3 Sustained was defined as having 2 consecutive measurements ≥28 days apart fulfilling the criteria.

Figure 7. Cumulative Incidence: Time to First Occurrence of the Primary Composite Endpoint - Sustained Decline in eGFR ≥50%, Sustained eGFR<15 mL/min/1.73m2, Chronic Renal Replacement Therapy, Renal Death or CV Death

Cumulative incidence estimates are based on time from randomization to first composite renal event with non-CV and non-renal death modelled as competing risk. The x-axis is truncated at 52 months where approximately 5% of the population was in the trial.

Sustained was defined as having 2 consecutive measurements ≥28 days apart fulfilling the criteria.

Figure 8. Cumulative incidence: Time to First Occurrence of MACE in FLOW Trial

Figure 9. Observed Mean Plot: eGFR (mL/min/1.73m2) by Week in FLOW Trial

How Supplied

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Injection: clear, colorless solution of 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide available in prefilled, disposable, single-patient-use pens in the following packaging configurations:

{ "type": "p", "children": [], "text": "Injection: clear, colorless solution of 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide available in prefilled, disposable, single-patient-use pens in the following packaging configurations:" }

<div class="scrollingtable"><table width="100%"> <col width="12%"/> <col width="13%"/> <col width="19%"/> <col width="18%"/> <col width="19%"/> <col width="18%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Dose per Injection</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Use For</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Total Strength per Total Volume</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Doses per Pen</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Carton Contents</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">NDC</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">0.25 mg</p> <p>0.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Initiation</p> <p>Maintenance</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 mg/3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="bottom"> <p class="First">4 doses of 0.25 mg and</p> <p>2 doses of 0.5 mg</p> <p>or</p> <p>4 doses of 0.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1 pen</p> <p>6 NovoFine<span class="Sup">®</span> Plus needles</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4181-13</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">1 mg </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Maintenance</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 mg/3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 doses of 1 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1 pen</p> <p>4 NovoFine<span class="Sup">®</span> Plus needles</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4130-13</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">2 mg </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Maintenance</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">8 mg/3 mL</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 doses of 2 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1 pen</p> <p>4 NovoFine<span class="Sup">®</span> Plus needles</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4772-12</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"12%\"/>\n<col width=\"13%\"/>\n<col width=\"19%\"/>\n<col width=\"18%\"/>\n<col width=\"19%\"/>\n<col width=\"18%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Dose per Injection</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Use For</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Total Strength per Total Volume</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Doses per Pen</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Carton Contents</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">NDC</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0.25 mg</p>\n<p>0.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Initiation</p>\n<p>Maintenance</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">2 mg/3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"bottom\">\n<p class=\"First\">4 doses of 0.25 mg and</p>\n<p>2 doses of 0.5 mg</p>\n<p>or</p>\n<p>4 doses of 0.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1 pen</p>\n<p>6 NovoFine<span class=\"Sup\">®</span> Plus needles</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4181-13</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">1 mg </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Maintenance</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">4 mg/3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">4 doses of 1 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1 pen</p>\n<p>4 NovoFine<span class=\"Sup\">®</span> Plus needles</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4130-13</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">2 mg </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Maintenance</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">8 mg/3 mL</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">4 doses of 2 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1 pen</p>\n<p>4 NovoFine<span class=\"Sup\">®</span> Plus needles</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4772-12</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

The 2 mg/1.5 mL (1.34 mg/mL) strength (NDC 0169-4132-12) is not currently marketed by Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "The 2 mg/1.5 mL (1.34 mg/mL) strength (NDC 0169-4132-12) is not currently marketed by Novo Nordisk Inc." }

Each OZEMPIC pen is for use by a single patient. An OZEMPIC pen must never be shared between patients, even if the needle is changed [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Each OZEMPIC pen is for use by a single patient. An OZEMPIC pen must never be shared between patients, even if the needle is changed [see Warnings and Precautions (5.4)]." }

Recommended Storage

{ "type": "p", "children": [], "text": "\nRecommended Storage\n" }

Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen.

{ "type": "p", "children": [], "text": "Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen." }

After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.

{ "type": "p", "children": [], "text": "After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight. " }

Always remove and safely discard the needle after each injection and store the OZEMPIC pen without an injection needle attached. Always use a new needle for each injection.

{ "type": "p", "children": [], "text": "Always remove and safely discard the needle after each injection and store the OZEMPIC pen without an injection needle attached. Always use a new needle for each injection." }

Recommended Storage Conditions for the OZEMPIC Pen

{ "type": "p", "children": [], "text": "\nRecommended Storage Conditions for the OZEMPIC Pen\n" }

<div class="scrollingtable"><table width="100%"> <col width="49%"/> <col width="24%"/> <col width="24%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Prior to first use</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">After first use</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Refrigerated</p> <p>36°F to 46°F</p> <p>(2°C to 8°C)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Room Temperature</p> <p>59°F to 86°F</p> <p>(15°C to 30°C)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Refrigerated</p> <p>36°F to 46°F</p> <p>(2°C to 8°C)</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Until expiration date</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First">56 days</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"49%\"/>\n<col width=\"24%\"/>\n<col width=\"24%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Prior to first use</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">After first use</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">Refrigerated</p>\n<p>36°F to 46°F</p>\n<p>(2°C to 8°C)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Room Temperature</p>\n<p>59°F to 86°F</p>\n<p>(15°C to 30°C)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Refrigerated</p>\n<p>36°F to 46°F</p>\n<p>(2°C to 8°C)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Until expiration date</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">56 days</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)." }

Risk of Thyroid C-cell Tumors

{ "type": "p", "children": [], "text": "\nRisk of Thyroid C-cell Tumors\n" }

Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions (5.1)]." }

Acute Pancreatitis

{ "type": "p", "children": [], "text": "\nAcute Pancreatitis\n" }

Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting. Instruct patients to discontinue OZEMPIC promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting. Instruct patients to discontinue OZEMPIC promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2)].\n" }

Diabetic Retinopathy Complications

{ "type": "p", "children": [], "text": "\nDiabetic Retinopathy Complications\n" }

Inform patients to contact their physician if changes in vision are experienced during treatment with OZEMPIC [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients to contact their physician if changes in vision are experienced during treatment with OZEMPIC [see Warnings and Precautions (5.3)].\n" }

Never Share an OZEMPIC Pen Between Patients

{ "type": "p", "children": [], "text": "\nNever Share an OZEMPIC Pen Between Patients\n" }

Advise patients that they must never share an OZEMPIC pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients that they must never share an OZEMPIC pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.4)]." }

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

{ "type": "p", "children": [], "text": "\nHypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin\n" }

Inform patients that the risk of hypoglycemia is increased when OZEMPIC is used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Inform patients that the risk of hypoglycemia is increased when OZEMPIC is used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.5)].\n" }

Acute Kidney Injury Due to Volume Depletion

{ "type": "p", "children": [], "text": "\nAcute Kidney Injury Due to Volume Depletion\n" }

Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions (5.6)]." }

Severe Gastrointestinal Adverse Reactions

{ "type": "p", "children": [], "text": "\nSevere Gastrointestinal Adverse Reactions\n" }

Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.7)]

{ "type": "p", "children": [], "text": "Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.7)]\n" }

Hypersensitivity Reactions

{ "type": "p", "children": [], "text": "\nHypersensitivity Reactions\n" }

Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of OZEMPIC. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking OZEMPIC and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.8)].

{ "type": "p", "children": [], "text": "Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of OZEMPIC. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking OZEMPIC and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.8)]." }

Acute Gallbladder Disease

{ "type": "p", "children": [], "text": "\nAcute Gallbladder Disease\n" }

Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.9)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.9)].\n" }

Pulmonary Aspiration During General Anesthesia or Deep Sedation

{ "type": "p", "children": [], "text": "\nPulmonary Aspiration During General Anesthesia or Deep Sedation\n" }

Inform patients that OZEMPIC may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC [see Warnings and Precautions (5.10)].

{ "type": "p", "children": [], "text": "Inform patients that OZEMPIC may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC [see Warnings and Precautions (5.10)].\n" }

Pregnancy

{ "type": "p", "children": [], "text": "\nPregnancy\n" }

Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations (8.1), (8.3)].

{ "type": "p", "children": [], "text": "Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations (8.1), (8.3)].\n" }

Missed doses

{ "type": "p", "children": [], "text": "\nMissed doses\n" }

Inform patients if a dose is missed, it should be administered as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, inform patients to resume their regular once weekly dosing schedule [see Dosage and Administration (2.1)].

{ "type": "p", "children": [], "text": "Inform patients if a dose is missed, it should be administered as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, inform patients to resume their regular once weekly dosing schedule [see Dosage and Administration (2.1)]." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Novo Nordisk A/S

{ "type": "p", "children": [], "text": "Novo Nordisk A/S" }

DK-2880 Bagsvaerd

{ "type": "p", "children": [], "text": "DK-2880 Bagsvaerd" }

Denmark

{ "type": "p", "children": [], "text": "Denmark" }

For information about OZEMPIC contact:

{ "type": "p", "children": [], "text": "For information about OZEMPIC contact:" }

Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "Novo Nordisk Inc." }

800 Scudders Mill Road

{ "type": "p", "children": [], "text": "800 Scudders Mill Road" }

Plainsboro, NJ 08536

{ "type": "p", "children": [], "text": "Plainsboro, NJ 08536" }

1-888-693-6742

{ "type": "p", "children": [], "text": "1-888-693-6742" }

Version: 11

{ "type": "p", "children": [], "text": "Version: 11" }

OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.

{ "type": "p", "children": [], "text": "\nOZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.\n" }

PATENT INFORMATION: http://www.novonordisk-us.com/products/product-patents.html

{ "type": "p", "children": [], "text": "\nPATENT INFORMATION: http://www.novonordisk-us.com/products/product-patents.html" }

© 2025 Novo Nordisk

{ "type": "p", "children": [], "text": "© 2025 Novo Nordisk" }

<div class="scrollingtable"><table width="100%"> <col width="35%"/> <col width="15%"/> <col width="11%"/> <col width="38%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Medication Guide</span> </p> <p> <span class="Bold">OZEMPIC<span class="Sup">®</span> (oh-ZEM-pick)</span> </p> <p>(semaglutide)</p> <p>injection, for subcutaneous use</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First">Read this Medication Guide before you start using OZEMPIC and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about OZEMPIC?</span> </p> <p> <span class="Bold">OZEMPIC may cause serious side effects, including:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Possible thyroid tumors, including cancer. </span>Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, OZEMPIC and medicines that work like OZEMPIC caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.</dd> <dt>•</dt> <dd>Do not use OZEMPIC if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What is OZEMPIC?</span> </p> <p>OZEMPIC is an injectable prescription medicine used: </p> <dl> <dt>•</dt> <dd>along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. </dd> <dt>•</dt> <dd>to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.</dd> <dt>•</dt> <dd>to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes mellitus and chronic kidney disease.</dd> </dl> <p>It is not known if OZEMPIC is safe and effective for use in children. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Do not use OZEMPIC if:</span> </p> <dl> <dt>•</dt> <dd>you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd> <dt>•</dt> <dd>you have had a serious allergic reaction to semaglutide or any of the ingredients in OZEMPIC. See the end of this Medication Guide for a complete list of ingredients in OZEMPIC. See <span class="Bold">“What are the possible side effects of OZEMPIC?” </span>for symptoms of a serious allergic reaction. </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Before using OZEMPIC, tell your healthcare provider if you have any other medical conditions, including if you:</span> </p> <dl> <dt>•</dt> <dd>have or have had problems with your pancreas.</dd> <dt>•</dt> <dd>have a history of diabetic retinopathy.</dd> <dt>•</dt> <dd>have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.</dd> <dt>•</dt> <dd>are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</dd> <dt>•</dt> <dd>are pregnant or plan to become pregnant. It is not known if OZEMPIC will harm your unborn baby. You should stop using OZEMPIC at least 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.</dd> <dt>•</dt> <dd>are breastfeeding or plan to breastfeed. It is not known if OZEMPIC passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using OZEMPIC.</dd> <dt> </dt> <dd> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. OZEMPIC may affect the way some medicines work and some medicines may affect the way OZEMPIC works. </dd> <dt> </dt> <dd> <span class="Bold">Before using OZEMPIC, talk to your healthcare provider about low blood sugar and how to manage it.</span> Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.</dd> </dl> <p>Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">How should I use OZEMPIC?</span> </p> <dl> <dt>•</dt> <dd>Read the <span class="Bold">Instructions for Use</span> that comes with OZEMPIC.</dd> <dt>•</dt> <dd>Use OZEMPIC exactly as your healthcare provider tells you to. </dd> <dt>•</dt> <dd> <span class="Bold">Your healthcare provider should show you how to use OZEMPIC before you use it for the first time.</span> </dd> <dt>•</dt> <dd>OZEMPIC is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. <span class="Bold">Do not</span> inject OZEMPIC into a muscle (intramuscularly) or vein (intravenously).</dd> <dt>•</dt> <dd> <span class="Bold">Use OZEMPIC 1 time each week, on the same day each week, at any time of the day.</span> </dd> <dt>•</dt> <dd>You may change the day of the week you use OZEMPIC as long as your last dose was given <span class="Bold">2</span> or more days before.</dd> <dt>•</dt> <dd>If you miss a dose of OZEMPIC, take the missed dose as soon as possible within <span class="Bold">5</span> days after the missed dose. If more than <span class="Bold">5</span> days have passed, skip the missed dose and take your next dose on the regularly scheduled day. </dd> <dt>•</dt> <dd>OZEMPIC may be taken with or without food. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> mix insulin and OZEMPIC together in the same injection.</dd> <dt>•</dt> <dd>You may give an injection of OZEMPIC and insulin in the same body area (such as your stomach area), but not right next to each other.</dd> <dt>•</dt> <dd>Change (rotate) your injection site with each injection. <span class="Bold">Do not</span> use the same site for each injection.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your OZEMPIC pen with other people, even if the needle has been changed.</span> You may give other people a serious infection, or get a serious infection from them.</dd> <dt>•</dt> <dd>If you take too much OZEMPIC, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of OZEMPIC?</span> </p> <p> <span class="Bold">OZEMPIC may cause serious side effects, including:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">See “What is the most important information I should know about OZEMPIC?”</span> </dd> <dt>•</dt> <dd> <span class="Bold">inflammation of your pancreas (pancreatitis). </span>Stop using OZEMPIC and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. </dd> <dt>•</dt> <dd> <span class="Bold">changes in vision.</span> Tell your healthcare provider if you have changes in vision during treatment with OZEMPIC.</dd> <dt>•</dt> <dd> <span class="Bold">low blood sugar (hypoglycemia).</span> Your risk for getting low blood sugar may be higher if you use OZEMPIC with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. <span class="Bold">Signs and symptoms of low blood sugar may include:</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>o</dt> <dd>dizziness or light-headedness</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>blurred vision</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>anxiety, irritability, or mood changes</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>o</dt> <dd>sweating</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>slurred speech</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>hunger</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>o</dt> <dd>confusion or drowsiness</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>shakiness</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>weakness</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>o</dt> <dd>headache</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>fast heartbeat</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt>o</dt> <dd>feeling jittery</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Dehydration leading to kidney problems. </span>Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.</dd> <dt>•</dt> <dd> <span class="Bold">Severe stomach problems. </span>Stomach problems, sometimes severe, have been reported in people who use OZEMPIC. Tell your healthcare provider if you have stomach problems that are severe or will not go away.</dd> <dt>•</dt> <dd> <span class="Bold">serious allergic reactions.</span> Stop using OZEMPIC and get medical help right away, if you have any symptoms of a serious allergic reaction including:<dl> <dt>o</dt> <dd>swelling of your face, lips, tongue or throat</dd> <dt>o</dt> <dd>problems breathing or swallowing</dd> <dt>o</dt> <dd>severe rash or itching</dd> <dt>o</dt> <dd>fainting or feeling dizzy</dd> <dt>o</dt> <dd>very rapid heartbeat</dd> </dl> </dd> <dt>•</dt> <dd> <span class="Bold">gallbladder problems. </span>Gallbladder problems have happened in some people who take OZEMPIC. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>pain in your upper stomach (abdomen)</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>yellowing of skin or eyes (jaundice)</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>fever</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>clay-colored stools</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). </span>OZEMPIC may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking OZEMPIC before you are scheduled to have surgery or other procedures.</dd> </dl> <p class="First"> <span class="Bold">The most common side effects of OZEMPIC may include</span> nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.</p> <p>Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of OZEMPIC. </p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of OZEMPIC.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OZEMPIC for a condition for which it was not prescribed. Do not give OZEMPIC to other people, even if they have the same symptoms that you have. It may harm them.</p> <p>You can ask your pharmacist or healthcare provider for information about OZEMPIC that is written for health professionals. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in OZEMPIC?</span> </p> <p> <span class="Bold">Active Ingredient:</span> semaglutide</p> <p> <span class="Bold">Inactive Ingredients: </span>disodium phosphate dihydrate, propylene glycol, phenol and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First">Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark</p> <p>OZEMPIC<span class="Sup">®</span> is a registered trademark of Novo Nordisk A/S.</p> <p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p> <p>© 2025 Novo Nordisk</p> <p>For more information, go to OZEMPIC.com or call 1-888-693-6742.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"35%\"/>\n<col width=\"15%\"/>\n<col width=\"11%\"/>\n<col width=\"38%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Medication Guide</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC<span class=\"Sup\">®</span> (oh-ZEM-pick)</span>\n</p>\n<p>(semaglutide)</p>\n<p>injection, for subcutaneous use</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">Read this Medication Guide before you start using OZEMPIC and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about OZEMPIC?</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC may cause serious side effects, including:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Possible thyroid tumors, including cancer. </span>Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, OZEMPIC and medicines that work like OZEMPIC caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.</dd>\n<dt>•</dt>\n<dd>Do not use OZEMPIC if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is OZEMPIC?</span>\n</p>\n<p>OZEMPIC is an injectable prescription medicine used: </p>\n<dl>\n<dt>•</dt>\n<dd>along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. </dd>\n<dt>•</dt>\n<dd>to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.</dd>\n<dt>•</dt>\n<dd>to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes mellitus and chronic kidney disease.</dd>\n</dl>\n<p>It is not known if OZEMPIC is safe and effective for use in children. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use OZEMPIC if:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd>\n<dt>•</dt>\n<dd>you have had a serious allergic reaction to semaglutide or any of the ingredients in OZEMPIC. See the end of this Medication Guide for a complete list of ingredients in OZEMPIC. See <span class=\"Bold\">“What are the possible side effects of OZEMPIC?” </span>for symptoms of a serious allergic reaction. </dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before using OZEMPIC, tell your healthcare provider if you have any other medical conditions, including if you:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>have or have had problems with your pancreas.</dd>\n<dt>•</dt>\n<dd>have a history of diabetic retinopathy.</dd>\n<dt>•</dt>\n<dd>have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.</dd>\n<dt>•</dt>\n<dd>are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</dd>\n<dt>•</dt>\n<dd>are pregnant or plan to become pregnant. It is not known if OZEMPIC will harm your unborn baby. You should stop using OZEMPIC at least 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.</dd>\n<dt>•</dt>\n<dd>are breastfeeding or plan to breastfeed. It is not known if OZEMPIC passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using OZEMPIC.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. OZEMPIC may affect the way some medicines work and some medicines may affect the way OZEMPIC works. </dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Before using OZEMPIC, talk to your healthcare provider about low blood sugar and how to manage it.</span> Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.</dd>\n</dl>\n<p>Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use OZEMPIC?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Read the <span class=\"Bold\">Instructions for Use</span> that comes with OZEMPIC.</dd>\n<dt>•</dt>\n<dd>Use OZEMPIC exactly as your healthcare provider tells you to. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Your healthcare provider should show you how to use OZEMPIC before you use it for the first time.</span>\n</dd>\n<dt>•</dt>\n<dd>OZEMPIC is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. <span class=\"Bold\">Do not</span> inject OZEMPIC into a muscle (intramuscularly) or vein (intravenously).</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Use OZEMPIC 1 time each week, on the same day each week, at any time of the day.</span>\n</dd>\n<dt>•</dt>\n<dd>You may change the day of the week you use OZEMPIC as long as your last dose was given <span class=\"Bold\">2</span> or more days before.</dd>\n<dt>•</dt>\n<dd>If you miss a dose of OZEMPIC, take the missed dose as soon as possible within <span class=\"Bold\">5</span> days after the missed dose. If more than <span class=\"Bold\">5</span> days have passed, skip the missed dose and take your next dose on the regularly scheduled day. </dd>\n<dt>•</dt>\n<dd>OZEMPIC may be taken with or without food. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> mix insulin and OZEMPIC together in the same injection.</dd>\n<dt>•</dt>\n<dd>You may give an injection of OZEMPIC and insulin in the same body area (such as your stomach area), but not right next to each other.</dd>\n<dt>•</dt>\n<dd>Change (rotate) your injection site with each injection. <span class=\"Bold\">Do not</span> use the same site for each injection.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your OZEMPIC pen with other people, even if the needle has been changed.</span> You may give other people a serious infection, or get a serious infection from them.</dd>\n<dt>•</dt>\n<dd>If you take too much OZEMPIC, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of OZEMPIC?</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC may cause serious side effects, including:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">See “What is the most important information I should know about OZEMPIC?”</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">inflammation of your pancreas (pancreatitis). </span>Stop using OZEMPIC and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">changes in vision.</span> Tell your healthcare provider if you have changes in vision during treatment with OZEMPIC.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">low blood sugar (hypoglycemia).</span> Your risk for getting low blood sugar may be higher if you use OZEMPIC with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. <span class=\"Bold\">Signs and symptoms of low blood sugar may include:</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>dizziness or light-headedness</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>blurred vision</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>anxiety, irritability, or mood changes</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>sweating</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>slurred speech</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>hunger</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>confusion or drowsiness</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>shakiness</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>weakness</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>headache</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>fast heartbeat</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>feeling jittery</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Dehydration leading to kidney problems. </span>Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Severe stomach problems. </span>Stomach problems, sometimes severe, have been reported in people who use OZEMPIC. Tell your healthcare provider if you have stomach problems that are severe or will not go away.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">serious allergic reactions.</span> Stop using OZEMPIC and get medical help right away, if you have any symptoms of a serious allergic reaction including:<dl>\n<dt>o</dt>\n<dd>swelling of your face, lips, tongue or throat</dd>\n<dt>o</dt>\n<dd>problems breathing or swallowing</dd>\n<dt>o</dt>\n<dd>severe rash or itching</dd>\n<dt>o</dt>\n<dd>fainting or feeling dizzy</dd>\n<dt>o</dt>\n<dd>very rapid heartbeat</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">gallbladder problems. </span>Gallbladder problems have happened in some people who take OZEMPIC. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>pain in your upper stomach (abdomen)</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>yellowing of skin or eyes (jaundice)</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>fever</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>clay-colored stools</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). </span>OZEMPIC may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking OZEMPIC before you are scheduled to have surgery or other procedures.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">The most common side effects of OZEMPIC may include</span> nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.</p>\n<p>Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of OZEMPIC. </p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of OZEMPIC.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OZEMPIC for a condition for which it was not prescribed. Do not give OZEMPIC to other people, even if they have the same symptoms that you have. It may harm them.</p>\n<p>You can ask your pharmacist or healthcare provider for information about OZEMPIC that is written for health professionals. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in OZEMPIC?</span>\n</p>\n<p>\n<span class=\"Bold\">Active Ingredient:</span> semaglutide</p>\n<p>\n<span class=\"Bold\">Inactive Ingredients: </span>disodium phosphate dihydrate, propylene glycol, phenol and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark</p>\n<p>OZEMPIC<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk A/S.</p>\n<p>PATENT Information: http://novonordisk-us.com/products/product-patents.html</p>\n<p>© 2025 Novo Nordisk</p>\n<p>For more information, go to OZEMPIC.com or call 1-888-693-6742.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

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<div class="scrollingtable"><table cellpadding="5.75pt" width="540pt"> <col width="53%"/> <col width="3%"/> <col width="44%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">INSTRUCTIONS FOR USE</span> </p> <p> <span class="Bold">OZEMPIC<span class="Sup">®</span> [oh-ZEM-pick]</span> </p> <p> <span class="Bold">(semaglutide)</span> </p> <p> <span class="Bold">injection, for subcutaneous use</span> </p> <p>0.25 mg or 0.5 mg doses</p> <p>(pen delivers doses in 0.25 mg or 0.5 mg increments only)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Read these instructions carefully before using your OZEMPIC<span class="Sup">®</span> pen.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span> </dd> </dl> <p class="First"> <a name="id-1944373253"></a><img alt="image_121" src="/dailymed/image.cfm?name=image-07.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help</span>. Get help from a person with good eyesight who is trained to use the OZEMPIC pen.</p> <dl> <dt>•</dt> <dd> <span class="Bold">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 2 mg of semaglutide, and you can select doses of 0.25 mg or 0.5 mg. Each prefilled pen contains 4 doses of 0.25 mg and 2 doses of 0.5 mg or contains 4 doses of 0.5 mg.</dd> <dt>•</dt> <dd>Your pen is made to be used with<span class="Bold"> NovoFine<span class="Sup">®</span> Plus or NovoFine<span class="Sup">®</span></span> disposable needles up to a length of 8 mm.</dd> <dt>•</dt> <dd>NovoFine<span class="Sup">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always use a new needle for each injection.</span> </dd> </dl> <p>Supplies you will need to give your OZEMPIC injection:</p> <dl> <dt>•</dt> <dd>OZEMPIC pen </dd> <dt>•</dt> <dd>a new NovoFine Plus or NovoFine needle</dd> <dt>•</dt> <dd>1 alcohol swab</dd> <dt>•</dt> <dd>1 gauze pad or cotton ball </dd> <dt>•</dt> <dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class="Bold"> See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><a name="id-291065376"></a><img alt="image_122" src="/dailymed/image.cfm?name=image-08.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Step 1.</span> </p> <p> <span class="Bold">Prepare your pen with a new needle</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Wash your hands </span>with soap and water.</dd> <dt>•</dt> <dd> <span class="Bold">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd> <dt> </dt> <dd>This is especially important if you take more than 1 type of medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the pen cap.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1256558806"></a><img alt="image_123" src="/dailymed/image.cfm?name=image-09.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd> <dt> </dt> <dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1357571078"></a><img alt="image_124" src="/dailymed/image.cfm?name=image-10.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Take a new needle, </span>and tear off the paper tab. <span class="Bold">Do not attach a new needle</span> to your pen until you are ready to give your injection. </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1737225900"></a><img alt="image_125" src="/dailymed/image.cfm?name=image-11.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Push the needle straight onto the pen. Turn until it is on tight.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id931095170"></a><img alt="image_126" src="/dailymed/image.cfm?name=image-12.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the outer needle cap. Do not</span> throw it away.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1838041183"></a><img alt="image_127" src="/dailymed/image.cfm?name=image-13.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Pull off the inner needle cap </span>and throw it away.</dd> <dt> </dt> <dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1173644971"></a><img alt="image_128" src="/dailymed/image.cfm?name=image-14.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold"><a name="id-1098331204"></a><img alt="image_129" src="/dailymed/image.cfm?name=image-15.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</p> <p> <span class="Bold">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span> </p> <p> <span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Step 2.</span> </p> <p> <span class="Bold">First Time Use for Each New Pen: Check the OZEMPIC flow</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Check the OZEMPIC flow <span class="Bold">before the first injection with each new pen only.</span> </dd> <dt> </dt> <dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd> <dt>•</dt> <dd>Turn the dose selector <span class="Bold">until the dose counter shows the flow check symbol (</span><span class="Bold"><a name="id1603691395"></a><img alt="image_flow_check_5" src="/dailymed/image.cfm?name=image-16.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold">).</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-361061244"></a><img alt="image_130" src="/dailymed/image.cfm?name=image-17.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Hold the pen with the needle pointing up.</dd> <dt> </dt> <dd> <span class="Bold">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd> <dt> </dt> <dd>A drop of OZEMPIC will appear at the needle tip.</dd> <dt>•</dt> <dd> <span class="Bold">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> 1 more time.</dd> <dt> </dt> <dd> <span class="Bold">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd> <dt> </dt> <dd>Contact Novo Nordisk at 1-888-693-6742.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-816799585"></a><img alt="image_131" src="/dailymed/image.cfm?name=image-18.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold"><a name="id1691497569"></a><img alt="image_132" src="/dailymed/image.cfm?name=image-19.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold"> Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </p> <p>If no drop appears, you will <span class="Bold">not </span>inject any OZEMPIC, even though the dose counter may move.<span class="Bold"> This may mean that there is a blocked or damaged needle.</span> </p> <p>A small drop may remain at the needle tip, but it will not be injected.</p> <p> <span class="Bold">Only check the OZEMPIC flow before your first injection with each new pen.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Step 3. </span> </p> <p> <span class="Bold">Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Turn the dose selector until the dose counter stops and shows your dose (0.25 mg or 0.5 mg).</span> </dd> <dt> </dt> <dd>The dashed line in the dose counter <a name="id-892186830"></a><img alt="image_dose_counter_5" src="/dailymed/image.cfm?name=image-20.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/>will guide </dd> <dt> </dt> <dd>you to your dose.</dd> <dt> </dt> <dd>Make sure you know the dose of OZEMPIC you should use. If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2069873838"></a><img alt="image_133" src="/dailymed/image.cfm?name=image-21.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <a name="id424626049"></a><img alt="image_134" src="/dailymed/image.cfm?name=image-22.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always use the dose counter and the dose pointer to see how many mg you select.</span> </p> <p>You will hear a “click” every time you turn the dose selector. <span class="Bold">Do not set the dose by counting the number of clicks you hear. </span> </p> <p> <span class="Bold">Only doses of 0.25 mg or 0.5 mg can be selected with the dose selector.</span> The selected dose must line up exactly with the dose pointer to make sure that you get a correct dose.</p> <p>The dose selector changes the dose. <span class="Bold">Only the dose counter and dose pointer will show how many mg you select for each dose.</span> </p> <p>You can select 0.25 mg or 0.5 mg for each dose. When your pen contains less than 0.5 or 0.25 mg, the dose counter stops before 0.5 mg or 0.25 mg is shown.</p> <p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">How much OZEMPIC is left?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd> <dt> </dt> <dd>Turn the dose selector until the<span class="Bold"> dose counter </span>stops.</dd> <dt>•</dt> <dd>If it shows 0.5, <span class="Bold">at least 0.5 mg </span>is left in your pen. If the <span class="Bold">dose counter stops before 0.5 mg,</span> there is not enough OZEMPIC left for a full dose of 0.5 mg.</dd> <dt>•</dt> <dd>If it shows 0.25, at least<span class="Bold"> 0.25 mg</span> is left in your pen. If the <span class="Bold">dose counter stops before 0.25 mg</span>, there is not enough OZEMPIC left for a full dose of 0.25 mg.</dd> <dt> </dt> <dd> <span class="Bold">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id2051254015"></a><img alt="image_135" src="/dailymed/image.cfm?name=image-23.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Step 4.</span> </p> <p> <span class="Bold">Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class="Bold">K</span>).</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-613443084"></a><img alt="image_136" src="/dailymed/image.cfm?name=image-24.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd> <dt>•</dt> <dd> <span class="Bold">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1873135877"></a><img alt="image_137" src="/dailymed/image.cfm?name=image-25.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Press and hold down the dose button until the dose counter shows 0. </span> </dd> <dt> </dt> <dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd> <dt> </dt> <dd> <span class="Bold">Continue pressing the dose button while keeping the needle in your skin.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1639489114"></a><img alt="image_138" src="/dailymed/image.cfm?name=image-26.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Count 6 seconds while keeping the dose button pressed. </span> </dd> <dt>•</dt> <dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2127848601"></a><img alt="image_139" src="/dailymed/image.cfm?name=image-27.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Remove the needle from your skin.</span> You can then release the dose button.</dd> <dt> </dt> <dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id560518512"></a><img alt="image_140" src="/dailymed/image.cfm?name=image-28.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <a name="id-1562622529"></a><img alt="image_141" src="/dailymed/image.cfm?name=image-29.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p> <p> <span class="Bold">How to identify a blocked or damaged needle?</span> </p> <dl> <dt>•</dt> <dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd> <dt>•</dt> <dd>If this happens you have <span class="Bold">not </span>received <span class="Bold">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd> </dl> <p> <span class="Bold">How to handle a blocked needle?</span> </p> <p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class="Bold">“Prepare your pen with a new needle”. </span> </p> <p> <span class="Bold">Never touch the dose counter when you inject. </span>This can stop the injection.</p> <p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Step 5.</span> </p> <p> <span class="Bold">After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id285851794"></a><img alt="image_142" src="/dailymed/image.cfm?name=image-30.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class="Bold"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-44752512"></a><img alt="image_143" src="/dailymed/image.cfm?name=image-31.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1987078964"></a><img alt="image_144" src="/dailymed/image.cfm?name=image-32.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1265993783"></a><img alt="image_145" src="/dailymed/image.cfm?name=image-33.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <a name="id-969203225"></a><img alt="image_146" src="/dailymed/image.cfm?name=image-34.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Never try to put the inner needle cap back on the needle.</span> You may stick yourself with the needle. </p> <p> <span class="Bold">Always remove the needle from your pen.</span> </p> <p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class="Bold">not</span> inject any OZEMPIC. </p> <p> <span class="Bold">Always dispose of the needle after each injection.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Disposing of used OZEMPIC pens and needles:</span> </p> <dl> <dt>•</dt> <dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd> <dt>•</dt> <dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl> <dt>o</dt> <dd>made of a heavy-duty plastic</dd> <dt>o</dt> <dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out</dd> <dt>o</dt> <dd>upright and stable during use</dd> <dt>o</dt> <dd>leak-resistant</dd> <dt>o</dt> <dd>properly labeled to warn of hazardous waste inside the container</dd> </dl> </dd> <dt>•</dt> <dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd> <dt>•</dt> <dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</dd> <dt>•</dt> <dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <a name="id-136658239"></a><img alt="image_147" src="/dailymed/image.cfm?name=image-35.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Important</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd> <dt>•</dt> <dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd> <dt>•</dt> <dd>Always keep your pen and needles <span class="Bold">out of reach of others,</span> especially children.</dd> <dt>•</dt> <dd> <span class="Bold">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Caring for your pen</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd> <dt>•</dt> <dd> <span class="Bold">Do not try to repair your pen</span> or pull it apart.</dd> <dt>•</dt> <dd> <span class="Bold">Do not expose your pen to dust, dirt or liquid.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd> </dl> <p class="First"> <span class="Bold">How should I store my OZEMPIC pen?</span> </p> <dl> <dt>•</dt> <dd>Store your <span class="Bold">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd> <span class="Bold">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> freeze OZEMPIC. <span class="Bold">Do not</span> use OZEMPIC if it has been frozen.</dd> <dt>•</dt> <dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd> <dt>•</dt> <dd>When stored in the refrigerator, do not store OZEMPIC pens directly next to the cooling element.</dd> <dt>•</dt> <dd>Keep OZEMPIC away from heat and out of the light.</dd> <dt>•</dt> <dd> <span class="Bold">Keep the pen cap on when not in use.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Keep OZEMPIC and all medicines out of the reach of children.</span> </dd> </dl> <a name="id-1110353684"></a><img alt="image_148" src="/dailymed/image.cfm?name=image-36.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><p>For more information go to<span class="Bold"><a href="http://www.OZEMPIC.com">www.OZEMPIC.com</a></span> </p> <p> <span class="Bold">Manufactured by:</span> </p> <p>Novo Nordisk A/S</p> <p>DK-2880 Bagsvaerd</p> <p>Denmark</p> <p> <span class="Bold">For information about OZEMPIC contact:</span> </p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536</p> <p>1-888-693-6742</p> <p>Version: 2</p> <p>OZEMPIC<span class="Sup">®</span> and NovoFine<span class="Sup">®</span> are registered trademarks of Novo Nordisk A/S.</p> <p> <span class="Bold">PATENT Information:</span> https://www.novonordisk-us.com/products/product-patents.html</p> <p>© 2023 Novo Nordisk</p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Revised: September 2023</p> <a name="id-1679188908"></a><img alt="image_149" src="/dailymed/image.cfm?name=image-37.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"5.75pt\" width=\"540pt\">\n<col width=\"53%\"/>\n<col width=\"3%\"/>\n<col width=\"44%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC<span class=\"Sup\">®</span> [oh-ZEM-pick]</span>\n</p>\n<p>\n<span class=\"Bold\">(semaglutide)</span>\n</p>\n<p>\n<span class=\"Bold\">injection, for subcutaneous use</span>\n</p>\n<p>0.25 mg or 0.5 mg doses</p>\n<p>(pen delivers doses in 0.25 mg or 0.5 mg increments only)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Read these instructions carefully before using your OZEMPIC<span class=\"Sup\">®</span> pen.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-1944373253\"></a><img alt=\"image_121\" src=\"/dailymed/image.cfm?name=image-07.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help</span>. Get help from a person with good eyesight who is trained to use the OZEMPIC pen.</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 2 mg of semaglutide, and you can select doses of 0.25 mg or 0.5 mg. Each prefilled pen contains 4 doses of 0.25 mg and 2 doses of 0.5 mg or contains 4 doses of 0.5 mg.</dd>\n<dt>•</dt>\n<dd>Your pen is made to be used with<span class=\"Bold\"> NovoFine<span class=\"Sup\">®</span> Plus or NovoFine<span class=\"Sup\">®</span></span> disposable needles up to a length of 8 mm.</dd>\n<dt>•</dt>\n<dd>NovoFine<span class=\"Sup\">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always use a new needle for each injection.</span>\n</dd>\n</dl>\n<p>Supplies you will need to give your OZEMPIC injection:</p>\n<dl>\n<dt>•</dt>\n<dd>OZEMPIC pen </dd>\n<dt>•</dt>\n<dd>a new NovoFine Plus or NovoFine needle</dd>\n<dt>•</dt>\n<dd>1 alcohol swab</dd>\n<dt>•</dt>\n<dd>1 gauze pad or cotton ball </dd>\n<dt>•</dt>\n<dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class=\"Bold\"> See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><a name=\"id-291065376\"></a><img alt=\"image_122\" src=\"/dailymed/image.cfm?name=image-08.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1.</span>\n</p>\n<p>\n<span class=\"Bold\">Prepare your pen with a new needle</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Wash your hands </span>with soap and water.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd>\n<dt> </dt>\n<dd>This is especially important if you take more than 1 type of medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the pen cap.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1256558806\"></a><img alt=\"image_123\" src=\"/dailymed/image.cfm?name=image-09.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd>\n<dt> </dt>\n<dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1357571078\"></a><img alt=\"image_124\" src=\"/dailymed/image.cfm?name=image-10.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Take a new needle, </span>and tear off the paper tab. <span class=\"Bold\">Do not attach a new needle</span> to your pen until you are ready to give your injection. </dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1737225900\"></a><img alt=\"image_125\" src=\"/dailymed/image.cfm?name=image-11.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Push the needle straight onto the pen. Turn until it is on tight.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id931095170\"></a><img alt=\"image_126\" src=\"/dailymed/image.cfm?name=image-12.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the outer needle cap. Do not</span> throw it away.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1838041183\"></a><img alt=\"image_127\" src=\"/dailymed/image.cfm?name=image-13.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the inner needle cap </span>and throw it away.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1173644971\"></a><img alt=\"image_128\" src=\"/dailymed/image.cfm?name=image-14.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id-1098331204\"></a><img alt=\"image_129\" src=\"/dailymed/image.cfm?name=image-15.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</p>\n<p>\n<span class=\"Bold\">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span>\n</p>\n<p>\n<span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2.</span>\n</p>\n<p>\n<span class=\"Bold\">First Time Use for Each New Pen: Check the OZEMPIC flow</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check the OZEMPIC flow <span class=\"Bold\">before the first injection with each new pen only.</span>\n</dd>\n<dt> </dt>\n<dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector <span class=\"Bold\">until the dose counter shows the flow check symbol (</span><span class=\"Bold\"><a name=\"id1603691395\"></a><img alt=\"image_flow_check_5\" src=\"/dailymed/image.cfm?name=image-16.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\">).</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-361061244\"></a><img alt=\"image_130\" src=\"/dailymed/image.cfm?name=image-17.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the pen with the needle pointing up.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC will appear at the needle tip.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> 1 more time.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd>\n<dt> </dt>\n<dd>Contact Novo Nordisk at 1-888-693-6742.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-816799585\"></a><img alt=\"image_131\" src=\"/dailymed/image.cfm?name=image-18.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id1691497569\"></a><img alt=\"image_132\" src=\"/dailymed/image.cfm?name=image-19.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\"> Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </p>\n<p>If no drop appears, you will <span class=\"Bold\">not </span>inject any OZEMPIC, even though the dose counter may move.<span class=\"Bold\"> This may mean that there is a blocked or damaged needle.</span>\n</p>\n<p>A small drop may remain at the needle tip, but it will not be injected.</p>\n<p>\n<span class=\"Bold\">Only check the OZEMPIC flow before your first injection with each new pen.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. </span>\n</p>\n<p>\n<span class=\"Bold\">Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Turn the dose selector until the dose counter stops and shows your dose (0.25 mg or 0.5 mg).</span>\n</dd>\n<dt> </dt>\n<dd>The dashed line in the dose counter <a name=\"id-892186830\"></a><img alt=\"image_dose_counter_5\" src=\"/dailymed/image.cfm?name=image-20.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/>will guide </dd>\n<dt> </dt>\n<dd>you to your dose.</dd>\n<dt> </dt>\n<dd>Make sure you know the dose of OZEMPIC you should use. If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2069873838\"></a><img alt=\"image_133\" src=\"/dailymed/image.cfm?name=image-21.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id424626049\"></a><img alt=\"image_134\" src=\"/dailymed/image.cfm?name=image-22.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always use the dose counter and the dose pointer to see how many mg you select.</span>\n</p>\n<p>You will hear a “click” every time you turn the dose selector. <span class=\"Bold\">Do not set the dose by counting the number of clicks you hear. </span>\n</p>\n<p>\n<span class=\"Bold\">Only doses of 0.25 mg or 0.5 mg can be selected with the dose selector.</span> The selected dose must line up exactly with the dose pointer to make sure that you get a correct dose.</p>\n<p>The dose selector changes the dose. <span class=\"Bold\">Only the dose counter and dose pointer will show how many mg you select for each dose.</span>\n</p>\n<p>You can select 0.25 mg or 0.5 mg for each dose. When your pen contains less than 0.5 or 0.25 mg, the dose counter stops before 0.5 mg or 0.25 mg is shown.</p>\n<p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How much OZEMPIC is left?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd>\n<dt> </dt>\n<dd>Turn the dose selector until the<span class=\"Bold\"> dose counter </span>stops.</dd>\n<dt>•</dt>\n<dd>If it shows 0.5, <span class=\"Bold\">at least 0.5 mg </span>is left in your pen. If the <span class=\"Bold\">dose counter stops before 0.5 mg,</span> there is not enough OZEMPIC left for a full dose of 0.5 mg.</dd>\n<dt>•</dt>\n<dd>If it shows 0.25, at least<span class=\"Bold\"> 0.25 mg</span> is left in your pen. If the <span class=\"Bold\">dose counter stops before 0.25 mg</span>, there is not enough OZEMPIC left for a full dose of 0.25 mg.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id2051254015\"></a><img alt=\"image_135\" src=\"/dailymed/image.cfm?name=image-23.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4.</span>\n</p>\n<p>\n<span class=\"Bold\">Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class=\"Bold\">K</span>).</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-613443084\"></a><img alt=\"image_136\" src=\"/dailymed/image.cfm?name=image-24.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1873135877\"></a><img alt=\"image_137\" src=\"/dailymed/image.cfm?name=image-25.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Press and hold down the dose button until the dose counter shows 0. </span>\n</dd>\n<dt> </dt>\n<dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Continue pressing the dose button while keeping the needle in your skin.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1639489114\"></a><img alt=\"image_138\" src=\"/dailymed/image.cfm?name=image-26.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Count 6 seconds while keeping the dose button pressed. </span>\n</dd>\n<dt>•</dt>\n<dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2127848601\"></a><img alt=\"image_139\" src=\"/dailymed/image.cfm?name=image-27.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Remove the needle from your skin.</span> You can then release the dose button.</dd>\n<dt> </dt>\n<dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id560518512\"></a><img alt=\"image_140\" src=\"/dailymed/image.cfm?name=image-28.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1562622529\"></a><img alt=\"image_141\" src=\"/dailymed/image.cfm?name=image-29.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p>\n<p>\n<span class=\"Bold\">How to identify a blocked or damaged needle?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd>\n<dt>•</dt>\n<dd>If this happens you have <span class=\"Bold\">not </span>received <span class=\"Bold\">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd>\n</dl>\n<p>\n<span class=\"Bold\">How to handle a blocked needle?</span>\n</p>\n<p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class=\"Bold\">“Prepare your pen with a new needle”. </span>\n</p>\n<p>\n<span class=\"Bold\">Never touch the dose counter when you inject. </span>This can stop the injection.</p>\n<p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5.</span>\n</p>\n<p>\n<span class=\"Bold\">After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id285851794\"></a><img alt=\"image_142\" src=\"/dailymed/image.cfm?name=image-30.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class=\"Bold\"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-44752512\"></a><img alt=\"image_143\" src=\"/dailymed/image.cfm?name=image-31.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1987078964\"></a><img alt=\"image_144\" src=\"/dailymed/image.cfm?name=image-32.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1265993783\"></a><img alt=\"image_145\" src=\"/dailymed/image.cfm?name=image-33.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-969203225\"></a><img alt=\"image_146\" src=\"/dailymed/image.cfm?name=image-34.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Never try to put the inner needle cap back on the needle.</span> You may stick yourself with the needle. </p>\n<p>\n<span class=\"Bold\">Always remove the needle from your pen.</span>\n</p>\n<p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class=\"Bold\">not</span> inject any OZEMPIC. </p>\n<p>\n<span class=\"Bold\">Always dispose of the needle after each injection.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Disposing of used OZEMPIC pens and needles:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd>\n<dt>•</dt>\n<dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl>\n<dt>o</dt>\n<dd>made of a heavy-duty plastic</dd>\n<dt>o</dt>\n<dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out</dd>\n<dt>o</dt>\n<dd>upright and stable during use</dd>\n<dt>o</dt>\n<dd>leak-resistant</dd>\n<dt>o</dt>\n<dd>properly labeled to warn of hazardous waste inside the container</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd>\n<dt>•</dt>\n<dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</dd>\n<dt>•</dt>\n<dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-136658239\"></a><img alt=\"image_147\" src=\"/dailymed/image.cfm?name=image-35.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Important</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd>\n<dt>•</dt>\n<dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd>\n<dt>•</dt>\n<dd>Always keep your pen and needles <span class=\"Bold\">out of reach of others,</span> especially children.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Caring for your pen</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not try to repair your pen</span> or pull it apart.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not expose your pen to dust, dirt or liquid.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">How should I store my OZEMPIC pen?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store your <span class=\"Bold\">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> freeze OZEMPIC. <span class=\"Bold\">Do not</span> use OZEMPIC if it has been frozen.</dd>\n<dt>•</dt>\n<dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator, do not store OZEMPIC pens directly next to the cooling element.</dd>\n<dt>•</dt>\n<dd>Keep OZEMPIC away from heat and out of the light.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the pen cap on when not in use.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep OZEMPIC and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n<a name=\"id-1110353684\"></a><img alt=\"image_148\" src=\"/dailymed/image.cfm?name=image-36.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><p>For more information go to<span class=\"Bold\"><a href=\"http://www.OZEMPIC.com\">www.OZEMPIC.com</a></span>\n</p>\n<p>\n<span class=\"Bold\">Manufactured by:</span>\n</p>\n<p>Novo Nordisk A/S</p>\n<p>DK-2880 Bagsvaerd</p>\n<p>Denmark</p>\n<p>\n<span class=\"Bold\">For information about OZEMPIC contact:</span>\n</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536</p>\n<p>1-888-693-6742</p>\n<p>Version: 2</p>\n<p>OZEMPIC<span class=\"Sup\">®</span> and NovoFine<span class=\"Sup\">®</span> are registered trademarks of Novo Nordisk A/S.</p>\n<p>\n<span class=\"Bold\">PATENT Information:</span> https://www.novonordisk-us.com/products/product-patents.html</p>\n<p>© 2023 Novo Nordisk</p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Revised: September 2023</p>\n<a name=\"id-1679188908\"></a><img alt=\"image_149\" src=\"/dailymed/image.cfm?name=image-37.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="544.5pt"> <col width="58%"/> <col width="42%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">INSTRUCTIONS FOR USE</span> </p> <p> <span class="Bold">OZEMPIC<span class="Sup">®</span> [oh-ZEM-pick]</span> </p> <p> <span class="Bold">(semaglutide)</span> </p> <p> <span class="Bold">injection, for subcutaneous use</span> </p> <p>1 mg dose</p> <p>(pen delivers doses in 1 mg increments only)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Read these instructions carefully before using your OZEMPIC<span class="Sup">®</span> pen.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span> </dd> </dl> <p class="First"> <a name="id2058201388"></a><img alt="image_61" src="/dailymed/image.cfm?name=image-38.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.</span> Get help from a person with good eyesight who is trained to use the OZEMPIC pen. </p> <dl> <dt>•</dt> <dd> <span class="Bold">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 4 mg of semaglutide, and you can only select doses of 1 mg. Each prefilled pen contains 4 doses of 1 mg.</dd> <dt>•</dt> <dd>Your pen is made to be used with<span class="Bold"> NovoFine<span class="Sup">®</span> Plus or NovoFine<span class="Sup">® </span></span>disposable needles up to a length of 8 mm.</dd> <dt>•</dt> <dd>NovoFine<span class="Sup">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always use a new needle for each injection.</span> </dd> </dl> <p>Supplies you will need to give your OZEMPIC injection:</p> <dl> <dt>•</dt> <dd>OZEMPIC pen 1 mg dose</dd> <dt>•</dt> <dd>a new NovoFine Plus or NovoFine needle</dd> <dt>•</dt> <dd>1 alcohol swab</dd> <dt>•</dt> <dd>1 gauze pad or cotton ball</dd> <dt>•</dt> <dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class="Bold"></span> </dd> <dt> </dt> <dd> <span class="Bold">See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1340280349"></a><img alt="image_62" src="/dailymed/image.cfm?name=image-39.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1.</span> </p> <p> <span class="Bold">Prepare your pen with a new needle</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Wash your hands </span>with soap and water.</dd> <dt>•</dt> <dd> <span class="Bold">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd> <dt> </dt> <dd>This is especially important if you take more than 1 type of medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the pen cap.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-890649016"></a><img alt="image_63" src="/dailymed/image.cfm?name=image-40.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd> <dt> </dt> <dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id593748930"></a><img alt="image_64" src="/dailymed/image.cfm?name=image-41.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Take a new needle, </span>and tear off the paper tab.</dd> <dt> </dt> <dd> <span class="Bold">Do not attach a new needle</span> to your pen until you are ready to give your injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-120308939"></a><img alt="image_65" src="/dailymed/image.cfm?name=image-42.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Push the needle straight onto the pen. Turn until it is on tight.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1299291183"></a><img alt="image_66" src="/dailymed/image.cfm?name=image-43.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the outer needle cap. Do not</span> throw it away.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <a name="id-1481461686"></a><img alt="image_67" src="/dailymed/image.cfm?name=image-44.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Pull off the inner needle cap </span>and throw it away.</dd> <dt> </dt> <dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1882434117"></a><img alt="image_68" src="/dailymed/image.cfm?name=image-45.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold"><a name="id1828629372"></a><img alt="image_69" src="/dailymed/image.cfm?name=image-46.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</dd> </dl> <p class="First"> <span class="Bold">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span> </p> <p> <span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2.</span> </p> <p> <span class="Bold">First Time Use for Each New Pen: Check the OZEMPIC flow</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check the OZEMPIC flow <span class="Bold">before the first injection with each new pen only.</span> </dd> <dt> </dt> <dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd> <dt>•</dt> <dd>Turn the dose selector <span class="Bold">until the dose counter shows the flow check symbol (</span><span class="Bold"><a name="id535621883"></a><img alt="image_flow_check_3" src="/dailymed/image.cfm?name=image-47.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold">).</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1019119305"></a><img alt="image_70" src="/dailymed/image.cfm?name=image-48.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the pen with the needle pointing up.</dd> <dt> </dt> <dd> <span class="Bold">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd> <dt> </dt> <dd>A drop of OZEMPIC will appear at the needle tip.</dd> <dt>•</dt> <dd> <span class="Bold">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> 1 more time.</dd> <dt> </dt> <dd> <span class="Bold">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd> <dt> </dt> <dd>Contact Novo Nordisk at 1-888-693-6742.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id719479622"></a><img alt="image_71" src="/dailymed/image.cfm?name=image-49.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold"><a name="id-802390333"></a><img alt="image_72" src="/dailymed/image.cfm?name=image-50.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold">Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </dd> </dl> <p class="First">If no drop appears, you will <span class="Bold">not </span>inject any OZEMPIC, even though the dose counter may move.<span class="Bold"> This may mean that there is a blocked or damaged needle.</span> </p> <p>A small drop may remain at the needle tip, but it will not be injected.</p> <p> <span class="Bold">Only check the OZEMPIC flow before your first injection with each new pen.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. </span> </p> <p> <span class="Bold">Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Turn the dose selector until the dose counter stops and shows your 1 mg dose. </span> </dd> <dt> </dt> <dd>The dashed line in the dose counter <a name="id1412510523"></a><img alt="image_dose_counter_3" src="/dailymed/image.cfm?name=image-51.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/>will guide you to 1 mg.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1150596082"></a><img alt="image_73" src="/dailymed/image.cfm?name=image-52.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id336193144"></a><img alt="image_74" src="/dailymed/image.cfm?name=image-53.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always use the dose counter and the dose pointer to see that 1 mg has been selected.</span> </p> <p>You will hear a “click” every time you turn the dose selector. <span class="Bold">Do not set the dose by counting the number of clicks you hear. </span> </p> <p> <span class="Bold">Only doses of 1 mg can be selected with the dose selector.</span> 1 mg must line up exactly with the dose pointer to make sure that you get a correct dose.</p> <p>The dose selector changes the dose. <span class="Bold">Only the dose counter and dose pointer will show that 1 mg has been selected.</span> </p> <p>You can only select 1 mg for each dose. When your pen contains less than 1 mg, the dose counter stops before 1 mg is shown.</p> <p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How much OZEMPIC is left?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd> <dt> </dt> <dd>Turn the dose selector until the<span class="Bold"> dose counter </span>stops.</dd> <dt>•</dt> <dd>If it shows 1,<span class="Bold"> at least 1 mg </span>is left in your pen. If the <span class="Bold">dose counter stops before 1 mg,</span> there is not enough OZEMPIC left for a full dose of 1 mg.</dd> <dt> </dt> <dd> <span class="Bold">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id133292513"></a><img alt="image_75" src="/dailymed/image.cfm?name=image-54.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4.</span> </p> <p> <span class="Bold">Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class="Bold">K</span>).</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-433131247"></a><img alt="image_76" src="/dailymed/image.cfm?name=image-55.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd> <dt>•</dt> <dd> <span class="Bold">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <a name="id-1915154980"></a><img alt="image_77" src="/dailymed/image.cfm?name=image-56.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Press and hold down the dose button until the dose counter shows 0. </span> </dd> <dt> </dt> <dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd> <dt> </dt> <dd> <span class="Bold">Continue pressing the dose button while keeping the needle in your skin.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1926095909"></a><img alt="image_78" src="/dailymed/image.cfm?name=image-57.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Count 6 seconds while keeping the dose button pressed. </span> </dd> <dt>•</dt> <dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <a name="id-2442495"></a><img alt="image_79" src="/dailymed/image.cfm?name=image-58.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Remove the needle from your skin.</span> You can then release the dose button.</dd> <dt> </dt> <dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2131929287"></a><img alt="image_80" src="/dailymed/image.cfm?name=image-59.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1828629231"></a><img alt="image_81" src="/dailymed/image.cfm?name=image-60.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p> <p> <span class="Bold">How to identify a blocked or damaged needle?</span> </p> <dl> <dt>•</dt> <dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd> <dt>•</dt> <dd>If this happens you have <span class="Bold">not </span>received <span class="Bold">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd> </dl> <p> <span class="Bold">How to handle a blocked needle?</span> </p> <p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class="Bold">“Prepare your pen with a new needle”.</span> </p> <p> <span class="Bold">Never touch the dose counter when you inject. </span>This can stop the injection.</p> <p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5.</span> </p> <p> <span class="Bold">After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-442924594"></a><img alt="image_82" src="/dailymed/image.cfm?name=image-61.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class="Bold"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id336890703"></a><img alt="image_83" src="/dailymed/image.cfm?name=image-62.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1164709617"></a><img alt="image_84" src="/dailymed/image.cfm?name=image-63.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id781690777"></a><img alt="image_85" src="/dailymed/image.cfm?name=image-64.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-83218630"></a><img alt="image_86" src="/dailymed/image.cfm?name=image-65.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Never try to put the inner needle cap back on the needle. </span>You may stick yourself with the needle. </p> <p> <span class="Bold">Always remove the needle from your pen.</span> </p> <p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class="Bold">not</span> inject any OZEMPIC. </p> <p> <span class="Bold">Always dispose of the needle after each injection.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Disposing of used OZEMPIC pens and needles:</span> </p> <dl> <dt>•</dt> <dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd> <dt>•</dt> <dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl> <dt>o</dt> <dd>made of a heavy-duty plastic </dd> <dt>o</dt> <dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out </dd> <dt>o</dt> <dd>upright and stable during use </dd> <dt>o</dt> <dd>leak-resistant</dd> <dt>o</dt> <dd>properly labeled to warn of hazardous waste inside the container</dd> </dl> </dd> <dt>•</dt> <dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd> <dt>•</dt> <dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. </dd> <dt>•</dt> <dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id190193898"></a><img alt="image_87" src="/dailymed/image.cfm?name=image-66.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Important</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd> <dt>•</dt> <dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd> <dt>•</dt> <dd>Always keep your pen and needles <span class="Bold">out of reach of others,</span> especially children.</dd> <dt>•</dt> <dd> <span class="Bold">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Caring for your pen</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd> <dt>•</dt> <dd> <span class="Bold">Do not try to repair your pen</span> or pull it apart.</dd> <dt>•</dt> <dd> <span class="Bold">Do not expose your pen to dust, dirt or liquid.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd> </dl> <p class="First"> <span class="Bold">How should I store my OZEMPIC pen?</span> </p> <dl> <dt>•</dt> <dd>Store your <span class="Bold">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd> <span class="Bold">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> freeze OZEMPIC. <span class="Bold">Do not</span> use OZEMPIC if it has been frozen.</dd> <dt>•</dt> <dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd> <dt>•</dt> <dd>When stored in the refrigerator,<span class="Bold"> do not </span>store OZEMPIC pens directly next to the cooling element.</dd> <dt>•</dt> <dd>Keep OZEMPIC away from heat and out of the light.</dd> <dt>•</dt> <dd> <span class="Bold">Keep the pen cap on when not in use.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Keep OZEMPIC and all medicines out of the reach of children.</span> </dd> </dl> <a name="id-213813270"></a><img alt="image_88" src="/dailymed/image.cfm?name=image-67.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><p>For more information go to<span class="Bold"> www.OZEMPIC.com</span> </p> <p> <span class="Bold">Manufactured by:</span> </p> <p>Novo Nordisk A/S</p> <p>DK-2880 Bagsvaerd</p> <p>Denmark</p> <p> <span class="Bold">For information about OZEMPIC contact:</span> </p> <p>Novo Nordisk Inc.</p> <p>800 Scudders Mill Road</p> <p>Plainsboro, NJ 08536</p> <p>1-888-693-6742</p> <p>Version: 4</p> <p>OZEMPIC<span class="Sup">® </span>and NovoFine<span class="Sup">® </span>are registered trademarks of Novo Nordisk A/S.</p> <p> <span class="Bold">PATENT Information:</span> https://www.novonordisk-us.com/products/product-patents.html</p> <p>© 2023 Novo Nordisk</p> <p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p> <p>Revised: September 2023</p> <a name="id-1241482894"></a><img alt="image_89" src="/dailymed/image.cfm?name=image-68.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"544.5pt\">\n<col width=\"58%\"/>\n<col width=\"42%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC<span class=\"Sup\">®</span> [oh-ZEM-pick]</span>\n</p>\n<p>\n<span class=\"Bold\">(semaglutide)</span>\n</p>\n<p>\n<span class=\"Bold\">injection, for subcutaneous use</span>\n</p>\n<p>1 mg dose</p>\n<p>(pen delivers doses in 1 mg increments only)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Read these instructions carefully before using your OZEMPIC<span class=\"Sup\">®</span> pen.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id2058201388\"></a><img alt=\"image_61\" src=\"/dailymed/image.cfm?name=image-38.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.</span> Get help from a person with good eyesight who is trained to use the OZEMPIC pen. </p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 4 mg of semaglutide, and you can only select doses of 1 mg. Each prefilled pen contains 4 doses of 1 mg.</dd>\n<dt>•</dt>\n<dd>Your pen is made to be used with<span class=\"Bold\"> NovoFine<span class=\"Sup\">®</span> Plus or NovoFine<span class=\"Sup\">® </span></span>disposable needles up to a length of 8 mm.</dd>\n<dt>•</dt>\n<dd>NovoFine<span class=\"Sup\">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always use a new needle for each injection.</span>\n</dd>\n</dl>\n<p>Supplies you will need to give your OZEMPIC injection:</p>\n<dl>\n<dt>•</dt>\n<dd>OZEMPIC pen 1 mg dose</dd>\n<dt>•</dt>\n<dd>a new NovoFine Plus or NovoFine needle</dd>\n<dt>•</dt>\n<dd>1 alcohol swab</dd>\n<dt>•</dt>\n<dd>1 gauze pad or cotton ball</dd>\n<dt>•</dt>\n<dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class=\"Bold\"></span>\n</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1340280349\"></a><img alt=\"image_62\" src=\"/dailymed/image.cfm?name=image-39.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1.</span>\n</p>\n<p>\n<span class=\"Bold\">Prepare your pen with a new needle</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Wash your hands </span>with soap and water.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd>\n<dt> </dt>\n<dd>This is especially important if you take more than 1 type of medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the pen cap.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-890649016\"></a><img alt=\"image_63\" src=\"/dailymed/image.cfm?name=image-40.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd>\n<dt> </dt>\n<dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id593748930\"></a><img alt=\"image_64\" src=\"/dailymed/image.cfm?name=image-41.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Take a new needle, </span>and tear off the paper tab.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not attach a new needle</span> to your pen until you are ready to give your injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-120308939\"></a><img alt=\"image_65\" src=\"/dailymed/image.cfm?name=image-42.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Push the needle straight onto the pen. Turn until it is on tight.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1299291183\"></a><img alt=\"image_66\" src=\"/dailymed/image.cfm?name=image-43.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the outer needle cap. Do not</span> throw it away.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1481461686\"></a><img alt=\"image_67\" src=\"/dailymed/image.cfm?name=image-44.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the inner needle cap </span>and throw it away.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1882434117\"></a><img alt=\"image_68\" src=\"/dailymed/image.cfm?name=image-45.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\"><a name=\"id1828629372\"></a><img alt=\"image_69\" src=\"/dailymed/image.cfm?name=image-46.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span>\n</p>\n<p>\n<span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2.</span>\n</p>\n<p>\n<span class=\"Bold\">First Time Use for Each New Pen: Check the OZEMPIC flow</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check the OZEMPIC flow <span class=\"Bold\">before the first injection with each new pen only.</span>\n</dd>\n<dt> </dt>\n<dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector <span class=\"Bold\">until the dose counter shows the flow check symbol (</span><span class=\"Bold\"><a name=\"id535621883\"></a><img alt=\"image_flow_check_3\" src=\"/dailymed/image.cfm?name=image-47.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\">).</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1019119305\"></a><img alt=\"image_70\" src=\"/dailymed/image.cfm?name=image-48.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the pen with the needle pointing up.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC will appear at the needle tip.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> 1 more time.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd>\n<dt> </dt>\n<dd>Contact Novo Nordisk at 1-888-693-6742.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id719479622\"></a><img alt=\"image_71\" src=\"/dailymed/image.cfm?name=image-49.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt> </dt>\n<dd>\n<span class=\"Bold\"><a name=\"id-802390333\"></a><img alt=\"image_72\" src=\"/dailymed/image.cfm?name=image-50.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\">Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </dd>\n</dl>\n<p class=\"First\">If no drop appears, you will <span class=\"Bold\">not </span>inject any OZEMPIC, even though the dose counter may move.<span class=\"Bold\"> This may mean that there is a blocked or damaged needle.</span>\n</p>\n<p>A small drop may remain at the needle tip, but it will not be injected.</p>\n<p>\n<span class=\"Bold\">Only check the OZEMPIC flow before your first injection with each new pen.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. </span>\n</p>\n<p>\n<span class=\"Bold\">Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Turn the dose selector until the dose counter stops and shows your 1 mg dose. </span>\n</dd>\n<dt> </dt>\n<dd>The dashed line in the dose counter <a name=\"id1412510523\"></a><img alt=\"image_dose_counter_3\" src=\"/dailymed/image.cfm?name=image-51.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/>will guide you to 1 mg.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1150596082\"></a><img alt=\"image_73\" src=\"/dailymed/image.cfm?name=image-52.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id336193144\"></a><img alt=\"image_74\" src=\"/dailymed/image.cfm?name=image-53.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always use the dose counter and the dose pointer to see that 1 mg has been selected.</span>\n</p>\n<p>You will hear a “click” every time you turn the dose selector. <span class=\"Bold\">Do not set the dose by counting the number of clicks you hear. </span>\n</p>\n<p>\n<span class=\"Bold\">Only doses of 1 mg can be selected with the dose selector.</span> 1 mg must line up exactly with the dose pointer to make sure that you get a correct dose.</p>\n<p>The dose selector changes the dose. <span class=\"Bold\">Only the dose counter and dose pointer will show that 1 mg has been selected.</span>\n</p>\n<p>You can only select 1 mg for each dose. When your pen contains less than 1 mg, the dose counter stops before 1 mg is shown.</p>\n<p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How much OZEMPIC is left?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd>\n<dt> </dt>\n<dd>Turn the dose selector until the<span class=\"Bold\"> dose counter </span>stops.</dd>\n<dt>•</dt>\n<dd>If it shows 1,<span class=\"Bold\"> at least 1 mg </span>is left in your pen. If the <span class=\"Bold\">dose counter stops before 1 mg,</span> there is not enough OZEMPIC left for a full dose of 1 mg.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id133292513\"></a><img alt=\"image_75\" src=\"/dailymed/image.cfm?name=image-54.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4.</span>\n</p>\n<p>\n<span class=\"Bold\">Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class=\"Bold\">K</span>).</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-433131247\"></a><img alt=\"image_76\" src=\"/dailymed/image.cfm?name=image-55.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1915154980\"></a><img alt=\"image_77\" src=\"/dailymed/image.cfm?name=image-56.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Press and hold down the dose button until the dose counter shows 0. </span>\n</dd>\n<dt> </dt>\n<dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Continue pressing the dose button while keeping the needle in your skin.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1926095909\"></a><img alt=\"image_78\" src=\"/dailymed/image.cfm?name=image-57.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Count 6 seconds while keeping the dose button pressed. </span>\n</dd>\n<dt>•</dt>\n<dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-2442495\"></a><img alt=\"image_79\" src=\"/dailymed/image.cfm?name=image-58.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Remove the needle from your skin.</span> You can then release the dose button.</dd>\n<dt> </dt>\n<dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2131929287\"></a><img alt=\"image_80\" src=\"/dailymed/image.cfm?name=image-59.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1828629231\"></a><img alt=\"image_81\" src=\"/dailymed/image.cfm?name=image-60.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p>\n<p>\n<span class=\"Bold\">How to identify a blocked or damaged needle?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd>\n<dt>•</dt>\n<dd>If this happens you have <span class=\"Bold\">not </span>received <span class=\"Bold\">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd>\n</dl>\n<p>\n<span class=\"Bold\">How to handle a blocked needle?</span>\n</p>\n<p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class=\"Bold\">“Prepare your pen with a new needle”.</span>\n</p>\n<p>\n<span class=\"Bold\">Never touch the dose counter when you inject. </span>This can stop the injection.</p>\n<p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5.</span>\n</p>\n<p>\n<span class=\"Bold\">After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-442924594\"></a><img alt=\"image_82\" src=\"/dailymed/image.cfm?name=image-61.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class=\"Bold\"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id336890703\"></a><img alt=\"image_83\" src=\"/dailymed/image.cfm?name=image-62.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1164709617\"></a><img alt=\"image_84\" src=\"/dailymed/image.cfm?name=image-63.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id781690777\"></a><img alt=\"image_85\" src=\"/dailymed/image.cfm?name=image-64.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-83218630\"></a><img alt=\"image_86\" src=\"/dailymed/image.cfm?name=image-65.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Never try to put the inner needle cap back on the needle. </span>You may stick yourself with the needle. </p>\n<p>\n<span class=\"Bold\">Always remove the needle from your pen.</span>\n</p>\n<p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class=\"Bold\">not</span> inject any OZEMPIC. </p>\n<p>\n<span class=\"Bold\">Always dispose of the needle after each injection.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Disposing of used OZEMPIC pens and needles:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd>\n<dt>•</dt>\n<dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl>\n<dt>o</dt>\n<dd>made of a heavy-duty plastic </dd>\n<dt>o</dt>\n<dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out </dd>\n<dt>o</dt>\n<dd>upright and stable during use </dd>\n<dt>o</dt>\n<dd>leak-resistant</dd>\n<dt>o</dt>\n<dd>properly labeled to warn of hazardous waste inside the container</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd>\n<dt>•</dt>\n<dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. </dd>\n<dt>•</dt>\n<dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id190193898\"></a><img alt=\"image_87\" src=\"/dailymed/image.cfm?name=image-66.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Important</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd>\n<dt>•</dt>\n<dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd>\n<dt>•</dt>\n<dd>Always keep your pen and needles <span class=\"Bold\">out of reach of others,</span> especially children.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Caring for your pen</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not try to repair your pen</span> or pull it apart.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not expose your pen to dust, dirt or liquid.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">How should I store my OZEMPIC pen?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store your <span class=\"Bold\">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> freeze OZEMPIC. <span class=\"Bold\">Do not</span> use OZEMPIC if it has been frozen.</dd>\n<dt>•</dt>\n<dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator,<span class=\"Bold\"> do not </span>store OZEMPIC pens directly next to the cooling element.</dd>\n<dt>•</dt>\n<dd>Keep OZEMPIC away from heat and out of the light.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the pen cap on when not in use.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep OZEMPIC and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n<a name=\"id-213813270\"></a><img alt=\"image_88\" src=\"/dailymed/image.cfm?name=image-67.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><p>For more information go to<span class=\"Bold\"> www.OZEMPIC.com</span>\n</p>\n<p>\n<span class=\"Bold\">Manufactured by:</span>\n</p>\n<p>Novo Nordisk A/S</p>\n<p>DK-2880 Bagsvaerd</p>\n<p>Denmark</p>\n<p>\n<span class=\"Bold\">For information about OZEMPIC contact:</span>\n</p>\n<p>Novo Nordisk Inc.</p>\n<p>800 Scudders Mill Road</p>\n<p>Plainsboro, NJ 08536</p>\n<p>1-888-693-6742</p>\n<p>Version: 4</p>\n<p>OZEMPIC<span class=\"Sup\">® </span>and NovoFine<span class=\"Sup\">® </span>are registered trademarks of Novo Nordisk A/S.</p>\n<p>\n<span class=\"Bold\">PATENT Information:</span> https://www.novonordisk-us.com/products/product-patents.html</p>\n<p>© 2023 Novo Nordisk</p>\n<p>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</p>\n<p>Revised: September 2023</p>\n<a name=\"id-1241482894\"></a><img alt=\"image_89\" src=\"/dailymed/image.cfm?name=image-68.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="544.5pt"> <col width="51%"/> <col width="49%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">INSTRUCTIONS FOR USE</span> </p> <p> <span class="Bold">OZEMPIC<span class="Sup">®</span> [oh-ZEM-pick]</span> </p> <p> <span class="Bold">(semaglutide)</span> </p> <p> <span class="Bold">injection, for subcutaneous use</span> </p> <p>2 mg dose</p> <p>(pen delivers doses in 2 mg increments only)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Read these instructions carefully before using your OZEMPIC<span class="Sup">®</span> pen.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd> <dt>•</dt> <dd> <span class="Bold">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span> </dd> </dl> <p class="First"> <a name="id-552457966"></a><img alt="image_91" src="/dailymed/image.cfm?name=image-73.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.</span> Get help from a person with good eyesight who is trained to use the OZEMPIC pen. </p> <dl> <dt>•</dt> <dd> <span class="Bold">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 8 mg of semaglutide, and you can only select doses of 2 mg. Each prefilled pen contains 4 doses of 2 mg.</dd> <dt>•</dt> <dd>Your pen is made to be used with<span class="Bold"> NovoFine<span class="Sup">®</span> Plus or NovoFine<span class="Sup">® </span></span>disposable needles up to a length of 8 mm.</dd> <dt>•</dt> <dd>NovoFine<span class="Sup">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always use a new needle for each injection.</span> </dd> </dl> <p>Supplies you will need to give your OZEMPIC injection:</p> <dl> <dt>•</dt> <dd>OZEMPIC pen 2 mg dose</dd> <dt>•</dt> <dd>a new NovoFine Plus or NovoFine needle</dd> <dt>•</dt> <dd>1 alcohol swab</dd> <dt>•</dt> <dd>1 gauze pad or cotton ball</dd> <dt>•</dt> <dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class="Bold"></span> </dd> <dt> </dt> <dd> <span class="Bold">See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-391976020"></a><img alt="image_92" src="/dailymed/image.cfm?name=image-74.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 1.</span> </p> <p> <span class="Bold">Prepare your pen with a new needle</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Wash your hands </span>with soap and water.</dd> <dt>•</dt> <dd> <span class="Bold">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd> <dt> </dt> <dd>This is especially important if you take more than 1 type of medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the pen cap.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1564012354"></a><img alt="image_93" src="/dailymed/image.cfm?name=image-75.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd> <dt> </dt> <dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1598100225"></a><img alt="image_94" src="/dailymed/image.cfm?name=image-76.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Take a new needle, </span>and tear off the paper tab.</dd> <dt> </dt> <dd> <span class="Bold">Do not attach a new needle</span> to your pen until you are ready to give your injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1466082507"></a><img alt="image_95" src="/dailymed/image.cfm?name=image-77.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Push the needle straight onto the pen. Turn until it is on tight.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1702663069"></a><img alt="image_96" src="/dailymed/image.cfm?name=image-78.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd> <dt>•</dt> <dd> <span class="Bold">Pull off the outer needle cap. Do not</span> throw it away.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1190033665"></a><img alt="image_97" src="/dailymed/image.cfm?name=image-79.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Pull off the inner needle cap </span>and throw it away.</dd> <dt> </dt> <dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1769581397"></a><img alt="image_98" src="/dailymed/image.cfm?name=image-80.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"><a name="id1219714103"></a><img alt="image_99" src="/dailymed/image.cfm?name=image-81.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</p> <p> <span class="Bold">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span> </p> <p> <span class="Bold">Never use a bent or damaged needle.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 2.</span> </p> <p> <span class="Bold">First Time Use for Each New Pen: Check the OZEMPIC flow</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Check the OZEMPIC flow <span class="Bold">before the first injection with each new pen only.</span> </dd> <dt> </dt> <dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd> <dt>•</dt> <dd>Turn the dose selector <span class="Bold">until the dose counter shows the flow check symbol (</span><span class="Bold"><a name="id297808622"></a><img alt="image_flow_check_4" src="/dailymed/image.cfm?name=image-82.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold">).</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id815465652"></a><img alt="image_100" src="/dailymed/image.cfm?name=image-83.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Hold the pen with the needle pointing up.</dd> <dt> </dt> <dd> <span class="Bold">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd> <dt> </dt> <dd>A drop of OZEMPIC will appear at the needle tip.</dd> <dt>•</dt> <dd> <span class="Bold">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class="Bold">G</span> and Figure <span class="Bold">H</span> 1 more time.</dd> <dt> </dt> <dd> <span class="Bold">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd> <dt> </dt> <dd>Contact Novo Nordisk at 1-888-693-6742.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-989318317"></a><img alt="image_101" src="/dailymed/image.cfm?name=image-84.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold"><a name="id1081866340"></a><img alt="image_102" src="/dailymed/image.cfm?name=image-85.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></span><span class="Bold">Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </p> <p>If no drop appears, you will <span class="Bold">not </span>inject any OZEMPIC, even though the dose counter may move.<span class="Bold"> This may mean that there is a blocked or damaged needle.</span> </p> <p>A small drop may remain at the needle tip, but it will not be injected.</p> <p> <span class="Bold">Only check the OZEMPIC flow before your first injection with each new pen.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 3. </span> </p> <p> <span class="Bold">Select your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Turn the dose selector until the dose counter stops and shows your 2 mg dose. </span> </dd> </dl> <p class="First">The dashed line in the dose counter <a name="id1888837671"></a><img alt="image_dose_counter_4" src="/dailymed/image.cfm?name=image-86.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/>will guide you to 2 mg.</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id490149390"></a><img alt="image_103" src="/dailymed/image.cfm?name=image-87.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1835874147"></a><img alt="image_104" src="/dailymed/image.cfm?name=image-88.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always use the dose counter and the dose pointer to see that 2 mg has been selected.</span> </p> <p>You will hear a “click” every time you turn the dose selector. <span class="Bold">Do not set the dose by counting the number of clicks you hear. </span> </p> <p> <span class="Bold">Only doses of 2 mg can be selected with the dose selector.</span> 2 mg must line up exactly with the dose pointer to make sure that you get a correct dose.</p> <p>The dose selector changes the dose. <span class="Bold">Only the dose counter and dose pointer will show that 2 mg has been selected.</span> </p> <p>You can only select 2 mg for each dose. When your pen contains less than 2 mg, the dose counter stops before 2 mg is shown.</p> <p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How much OZEMPIC is left?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd> <dt> </dt> <dd>Turn the dose selector until the<span class="Bold"> dose counter </span>stops.</dd> <dt>•</dt> <dd>If it shows 2,<span class="Bold"> at least 2 mg </span>is left in your pen. If the <span class="Bold">dose counter stops before 2 mg,</span> there is not enough OZEMPIC left for a full dose of 2 mg.</dd> <dt> </dt> <dd> <span class="Bold">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id759262506"></a><img alt="image_105" src="/dailymed/image.cfm?name=image-89.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 4.</span> </p> <p> <span class="Bold">Inject your dose</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class="Bold">K</span>).</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1205215169"></a><img alt="image_106" src="/dailymed/image.cfm?name=image-90.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd> <dt>•</dt> <dd> <span class="Bold">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-2045056655"></a><img alt="image_107" src="/dailymed/image.cfm?name=image-91.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Press and hold down the dose button until the dose counter shows 0. </span> </dd> <dt> </dt> <dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd> <dt> </dt> <dd> <span class="Bold">Continue pressing the dose button while keeping the needle in your skin.</span> </dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-11383709"></a><img alt="image_108" src="/dailymed/image.cfm?name=image-92.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Count 6 seconds while keeping the dose button pressed. </span> </dd> <dt>•</dt> <dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-775328677"></a><img alt="image_109" src="/dailymed/image.cfm?name=image-93.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Remove the needle from your skin.</span> You can then release the dose button.</dd> <dt> </dt> <dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id802660462"></a><img alt="image_110" src="/dailymed/image.cfm?name=image-94.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-273322901"></a><img alt="image_111" src="/dailymed/image.cfm?name=image-95.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p> <p> <span class="Bold">How to identify a blocked or damaged needle?</span> </p> <dl> <dt>•</dt> <dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd> <dt>•</dt> <dd>If this happens you have <span class="Bold">not </span>received <span class="Bold">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd> </dl> <p> <span class="Bold">How to handle a blocked needle?</span> </p> <p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class="Bold">“Prepare your pen with a new needle”.</span> </p> <p> <span class="Bold">Never touch the dose counter when you inject. </span>This can stop the injection.</p> <p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Step 5.</span> </p> <p> <span class="Bold">After your injection</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1840776341"></a><img alt="image_112" src="/dailymed/image.cfm?name=image-96.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class="Bold"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1240555872"></a><img alt="image_113" src="/dailymed/image.cfm?name=image-97.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1317339802"></a><img alt="image_114" src="/dailymed/image.cfm?name=image-98.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-1785646999"></a><img alt="image_115" src="/dailymed/image.cfm?name=image-99.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id1907725249"></a><img alt="image_116" src="/dailymed/image.cfm?name=image-100.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Never try to put the inner needle cap back on the needle.</span> You may stick yourself with the needle. </p> <p> <span class="Bold">Always remove the needle from your pen.</span> </p> <p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class="Bold">not</span> inject any OZEMPIC. </p> <p> <span class="Bold">Always dispose of the needle after each injection.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Disposing of used OZEMPIC pens and needles:</span> </p> <dl> <dt>•</dt> <dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd> <dt>•</dt> <dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl> <dt>o</dt> <dd>made of a heavy-duty plastic </dd> <dt>o</dt> <dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out </dd> <dt>o</dt> <dd>upright and stable during use </dd> <dt>o</dt> <dd>leak-resistant</dd> <dt>o</dt> <dd>properly labeled to warn of hazardous waste inside the container</dd> </dl> </dd> <dt>•</dt> <dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd> <dt>•</dt> <dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. </dd> <dt>•</dt> <dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="id-1486925373"></a><img alt="image_117" src="/dailymed/image.cfm?name=image-101.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/><span class="Bold">Important</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd>Caregivers must <span class="Bold">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd> <dt>•</dt> <dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd> <dt>•</dt> <dd> <span class="Bold">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd> <dt>•</dt> <dd>Always keep your pen and needles <span class="Bold">out of reach of others,</span> especially children.</dd> <dt>•</dt> <dd> <span class="Bold">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Caring for your pen</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd> <dt>•</dt> <dd> <span class="Bold">Do not try to repair your pen</span> or pull it apart.</dd> <dt>•</dt> <dd> <span class="Bold">Do not expose your pen to dust, dirt or liquid.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd> </dl> <p class="First"> <span class="Bold">How should I store my OZEMPIC pen?</span> </p> <dl> <dt>•</dt> <dd>Store your <span class="Bold">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd> <span class="Bold">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd> <dt>•</dt> <dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd> <dt>•</dt> <dd> <span class="Bold">Do not</span> freeze OZEMPIC. <span class="Bold">Do not</span> use OZEMPIC if it has been frozen.</dd> <dt>•</dt> <dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd> <dt>•</dt> <dd>When stored in the refrigerator,<span class="Bold"> do not </span>store OZEMPIC pens directly next to the cooling element.</dd> <dt>•</dt> <dd>Keep OZEMPIC away from heat and out of the light.</dd> <dt>•</dt> <dd> <span class="Bold">Keep the pen cap on when not in use.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Keep OZEMPIC and all medicines out of the reach of children.</span> </dd> </dl> <a name="id3639659"></a><img alt="image_118" src="/dailymed/image.cfm?name=image-104.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"544.5pt\">\n<col width=\"51%\"/>\n<col width=\"49%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">INSTRUCTIONS FOR USE</span>\n</p>\n<p>\n<span class=\"Bold\">OZEMPIC<span class=\"Sup\">®</span> [oh-ZEM-pick]</span>\n</p>\n<p>\n<span class=\"Bold\">(semaglutide)</span>\n</p>\n<p>\n<span class=\"Bold\">injection, for subcutaneous use</span>\n</p>\n<p>2 mg dose</p>\n<p>(pen delivers doses in 2 mg increments only)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Read these instructions carefully before using your OZEMPIC<span class=\"Sup\">®</span> pen.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not use your pen without proper training from your healthcare provider. </span>Make sure that you know how to give yourself an injection with the pen before you start your treatment.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.</span>\n</dd>\n</dl>\n<p class=\"First\">\n<a name=\"id-552457966\"></a><img alt=\"image_91\" src=\"/dailymed/image.cfm?name=image-73.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.</span> Get help from a person with good eyesight who is trained to use the OZEMPIC pen. </p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Your pen is a prefilled, single-patient-use, dial-a-dose pen. </span>It contains 8 mg of semaglutide, and you can only select doses of 2 mg. Each prefilled pen contains 4 doses of 2 mg.</dd>\n<dt>•</dt>\n<dd>Your pen is made to be used with<span class=\"Bold\"> NovoFine<span class=\"Sup\">®</span> Plus or NovoFine<span class=\"Sup\">® </span></span>disposable needles up to a length of 8 mm.</dd>\n<dt>•</dt>\n<dd>NovoFine<span class=\"Sup\">®</span> Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always use a new needle for each injection.</span>\n</dd>\n</dl>\n<p>Supplies you will need to give your OZEMPIC injection:</p>\n<dl>\n<dt>•</dt>\n<dd>OZEMPIC pen 2 mg dose</dd>\n<dt>•</dt>\n<dd>a new NovoFine Plus or NovoFine needle</dd>\n<dt>•</dt>\n<dd>1 alcohol swab</dd>\n<dt>•</dt>\n<dd>1 gauze pad or cotton ball</dd>\n<dt>•</dt>\n<dd>1 sharps disposal container for throwing away used OZEMPIC pens and needles.<span class=\"Bold\"></span>\n</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-391976020\"></a><img alt=\"image_92\" src=\"/dailymed/image.cfm?name=image-74.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 1.</span>\n</p>\n<p>\n<span class=\"Bold\">Prepare your pen with a new needle</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Wash your hands </span>with soap and water.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check the name and colored label </span>of your pen, to make sure that it contains OZEMPIC. </dd>\n<dt> </dt>\n<dd>This is especially important if you take more than 1 type of medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the pen cap.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1564012354\"></a><img alt=\"image_93\" src=\"/dailymed/image.cfm?name=image-75.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Check that the OZEMPIC medicine in your pen is clear and colorless</span>. </dd>\n<dt> </dt>\n<dd>Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1598100225\"></a><img alt=\"image_94\" src=\"/dailymed/image.cfm?name=image-76.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Take a new needle, </span>and tear off the paper tab.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not attach a new needle</span> to your pen until you are ready to give your injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1466082507\"></a><img alt=\"image_95\" src=\"/dailymed/image.cfm?name=image-77.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Push the needle straight onto the pen. Turn until it is on tight.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1702663069\"></a><img alt=\"image_96\" src=\"/dailymed/image.cfm?name=image-78.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">The needle is covered by 2 caps. You must remove both caps.</span> If you forget to remove both caps, you will not inject any medicine.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the outer needle cap. Do not</span> throw it away.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1190033665\"></a><img alt=\"image_97\" src=\"/dailymed/image.cfm?name=image-79.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Pull off the inner needle cap </span>and throw it away.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1769581397\"></a><img alt=\"image_98\" src=\"/dailymed/image.cfm?name=image-80.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id1219714103\"></a><img alt=\"image_99\" src=\"/dailymed/image.cfm?name=image-81.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\"> Always use a new needle for each injection. </span>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.</p>\n<p>\n<span class=\"Bold\">Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.</span>\n</p>\n<p>\n<span class=\"Bold\">Never use a bent or damaged needle.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 2.</span>\n</p>\n<p>\n<span class=\"Bold\">First Time Use for Each New Pen: Check the OZEMPIC flow</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Check the OZEMPIC flow <span class=\"Bold\">before the first injection with each new pen only.</span>\n</dd>\n<dt> </dt>\n<dd>If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.</dd>\n<dt>•</dt>\n<dd>Turn the dose selector <span class=\"Bold\">until the dose counter shows the flow check symbol (</span><span class=\"Bold\"><a name=\"id297808622\"></a><img alt=\"image_flow_check_4\" src=\"/dailymed/image.cfm?name=image-82.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\">).</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id815465652\"></a><img alt=\"image_100\" src=\"/dailymed/image.cfm?name=image-83.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Hold the pen with the needle pointing up.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Press and hold in the dose button </span>until the dose counter shows 0. The 0 must line up with the dose pointer.</dd>\n<dt> </dt>\n<dd>A drop of OZEMPIC will appear at the needle tip.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">If no drop appears</span>, repeat Step 2 above as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure <span class=\"Bold\">G</span> and Figure <span class=\"Bold\">H</span> 1 more time.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Do not use the pen</span> if a drop of OZEMPIC still does not appear. </dd>\n<dt> </dt>\n<dd>Contact Novo Nordisk at 1-888-693-6742.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-989318317\"></a><img alt=\"image_101\" src=\"/dailymed/image.cfm?name=image-84.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\"><a name=\"id1081866340\"></a><img alt=\"image_102\" src=\"/dailymed/image.cfm?name=image-85.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></span><span class=\"Bold\">Always make sure that a drop appears </span>at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. </p>\n<p>If no drop appears, you will <span class=\"Bold\">not </span>inject any OZEMPIC, even though the dose counter may move.<span class=\"Bold\"> This may mean that there is a blocked or damaged needle.</span>\n</p>\n<p>A small drop may remain at the needle tip, but it will not be injected.</p>\n<p>\n<span class=\"Bold\">Only check the OZEMPIC flow before your first injection with each new pen.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 3. </span>\n</p>\n<p>\n<span class=\"Bold\">Select your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Turn the dose selector until the dose counter stops and shows your 2 mg dose. </span>\n</dd>\n</dl>\n<p class=\"First\">The dashed line in the dose counter <a name=\"id1888837671\"></a><img alt=\"image_dose_counter_4\" src=\"/dailymed/image.cfm?name=image-86.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/>will guide you to 2 mg.</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id490149390\"></a><img alt=\"image_103\" src=\"/dailymed/image.cfm?name=image-87.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1835874147\"></a><img alt=\"image_104\" src=\"/dailymed/image.cfm?name=image-88.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always use the dose counter and the dose pointer to see that 2 mg has been selected.</span>\n</p>\n<p>You will hear a “click” every time you turn the dose selector. <span class=\"Bold\">Do not set the dose by counting the number of clicks you hear. </span>\n</p>\n<p>\n<span class=\"Bold\">Only doses of 2 mg can be selected with the dose selector.</span> 2 mg must line up exactly with the dose pointer to make sure that you get a correct dose.</p>\n<p>The dose selector changes the dose. <span class=\"Bold\">Only the dose counter and dose pointer will show that 2 mg has been selected.</span>\n</p>\n<p>You can only select 2 mg for each dose. When your pen contains less than 2 mg, the dose counter stops before 2 mg is shown.</p>\n<p>The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How much OZEMPIC is left?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">To see how much OZEMPIC is left in your pen, </span>use the dose counter:</dd>\n<dt> </dt>\n<dd>Turn the dose selector until the<span class=\"Bold\"> dose counter </span>stops.</dd>\n<dt>•</dt>\n<dd>If it shows 2,<span class=\"Bold\"> at least 2 mg </span>is left in your pen. If the <span class=\"Bold\">dose counter stops before 2 mg,</span> there is not enough OZEMPIC left for a full dose of 2 mg.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">If there is not enough OZEMPIC left in your pen for a full dose, do not use it.</span> Use a new OZEMPIC pen.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id759262506\"></a><img alt=\"image_105\" src=\"/dailymed/image.cfm?name=image-89.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 4.</span>\n</p>\n<p>\n<span class=\"Bold\">Inject your dose</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure <span class=\"Bold\">K</span>).</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1205215169\"></a><img alt=\"image_106\" src=\"/dailymed/image.cfm?name=image-90.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Insert the needle into your skin </span>as your healthcare provider has shown you.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Make sure you can see the dose counter. </span>Do not cover it with your fingers. This could stop the injection.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-2045056655\"></a><img alt=\"image_107\" src=\"/dailymed/image.cfm?name=image-91.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Press and hold down the dose button until the dose counter shows 0. </span>\n</dd>\n<dt> </dt>\n<dd>The 0 must line up with the dose pointer. You may then hear or feel a click.</dd>\n<dt> </dt>\n<dd>\n<span class=\"Bold\">Continue pressing the dose button while keeping the needle in your skin.</span>\n</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-11383709\"></a><img alt=\"image_108\" src=\"/dailymed/image.cfm?name=image-92.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Count 6 seconds while keeping the dose button pressed. </span>\n</dd>\n<dt>•</dt>\n<dd>If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-775328677\"></a><img alt=\"image_109\" src=\"/dailymed/image.cfm?name=image-93.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Remove the needle from your skin.</span> You can then release the dose button.</dd>\n<dt> </dt>\n<dd>If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id802660462\"></a><img alt=\"image_110\" src=\"/dailymed/image.cfm?name=image-94.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-273322901\"></a><img alt=\"image_111\" src=\"/dailymed/image.cfm?name=image-95.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Always watch the dose counter to make sure you have injected your complete dose.</span> Hold the dose button down until the dose counter shows 0.</p>\n<p>\n<span class=\"Bold\">How to identify a blocked or damaged needle?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.</dd>\n<dt>•</dt>\n<dd>If this happens you have <span class=\"Bold\">not </span>received <span class=\"Bold\">any</span> OZEMPIC even though the dose counter has moved from the original dose that you have set.</dd>\n</dl>\n<p>\n<span class=\"Bold\">How to handle a blocked needle?</span>\n</p>\n<p>Change the needle as described in Step 5, and repeat all steps starting with Step 1: <span class=\"Bold\">“Prepare your pen with a new needle”.</span>\n</p>\n<p>\n<span class=\"Bold\">Never touch the dose counter when you inject. </span>This can stop the injection.</p>\n<p>You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Step 5.</span>\n</p>\n<p>\n<span class=\"Bold\">After your injection</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Carefully remove the needle from the pen. </span>Do not put the needle caps back on the needle to avoid needle sticks.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1840776341\"></a><img alt=\"image_112\" src=\"/dailymed/image.cfm?name=image-96.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Place the needle in a sharps disposal container </span>right away to reduce the risk of needle sticks. See<span class=\"Bold\"> “Disposing of used OZEMPIC pens and needles” </span>below for more information about how to dispose of used pens and needles the right way.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1240555872\"></a><img alt=\"image_113\" src=\"/dailymed/image.cfm?name=image-97.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Put the pen cap on </span>your pen after each use to protect OZEMPIC from light.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1317339802\"></a><img alt=\"image_114\" src=\"/dailymed/image.cfm?name=image-98.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>If you do not have a sharps disposal container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.</dd>\n</dl>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-1785646999\"></a><img alt=\"image_115\" src=\"/dailymed/image.cfm?name=image-99.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id1907725249\"></a><img alt=\"image_116\" src=\"/dailymed/image.cfm?name=image-100.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Never try to put the inner needle cap back on the needle.</span> You may stick yourself with the needle. </p>\n<p>\n<span class=\"Bold\">Always remove the needle from your pen.</span>\n</p>\n<p>This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will <span class=\"Bold\">not</span> inject any OZEMPIC. </p>\n<p>\n<span class=\"Bold\">Always dispose of the needle after each injection.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Disposing of used OZEMPIC pens and needles:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.</dd>\n<dt>•</dt>\n<dd>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<dl>\n<dt>o</dt>\n<dd>made of a heavy-duty plastic </dd>\n<dt>o</dt>\n<dd>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out </dd>\n<dt>o</dt>\n<dd>upright and stable during use </dd>\n<dt>o</dt>\n<dd>leak-resistant</dd>\n<dt>o</dt>\n<dd>properly labeled to warn of hazardous waste inside the container</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal</dd>\n<dt>•</dt>\n<dd>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. </dd>\n<dt>•</dt>\n<dd>Safely dispose of OZEMPIC that is out of date or no longer needed.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"id-1486925373\"></a><img alt=\"image_117\" src=\"/dailymed/image.cfm?name=image-101.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/><span class=\"Bold\">Important</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Caregivers must <span class=\"Bold\">be very careful when handling used needles</span> to prevent accidental needle stick injuries and prevent passing (transmission) of infection. </dd>\n<dt>•</dt>\n<dd>Never use a syringe to withdraw OZEMPIC from your pen.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always carry an extra pen and new needles</span> with you, in case of loss or damage.</dd>\n<dt>•</dt>\n<dd>Always keep your pen and needles <span class=\"Bold\">out of reach of others,</span> especially children.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Always keep your pen with you.</span> Do not leave it in a car or other place where it can get too hot or too cold.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Caring for your pen</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not drop your pen</span> or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not try to repair your pen</span> or pull it apart.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not expose your pen to dust, dirt or liquid.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not wash, soak, or lubricate your pen.</span> If necessary, clean it with mild detergent on a moistened cloth.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">How should I store my OZEMPIC pen?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store your <span class=\"Bold\">new, unused</span> OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Store your pen in use</span> for 56 days at room temperature between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between 36°F to 46°F (2°C to 8°C).</dd>\n<dt>•</dt>\n<dd>The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar. </dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not</span> freeze OZEMPIC. <span class=\"Bold\">Do not</span> use OZEMPIC if it has been frozen.</dd>\n<dt>•</dt>\n<dd>Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.</dd>\n<dt>•</dt>\n<dd>When stored in the refrigerator,<span class=\"Bold\"> do not </span>store OZEMPIC pens directly next to the cooling element.</dd>\n<dt>•</dt>\n<dd>Keep OZEMPIC away from heat and out of the light.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep the pen cap on when not in use.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep OZEMPIC and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n<a name=\"id3639659\"></a><img alt=\"image_118\" src=\"/dailymed/image.cfm?name=image-104.jpg&amp;setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79\"/></td>\n</tr>\n</tbody>\n</table></div>" }

For more information go to www.OZEMPIC.com

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Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:\n" }

Novo Nordisk A/S

{ "type": "p", "children": [], "text": "Novo Nordisk A/S" }

DK-2880 Bagsvaerd

{ "type": "p", "children": [], "text": "DK-2880 Bagsvaerd" }

Denmark

{ "type": "p", "children": [], "text": "Denmark" }

For information about OZEMPIC contact:

{ "type": "p", "children": [], "text": "\nFor information about OZEMPIC contact:\n" }

Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "Novo Nordisk Inc." }

800 Scudders Mill Road

{ "type": "p", "children": [], "text": "800 Scudders Mill Road" }

Plainsboro, NJ 08536

{ "type": "p", "children": [], "text": "Plainsboro, NJ 08536" }

1-888-693-6742

{ "type": "p", "children": [], "text": "1-888-693-6742" }

Version: 2

{ "type": "p", "children": [], "text": "Version: 2" }

OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.

{ "type": "p", "children": [], "text": "OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S." }

PATENT Information: https://novonordisk-us.com/products/product-patents.html

{ "type": "p", "children": [], "text": "\nPATENT Information: https://novonordisk-us.com/products/product-patents.html" }

© 2023 Novo Nordisk

{ "type": "p", "children": [], "text": "© 2023 Novo Nordisk" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Revised: September 2023

{ "type": "p", "children": [], "text": "Revised: September 2023" }

0.25 mg

{ "type": "p", "children": [], "text": "\n0.25 mg\n" }

0.5 mg

{ "type": "p", "children": [], "text": "\n0.5 mg\n" }

NDC 0169-4181-13List 418113

{ "type": "p", "children": [], "text": "NDC 0169-4181-13List 418113" }

OZEMPIC®

{ "type": "p", "children": [], "text": "\nOZEMPIC®\n" }

(semaglutide) injection

{ "type": "p", "children": [], "text": "(semaglutide) injection" }

For Single Patient Use Only

{ "type": "p", "children": [], "text": "\nFor Single Patient Use Only\n" }

2 mg/3 mL (0.68 mg/mL) Prefilled pen

{ "type": "p", "children": [], "text": "2 mg/3 mL (0.68 mg/mL) Prefilled pen" }

Pen delivers doses in 0.25 mg or 0.5 mg increments only

{ "type": "p", "children": [], "text": "Pen delivers doses in 0.25 mg or 0.5 mg increments only" }

For subcutaneous use only

{ "type": "p", "children": [], "text": "\nFor subcutaneous use only\n" }

Use OZEMPIC once weekly

{ "type": "p", "children": [], "text": "\nUse OZEMPIC once weekly\n" }

Contains: 1 OZEMPIC pen, 6 NovoFine® Plus 32G needles, Product Literature.

{ "type": "p", "children": [], "text": "Contains: 1 OZEMPIC pen, 6 NovoFine® Plus 32G needles, Product Literature." }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "\nDispense the enclosed Medication Guide to each patient.\n" }

1 mg

{ "type": "p", "children": [], "text": "\n1 mg \n" }

NDC 0169-4130-13List 413013

{ "type": "p", "children": [], "text": "NDC 0169-4130-13List 413013" }

OZEMPIC®

{ "type": "p", "children": [], "text": "\nOZEMPIC®\n" }

(semaglutide) injection

{ "type": "p", "children": [], "text": "(semaglutide) injection" }

For Single Patient Use Only

{ "type": "p", "children": [], "text": "\nFor Single Patient Use Only\n" }

4 mg/3 mL (1.34 mg/mL) Prefilled pen

{ "type": "p", "children": [], "text": "4 mg/3 mL (1.34 mg/mL) Prefilled pen" }

Pen delivers doses in 1 mg increments only

{ "type": "p", "children": [], "text": "Pen delivers doses in 1 mg increments only" }

For subcutaneous use only

{ "type": "p", "children": [], "text": "\nFor subcutaneous use only\n" }

Use OZEMPIC once weekly

{ "type": "p", "children": [], "text": "\nUse OZEMPIC once weekly\n" }

Contains: 1 OZEMPIC pen, 4 NovoFine® Plus 32G needles, Product Literature.

{ "type": "p", "children": [], "text": "Contains: 1 OZEMPIC pen, 4 NovoFine® Plus 32G needles, Product Literature." }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "\nDispense the enclosed Medication Guide to each patient.\n" }

2 mg

{ "type": "p", "children": [], "text": "\n2 mg\n" }

NDC 0169-4772-12List 477212

{ "type": "p", "children": [], "text": "NDC 0169-4772-12List 477212" }

OZEMPIC®

{ "type": "p", "children": [], "text": "\nOZEMPIC®\n" }

(semaglutide) injection

{ "type": "p", "children": [], "text": "(semaglutide) injection" }

For Single Patient Use Only

{ "type": "p", "children": [], "text": "\nFor Single Patient Use Only\n" }

8 mg/3 mL (2.68 mg/mL) Prefilled pen

{ "type": "p", "children": [], "text": "8 mg/3 mL (2.68 mg/mL) Prefilled pen" }

Pen delivers 4 doses of 2 mg only

{ "type": "p", "children": [], "text": "Pen delivers 4 doses of 2 mg only" }

For subcutaneous use only

{ "type": "p", "children": [], "text": "\nFor subcutaneous use only\n" }

Use OZEMPIC once weekly

{ "type": "p", "children": [], "text": "\nUse OZEMPIC once weekly\n" }

Contains: 1 OZEMPIC pen, 4 NovoFine® Plus 32G needles, Product Literature.

{ "type": "p", "children": [], "text": "Contains: 1 OZEMPIC pen, 4 NovoFine® Plus 32G needles, Product Literature." }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "\nDispense the enclosed Medication Guide to each patient.\n" }

0.25 mg

{ "type": "p", "children": [], "text": "\n0.25 mg\n" }

0.5 mg

{ "type": "p", "children": [], "text": "\n0.5 mg\n" }

NDC 0169-4132-12List 413212

{ "type": "p", "children": [], "text": "NDC 0169-4132-12List 413212" }

OZEMPIC®

{ "type": "p", "children": [], "text": "\nOZEMPIC®\n" }

(semaglutide) injection

{ "type": "p", "children": [], "text": "(semaglutide) injection" }

For Single Patient Use Only

{ "type": "p", "children": [], "text": "\nFor Single Patient Use Only\n" }

2 mg/1.5 mL (1.34 mg/mL) Prefilled pen

{ "type": "p", "children": [], "text": "2 mg/1.5 mL (1.34 mg/mL) Prefilled pen" }

Pen delivers doses in 0.25 mg or 0.5 mg increments only

{ "type": "p", "children": [], "text": "Pen delivers doses in 0.25 mg or 0.5 mg increments only" }

For subcutaneous use only

{ "type": "p", "children": [], "text": "\nFor subcutaneous use only\n" }

Use OZEMPIC once weekly

{ "type": "p", "children": [], "text": "\nUse OZEMPIC once weekly\n" }

Contains: 1 OZEMPIC pen, 6 NovoFine® Plus 32G needles, Product Literature.

{ "type": "p", "children": [], "text": "Contains: 1 OZEMPIC pen, 6 NovoFine® Plus 32G needles, Product Literature." }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "\nDispense the enclosed Medication Guide to each patient.\n" }

1 mg

{ "type": "p", "children": [], "text": "\n1 mg \n" }

NDC 0169-4136-02List 413602

{ "type": "p", "children": [], "text": "NDC 0169-4136-02List 413602" }

OZEMPIC®

{ "type": "p", "children": [], "text": "\nOZEMPIC®\n" }

(semaglutide) injection

{ "type": "p", "children": [], "text": "(semaglutide) injection" }

For Single Patient Use Only

{ "type": "p", "children": [], "text": "\nFor Single Patient Use Only\n" }

2 mg/1.5 mL (1.34 mg/mL) Prefilled pen

{ "type": "p", "children": [], "text": "2 mg/1.5 mL (1.34 mg/mL) Prefilled pen" }

Pen delivers doses in 1 mg increments only

{ "type": "p", "children": [], "text": "Pen delivers doses in 1 mg increments only" }

For subcutaneous use only

{ "type": "p", "children": [], "text": "\nFor subcutaneous use only\n" }

Use OZEMPIC once weekly

{ "type": "p", "children": [], "text": "\nUse OZEMPIC once weekly\n" }

Contains: 2 OZEMPIC pens, 4 NovoFine® Plus 32G needles, Product Literature.

{ "type": "p", "children": [], "text": "Contains: 2 OZEMPIC pens, 4 NovoFine® Plus 32G needles, Product Literature." }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "\nDispense the enclosed Medication Guide to each patient.\n" }

RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

{ "type": "p", "children": [], "text": "RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus." }

Limitations of Use

{ "type": "p", "children": [], "text": "\nLimitations of Use\n" }

RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.

{ "type": "p", "children": [], "text": "RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus." }

RYBELSUS (formulation R1)

RYBELSUS (formulation R1) includes the following strengths: 3 mg, 7 mg and 14 mg.

Recommend the following RYBELSUS (formulation R1) dosage to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.6), Adverse Reactions (6.1)]:

RYBELSUS (formulation R2)

RYBELSUS (formulation R2) includes the following strengths: 1.5 mg, 4 mg and 9 mg.

Recommend the following RYBELSUS (formulation R2) dosage to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.6), Adverse Reactions (6.1)]:

Switching Between RYBELSUS Formulations

<div class="scrollingtable"><table width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">RYBELSUS (formulation R1) *</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">RYBELSUS (formulation R2) *</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">7 mg orally once daily</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">4 mg orally once daily</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">14 mg orally once daily</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First" style="border-left:1px solid;"> <span class="XmChange">9 mg orally once daily</span> </p> </td> </tr> </tbody> </table></div>

Switching from OZEMPIC to RYBELSUS (formulation R1) or RYBELSUS (formulation R2)

Switching from OZEMPIC to RYBELSUS (formulation R1)

Switching from OZEMPIC to RYBELSUS (formulation R2)

RYBELSUS (semaglutide) tablets (formulation R1) are available as:

{ "type": "p", "children": [], "text": "RYBELSUS (semaglutide) tablets (formulation R1) are available as:" }

{ "type": "", "children": [], "text": "" }

RYBELSUS (semaglutide) tablets (formulation R2) are available as:

{ "type": "p", "children": [], "text": "RYBELSUS (semaglutide) tablets (formulation R2) are available as:" }

{ "type": "", "children": [], "text": "" }

RYBELSUS is contraindicated in patients with:

{ "type": "p", "children": [], "text": "RYBELSUS is contraindicated in patients with:" }

{ "type": "", "children": [], "text": "" }

In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

RYBELSUS is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of RYBELSUS and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS [see Adverse Reactions (6.1)].

After initiation of RYBELSUS, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue RYBELSUS and initiate appropriate management.

In a pooled analysis of glycemic control trials with RYBELSUS, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with RYBELSUS and 3.8% with comparator) [see Adverse Reactions (6.1)].

In a 2-year cardiovascular outcomes trial with semaglutide injection involving patients with type 2 diabetes mellitus and high cardiovascular risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (semaglutide injection 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%).

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Patients receiving RYBELSUS in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions (6.1), Drug Interactions (7)].

The risk of hypoglycemia may be lowered by a reduction in the dosage of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists, including semaglutide. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea or dehydration.

Monitor renal function when initiating or escalating doses of RYBELSUS in patients reporting severe adverse gastrointestinal reactions.

Use of RYBELSUS has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6.1)]. In RYBELSUS clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving RYBELSUS (7 mg 0.6%, 14 mg 2%) than placebo (0.3%).

RYBELSUS is not recommended in patients with severe gastroparesis.

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with RYBELSUS. If hypersensitivity reactions occur, discontinue use of RYBELSUS; treat promptly per standard of care and monitor until signs and symptoms resolve. RYBELSUS is contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS [see Adverse Reactions (6.2)].

Anaphylaxis and angioedema have been reported with GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with RYBELSUS.

Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1% of patients treated with RYBELSUS 7 mg. Cholelithiasis was not reported in RYBELSUS 14 mg or placebo-treated patients [see Adverse Reactions (6.1)]. If cholelithiasis or cholecystitis is suspected, gallbladder studies and appropriate clinical follow-up are indicated [see Adverse Reactions (6.2)].

RYBELSUS delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking RYBELSUS, including whether modifying preoperative fasting recommendations or temporarily discontinuing RYBELSUS could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of RYBELSUS (formulation R2 - 1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration (2.2)] and RYBELSUS (formulation R1 - 3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration (2.3)] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology (12.3), Clinical Studies (14)]. Below is a display of the safety results of the adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus.

Pool of Placebo-Controlled Trials

The data in Table 2 are derived from 2 placebo-controlled trials in adult patients with type 2 diabetes mellitus [see Clinical Studies (14)]. These data reflect exposure of 1071 patients to RYBELSUS with a mean duration of exposure of 41.8 weeks. The mean age of patients was 58 years, 3.9% were 75 years or older and 52% were male. In these trials, 63% were White, 6% were Black or African American and 27% were Asian; 19% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 mellitus diabetes for an average of 9.4 years and had a mean HbA1c of 8.1%. At baseline, 20.1% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m2) in 66.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m2) in 32.4% and moderately impaired (eGFR 30 to 60 mL/min/1.73m2) in 1.4% of patients.

Pool of Placebo- and Active-Controlled Trials

The occurrence of adverse reactions was also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in 9 placebo- and active-controlled trials [see Clinical Studies (14)]. In this pool, 4,116 patients with type 2 diabetes mellitus were treated with RYBELSUS for a mean duration of 59.8 weeks. The mean age of patients was 58 years, 5% were 75 years or older and 55% were male. In these trials, 65% were White, 6% were Black or African American and 24% were Asian; 15% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes mellitus for an average of 8.8 years and had a mean HbA1c of 8.2%. At baseline, 16.6% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m2) in 65.9%, mildly impaired (eGFR 60 to 90 mL/min/1.73m2) in 28.5% and moderately impaired (eGFR 30 to 60 mL/min/1.73m2) in 5.4% of the patients.

Common Adverse Reactions

Table 2 shows common adverse reactions, excluding hypoglycemia, associated with the use of RYBELSUS in adult patients with type 2 diabetes mellitus in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on RYBELSUS than on placebo and occurred in at least 5% of patients treated with RYBELSUS.

Table 2. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of RYBELSUS-Treated Patients with Type 2 Diabetes Mellitus

<div class="scrollingtable"><table width="100%"> <col width="24%"/> <col width="25%"/> <col width="25%"/> <col width="25%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Adverse Reaction</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=362)</span> </p> <p> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS 7 mg</span> </p> <p> <span class="Bold">(N=356)</span> </p> <p> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS 14 mg</span> </p> <p> <span class="Bold">(N=356)</span> </p> <p> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nausea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">20</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Abdominal Pain</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">11</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Diarrhea </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased appetite </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">9</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Vomiting</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Constipation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5</p> </td> </tr> </tbody> </table></div>

In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 2.

Gastrointestinal Adverse Reactions

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients who received RYBELSUS than placebo: RYBELSUS 14 mg once daily (41%), RYBELSUS 7 mg once daily (32%) and placebo (21%), including severe reactions (RYBELSUS 14 mg 2.0%, RYBELSUS 7 mg 0.6%, placebo 0.3%). The majority of reports of nausea, vomiting and/or diarrhea occurred during dose escalation. A greater percentage of patients who received RYBELSUS 14 mg once daily (8%) and RYBELSUS 7 mg once daily (4%) discontinued treatment due to gastrointestinal adverse reactions than patients who received placebo (1%).

In addition to the reactions in Table 2, the following gastrointestinal adverse reactions with a frequency of <5% occurred in RYBELSUS-treated patients (frequencies listed, respectively, as 14 mg once daily, 7 mg once daily and placebo): abdominal distension (3%, 2% and 1%), dyspepsia (0.6%, 3%, 0.6%), eructation (2%, 0.6%, 0%,), flatulence (1%, 2%, 0%), gastroesophageal reflux disease (2%, 2%, 0.3%) and gastritis (2%, 2%, 0.8%).

Other Adverse Reactions

Pancreatitis: In the pool of placebo- and active-controlled trials with RYBELSUS, pancreatitis was reported as a serious adverse event in 6 RYBELSUS-treated patients (0.1 events per 100 patient years) versus 1 in comparator-treated patients (<0.1 events per 100 patient years).

Diabetic Retinopathy Complications: In the pool of placebo- and active-controlled trials with RYBELSUS, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with RYBELSUS and 3.8% with comparator).

Hypoglycemia: Table 3 summarizes the incidence of hypoglycemia by various definitions in the placebo-controlled trials.

Table 3. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials In Patients with Type 2 Diabetes Mellitus

<div class="scrollingtable"><table width="525.35pt"> <col width="25%"/> <col width="25%"/> <col width="25%"/> <col width="25%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS </span> </p> <p> <span class="Bold">7 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS </span> </p> <p> <span class="Bold">14 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Monotherapy</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold"> (26 weeks)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=178</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=175</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=175</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Severe*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Plasma glucose</dd> <dt> </dt> <dd>&lt;54 mg/dL</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Add-on to metformin and/or sulfonylurea, basal insulin alone or metformin in combination with basal insulin in patients with moderate renal impairment</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold">(26 weeks)</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=161</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">-</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=163</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> Severe*</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Plasma glucose</dd> <dt> </dt> <dd>&lt;54 mg/dL</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Add-on to insulin with or without metformin</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> <span class="Bold"> (52 weeks)</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=184</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=181</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">N=181</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd> Severe*</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">0%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Plasma glucose</dd> <dt> </dt> <dd>&lt;54 mg/dL</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">32%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">26%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">30%</p> </td> </tr> </tbody> </table></div>

* “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person.

Hypoglycemia was more frequent when RYBELSUS was used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.

Increases in Amylase and Lipase: In placebo-controlled trials, patients exposed to RYBELSUS 7 mg and 14 mg had a mean increase from baseline in amylase of 10% and 13%, respectively and lipase of 30% and 34%, respectively. These changes were not observed in placebo-treated patients.

Cholelithiasis: In placebo-controlled trials, cholelithiasis was reported in 1% of patients treated with RYBELSUS 7 mg. Cholelithiasis was not reported in RYBELSUS 14 mg or placebo-treated patients.

Increases in Heart Rate: In placebo-controlled trials, RYBELSUS 7 mg and 14 mg resulted in a mean increase in heart rate of 1 to 3 beats per minute. There was no change in heart rate in placebo-treated patients.

The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of RYBELSUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

RYBELSUS stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving RYBELSUS in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.

When initiating RYBELSUS, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.4), Adverse Reactions (6.1)].

RYBELSUS causes a delay of gastric emptying and thereby has the potential to impact the absorption of other oral drugs. Levothyroxine exposure was increased 33% (90% CI: 125-142) when administered with RYBELSUS in a drug interaction study [see Clinical Pharmacology (12.3)].

When coadministering RYBELSUS with other oral drugs that have a narrow therapeutic index or that require clinical monitoring, consider increased clinical or laboratory monitoring [see Dosage and Administration (2)].

Risk Summary

Available data with RYBELSUS use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to RYBELSUS during pregnancy. RYBELSUS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data).

The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an HbA1c >7 and has been reported to be as high as 20 to 25% in women with a HbA1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease Associated Maternal and Fetal Risk: Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity.

Data

Animal Data: In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.

In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures.

In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure).

In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.3-, 6.4- and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥6X human exposure).

Salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through lactation day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed.

Risk Summary

A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Since the activity of enzymes involved in SNAC clearance may be lower in infants compared to adults, higher SNAC plasma levels may occur in neonates and infants. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS.

Discontinue RYBELSUS in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations (8.1)].

The safety and effectiveness of RYBELSUS have not been established in pediatric patients.

In the pool of glycemic control trials, 1,229 (30%) RYBELSUS-treated patients were 65 years of age and over and 199 (5%) RYBELSUS-treated patients were 75 years of age and over [see Clinical Studies (14)]. In PIONEER 6, the cardiovascular outcomes trial, 891 (56%) RYBELSUS-treated patients were 65 years of age and over and 200 (13%) RYBELSUS-treated patients were 75 years of age and over.

No overall differences in safety or effectiveness for RYBELSUS have been observed between patients 65 years of age and older and younger adult patients.

The recommended dosage of RYBELSUS in patients with renal impairment is the same as those with normal renal function.

The safety and effectiveness of RYBELSUS was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2) [see Clinical Studies (14.1)]. In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics was observed [see Clinical Pharmacology (12.3)].

The recommended dosage in patients with hepatic impairment is the same as those with normal hepatic function.

In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics was observed [see Clinical Pharmacology (12.3)].

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of RYBELSUS of approximately 1 week.

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RYBELSUS tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.

{ "type": "p", "children": [], "text": "RYBELSUS tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol." }

Structural formula:

{ "type": "p", "children": [], "text": "\nStructural formula:\n" }

Semaglutide is a white to almost white hygroscopic powder.

{ "type": "p", "children": [], "text": "Semaglutide is a white to almost white hygroscopic powder." }

Each tablet of:

{ "type": "p", "children": [], "text": "Each tablet of:" }

{ "type": "", "children": [], "text": "" }

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.

GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.

The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.

Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

The pharmacodynamic evaluations described below were in patients with type 2 diabetes mellitus who received once weekly subcutaneous injections of placebo or semaglutide injection over 12 weeks (semaglutide injection-treated patients were started on lower dosages and then titrated up to 1 mg once weekly). RYBELSUS is not approved for subcutaneous use.

Fasting and Postprandial Glucose

Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes mellitus, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose and 30 mg/dL (22%) for mean 24 hour glucose concentration.

Insulin Secretion

Both first- and second-phase insulin secretion are increased in patients with type 2 diabetes mellitus treated with semaglutide compared with placebo.

Glucagon Secretion

Semaglutide lowers the fasting and postprandial glucagon concentrations.

Glucose dependent insulin and glucagon secretion

Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner.

During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes mellitus.

Gastric emptying

Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.

Cardiac Electrophysiology

The effect of subcutaneously administered semaglutide on cardiac repolarization was tested in a thorough QTc trial. At an average exposure level 4-fold higher than that of the maximum recommended dose of RYBELSUS, semaglutide does not prolong QTc intervals to any clinically relevant extent.

Semaglutide estimated mean steady-state concentration was 6.7 nmol/L and 14.6 nmol/L following once daily oral administration of 7 mg and 14 mg of RYBELSUS (formulation R1), respectively, in patients with type 2 diabetes mellitus.

Semaglutide exposures increased in a dose-proportional manner. Steady-state exposure was achieved following 4-5 weeks of RYBELSUS oral administration.

Absorption

Semaglutide is co-formulated with salcaprozate sodium which facilitates the absorption of semaglutide after oral RYBELSUS administration. The absorption of semaglutide predominantly occurs in the stomach.

Semaglutide estimated absolute bioavailability was approximately:

Semaglutide maximum concentration was reached approximately 1-hour after oral RYBELSUS administration.

Effect of RYBELSUS Formulation: There were no clinically significant differences observed in the mean steady state AUC0-24h,SS and Cmax,SS between the 3 mg, 7 mg and 14 mg doses of RYBELSUS (formulation R1) and the 1.5 mg, 4 mg and 9 mg doses of RYBELSUS (formulation R2), respectively, in a clinical study conducted in healthy subjects.

Effect of Volume and Timing of Water Consumption: Single 10 mg doses of oral semaglutide (formulation R1) were administered with 50 mL or 240 mL of water after an 8-hour overnight fast and a continued fast of 4 hours post-dose in healthy subjects. Semaglutide absorption (i.e., area under the curve (AUC) and peak concentrations (Cmax)) were higher following dosing with 50 mL water compared to that of 240 mL water.

For 10 days, healthy subjects received 10 mg of oral semaglutide (formulation R1) once daily doses with 50 mL or 120 mL of water under fasting conditions with post-dose fasting period of 15, 30, 60 or 120 minutes. In this study, semaglutide absorption (i.e., AUC and Cmax) was higher after a longer post-dose fasting period. There were no clinically significant differences in semaglutide absorption with administration of 50 mL or 120 mL of water.

Distribution

Semaglutide absolute volume of distribution is approximately 8 L in patients with type 2 diabetes. Semaglutide is >99% bound to plasma albumin.

Elimination

Semaglutide elimination half-life is approximately one week with an absolute clearance of approximately 0.04 L/hour in patients with type 2 diabetes. Semaglutide is present in the circulation for about five weeks after the last RYBELSUS dose.

Metabolism: The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid side chain.

Excretion: The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the absorbed dose is excreted in the urine as intact semaglutide.

Specific Populations

No clinically significant differences in semaglutide pharmacokinetics were observed based on age (≥18 years old), sex, race (White, Asian or Black or African American), ethnicity, body weight (40 to 188 kg), upper GI disease (i.e., chronic gastritis and/or gastroesophageal reflux disease), hepatic impairment (i.e., mild, moderate, severe based on the Child-Pugh system) and renal impairment (i.e., mild, moderate, severe, end staged renal disease).

Drug Interaction Studies

Clinical Studies and Model-Informed Approaches: The delay of gastric emptying with semaglutide may influence the absorption of concomitantly administered oral drugs. Trials were conducted to study the potential effect of semaglutide on the absorption of oral drugs taken with semaglutide administered orally at steady-state exposure.

In Vitro Studies: Semaglutide has very low potential to inhibit or induce CYP enzymes, and to inhibit drug transporters.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of semaglutide or of other semaglutide products.

During the 26- to 78-week treatment periods in 5 clinical trials in adults with type 2 diabetes mellitus [see Clinical Studies (14.2, 14.3)] and 1 clinical trial in Japanese adults with type 2 diabetes mellitus, 14/2924 (0.5%) of RYBELSUS-treated patients developed anti-semaglutide antibodies. Of these 14 RYBELSUS-treated patients, 7 patients (0.2% of the total RYBELSUS-treated study population) developed antibodies that cross-reacted with native GLP-1. No identified clinically significant effect of anti-semaglutide antibodies on pharmacokinetics of RYBELSUS was observed. There is insufficient information to characterize the effects of anti-semaglutide antibodies on pharmacodynamics, safety or effectiveness of semaglutide.

In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of RYBELSUS 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3X human exposure).

In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures.

Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning, Warnings and Precautions (5.1)].

Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).

In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight.

Increase in lactate levels and decrease in glucose levels in the plasma and cerebrospinal fluid (CSF) were observed in mechanistic studies with SNAC in rats. Small but statistically significant increases in lactate levels (up to 2-fold) were observed in a few animals at approximately the clinical exposure. At higher exposures these findings were associated with moderate to marked adverse clinical signs (lethargy, abnormal respiration, ataxia, reduced activity, body tone and reflexes) and marked decreases in plasma and CSF glucose levels. These findings are consistent with inhibition of cellular respiration and lead to mortality at SNAC concentrations ≥100-times the clinical Cmax.

RYBELSUS has been studied as monotherapy and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones in patients with type 2 diabetes mellitus. The efficacy of RYBELSUS was compared with placebo, empagliflozin, sitagliptin and liraglutide. RYBELSUS has also been studied in patients with type 2 diabetes mellitus with mild and moderate renal impairment.

In patients with type 2 diabetes mellitus, RYBELSUS produced clinically significant reduction from baseline in HbA1c compared with placebo.

The effectiveness of RYBELSUS (formulation R2 - 1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration (2.2)] and RYBELSUS (formulation R1 - 3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration (2.3)] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology (12.3)]. Below is a display of the efficacy results of the adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus.

The efficacy of RYBELSUS was not impacted by baseline age, sex, race, ethnicity, BMI, body weight, duration of diabetes and degree of renal impairment.

In a 26-week double-blind trial (NCT02906930), 703 adult patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized to RYBELSUS 3 mg, RYBELSUS 7 mg or RYBELSUS 14 mg once daily or placebo. Patients had a mean age of 55 years and 51% were men. The mean duration of type 2 diabetes mellitus was 3.5 years and the mean BMI was 32 kg/m2. Overall, 75% were White, 5% were Black or African American and 17% were Asian; 26% identified as Hispanic or Latino ethnicity.

Monotherapy with RYBELSUS 7 mg and RYBELSUS 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 4).

Table 4. Results at Week 26 in a Trial of RYBELSUS as Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

<div class="scrollingtable"><table cellpadding="5.75pt" width="534pt"> <col width="38%"/> <col width="20%"/> <col width="21%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">7 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">178</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">175</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">175</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.4</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.9</p> <p>[-1.1; -0.6]<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.1</p> <p>[-1.3; -0.9]<span class="Sup">c</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">31</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">69</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">77</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">160</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">162</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">158</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-28</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-33</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients. At week 26, the primary HbA1c endpoint was missing for 5.6%, 8.6% and 8.6% of patients randomized to placebo, RYBELSUS 7 mg and RYBELSUS 14 mg, respectively. Missing data were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 15%, 2% and 1% of patients randomized to placebo, RYBELSUS 7 mg and RYBELSUS 14 mg, respectively.

b Estimated using an ANCOVA model based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 88.6 kg, 89.0 kg and 88.1 kg in the placebo, RYBELSUS 7 mg, and RYBELSUS 14 mg arms, respectively. The mean changes from baseline to week 26 were -1.4 kg, -2.3 kg and

-3.7 kg in the placebo, RYBELSUS 7 mg and RYBELSUS 14 mg arms, respectively. The difference from placebo (95% CI) for RYBELSUS 7 mg was -0.9 kg (-1.9, 0.1) and for RYBELSUS 14 mg was -2.3 kg (-3.1, -1.5).

Combination with Metformin

In a 26-week trial (NCT02863328), 822 adult patients with type 2 mellitus diabetes were randomized to RYBELSUS 14 mg once daily or empagliflozin 25 mg once daily, all in combination with metformin. Patients had a mean age of 58 years and 50% were men. The mean duration of type 2 diabetes mellitus was 7.4 years and the mean BMI was 33 kg/m2. Overall, 86% were White, 7% were Black or African American and 6% were Asian; 24% identified as Hispanic or Latino ethnicity.

Treatment with RYBELSUS 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA1c compared to empagliflozin 25 mg once daily (see Table 5).

Table 5. Results at Week 26 in a Trial of RYBELSUS Compared to Empagliflozin in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin

<div class="scrollingtable"><table cellpadding="5.75pt" width="98.96%"> <col width="39%"/> <col width="31%"/> <col width="31%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Empagliflozin</span> </p> <p> <span class="Bold">25 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">411</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">410</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.9</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from empagliflozin<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.4 </p> <p>[-0.6, -0.3]<span class="Sup">c</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">67</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">40</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">172</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">174</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-36</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-36</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients. At week 26, the primary HbA1c endpoint was missing for 4.6% and 3.7% of patients randomized to RYBELSUS 14 mg and empagliflozin 25 mg, respectively. Missing data were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 1.9% and 1.2% of patients randomized to RYBELSUS 14 mg and empagliflozin 25 mg, respectively.

b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 91.9 kg and 91.3 kg in the RYBELSUS 14 mg and empagliflozin 25 mg arms, respectively. The mean changes from baseline to week 26 were -3.8 kg and -3.7 kg in the RYBELSUS 14 mg and empagliflozin 25 mg arms, respectively. The difference from empagliflozin (95% CI) for RYBELSUS 14 mg was -0.1 kg (-0.7, 0.5).

Combination with Metformin or Metformin with Sulfonylurea

In a 26-week, double-blind trial (NCT02607865), 1864 adult patients with type 2 mellitus diabetes on metformin alone or metformin with sulfonylurea were randomized to RYBELSUS 3 mg, RYBELSUS 7 mg, RYBELSUS 14 mg or sitagliptin 100 mg once daily. Patients had a mean age of 58 years and 53% were men. The mean duration of type 2 diabetes mellitus was 8.6 years, and the mean BMI was 32 kg/m2. Overall, 71% were White, 9% were Black or African American and 13% were Asian; 17% identified as Hispanic or Latino ethnicity.

Treatment with RYBELSUS 7 mg and RYBELSUS 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA1c compared to sitagliptin 100 mg once daily (see Table 6).

Table 6. Results at Week 26 in a Trial of RYBELSUS Compared to Sitagliptin 100 mg Once Daily in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with Sulfonylurea

<div class="scrollingtable"><table cellpadding="5.75pt" width="534.25pt"> <col width="38%"/> <col width="21%"/> <col width="21%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">7 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"> Sitagliptin</span> </p> <p> <span class="Bold">100 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">465</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">465</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">467</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.3</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from sitagliptin<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.3</p> <p>[-0.4; -0.1]<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.5</p> <p>[-0.6; -0.4]<span class="Sup">c</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">44</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">56</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">32</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">170</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">168</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">172</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-21</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-31</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-15</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients. At week 26, the primary HbA1c endpoint was missing for 5.8%, 6.2% and 4.5% of patients randomized to RYBELSUS 7 mg, RYBELSUS 14 mg and sitagliptin 100 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 2.4%, 1.1% and 2.8% of patients randomized to RYBELSUS 7 mg, RYBELSUS 14 mg and sitagliptin 100 mg, respectively.

b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 91.3 kg, 91.2 kg and 90.9 kg in the RYBELSUS 7 mg, RYBELSUS 14 mg and sitagliptin 100 mg arms, respectively. The mean changes from baseline to week 26 were -2.2 kg, -3.1 kg and -0.6 kg in the RYBELSUS 7 mg, RYBELSUS 14 mg and sitagliptin 100 mg arms, respectively. The difference from sitagliptin (95% CI) for RYBELSUS 7 mg was -1.6 kg (-2.0, -1.1) and RYBELSUS 14 mg was -2.5 kg (-3.0, -2.0).

Combination with Metformin or Metformin with SGLT-2 Inhibitors

In a 26-week, double-blind, double-dummy trial (NCT02863419), 711 adult patients with type 2 diabetes mellitus on metformin alone or metformin with SGLT-2 inhibitors were randomized to RYBELSUS 14 mg once daily, liraglutide 1.8 mg subcutaneous injection once daily or placebo. Patients had a mean age of 56 years and 52% were men. The mean duration of type 2 diabetes mellitus was 7.6 years and the mean BMI was 33 kg/m2. Overall, 73% were White, 4% were Black or African American and 13% were Asian; 6% identified as Hispanic or Latino ethnicity.

Treatment with RYBELSUS 14 mg once daily for 26 weeks resulted in statistically significant reductions in HbA1c compared to placebo. Treatment with RYBELSUS 14 mg once daily for 26 weeks resulted in non-inferior reductions in HbA1c compared to liraglutide 1.8 mg (see Table 7).

Table 7. Results at Week 26 in a Trial of RYBELSUS Compared to Liraglutide and Placebo in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with SGLT-2i

<div class="scrollingtable"><table width="534.65pt"> <col width="38%"/> <col width="21%"/> <col width="21%"/> <col width="21%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Liraglutide</span> </p> <p> <span class="Bold">1.8 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">142</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">285</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">284</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.1</p> <p>[-1.2; -0.9]<span class="Sup">c</span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from liraglutide<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.1</p> <p>[-0.3; 0]<span class="Sup"></span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">14</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">68</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">62</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">167</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">167</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">168</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-36</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-34</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients. At week 26, the primary HbA1c endpoint was missing for 5.6%, 4.2% and 2.5% of patients randomized to placebo, liraglutide 1.8 mg and RYBELSUS 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 7.7%, 3.2% and 3.5% of patients randomized to placebo, liraglutide 1.8 mg and RYBELSUS 14 mg respectively.

b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 93.2 kg, 95.5 kg and 92.9 kg in the placebo, liraglutide 1.8 mg and RYBELSUS 14 mg arms, respectively. The mean changes from baseline to week 26 were -0.5 kg, -3.1 kg and

-4.4 kg in the placebo, liraglutide 1.8 mg and RYBELSUS 14 mg arms, respectively. The difference from placebo (95% CI) for RYBELSUS 14 mg was -3.8 kg (-4.7, -3.0). The difference from liraglutide 1.8 mg for RYBELSUS 14 mg was -1.2 (-1.9, -0.6).

Combination in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment with Metformin alone, Sulfonylurea alone, Basal Insulin alone or Metformin in Combination with either Sulfonylurea or Basal Insulin

In a 26-week, double-blind trial (NCT02827708), 324 adult patients with moderate renal impairment (eGFRCKD-EPI 30-59 mL/min/1.73 m2) were randomized to RYBELSUS 14 mg or placebo once daily. RYBELSUS was added to the patient’s stable pre-trial antidiabetic regimen. The insulin dose was reduced by 20% at randomization for patients on basal insulin. Dose reduction of insulin and sulfonylurea was allowed in case of hypoglycemia; up titration of insulin was allowed but not beyond the pre-trial dose.

Patients had a mean age of 70 years and 48% were men. The mean duration of type 2 diabetes mellitus was 14 years and the mean BMI was 32 kg/m2. Overall, 96% were White, 4% were Black or African American and 0.3% were Asian; 6.5% identified as Hispanic or Latino ethnicity. 39.5% of patients had an eGFR value of 30 to 44 mL/min/1.73 m2.

Treatment with RYBELSUS 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA1c from baseline compared to placebo (see Table 8).

Table 8. Results at Week 26 in a Trial of RYBELSUS Compared to Placebo in Patients with Moderate Renal Impairment

<div class="scrollingtable"><table width="534.6pt"> <col width="42%"/> <col width="29%"/> <col width="29%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">161</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">163</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b</span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.8</p> <p>[-1.0; -0.6]<span class="Sup">c</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">23</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">58</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">164</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">164</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-28</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients including patients on rescue medication. At week 26, the primary HbA1c endpoint was missing for 3.7% and 5.5% of patients randomized to placebo and RYBELSUS 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 10% and 4.3% of patients randomized to placebo and RYBELSUS 14 mg, respectively.

b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication, renal status and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 90.4 kg and 91.3 kg in the placebo and RYBELSUS 14 mg arms, respectively. The mean changes from baseline to week 26 were -0.9 kg and -3.4 kg in the placebo and RYBELSUS 14 mg arms, respectively. The difference from placebo (95% CI) for RYBELSUS 14 mg was -2.5 kg (-3.2, -1.8).

Combination with Insulin with or without Metformin

In a 26-week double blind trial (NCT03021187), 731 adult patients with type 2 diabetes mellitus inadequately controlled on insulin (basal, basal/bolus or premixed) with or without metformin, were randomized to RYBELSUS 3 mg, 7 mg and 14 mg once daily or placebo once daily. All patients reduced their insulin dose by 20% at randomization to reduce the risk of hypoglycemia. Patients were allowed to increase the insulin dose only up to the starting insulin dose prior to randomization.

Patients had a mean age of 61 years and 54% were men. The mean duration of type 2 diabetes mellitus was 15 years and the mean BMI was 31 kg/m2. Overall, 51% were White, 7% were Black or African American and 36% were Asian; 13% identified as Hispanic or Latino ethnicity.

Treatment with RYBELSUS 7 mg and 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA1c from baseline compared to placebo once daily (see Table 9).

Table 9. Results at Week 26 in a Trial of RYBELSUS Compared to Placebo in Adult Patients with Type 2 Diabetes Mellitus in Combination with Insulin alone or with Metformin

<div class="scrollingtable"><table width="534.6pt"> <col width="40%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Placebo</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">7 mg</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">RYBELSUS</span> </p> <p> <span class="Bold">14 mg</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Intent-to-Treat (ITT) Population (N)<span class="Sup">a</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">184</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">182</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">181</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">HbA<span class="Sub">1c</span> (%)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.2</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">8.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.9</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.3</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Difference from placebo<span class="Sup">b </span> </dd> <dt> </dt> <dd>[95% CI]</dd> </dl> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-0.9</p> <p>[-1.1; -0.7]<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-1.2</p> <p>[-1.4; -1.0]<span class="Sup">c</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Patients (%) achieving HbA<span class="Sub">1c</span> &lt;7%<span class="Sup"></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">43</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">58</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">FPG (mg/dL)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <dl> <dt> </dt> <dd>Baseline (mean)</dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">150</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">153</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">150</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <dl> <dt> </dt> <dd>Change at week 26<span class="Sup">b</span> </dd> </dl> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-20</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">-24</p> </td> </tr> </tbody> </table></div>

a The intent-to-treat population includes all randomized patients. At week 26, the primary HbA1c endpoint was missing for 4.3%, 4.4% and 4.4% of patients randomized to placebo, RYBELSUS 7 mg and RYBELSUS 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 4.9%, 1.1 % and 2.2% of patients randomized to placebo, RYBELSUS 7 mg and RYBELSUS 14 mg, respectively.

b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region.

c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity.

The mean baseline body weight was 86.0 kg, 87.1 kg and 84.6 kg in the placebo, RYBELSUS 7 mg and RYBELSUS 14 mg arms, respectively. The mean changes from baseline to week 26 were -0.4 kg, -2.4 kg and

-3.7 kg in the placebo, RYBELSUS 7 mg and RYBELSUS 14 mg arms, respectively. The difference from placebo (95% CI) for RYBELSUS 7 mg was -2.0 kg (-3.0, -1.0) and for RYBELSUS 14 mg was -3.3 kg (-4.2, -2.3).

PIONEER 6 (NCT02692716) was a multi-center, multi-national, placebo-controlled, double-blind trial. In this trial, 3,183 adult patients with inadequately controlled type 2 diabetes mellitus and atherosclerotic cardiovascular disease were randomized to RYBELSUS 14 mg once daily or placebo for a median observation time of 16 months. The trial compared the risk of a Major Adverse Cardiovascular Event (MACE) between RYBELSUS 14 mg and placebo when these were added to and used concomitantly with standard of care treatments for diabetes and cardiovascular disease. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

Patients eligible to enter the trial were 50 years of age or older and had established, stable, cardiovascular, cerebrovascular, peripheral artery disease, chronic kidney disease or NYHA class II and III heart failure or were 60 years of age or older and had other specified risk factors for cardiovascular disease. In total, 1,797 patients (56.5%) had established cardiovascular disease without chronic kidney disease, 354 patients (11.1%) had chronic kidney disease only, and 544 patients (17.1%) had both cardiovascular disease and kidney disease; 488 patients (15.3%) had cardiovascular risk factors without established cardiovascular disease or chronic kidney disease. The mean age at baseline was 66 years and 68% were men. The mean duration of diabetes was 14.9 years and mean BMI was 32 kg/m2. Overall, 72% were White, 6% were Black or African American and 20% were Asian; 16% identified as Hispanic or Latino ethnicity. Concomitant diseases of patients in this trial included, but were not limited to, heart failure (12%), history of ischemic stroke (8%) and history of a myocardial infarction (36%). In total, 99.7% of the patients completed the trial and the vital status was known at the end of the trial for 100%.

For the primary analysis, a Cox proportional hazards model was used to test for non-inferiority of RYBELSUS 14 mg to placebo for time to first MACE using a risk margin of 1.3. Type-1 error was controlled across multiple tests using a hierarchical testing strategy. Non‑inferiority to placebo was established, with a hazard ratio equal to 0.79 (95% CI: 0.57, 1.11) over the median observation time of 16-months. The proportion of patients who experienced at least one MACE was 3.8% (61/1591) for RYBELSUS 14 mg and 4.8% (76/1592) for placebo.

How Supplied

{ "type": "p", "children": [], "text": "\nHow Supplied\n" }

RYBELSUS (formulation R1) strengths are available as follows:

{ "type": "p", "children": [], "text": "RYBELSUS (formulation R1) strengths are available as follows:" }

<div class="scrollingtable"><table width="513pt"> <col width="11%"/> <col width="51%"/> <col width="18%"/> <col width="19%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Tablet Strength</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Description</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Package Configuration</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">NDC Number</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">3 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4303-30</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">7 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4307-30</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">14 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4314-30</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"513pt\">\n<col width=\"11%\"/>\n<col width=\"51%\"/>\n<col width=\"18%\"/>\n<col width=\"19%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Tablet Strength</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Description</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Package Configuration</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">NDC Number</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">3 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4303-30</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">7 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4307-30</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">14 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4314-30</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

RYBELSUS (formulation R2) strengths are available as follows:

{ "type": "p", "children": [], "text": "RYBELSUS (formulation R2) strengths are available as follows:" }

<div class="scrollingtable"><table width="100%"> <col width="11%"/> <col width="51%"/> <col width="18%"/> <col width="19%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Tablet Strength</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Description</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Package Configuration</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">NDC Number</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">1.5 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4815-30 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">4 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4804-30 </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">9 mg</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side</p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Bottle of 30 tablets </p> </td><td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0169-4809-30 </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"11%\"/>\n<col width=\"51%\"/>\n<col width=\"18%\"/>\n<col width=\"19%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Tablet Strength</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Description</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">Package Configuration</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">NDC Number</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">1.5 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4815-30 </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">4 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4804-30 </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">9 mg</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Bottle of 30 tablets </p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0169-4809-30 </p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Storage and Handling

{ "type": "p", "children": [], "text": "\nStorage and Handling\n" }

Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Store and dispense in the original bottle.

{ "type": "p", "children": [], "text": "Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Store and dispense in the original bottle." }

Store tablet in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture.

{ "type": "p", "children": [], "text": "Store tablet in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture." }

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Medication Guide)." }

Risk of Thyroid C-cell Tumors

{ "type": "p", "children": [], "text": "\nRisk of Thyroid C-cell Tumors\n" }

Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions (5.1)]." }

Acute Pancreatitis

{ "type": "p", "children": [], "text": "\nAcute Pancreatitis\n" }

Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting. Instruct patients to discontinue RYBELSUS promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting. Instruct patients to discontinue RYBELSUS promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2)]." }

Diabetic Retinopathy Complications

{ "type": "p", "children": [], "text": "\nDiabetic Retinopathy Complications\n" }

Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS [see Warnings and Precautions (5.3)]." }

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

{ "type": "p", "children": [], "text": "\nHypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin\n" }

Inform patients that the risk of hypoglycemia is increased when RYBELSUS is used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Inform patients that the risk of hypoglycemia is increased when RYBELSUS is used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4)].\n" }

Dehydration and Renal Failure

{ "type": "p", "children": [], "text": "\nDehydration and Renal Failure\n" }

Advise patients treated with RYBELSUS of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Advise patients treated with RYBELSUS of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs [see Warnings and Precautions (5.5)]." }

Severe Gastrointestinal Adverse Reactions

{ "type": "p", "children": [], "text": "\nSevere Gastrointestinal Adverse Reactions\n" }

Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.6)].\n" }

Hypersensitivity Reactions

{ "type": "p", "children": [], "text": "\nHypersensitivity Reactions\n" }

Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of RYBELSUS. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking RYBELSUS and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of RYBELSUS. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking RYBELSUS and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.7)]." }

Acute Gallbladder Disease

{ "type": "p", "children": [], "text": "\nAcute Gallbladder Disease\n" }

Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.8)].

{ "type": "p", "children": [], "text": "Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.8)]. " }

Pulmonary Aspiration During General Anesthesia or Deep Sedation:

{ "type": "p", "children": [], "text": "\nPulmonary Aspiration During General Anesthesia or Deep Sedation:\n" }

Inform patients that RYBELSUS may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS [see Warnings and Precautions (5.9)].

{ "type": "p", "children": [], "text": "Inform patients that RYBELSUS may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS [see Warnings and Precautions (5.9)].\n" }

Pregnancy

{ "type": "p", "children": [], "text": "\nPregnancy\n" }

Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in SpecificPopulations (8.1), (8.3)].

{ "type": "p", "children": [], "text": "Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in SpecificPopulations (8.1), (8.3)]." }

Lactation

{ "type": "p", "children": [], "text": "\nLactation \n" }

RYBELSUS passes into breast milk, and it is not known how it affects your baby. Advise females not to breastfeed during treatment with RYBELSUS [see Use in Specific Populations (8.2)].

{ "type": "p", "children": [], "text": "RYBELSUS passes into breast milk, and it is not known how it affects your baby. Advise females not to breastfeed during treatment with RYBELSUS [see Use in Specific Populations (8.2)]." }

Females and Males of Reproductive Potential

{ "type": "p", "children": [], "text": "\nFemales and Males of Reproductive Potential\n" }

Discontinue RYBELSUS at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations (8.3)].

{ "type": "p", "children": [], "text": "Discontinue RYBELSUS at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations (8.3)]." }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Novo Nordisk A/S

{ "type": "p", "children": [], "text": "Novo Nordisk A/S" }

DK-2880 Bagsvaerd

{ "type": "p", "children": [], "text": "DK-2880 Bagsvaerd" }

Denmark

{ "type": "p", "children": [], "text": "Denmark" }

For additional information about RYBELSUS contact:

{ "type": "p", "children": [], "text": "For additional information about RYBELSUS contact:" }

Novo Nordisk Inc.

{ "type": "p", "children": [], "text": "Novo Nordisk Inc." }

800 Scudders Mill Road

{ "type": "p", "children": [], "text": "800 Scudders Mill Road" }

Plainsboro, NJ 08536

{ "type": "p", "children": [], "text": "Plainsboro, NJ 08536" }

1-833-457-7455

{ "type": "p", "children": [], "text": "1-833-457-7455" }

Version: 8

{ "type": "p", "children": [], "text": "Version: 8" }

RYBELSUS® and OZEMPIC® are registered trademarks of Novo Nordisk A/S.

{ "type": "p", "children": [], "text": "\nRYBELSUS® and OZEMPIC® are registered trademarks of Novo Nordisk A/S.\n" }

Patent Information: http://www.novonordisk-us.com/products/product-patents.html

{ "type": "p", "children": [], "text": "Patent Information: http://www.novonordisk-us.com/products/product-patents.html" }

© 2024 Novo Nordisk

{ "type": "p", "children": [], "text": "© 2024 Novo Nordisk" }

<div class="scrollingtable"><table width="540pt"> <col width="33%"/> <col width="17%"/> <col width="6%"/> <col width="43%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First"> <span class="Bold">MEDICATION GUIDE</span> </p> <p>RYBELSUS<span class="Sup">®</span> (reb-EL-sus)</p> <p>(semaglutide)</p> <p>tablets, for oral use</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First">Read this Medication Guide before you start using RYBELSUS and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about RYBELSUS?</span> </p> <p> <span class="Bold">RYBELSUS may cause serious side effects, including:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Possible thyroid tumors, including cancer. </span>Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and medicines that work like RYBELSUS caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.</dd> <dt>•</dt> <dd>Do not use RYBELSUS if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What is RYBELSUS?</span> </p> <p>RYBELSUS is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.</p> <dl> <dt>•</dt> <dd>RYBELSUS is not for use in people with type 1 diabetes.</dd> </dl> <p>It is not known if RYBELSUS is safe and effective for use in children.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Do not use RYBELSUS if:</span> </p> <dl> <dt>•</dt> <dd>you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd> <dt>•</dt> <dd>you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS.<span class="Bold"></span>Symptoms of a serious allergic reaction include:<dl> <dt>o</dt> <dd>swelling of your face, lips, tongue or throat</dd> <dt>o</dt> <dd>problems breathing or swallowing</dd> <dt>o</dt> <dd>severe rash or itching</dd> <dt>o</dt> <dd>fainting or feeling dizzy</dd> <dt>o</dt> <dd>very rapid heartbeat</dd> </dl> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Before using RYBELSUS, tell your healthcare provider if you have any other medical conditions, including if you:</span> </p> <dl> <dt>•</dt> <dd>have or have had problems with your pancreas or kidneys.</dd> <dt>•</dt> <dd>have a history of vision problems related to your diabetes.</dd> <dt>•</dt> <dd>are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</dd> <dt>•</dt> <dd>are pregnant or plan to become pregnant. It is not known if RYBELSUS will harm your unborn baby. You should stop using RYBELSUS 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.</dd> <dt>•</dt> <dd>are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS.</dd> </dl> <p> <span class="Bold">Tell your healthcare provider about all the medicines you take, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS may affect the way some medicines work, and some medicines may affect the way RYBELSUS works.</p> <p> <span class="Bold">Before using RYBELSUS, talk to your healthcare provider about low blood sugar and how to manage it. </span>Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.</p> <p>Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">How should I take RYBELSUS?</span> </p> <dl> <dt>•</dt> <dd>Take RYBELSUS exactly as your healthcare provider tells you to.</dd> <dt>•</dt> <dd>Do not take more than 1 tablet each day.</dd> <dt>•</dt> <dd>Take RYBELSUS by mouth on an empty stomach in the morning.</dd> <dt>•</dt> <dd>Take RYBELSUS with a sip of plain water (no more than 4 ounces). Do not take RYBELSUS with any other liquids besides water.</dd> <dt>•</dt> <dd>Do not split, crush or chew. Swallow RYBELSUS whole.</dd> <dt>•</dt> <dd>After 30 minutes, you can eat, drink, or take other oral medicines.</dd> <dt>•</dt> <dd>If you miss a dose of RYBELSUS, skip the missed dose and go back to your regular schedule.</dd> <dt>•</dt> <dd>If you take too much RYBELSUS, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.</dd> </dl> <p> <span class="Bold">Your dose of RYBELSUS and other diabetes medicines may need to change because of:</span> </p> <p>change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of RYBELSUS?</span> </p> <p> <span class="Bold">RYBELSUS may cause serious side effects, including:</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">See “What is the most important information I should know about RYBELSUS?”</span> </dd> <dt>•</dt> <dd> <span class="Bold">inflammation of your pancreas</span><span class="Bold">(pancreatitis). </span>Stop using RYBELSUS and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.</dd> <dt>•</dt> <dd> <span class="Bold">changes in vision.</span> Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS.</dd> <dt>•</dt> <dd> <span class="Bold">low blood sugar (hypoglycemia).</span> Your risk for getting low blood sugar may be higher if you use RYBELSUS with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. <span class="Bold">Signs and symptoms of low blood sugar may include:</span> </dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"> <dl> <dt>o</dt> <dd>dizziness or light-headedness</dd> </dl> </td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>blurred vision</dd> </dl> </td><td class="Rrule" valign="top"> <dl> <dt>o</dt> <dd>anxiety, irritability, or mood changes</dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"> <dl> <dt>o</dt> <dd>sweating</dd> </dl> </td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>slurred speech</dd> </dl> </td><td class="Rrule" valign="top"> <dl> <dt>o</dt> <dd>hunger</dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"> <dl> <dt>o</dt> <dd>confusion or drowsiness</dd> </dl> </td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>shakiness</dd> </dl> </td><td class="Rrule" valign="top"> <dl> <dt>o</dt> <dd>weakness</dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"> <dl> <dt>o</dt> <dd>headache</dd> </dl> </td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>fast heartbeat</dd> </dl> </td><td class="Rrule" valign="top"> <dl> <dt>o</dt> <dd>feeling jittery</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">kidney problems (kidney failure).</span> In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.</dd> <dt>•</dt> <dd> <span class="Bold">severe stomach problems. </span>Stomach problems, sometimes severe, have been reported in people who use RYBELSUS. Tell your healthcare provider if you have stomach problems that are severe or will not go away.</dd> <dt>•</dt> <dd> <span class="Bold">serious</span><span class="Bold">allergic reactions.</span> Stop using RYBELSUS and get medical help right away, if you have any symptoms of a serious allergic reaction including:<dl> <dt>o</dt> <dd>swelling of your face, lips, tongue or throat</dd> <dt>o</dt> <dd>problems breathing or swallowing</dd> <dt>o</dt> <dd>severe rash or itching</dd> <dt>o</dt> <dd>fainting or feeling dizzy</dd> <dt>o</dt> <dd>very rapid heartbeat</dd> </dl> </dd> <dt>•</dt> <dd> <span class="Bold">gallbladder problems.</span> Gallbladder problems have happened in some people who take RYBELSUS. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:</dd> </dl> </td> </tr> <tr> <td class="Lrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>pain in your upper stomach (abdomen)</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>yellowing of skin or eyes (jaundice)</dd> </dl> </td> </tr> <tr> <td class="Lrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>fever</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>clay-colored stools</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</span> RYBELSUS may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS before you are scheduled to have surgery or other procedures.</dd> </dl> <p class="First"> <span class="Bold">The most common side effects of RYBELSUS may include</span> nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS. </p> <p>Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS.</p> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">How should I store RYBELSUS?</span> </p> <dl> <dt>•</dt> <dd>Store RYBELSUS at room temperature between 68°F and 77°F (20°C to 25°C).</dd> <dt>•</dt> <dd>Store in a dry place away from moisture.</dd> <dt>•</dt> <dd>Store tablets in the original closed RYBELSUS bottle until you are ready to take one. Do not store in any other container.</dd> <dt>•</dt> <dd> <span class="Bold">Keep RYBELSUS and all medicines out of the reach of children.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of RYBELSUS.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS for a condition for which it was not prescribed. Do not give RYBELSUS to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS that is written for health professionals.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in RYBELSUS?</span> </p> <p> <span class="Bold">Active Ingredient: </span>semaglutide</p> <p> <span class="Bold">Inactive Ingredients:</span> </p> <dl> <dt>•</dt> <dd>RYBELSUS (formulation R1): magnesium stearate, microcrystalline cellulose, povidone and<span class="Bold"></span>salcaprozate sodium</dd> <dt>•</dt> <dd>RYBELSUS (formulation R2): salcaprozate sodium and magnesium stearate</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" colspan="4" valign="top"> <p class="First">Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark</p> <p> <span class="Italics">RYBELSUS<span class="Sup">®</span> is a registered trademark of Novo Nordisk A/S.</span> </p> <p>PATENT Information: http://www.novonordisk-us.com/products/product-patents.html</p> <p>© 2024 Novo Nordisk</p> <p>For more information, go to www.RYBELSUS.com or call 1-833-GLP-PILL.</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"540pt\">\n<col width=\"33%\"/>\n<col width=\"17%\"/>\n<col width=\"6%\"/>\n<col width=\"43%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">MEDICATION GUIDE</span>\n</p>\n<p>RYBELSUS<span class=\"Sup\">®</span> (reb-EL-sus)</p>\n<p>(semaglutide)</p>\n<p>tablets, for oral use</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">Read this Medication Guide before you start using RYBELSUS and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about RYBELSUS?</span>\n</p>\n<p>\n<span class=\"Bold\">RYBELSUS may cause serious side effects, including:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Possible thyroid tumors, including cancer. </span>Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and medicines that work like RYBELSUS caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.</dd>\n<dt>•</dt>\n<dd>Do not use RYBELSUS if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is RYBELSUS?</span>\n</p>\n<p>RYBELSUS is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.</p>\n<dl>\n<dt>•</dt>\n<dd>RYBELSUS is not for use in people with type 1 diabetes.</dd>\n</dl>\n<p>It is not known if RYBELSUS is safe and effective for use in children.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use RYBELSUS if:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).</dd>\n<dt>•</dt>\n<dd>you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS.<span class=\"Bold\"></span>Symptoms of a serious allergic reaction include:<dl>\n<dt>o</dt>\n<dd>swelling of your face, lips, tongue or throat</dd>\n<dt>o</dt>\n<dd>problems breathing or swallowing</dd>\n<dt>o</dt>\n<dd>severe rash or itching</dd>\n<dt>o</dt>\n<dd>fainting or feeling dizzy</dd>\n<dt>o</dt>\n<dd>very rapid heartbeat</dd>\n</dl>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before using RYBELSUS, tell your healthcare provider if you have any other medical conditions, including if you:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>have or have had problems with your pancreas or kidneys.</dd>\n<dt>•</dt>\n<dd>have a history of vision problems related to your diabetes.</dd>\n<dt>•</dt>\n<dd>are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</dd>\n<dt>•</dt>\n<dd>are pregnant or plan to become pregnant. It is not known if RYBELSUS will harm your unborn baby. You should stop using RYBELSUS 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.</dd>\n<dt>•</dt>\n<dd>are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take, </span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS may affect the way some medicines work, and some medicines may affect the way RYBELSUS works.</p>\n<p>\n<span class=\"Bold\">Before using RYBELSUS, talk to your healthcare provider about low blood sugar and how to manage it. </span>Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.</p>\n<p>Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take RYBELSUS?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Take RYBELSUS exactly as your healthcare provider tells you to.</dd>\n<dt>•</dt>\n<dd>Do not take more than 1 tablet each day.</dd>\n<dt>•</dt>\n<dd>Take RYBELSUS by mouth on an empty stomach in the morning.</dd>\n<dt>•</dt>\n<dd>Take RYBELSUS with a sip of plain water (no more than 4 ounces). Do not take RYBELSUS with any other liquids besides water.</dd>\n<dt>•</dt>\n<dd>Do not split, crush or chew. Swallow RYBELSUS whole.</dd>\n<dt>•</dt>\n<dd>After 30 minutes, you can eat, drink, or take other oral medicines.</dd>\n<dt>•</dt>\n<dd>If you miss a dose of RYBELSUS, skip the missed dose and go back to your regular schedule.</dd>\n<dt>•</dt>\n<dd>If you take too much RYBELSUS, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Your dose of RYBELSUS and other diabetes medicines may need to change because of:</span>\n</p>\n<p>change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of RYBELSUS?</span>\n</p>\n<p>\n<span class=\"Bold\">RYBELSUS may cause serious side effects, including:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">See “What is the most important information I should know about RYBELSUS?”</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">inflammation of your pancreas</span><span class=\"Bold\">(pancreatitis). </span>Stop using RYBELSUS and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">changes in vision.</span> Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">low blood sugar (hypoglycemia).</span> Your risk for getting low blood sugar may be higher if you use RYBELSUS with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. <span class=\"Bold\">Signs and symptoms of low blood sugar may include:</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>dizziness or light-headedness</dd>\n</dl>\n</td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>blurred vision</dd>\n</dl>\n</td><td class=\"Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>anxiety, irritability, or mood changes</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>sweating</dd>\n</dl>\n</td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>slurred speech</dd>\n</dl>\n</td><td class=\"Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>hunger</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>confusion or drowsiness</dd>\n</dl>\n</td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>shakiness</dd>\n</dl>\n</td><td class=\"Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>weakness</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>headache</dd>\n</dl>\n</td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>fast heartbeat</dd>\n</dl>\n</td><td class=\"Rrule\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>feeling jittery</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">kidney problems (kidney failure).</span> In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">severe stomach problems. </span>Stomach problems, sometimes severe, have been reported in people who use RYBELSUS. Tell your healthcare provider if you have stomach problems that are severe or will not go away.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">serious</span><span class=\"Bold\">allergic reactions.</span> Stop using RYBELSUS and get medical help right away, if you have any symptoms of a serious allergic reaction including:<dl>\n<dt>o</dt>\n<dd>swelling of your face, lips, tongue or throat</dd>\n<dt>o</dt>\n<dd>problems breathing or swallowing</dd>\n<dt>o</dt>\n<dd>severe rash or itching</dd>\n<dt>o</dt>\n<dd>fainting or feeling dizzy</dd>\n<dt>o</dt>\n<dd>very rapid heartbeat</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">gallbladder problems.</span> Gallbladder problems have happened in some people who take RYBELSUS. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>pain in your upper stomach (abdomen)</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>yellowing of skin or eyes (jaundice)</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>fever</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>clay-colored stools</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).</span> RYBELSUS may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS before you are scheduled to have surgery or other procedures.</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">The most common side effects of RYBELSUS may include</span> nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS. </p>\n<p>Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS.</p>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store RYBELSUS?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Store RYBELSUS at room temperature between 68°F and 77°F (20°C to 25°C).</dd>\n<dt>•</dt>\n<dd>Store in a dry place away from moisture.</dd>\n<dt>•</dt>\n<dd>Store tablets in the original closed RYBELSUS bottle until you are ready to take one. Do not store in any other container.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Keep RYBELSUS and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of RYBELSUS.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS for a condition for which it was not prescribed. Do not give RYBELSUS to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS that is written for health professionals.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in RYBELSUS?</span>\n</p>\n<p>\n<span class=\"Bold\">Active Ingredient: </span>semaglutide</p>\n<p>\n<span class=\"Bold\">Inactive Ingredients:</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>RYBELSUS (formulation R1): magnesium stearate, microcrystalline cellulose, povidone and<span class=\"Bold\"></span>salcaprozate sodium</dd>\n<dt>•</dt>\n<dd>RYBELSUS (formulation R2): salcaprozate sodium and magnesium stearate</dd>\n</dl>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark</p>\n<p>\n<span class=\"Italics\">RYBELSUS<span class=\"Sup\">®</span> is a registered trademark of Novo Nordisk A/S.</span>\n</p>\n<p>PATENT Information: http://www.novonordisk-us.com/products/product-patents.html</p>\n<p>© 2024 Novo Nordisk</p>\n<p>For more information, go to www.RYBELSUS.com or call 1-833-GLP-PILL.</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "", "children": [], "text": "" }

NDC 0169-4303-13List 430313

{ "type": "p", "children": [], "text": "NDC 0169-4303-13List 430313" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

3 mg

{ "type": "p", "children": [], "text": "\n3 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Each tablet contains 3 mg semaglutide

{ "type": "p", "children": [], "text": "Each tablet contains 3 mg semaglutide" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

Dispense the Enclosed Medication Guide to Each Patient

{ "type": "p", "children": [], "text": "\nDispense the Enclosed Medication Guide to Each Patient\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

3 blister packs. Each pack contains 10 tablets.

{ "type": "p", "children": [], "text": "3 blister packs. Each pack contains 10 tablets." }

Open Here

{ "type": "p", "children": [], "text": "\nOpen Here\n" }

NDC 0169-4307-13List 430313

{ "type": "p", "children": [], "text": "NDC 0169-4307-13List 430313" }

RYBELSUS®7mg

{ "type": "p", "children": [], "text": "\nRYBELSUS®7mg\n" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

7 mg

{ "type": "p", "children": [], "text": "\n7 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Each tablet contains 7 mg semaglutide

{ "type": "p", "children": [], "text": "Each tablet contains 7 mg semaglutide" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

Dispense the Enclosed Medication Guide to Each Patient

{ "type": "p", "children": [], "text": "\nDispense the Enclosed Medication Guide to Each Patient\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

3 blister packs. Each pack contains 10 tablets.

{ "type": "p", "children": [], "text": "3 blister packs. Each pack contains 10 tablets." }

Open Here

{ "type": "p", "children": [], "text": "\nOpen Here\n" }

NDC 0169-4314-13List 431413

{ "type": "p", "children": [], "text": "NDC 0169-4314-13List 431413" }

RYBELSUS® 14mg

{ "type": "p", "children": [], "text": "\nRYBELSUS®\t14mg\n" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

14 mg

{ "type": "p", "children": [], "text": "\n14 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Each tablet contains 14 mg semaglutide

{ "type": "p", "children": [], "text": "Each tablet contains 14 mg semaglutide" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

Dispense the Enclosed Medication Guide to Each Patient

{ "type": "p", "children": [], "text": "\nDispense the Enclosed Medication Guide to Each Patient\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

3 blister packs. Each pack contains 10 tablets.

{ "type": "p", "children": [], "text": "3 blister packs. Each pack contains 10 tablets." }

Open Here

{ "type": "p", "children": [], "text": "\nOpen Here\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

3 mg

{ "type": "p", "children": [], "text": "\n3 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

7 mg

{ "type": "p", "children": [], "text": "\n7 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

14 mg

{ "type": "p", "children": [], "text": "\n14 mg\n" }

Once daily

{ "type": "p", "children": [], "text": "\nOnce daily\n" }

Oral use only

{ "type": "p", "children": [], "text": "\nOral use only\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

1.5 mg

{ "type": "p", "children": [], "text": "\n1.5 mg\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis

{ "type": "p", "children": [], "text": "\nNote to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis\n" }

New Formulation

{ "type": "p", "children": [], "text": "\nNew Formulation\n" }

(Formulation R2)

{ "type": "p", "children": [], "text": "\n(Formulation R2)\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

4 mg

{ "type": "p", "children": [], "text": "\n4 mg\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis

{ "type": "p", "children": [], "text": "\nNote to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis\n" }

New Formulation

{ "type": "p", "children": [], "text": "\nNew Formulation\n" }

(Formulation R2)

{ "type": "p", "children": [], "text": "\n(Formulation R2)\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }

{ "type": "", "children": [], "text": "" }

(semaglutide) Tablets

{ "type": "p", "children": [], "text": "\n(semaglutide) Tablets\n" }

9 mg

{ "type": "p", "children": [], "text": "\n9 mg\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

DISPENSE WITH MEDICATION GUIDE

{ "type": "p", "children": [], "text": "\nDISPENSE WITH MEDICATION GUIDE\n" }

Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis

{ "type": "p", "children": [], "text": "\nNote to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis\n" }

New Formulation

{ "type": "p", "children": [], "text": "\nNew Formulation\n" }

(Formulation R2)

{ "type": "p", "children": [], "text": "\n(Formulation R2)\n" }

30 tablets

{ "type": "p", "children": [], "text": "\n30 tablets\n" }