Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.

Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about Glucagon for Injection and its Instructions for Use. Administer Glucagon for Injection as soon as possible when severe hypoglycemia is recognized.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Glucagon for Injection. Emphasize the following instructions to the patient or caregiver:

Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Older

Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age

Glucagon for Injection is a white lyophilized powder supplied as follows:

{ "type": "p", "children": [], "text": "Glucagon for Injection is a white lyophilized powder supplied as follows:\n" }

Treatment of Severe Hypoglycemia

{ "type": "p", "children": [], "text": "\nTreatment of Severe Hypoglycemia\n" }

{ "type": "ul", "children": [ "1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose syringe of Sterile Water for Injection, USP (Glucagon Emergency Kit for Low Blood Sugar)\n" ], "text": "" }

Use as a Diagnostic Aid

{ "type": "p", "children": [], "text": "\nUse as a Diagnostic Aid\n" }

{ "type": "ul", "children": [ "1 mg single-dose vial of Glucagon for Injection\n", "1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit)\n" ], "text": "" }

Glucagon for Injection is contraindicated in patients with:

{ "type": "p", "children": [], "text": "Glucagon for Injection is contraindicated in patients with:\n" }

{ "type": "ul", "children": [ "Pheochromocytoma [see Warnings and Precautions (5.1)]\n", "Insulinoma [see Warnings and Precautions (5.2)] because of the risk of hypoglycemia\n", "Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)]\n", "Glucagonoma [see Warnings and Precautions (5.8)] because of risk of hypoglycemia when used as a diagnostic aid\n" ], "text": "" }

Glucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see Contraindications (4)]. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Glucagon for Injection administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Glucagon for Injection is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Glucagon for Injection is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].

Glucagon for Injection is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for Glucagon for Injection administration to be effective. Patients with these conditions should be treated with glucose.

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagonproducing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

Treatment with Glucagon for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated.

Glucagon for Injection may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of Glucagon for Injection as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy.

Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Glucagon for Injection is contraindicated in patients with glucagonoma when used as a diagnostic aid [see Contraindications (4)]. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.

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 the rates in clinical trials of another drug and may not reflect the rates observed in practice.

In a randomized single-blind clinical study of Glucagon for Injection, 29 healthy subjects received a single dose of 1 mg Glucagon for Injection intramuscularly. Table 1 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: Adverse Reactions Occurring in ≥ 5% of Healthy Subjects Who Received Glucagon for Injection Intramuscularly </span> </caption> <col align="left" width="32.150%"/> <col align="left" width="67.850%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="left" class="Botrule Rrule Toprule" valign="top">Glucagon for Injection<br/>(N=29)<br/>% of Patients </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea </td><td align="left" class="Botrule Rrule" valign="top">17 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting </td><td align="left" class="Botrule Rrule" valign="top">7 </td> </tr> </tbody> </table></div>

In a randomized, single-blind clinical study of Glucagon for Injection, 31 healthy subjects received a single dose of 1 mg Glucagon for Injection subcutaneously. Table 2 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients. (2.1)].

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: Adverse Reactions Occurring ≥5% in Healthy Subjects Who Received Glucagon for Injection Subcutaneously </span> </caption> <col align="left" width="52.750%"/> <col align="left" width="47.250%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" valign="top">Glucagon for Injection<br/>(N=31)<br/>% of Patients </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Injection site swelling </td><td align="center" class="Botrule Rrule" valign="top">58 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Injection site erythema </td><td align="center" class="Botrule Rrule" valign="top">55 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting </td><td align="center" class="Botrule Rrule" valign="top">36 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea </td><td align="center" class="Botrule Rrule" valign="top">32 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Decreased blood pressure </td><td align="center" class="Botrule Rrule" valign="top">23 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Asthenia </td><td align="center" class="Botrule Rrule" valign="top">23 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Headache </td><td align="center" class="Botrule Rrule" valign="top">13 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dizziness </td><td align="center" class="Botrule Rrule" valign="top">10 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Pallor </td><td align="center" class="Botrule Rrule" valign="top">10 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Diarrhea </td><td align="center" class="Botrule Rrule" valign="top">7 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Somnolence </td><td align="center" class="Botrule Rrule" valign="top">7 </td> </tr> </tbody> </table></div>

Other Adverse Reactions

Hypertension and tachycardia have occurred with glucagon treatment.

Additional adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Clinically Significant Drug Interactions with Glucagon for Injection </span> </caption> <col align="left" width="17.100%"/> <col align="left" width="82.900%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Beta-Blockers</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact:</span></td><td align="left" class="Botrule Rrule" valign="top">Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Glucagon for Injection. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention:</span></td><td align="left" class="Botrule Rrule" valign="top">The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Indomethacin</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact:</span></td><td align="left" class="Botrule Rrule" valign="top">In patients taking indomethacin, Glucagon for Injection may lose its ability to raise blood glucose or may even produce hypoglycemia. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention:</span></td><td align="left" class="Botrule Rrule" valign="top">Monitor blood glucose levels during glucagon treatment of patients taking indomethacin. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Anticholinergic Drugs</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle"><span class="Italics">Clinical Impact:</span></td><td align="left" class="Botrule Rrule" valign="top">The concomitant use of anticholinergic drugs and Glucagon for Injection increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention:</span></td><td align="left" class="Botrule Rrule" valign="top">Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Warfarin</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact:</span></td><td align="left" class="Botrule Rrule" valign="top">Glucagon for Injection may increase the anticoagulant effect of warfarin. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention:</span></td><td align="left" class="Botrule Rrule" valign="top">Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Insulin</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Clinical Impact:</span></td><td align="left" class="Botrule Rrule" valign="top">Insulin acts antagonistically to glucagon. </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Italics">Intervention:</span></td><td align="left" class="Botrule Rrule" valign="top">Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. </td> </tr> </tbody> </table></div>

Risk Summary

Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m2) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Data

Animal Data

In rats and rabbits given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality.

Risk Summary

There is no information available on the presence of glucagon in human or animal milk, the effects of glucagon on the breastfed child or the effects of glucagon on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.

The safety and effectiveness of Glucagon for Injection for the treatment of severe hypoglycemia in pediatric patients with diabetes have been established.

Safety and effectiveness for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

{ "type": "p", "children": [], "text": "If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.\n" }

Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by solid phase peptide synthesis. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:

{ "type": "p", "children": [], "text": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by solid phase peptide synthesis. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="50.000%"/> <col align="left" width="50.000%"/> <tbody class="Headless"> <tr> <td align="center" colspan="2" valign="top"><a name="f01"></a><img alt="Figure " src="/dailymed/image.cfm?name=glu02-0004-01.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/></td> </tr> <tr> <td align="right" valign="top">Molecular Formula = C<span class="Sub">153</span>H<span class="Sub">225</span>N<span class="Sub">43</span>O<span class="Sub">49</span>S                </td><td align="left" valign="top">               Molecular Weight = 3483 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"50.000%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" colspan=\"2\" valign=\"top\"><a name=\"f01\"></a><img alt=\"Figure\n\" src=\"/dailymed/image.cfm?name=glu02-0004-01.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/></td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\">Molecular Formula = C<span class=\"Sub\">153</span>H<span class=\"Sub\">225</span>N<span class=\"Sub\">43</span>O<span class=\"Sub\">49</span>S               \n</td><td align=\"left\" valign=\"top\">               Molecular Weight = 3483\n</td>\n</tr>\n</tbody>\n</table></div>" }

Glucagon for Injection is a sterile, lyophilized white powder in a 3 mL vial for subcutaneous, intramuscular or intravenous use. The reconstituted solution contains glucagon as hydrochloride 1 mg per mL and lactose monohydrate (107 mg). Glucagon for Injection is supplied at pH 2.5 to 3.5 and is soluble in water.

{ "type": "p", "children": [], "text": "Glucagon for Injection is a sterile, lyophilized white powder in a 3 mL vial for subcutaneous, intramuscular or intravenous use. The reconstituted solution contains glucagon as hydrochloride 1 mg per mL and lactose monohydrate (107 mg). Glucagon for Injection is supplied at pH 2.5 to 3.5 and is soluble in water.\n" }

Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.

Treatment of Severe Hypoglycemia

Blood glucose concentration rises within 10 minutes of injection and maximal concentrations are attained at approximately 30 minutes after injection (see Figure 1). The duration of hyperglycemic action after intravenous or intramuscular injection is 60 to 90 minutes.

Figure 1. Recovery from Insulin Induced Hypoglycemia (mean blood glucose) After Intramuscular Injection of 1 mg of Another Glucagon for Injection Product in Type I Diabetic Men

Diagnostic Aid

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 4: Pharmacodynamic Properties of Another Glucagon for Injection Product For Intravenous Route </span> </caption> <col align="left" width="24.755%"/> <col align="left" width="14.937%"/> <col align="left" width="21.636%"/> <col align="left" width="21.556%"/> <col align="left" width="17.117%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top"> <p class="First Footnote"> <span class="Sup">a</span>Dose is determined based on the length of the procedure. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Route of Administration</span></td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Dose</span><span class="Bold"><span class="Sup">a</span></span></td><td align="left" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Time of Maximal</span> <br/> <span class="Bold">Glucose</span> <br/> <span class="Bold">Concentration</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Time of Onset of</span> <br/> <span class="Bold">Action for GI Smooth Muscle Relaxation</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Duration of</span> <br/> <span class="Bold">Smooth Muscle Relaxation</span></td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top">Intravenous </td><td align="left" class="Botrule Rrule" valign="top">0.25 to 0.5 mg </td><td align="center" class="Botrule Rrule" valign="top">5 to 20 minutes </td><td align="center" class="Botrule Rrule" valign="top">45 seconds </td><td align="left" class="Botrule Rrule" valign="top">9 to 17 minutes </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 5 Pharmacodynamic Properties of Another Glucagon for Injection Product For Intramuscular Route </span> </caption> <col align="left" width="24.755%"/> <col align="left" width="14.937%"/> <col align="left" width="21.636%"/> <col align="left" width="21.556%"/> <col align="left" width="17.117%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top"> <p class="First Footnote"> <span class="Sup">a</span>Dose is determined based on the length of the procedure. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Route of Administration</span></td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Dose</span><span class="Bold"><span class="Sup">a</span></span></td><td align="left" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Time of Maximal</span> <br/> <span class="Bold">Glucose</span> <br/> <span class="Bold">Concentration</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Time of Onset of</span> <br/> <span class="Bold">Action for GI Smooth Muscle Relaxation</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Duration of</span> <br/> <span class="Bold">Smooth Muscle Relaxation</span></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" rowspan="2" valign="top">Intramuscular </td><td align="center" class="Botrule Rrule" valign="top">1 mg </td><td align="center" class="Botrule Rrule" valign="top">30 minutes </td><td align="center" class="Botrule Rrule" valign="top">8 to 10 minutes </td><td align="left" class="Botrule Rrule" valign="top">12 to 27 minutes </td> </tr> <tr class="Last"> <td align="center" class="Botrule Rrule" valign="top">2 mg </td><td align="center" class="Botrule Rrule" valign="top">30 minutes </td><td align="center" class="Botrule Rrule" valign="top">4 to 7 minutes </td><td align="left" class="Botrule Rrule" valign="top">21 to 32 minutes </td> </tr> </tbody> </table></div>

In a study in healthy subjects, a subcutaneous dose of 1 mg Glucagon for Injection resulted on average a peak blood glucose concentration of 79.3 mg/dL with a median time of 50 minutes after injection.

Absorption

Following subcutaneous administration of Glucagon for Injection, the median time to reach the maximum baseline uncorrected plasma glucagon concentrations of 3533 pg/mL was approximately 10 to 13 minutes after dosing Following intramuscular administration of 1 mg dose, the maximum baseline uncorrected plasma glucagon concentrations of 3391 pg/mL were attained approximately 10 minutes after dosing.

Elimination

The mean apparent half-life of glucagon was about 42 minutes after subcutaneous administration. The mean apparent half-life of glucagon was 26 minutes after intramuscular administration.

Metabolism

Glucagon is degraded in the liver, kidney, and plasma.

Carcinogenesis

Long term studies in animals to evaluate carcinogenic potential have not been performed.

Mutagenesis

Synthetic glucagon was negative in the bacterial reverse mutation assay (Ames test). The clastogenic potential of synthetic glucagon in the Chinese Hamster Ovary (CHO) assay was positive in the absence of metabolic activation. Doses of 100 and 200 mg/kg of glucagon of both pancreatic and recombinant origins gave slightly higher incidences of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that synthetic and recombinant glucagon are not different and do not pose a genotoxic risk to humans.

Impairment of Fertility

Glucagon was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.

Glucagon for Injection is supplied as a sterile, lyophilized white powder available as follows:

<div class="scrollingtable"><table width="100%"> <col align="left" width="24.000%"/> <col align="left" width="14.675%"/> <col align="left" width="13.325%"/> <col align="left" width="48.000%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Presentation</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">NDC</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Strength</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Description</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Treatment of Severe Hypoglycemia</span></td><td align="left" class="Botrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Glucagon Emergency Kit for Low Blood Sugar </td><td align="left" class="Botrule Rrule" valign="top">63323-582-82 </td><td align="left" class="Botrule Rrule" valign="top">1 mg per vial </td><td align="left" class="Botrule Rrule" valign="top">1 mL single-dose vial of Glucagon for Injection with 1 mL single-dose syringe of Sterile Water for<br/>Injection, USP for reconstitution </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Use as a Diagnostic Aid</span></td><td align="left" class="Botrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">10 Single-dose vials </td><td align="left" class="Botrule Rrule" valign="top">63323-596-13 </td><td align="left" class="Botrule Rrule" valign="top">1 mg per vial </td><td align="left" class="Botrule Rrule" valign="top">1 mL single-dose vial of Glucagon for Injection </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Diagnostic Kit </td><td align="left" class="Botrule Rrule" valign="top">63323-593-03 </td><td align="left" class="Botrule Rrule" valign="top">1 mg per vial </td><td align="left" class="Botrule Rrule" valign="top">1 mL single-dose vial of Glucagon for Injection with<br/>1 mL single-dose vial of Sterile Water for Injection,<br/>USP for reconstitution </td> </tr> </tbody> </table></div>

Before Reconstitution

The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] prior to reconstitution. Do not freeze. Keep in the original package to protect from light.

After Reconstitution

Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration (2.3)].

Recognition of Severe Hypoglycemia

Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Administration

Review the Patient Information and Instructions for Use with the patient and family members or caregivers.

Serious Hypersensitivity

Inform patients that allergic reactions can occur with Glucagon for Injection. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

<div class="scrollingtable"><table width="100%"> <col align="left" width="35.712%"/> <col align="left" width="32.578%"/> <col align="left" width="31.711%"/> <tfoot> <tr class="First Last"> <td align="left" class="Botrule" colspan="2" valign="top"> <p class="First Footnote">This Patient Information has been approved by the U.S. Food and Drug Administration </p> </td><td align="right" class="Botrule" colspan="2" valign="top"> <p class="First Footnote">Approved: 09/2019 </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"><span class="Bold">PATIENT INFORMATION</span> <br/> <span class="Bold">Glucagon (GLOO-ka-gon)</span> <br/> <span class="Bold">for injection, for subcutaneous, intramuscular or</span> <br/> <span class="Bold">intravenous use</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">What is Glucagon?</span> <br/>Glucagon is a prescription medicine used:<br/> <ul class="Disc"> <li>to treat very low blood sugar (severe hypoglycemia) in people with diabetes. </li> <li>to stop stomach movement (gastrointestinal motility inhibitor) in patients receiving radiology exams. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Who should not use Glucagon?</span> <br/>Do not use Glucagon if:<br/> <ul class="Disc"> <li>you have a tumor in the gland on top of your kidneys (adrenal gland) called a pheochromocytoma. </li> <li>you have a tumor in your pancreas called an insulinoma. </li> <li>you are allergic to glucagon or lactose or any of the ingredients in Glucagon. See the end of this Patient Information leaflet for a complete list of ingredients in Glucagon. </li> <li>you have tumors in your pancreas called Glucagonomas because it could cause low blood sugar when used for your radiology exam. </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">What should I tell my doctor before using Glucagon?</span> <br/> <span class="Bold">Before using Glucagon, tell your doctor about all of your medical conditions, including if you:</span> <br/> <ul class="Disc"> <li>have kidney problems. </li> <li>have pancreas problems. </li> <li>have not had food or water for a long time (prolonged fasting or starvation). </li> <li>have low blood sugar that does not go away (chronic hypoglycemia). </li> <li>have heart problems. </li> <li>are pregnant or plan to become pregnant. It is not known if Glucagon will harm your unborn baby. </li> <li>are breastfeeding or plan to breastfeed. It is not known if Glucagon passes into your breast milk.<br/> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Tell your doctor about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins and herbal supplements. Glucagon may affect the way other medicines work, and other medicines may affect how Glucagon works. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">How should I use Glucagon?</span> <br/> <ul class="Disc"> <li>Read the detailed <span class="Bold"><a href="#s60">Instructions for Use</a></span> that come with Glucagon. </li> <li>Use Glucagon exactly as your doctor tells you to. </li> <li>Make sure that you and your family know how to use Glucagon the right way before you need it. </li> <li>Act quickly. Having very low blood sugar for a period of time may be harmful. </li> <li> <span class="Bold">Call for emergency medical help right after you use Glucagon.</span> </li> <li>If the person does not respond after 15 minutes, another dose may be given, if available. </li> <li>Eat sugar or a sugar sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow. </li> <li>Tell your doctor each time you use Glucagon. Your doctor may need to change the dose of your diabetes medicines. </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">What are the possible side effects of Glucagon?</span> <br/> <span class="Bold">Glucagon may cause serious side effects, including:</span> <br/> <ul class="Disc"> <li> <span class="Bold">High blood pressure</span>. Glucagon can cause high blood pressure in certain people with tumors in their adrenal glands. </li> <li> <span class="Bold">Low blood sugar</span>. Glucagon can cause low blood sugar in patients with tumors in their pancreas called insulinomas and Glucagonomas by making too much insulin in their bodies. </li> <li> <span class="Bold">Serious allergic reactions.</span> Call your doctor or get medical help <span class="Bold">right away</span> if you have a serious allergic reaction including:<ul class="Circle"> <li>rash </li> <li>difficulty breathing </li> <li>low blood pressure </li> </ul> </li> <li> <span class="Bold">High blood sugar.</span> If you receive Glucagon before your radiology exam it can cause high blood sugar. Your doctor will monitor your blood sugar levels during your treatment. </li> <li> <span class="Bold">Heart problems.</span> If you have heart problems and receive Glucagon before your radiology exam, you may have an increase in your blood pressure and pulse while using Glucagon which could be life threatening.Your doctor will monitor your heart during treatment.<br/> <br/> </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top">The most common side effects of Glucagon include: </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> <ul class="Disc"> <li>swelling at the injection site </li> <li>redness at the injection site </li> <li>vomiting </li> <li>nausea </li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>decreased blood pressure </li> <li>weakness </li> <li>headache </li> <li>dizziness </li> </ul> </td><td align="left" class="Rrule" valign="top"> <ul class="Disc"> <li>pale skin </li> <li>diarrhea </li> <li>sleepiness or drowsiness </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top">Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Glucagon. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">How should I store Glucagon?</span> <br/> <span class="Bold">Before you mix the Glucagon powder and liquid:</span> <br/> <ul class="Disc"> <li>Store Glucagon at room temperature between 68°F to 77°F (20°C to 25°C) for up to 24 months (2 years). </li> <li>Do not freeze Glucagon. </li> <li>Keep Glucagon in its original package Glucagon and out of light. </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">After you mix the Glucagon powder and liquid:</span> <br/> <ul class="Disc"> <li>Use Glucagon right away. </li> <li>Throw away any unused Glucagon. </li> <li>Glucagon should be clear and colorless. Do not use Glucagon if it is cloudy or if you see particles in the solution. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Keep Glucagon and all medicines out of the reach of children</span>. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">General information about the safe and effective use of Glucagon:</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Glucagon for a condition for which it was not prescribed. Do not give Glucagon 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 Glucagon that is written for health professionals. </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">What are the ingredients in the Glucagon?</span> <br/> <span class="Bold">Active Ingredient:</span> Glucagon<br/> <span class="Bold">Inactive ingredients:</span> lactose monohydrate and sterile water for reconstitution<br/>For more information, go to www.fresenius-kabi.com/us or call 1-800-551-7176. </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"35.712%\"/>\n<col align=\"left\" width=\"32.578%\"/>\n<col align=\"left\" width=\"31.711%\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Botrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First Footnote\">This Patient Information has been approved by the U.S. Food and Drug Administration\n</p>\n</td><td align=\"right\" class=\"Botrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First Footnote\">Approved: 09/2019\n</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\">Glucagon (GLOO-ka-gon)</span>\n<br/>\n<span class=\"Bold\">for injection, for subcutaneous, intramuscular or</span>\n<br/>\n<span class=\"Bold\">intravenous use</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What is Glucagon?</span>\n<br/>Glucagon is a prescription medicine used:<br/>\n<ul class=\"Disc\">\n<li>to treat very low blood sugar (severe hypoglycemia) in people with diabetes.\n</li>\n<li>to stop stomach movement (gastrointestinal motility inhibitor) in patients receiving radiology exams.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Who should not use Glucagon?</span>\n<br/>Do not use Glucagon if:<br/>\n<ul class=\"Disc\">\n<li>you have a tumor in the gland on top of your kidneys (adrenal gland) called a pheochromocytoma.\n</li>\n<li>you have a tumor in your pancreas called an insulinoma.\n</li>\n<li>you are allergic to glucagon or lactose or any of the ingredients in Glucagon. See the end of this Patient Information leaflet for a complete list of ingredients in Glucagon.\n</li>\n<li>you have tumors in your pancreas called Glucagonomas because it could cause low blood sugar when used for your radiology exam.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What should I tell my doctor before using Glucagon?</span>\n<br/>\n<span class=\"Bold\">Before using Glucagon, tell your doctor about all of your medical conditions, including if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>have kidney problems.\n</li>\n<li>have pancreas problems.\n</li>\n<li>have not had food or water for a long time (prolonged fasting or starvation).\n</li>\n<li>have low blood sugar that does not go away (chronic hypoglycemia).\n</li>\n<li>have heart problems.\n</li>\n<li>are pregnant or plan to become pregnant. It is not known if Glucagon will harm your unborn baby.\n</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if Glucagon passes into your breast milk.<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Tell your doctor about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins and herbal supplements. Glucagon may affect the way other medicines work, and other medicines may affect how Glucagon works. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">How should I use Glucagon?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Read the detailed <span class=\"Bold\"><a href=\"#s60\">Instructions for Use</a></span> that come with Glucagon.\n</li>\n<li>Use Glucagon exactly as your doctor tells you to.\n</li>\n<li>Make sure that you and your family know how to use Glucagon the right way before you need it.\n</li>\n<li>Act quickly. Having very low blood sugar for a period of time may be harmful.\n</li>\n<li>\n<span class=\"Bold\">Call for emergency medical help right after you use Glucagon.</span>\n</li>\n<li>If the person does not respond after 15 minutes, another dose may be given, if available.\n</li>\n<li>Eat sugar or a sugar sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow.\n</li>\n<li>Tell your doctor each time you use Glucagon. Your doctor may need to change the dose of your diabetes medicines.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What are the possible side effects of Glucagon?</span>\n<br/>\n<span class=\"Bold\">Glucagon may cause serious side effects, including:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">High blood pressure</span>. Glucagon can cause high blood pressure in certain people with tumors in their adrenal glands.\n</li>\n<li>\n<span class=\"Bold\">Low blood sugar</span>. Glucagon can cause low blood sugar in patients with tumors in their pancreas called insulinomas and Glucagonomas by making too much insulin in their bodies.\n</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> Call your doctor or get medical help <span class=\"Bold\">right away</span> if you have a serious allergic reaction including:<ul class=\"Circle\">\n<li>rash\n</li>\n<li>difficulty breathing\n</li>\n<li>low blood pressure\n</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">High blood sugar.</span> If you receive Glucagon before your radiology exam it can cause high blood sugar. Your doctor will monitor your blood sugar levels during your treatment.\n</li>\n<li>\n<span class=\"Bold\">Heart problems.</span> If you have heart problems and receive Glucagon before your radiology exam, you may have an increase in your blood pressure and pulse while using Glucagon which could be life threatening.Your doctor will monitor your heart during treatment.<br/>\n<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\">The most common side effects of Glucagon include:\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>swelling at the injection site\n</li>\n<li>redness at the injection site\n</li>\n<li>vomiting\n</li>\n<li>nausea\n</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>decreased blood pressure\n</li>\n<li>weakness\n</li>\n<li>headache\n</li>\n<li>dizziness\n</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>pale skin\n</li>\n<li>diarrhea\n</li>\n<li>sleepiness or drowsiness\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Glucagon. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">How should I store Glucagon?</span>\n<br/>\n<span class=\"Bold\">Before you mix the Glucagon powder and liquid:</span>\n<br/>\n<ul class=\"Disc\">\n<li>Store Glucagon at room temperature between 68°F to 77°F (20°C to 25°C) for up to 24 months (2 years).\n</li>\n<li>Do not freeze Glucagon.\n</li>\n<li>Keep Glucagon in its original package Glucagon and out of light.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">After you mix the Glucagon powder and liquid:</span>\n<br/>\n<ul class=\"Disc\">\n<li>Use Glucagon right away.\n</li>\n<li>Throw away any unused Glucagon.\n</li>\n<li>Glucagon should be clear and colorless. Do not use Glucagon if it is cloudy or if you see particles in the solution.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Keep Glucagon and all medicines out of the reach of children</span>.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">General information about the safe and effective use of Glucagon:</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Glucagon for a condition for which it was not prescribed. Do not give Glucagon 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 Glucagon that is written for health professionals.\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What are the ingredients in the Glucagon?</span>\n<br/>\n<span class=\"Bold\">Active Ingredient:</span> Glucagon<br/>\n<span class=\"Bold\">Inactive ingredients:</span> lactose monohydrate and sterile water for reconstitution<br/>For more information, go to www.fresenius-kabi.com/us or call 1-800-551-7176.\n</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Glucagon (GLOO-ka-gon)

{ "type": "p", "children": [], "text": "\nGlucagon (GLOO-ka-gon)\n" }

for injection, for subcutaneous, intramuscular or intravenous use

{ "type": "p", "children": [], "text": "\nfor injection, for subcutaneous, intramuscular or intravenous use\n" }

Read this Instructions for Use before you start using Glucagon and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use Glucagon.

{ "type": "p", "children": [], "text": "Read this Instructions for Use before you start using Glucagon and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use Glucagon.\n" }

Important:

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

{ "type": "ul", "children": [ "\nRead and become familiar with this Instructions for Use before an emergency happens.\n", "Show your family members and others where you keep your Glucagon Emergency Kit for Low Blood Sugar and how to use it the right way.\n", "Call for emergency medical help right after you use Glucagon.\n", "Do not share your Glucagon syringes or needles with another person. You may give other people a serious infection or other people may get a serious infection from you.\n", "The prefilled syringe that comes with your Glucagon Emergency Kit for Low Blood Sugar is meant for use with Glucagon only. Do not use Glucagon syringes to inject other medicines.\n" ], "text": "" }

How should I store Glucagon?

{ "type": "p", "children": [], "text": "\nHow should I store Glucagon?\n" }

Before you mix the Glucagon powder and liquid:

{ "type": "p", "children": [], "text": "Before you mix the Glucagon powder and liquid:\n" }

{ "type": "ul", "children": [ "Store Glucagon at room temperature between 68° to 77°F (20° to 25°C). Check the expiration date on your vial of Glucagon. Do not use Glucagon if the expiration date has passed.\n", "Do not freeze Glucagon.\n", "Keep Glucagon in its original package and Glucagon out of light.\n" ], "text": "" }

After you mix the Glucagon powder and liquid:

{ "type": "p", "children": [], "text": "After you mix the Glucagon powder and liquid:\n" }

{ "type": "ul", "children": [ "Use Glucagon right away.\n", "Throw away any unused Glucagon.\n", "Glucagon should be clear and colorless. Do not use Glucagon if it is cloudy or if you see particles in the solution.\n" ], "text": "" }

Supplies you will need for your Glucagon injection (See Figure A):

{ "type": "p", "children": [], "text": "\nSupplies you will need for your Glucagon injection (See Figure A):\n" }

{ "type": "ul", "children": [ "1 Glucagon Emergency Kit for Low Blood Sugar that contains:\n1 vial that contains 1 mg of Glucagon for injection and 1 prefilled glass syringe with attached needle that contains 1 mL of Sterile Water for Injection.\n\n\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="100.000%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"><a name="f03"></a><img alt="Figure A " src="/dailymed/image.cfm?name=glu02-0004-03.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/></td> </tr> <tr> <td align="center" valign="top">Figure A </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"100.000%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\"><a name=\"f03\"></a><img alt=\"Figure A\n\" src=\"/dailymed/image.cfm?name=glu02-0004-03.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/></td>\n</tr>\n<tr>\n<td align=\"center\" valign=\"top\">Figure A\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "1 puncture resistant container for throwing away used needles and syringes. See “How should I dispose of (throw away) used Glucagon prefilled syringes” at the end of these instructions.\n", "Cotton ball or gauze pad (not included in kit)\n", "\nPreparing the Glucagon dose:\n", "The Glucagon medicine comes as a dry powder. Before you use Glucagon, you must mix the dry powder with the syringe of sterile water that comes in the Glucagon Emergency Kit for Low Blood Sugar. Do not use any other liquid to mix the medicine.\n", "Check that the orange plastic cap on your vial of Glucagon is firmly attached. Do not use the vial of Glucagon if the orange plastic cap is loose or missing.\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="50.000%"/> <col align="left" width="12.667%"/> <col align="left" width="37.333%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"><span class="Bold">Step 1</span>. Using your thumb, flip the orange plastic cap off the Glucagon vial (<span class="Bold">See <a href="#f04">Figure B</a></span>). </td><td align="right" valign="top"><span class="Bold">Figure B</span> <br/> </td><td align="center" valign="top"><a name="f04"></a><img alt="Figure B " src="/dailymed/image.cfm?name=glu02-0004-04.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 2</span>. Pick up the prefilled syringe containing sterile water. Hold the syringe with 1 hand and with your other hand pull the needle cover off the syringe (<span class="Bold">See <a href="#f05">Figure C</a></span>).<br/> <ul class="Disc"> <li> <span class="Bold">Do not</span> remove the plastic backstop from the syringe. </li> </ul> </td><td align="right" valign="top"><span class="Bold">Figure C</span></td><td align="center" valign="top"><a name="f05"></a><img alt="Figure C " src="/dailymed/image.cfm?name=glu02-0004-05.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 3.</span> Pick up the Glucagon vial. Hold the vial of dry powder with 1 hand and with your other hand push the needle of the prefilled syringe through the center of the rubber stopper (<span class="Bold">See <a href="#f06">Figure D</a></span>). </td><td align="right" valign="top"><span class="Bold">Figure D</span></td><td align="center" valign="top"><a name="f06"></a><img alt="Figure D " src="/dailymed/image.cfm?name=glu02-0004-06.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 4</span>. Hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together right side up. Slowly push the plunger down until the syringe is empty (<span class="Bold">See <a href="#f07">Figure E</a></span>).<br/> <ul class="Disc"> <li> <span class="Bold">Do not take the syringe out of the vial.</span> </li> </ul> </td><td align="right" valign="top"><span class="Bold">Figure E</span></td><td align="center" valign="top"><a name="f07"></a><img alt="Figure E " src="/dailymed/image.cfm?name=glu02-0004-07.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 5</span>. Hold the entire unit (the vial and syringe) in 1 hand and gently shake the vial until the powder is completely dissolved (<span class="Bold">See <a href="#f08">Figure F</a></span>).<br/> <ul class="Disc"> <li>Do not use if it is cloudy or if you see particles in the solution. </li> <li> <span class="Bold">Do not take the syringe out of the vial.</span> </li> </ul> </td><td align="right" valign="top"><span class="Bold">Figure F</span></td><td align="center" valign="top"><a name="f08"></a><img alt="Figure F " src="/dailymed/image.cfm?name=glu02-0004-08.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 6</span>. Firmly hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together upside down. Gently pull down on the plunger and slowly withdraw all of the liquid into the syringe (<span class="Bold">See <a href="#f09">Figure G</a></span>).<br/> <ul class="Disc"> <li>Do not pull the plunger out of the syringe. </li> </ul> </td><td align="right" valign="top"><span class="Bold">Figure G</span></td><td align="center" valign="top"><a name="f09"></a><img alt="Figure G " src="/dailymed/image.cfm?name=glu02-0004-09.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 7.</span> Keep the needle inside the vial. Check the syringe for air bubbles. If you see bubbles, tap the syringe until the bubbles rise to the top of the syringe (<span class="Bold">See <a href="#f10">Figure H</a></span>). Gently push on the plunger to move only the air bubbles back into the vial. </td><td align="right" valign="top"><span class="Bold">Figure H</span></td><td align="center" valign="top"><a name="f10"></a><img alt="Figure H " src="/dailymed/image.cfm?name=glu02-0004-10.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 8</span>. Hold the vial and syringe as shown (<span class="Bold">See <a href="#f11">Figure I</a></span>) </td><td align="right" valign="top"><span class="Bold">Figure I</span></td><td align="center" valign="top"><a name="f11"></a><img alt="Figure I " src="/dailymed/image.cfm?name=glu02-0004-11.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Giving the Glucagon for Injection:</span></td><td align="left" valign="top"></td><td align="left" valign="top"></td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 9.</span> Choose the injection site (<span class="Bold">See <a href="#f12">Figure J</a></span>).<br/>Common injection sites for Glucagon are upper arms, thighs, or buttocks. Patient does not need to be laying down to administer the medication as long as the common injection sites can be easily accessed. </td><td align="right" valign="top"><span class="Bold">Figure J</span></td><td align="center" valign="top"><a name="f12"></a><img alt="Figure J " src="/dailymed/image.cfm?name=glu02-0004-12.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 10</span>. With 1 hand gently pinch the skin at the injection site. With your other hand insert the needle into the skin and push the syringe plunger down until the syringe is empty (<span class="Bold">See <a href="#f13">Figure K</a></span>). </td><td align="right" valign="top"><span class="Bold">Figure K</span></td><td align="center" valign="top"><a name="f13"></a><img alt="Figure K " src="/dailymed/image.cfm?name=glu02-0004-13.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> <tr> <td align="left" valign="top"><span class="Bold">After Giving the Glucagon injection:</span></td><td align="left" valign="top"></td><td align="center" valign="top"></td> </tr> <tr> <td align="left" valign="top"><span class="Bold">Step 11</span>. Pull the needle out of the skin and press on the injection site (<span class="Bold">See <a href="#f14">Figure L</a></span>). Use a gauze pad or cotton ball (not included<br/>in the kit) if needed to press the injection site to make sure there is no direct contact with the skin. </td><td align="right" valign="top"><span class="Bold">Figure L</span></td><td align="center" valign="top"><a name="f14"></a><img alt="Figure L " src="/dailymed/image.cfm?name=glu02-0004-14.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6"/><br/> <br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"50.000%\"/>\n<col align=\"left\" width=\"12.667%\"/>\n<col align=\"left\" width=\"37.333%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 1</span>. Using your thumb, flip the orange plastic cap off the Glucagon vial (<span class=\"Bold\">See <a href=\"#f04\">Figure B</a></span>).\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure B</span>\n<br/>\n</td><td align=\"center\" valign=\"top\"><a name=\"f04\"></a><img alt=\"Figure B\n\" src=\"/dailymed/image.cfm?name=glu02-0004-04.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 2</span>. Pick up the prefilled syringe containing sterile water. Hold the syringe with 1 hand and with your other hand pull the needle cover off the syringe (<span class=\"Bold\">See <a href=\"#f05\">Figure C</a></span>).<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not</span> remove the plastic backstop from the syringe.\n</li>\n</ul>\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure C</span></td><td align=\"center\" valign=\"top\"><a name=\"f05\"></a><img alt=\"Figure C\n\" src=\"/dailymed/image.cfm?name=glu02-0004-05.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 3.</span> Pick up the Glucagon vial. Hold the vial of dry powder with 1 hand and with your other hand push the needle of the prefilled syringe through the center of the rubber stopper (<span class=\"Bold\">See <a href=\"#f06\">Figure D</a></span>).\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure D</span></td><td align=\"center\" valign=\"top\"><a name=\"f06\"></a><img alt=\"Figure D\n\" src=\"/dailymed/image.cfm?name=glu02-0004-06.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 4</span>. Hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together right side up. Slowly push the plunger down until the syringe is empty (<span class=\"Bold\">See <a href=\"#f07\">Figure E</a></span>).<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Do not take the syringe out of the vial.</span>\n</li>\n</ul>\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure E</span></td><td align=\"center\" valign=\"top\"><a name=\"f07\"></a><img alt=\"Figure E\n\" src=\"/dailymed/image.cfm?name=glu02-0004-07.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 5</span>. Hold the entire unit (the vial and syringe) in 1 hand and gently shake the vial until the powder is completely dissolved (<span class=\"Bold\">See <a href=\"#f08\">Figure F</a></span>).<br/>\n<ul class=\"Disc\">\n<li>Do not use if it is cloudy or if you see particles in the solution.\n</li>\n<li>\n<span class=\"Bold\">Do not take the syringe out of the vial.</span>\n</li>\n</ul>\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure F</span></td><td align=\"center\" valign=\"top\"><a name=\"f08\"></a><img alt=\"Figure F\n\" src=\"/dailymed/image.cfm?name=glu02-0004-08.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 6</span>. Firmly hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together upside down. Gently pull down on the plunger and slowly withdraw all of the liquid into the syringe (<span class=\"Bold\">See <a href=\"#f09\">Figure G</a></span>).<br/>\n<ul class=\"Disc\">\n<li>Do not pull the plunger out of the syringe.\n</li>\n</ul>\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure G</span></td><td align=\"center\" valign=\"top\"><a name=\"f09\"></a><img alt=\"Figure G\n\" src=\"/dailymed/image.cfm?name=glu02-0004-09.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 7.</span> Keep the needle inside the vial. Check the syringe for air bubbles. If you see bubbles, tap the syringe until the bubbles rise to the top of the syringe (<span class=\"Bold\">See <a href=\"#f10\">Figure H</a></span>). Gently push on the plunger to move only the air bubbles back into the vial.\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure H</span></td><td align=\"center\" valign=\"top\"><a name=\"f10\"></a><img alt=\"Figure H\n\" src=\"/dailymed/image.cfm?name=glu02-0004-10.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 8</span>. Hold the vial and syringe as shown (<span class=\"Bold\">See <a href=\"#f11\">Figure I</a></span>)\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure I</span></td><td align=\"center\" valign=\"top\"><a name=\"f11\"></a><img alt=\"Figure I\n\" src=\"/dailymed/image.cfm?name=glu02-0004-11.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Giving the Glucagon for Injection:</span></td><td align=\"left\" valign=\"top\"></td><td align=\"left\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 9.</span> Choose the injection site (<span class=\"Bold\">See <a href=\"#f12\">Figure J</a></span>).<br/>Common injection sites for Glucagon are upper arms, thighs, or buttocks. Patient does not need to be laying down to administer the medication as long as the common injection sites can be easily accessed.\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure J</span></td><td align=\"center\" valign=\"top\"><a name=\"f12\"></a><img alt=\"Figure J\n\" src=\"/dailymed/image.cfm?name=glu02-0004-12.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 10</span>. With 1 hand gently pinch the skin at the injection site. With your other hand insert the needle into the skin and push the syringe plunger down until the syringe is empty (<span class=\"Bold\">See <a href=\"#f13\">Figure K</a></span>).\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure K</span></td><td align=\"center\" valign=\"top\"><a name=\"f13\"></a><img alt=\"Figure K\n\" src=\"/dailymed/image.cfm?name=glu02-0004-13.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">After Giving the Glucagon injection:</span></td><td align=\"left\" valign=\"top\"></td><td align=\"center\" valign=\"top\"></td>\n</tr>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Bold\">Step 11</span>. Pull the needle out of the skin and press on the injection site (<span class=\"Bold\">See <a href=\"#f14\">Figure L</a></span>). Use a gauze pad or cotton ball (not included<br/>in the kit) if needed to press the injection site to make sure there is no direct contact with the skin.\n</td><td align=\"right\" valign=\"top\"><span class=\"Bold\">Figure L</span></td><td align=\"center\" valign=\"top\"><a name=\"f14\"></a><img alt=\"Figure L\n\" src=\"/dailymed/image.cfm?name=glu02-0004-14.jpg&amp;setid=c5c431b4-5618-4ff4-954e-4c0fbfed67b6\"/><br/>\n<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Throw away your used syringe with the needle attached and any Glucagon you did not use. See “How should I dispose of (throw away) used Glucagon prefilled syringes” at the end of these instructions.

{ "type": "p", "children": [], "text": "Throw away your used syringe with the needle attached and any Glucagon you did not use. See “How should I dispose of (throw away) used Glucagon prefilled syringes” at the end of these instructions.\n" }

Step 12. Turn the person on their side. When an unconscious person awakens, they may vomit. Turning the person on their side will lessen the chance of choking.

{ "type": "p", "children": [], "text": "\nStep 12. Turn the person on their side. When an unconscious person awakens, they may vomit. Turning the person on their side will lessen the chance of choking.\n" }

Step 13. Call for emergency medical help right away. If the person does not respond after 15 minutes,

{ "type": "p", "children": [], "text": "\nStep 13. Call for emergency medical help right away. If the person does not respond after 15 minutes,\n" }

another dose may be given, if available.

{ "type": "p", "children": [], "text": "\nanother dose may be given, if available.\n" }

Step 14. Feed the person as soon as they are awake and able to swallow.

{ "type": "p", "children": [], "text": "\nStep 14. Feed the person as soon as they are awake and able to swallow.\n" }

Give the person a fast acting source of sugar (such as a regular soft drink or fruit juice) and a long acting source of sugar (such as crackers and cheese or a meat sandwich).

{ "type": "p", "children": [], "text": "Give the person a fast acting source of sugar (such as a regular soft drink or fruit juice) and a long acting source of sugar (such as crackers and cheese or a meat sandwich).\n" }

Step 15. Even if the Glucagon for Injection treatment wakes the person, tell their doctor right away. The doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. The person's dose of diabetes medicine may need to be changed.

{ "type": "p", "children": [], "text": "\nStep 15. Even if the Glucagon for Injection treatment wakes the person, tell their doctor right away. The doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. The person's dose of diabetes medicine may need to be changed.\n" }

Hypoglycemia may happen again after receiving Glucagon for Injection treatment. Early symptoms of hypoglycemia may include:

{ "type": "p", "children": [], "text": "\nHypoglycemia may happen again after receiving Glucagon for Injection treatment. Early symptoms of hypoglycemia may include:\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="52.400%"/> <col align="left" width="47.600%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"> <ul class="Disc"> <li>sweating </li> <li>drowsiness </li> <li>dizziness </li> <li>sleep disturbances </li> <li>irregular heartbeat (palpitation) </li> <li>anxiety </li> <li>tremor </li> <li>blurred vision </li> <li>hunger </li> <li>slurred speech </li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>restlessness </li> <li>depressed mood </li> <li>tingling in the hands, feet, lips, or tongue </li> <li>irritability </li> <li>abnormal behavior </li> <li>lightheadedness </li> <li>unsteady movement </li> <li>inability to concentrate </li> <li>personality changes </li> <li>headache </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"52.400%\"/>\n<col align=\"left\" width=\"47.600%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>sweating\n</li>\n<li>drowsiness\n</li>\n<li>dizziness\n</li>\n<li>sleep disturbances\n</li>\n<li>irregular heartbeat (palpitation)\n</li>\n<li>anxiety\n</li>\n<li>tremor\n</li>\n<li>blurred vision\n</li>\n<li>hunger\n</li>\n<li>slurred speech\n</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>restlessness\n</li>\n<li>depressed mood\n</li>\n<li>tingling in the hands, feet, lips, or tongue\n</li>\n<li>irritability\n</li>\n<li>abnormal behavior\n</li>\n<li>lightheadedness\n</li>\n<li>unsteady movement\n</li>\n<li>inability to concentrate\n</li>\n<li>personality changes\n</li>\n<li>headache\n</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

If not treated early, hypoglycemia may worsen and the person may have severe hypoglycemia. Signs of severe hypoglycemia include:

{ "type": "p", "children": [], "text": "If not treated early, hypoglycemia may worsen and the person may have severe hypoglycemia. Signs of severe hypoglycemia include:\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="50.300%"/> <col align="left" width="49.700%"/> <tbody class="Headless"> <tr> <td align="left" valign="top"> <ul class="Disc"> <li>confusion </li> <li>unconsciousness </li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>seizures </li> <li>death </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"50.300%\"/>\n<col align=\"left\" width=\"49.700%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>confusion\n</li>\n<li>unconsciousness\n</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>seizures\n</li>\n<li>death\n</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

How should I dispose of (throw away) Glucagon pre-filled syringes?

{ "type": "p", "children": [], "text": "\nHow should I dispose of (throw away) Glucagon pre-filled syringes?\n" }

{ "type": "ul", "children": [ "Put used syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.\n", "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:\nmade of a heavy-duty plastic,\n\ncan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,\n\nupright and stable during use,\n\nleak-resistant, and\n\nproperly labeled to warn of hazardous waste inside the container.\n\n\n", "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 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.\n", "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.\n" ], "text": "" }

Keep Glucagon and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep Glucagon and all medicines out of the reach of children.\n" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 09/2019

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 09/2019\n" }

The brand names mentioned in this document are the trademarks of their respective owners.

{ "type": "p", "children": [], "text": "The brand names mentioned in this document are the trademarks of their respective owners.\n" }

Manufactured by: Fresenius KabiLake Zurich, IL 60047

{ "type": "p", "children": [], "text": "Manufactured by: Fresenius KabiLake Zurich, IL 60047\n" }

www.fresenius-kabi.com/us451541

{ "type": "p", "children": [], "text": "www.fresenius-kabi.com/us451541\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Label 509813 Glucagon for Injection (Synthetic) 1 mg per vial For subcutaneous, intramuscular or intravenous injection. Reconstitute with Sterile Water for Injection, USP Rx only

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Vial Label\n509813\nGlucagon for Injection (Synthetic)\n1 mg per vial\nFor subcutaneous, intramuscular or intravenous injection. Reconstitute with Sterile Water for Injection, USP Rx only\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water 1 mL Single-Dose Syringe Label 1 mL Single-Dose Syringe Sterile Water for Injection, USP For drug diluent use only 1 mL

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water 1 mL Single-Dose Syringe Label\n1 mL Single-Dose Syringe Sterile Water for Injection, USP\nFor drug diluent use only\n1 mL\n\n" }

PACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Top of Clamshell NDC 63323-582-82Reconstitute with accompanying diluent immediately before use.

{ "type": "p", "children": [], "text": "\nPACKAGE LABEL - PRINCIPAL DISPLAY - Glucagon 1 mg Top of Clamshell\nNDC 63323-582-82Reconstitute with accompanying diluent immediately before use.\n" }

Glucagon Emergency Kit for Low Blood Sugar Glucagon for Injection 1 mg per vial This Kit contains:

{ "type": "p", "children": [], "text": "\nGlucagon Emergency Kit for Low Blood Sugar Glucagon for Injection 1 mg per vial This Kit contains: \n" }

{ "type": "ul", "children": [ "One single-dose vial with 1 mg of Glucagon for Injection \n", "One prefilled syringe with 1 mL of Sterile Water for Injection, USP (Diluent)\n" ], "text": "" }

For subcutaneous, intramuscular or intravenous injection

{ "type": "p", "children": [], "text": "\nFor subcutaneous, intramuscular or intravenous injection\n" }

Rx only

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

BAQSIMI™ is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above.

{ "type": "p", "children": [], "text": "BAQSIMI™ is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above.\n" }

BAQSIMI is for intranasal use only.

Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires help of others to recover, instruct the patient to inform those around them about BAQSIMI and its Instructions for Use. Administer BAQSIMI as soon as possible when severe hypoglycemia is recognized.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for BAQSIMI. Emphasize the following instructions to the patient or caregiver:

The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril.

If there has been no response after 15 minutes, an additional 3 mg dose of BAQSIMI from a new device may be administered while waiting for emergency assistance.

Nasal Powder:

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

{ "type": "ul", "children": [ "3 mg glucagon: as a white powder in an intranasal device containing one dose of glucagon\n" ], "text": "" }

BAQSIMI is contraindicated in patients with:

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

{ "type": "ul", "children": [ "Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1)]\n", "Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2)]\n", "Known hypersensitivity to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)]\n" ], "text": "" }

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor [see Contraindications (4)]. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].

BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflect the rates observed in practice.

Adverse Reactions in Adult Patients

Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes [see Clinical Studies (14)].

Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and Study 2.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: Pooled Adverse Reactions (≥2%) in Adult Patients with Type 1 and Type 2 Diabetes in Study 1 and Study 2 </span> </caption> <colgroup> <col align="left" width="57.800%"/> <col align="left" width="42.200%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="2" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">BAQSIMI 3 mg</span> <br/> <span class="Bold">(N=153)</span> <br/> <span class="Bold">%</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea</td><td align="center" class="Botrule Rrule" valign="middle">26.1</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Headache</td><td align="center" class="Botrule Rrule" valign="middle">18.3</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting</td><td align="center" class="Botrule Rrule" valign="middle">15.0</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Upper Respiratory Tract Irritation<span class="Sup">a</span></td><td align="center" class="Botrule Rrule" valign="middle">12.4</td> </tr> </tbody> </table></div>

Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in Study 1 and 2 and these adverse reactions are presented in Table 2.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: Solicited Nasal and Non-Nasal Adverse Reactions in Adult Patients with Type 1 and Type 2 Diabetes Pooled from Study 1 and 2 </span> </caption> <colgroup> <col align="left" width="58.700%"/> <col align="left" width="41.300%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="2" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"><span class="Bold">Adverse Reaction</span><span class="Bold"><span class="Sup">a</span></span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">BAQSIMI 3 mg</span> <br/> <span class="Bold">(n=153)</span> <br/> <span class="Bold">%</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Any increase in symptom severity</span><span class="Bold"><span class="Sup">a</span></span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Watery eyes</td><td align="center" class="Botrule Rrule" valign="top">58.8</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nasal congestion</td><td align="center" class="Botrule Rrule" valign="top">42.5</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nasal itching</td><td align="center" class="Botrule Rrule" valign="top">39.2</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Runny nose</td><td align="center" class="Botrule Rrule" valign="top">34.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Redness of eyes</td><td align="center" class="Botrule Rrule" valign="top">24.8</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Itchy eyes</td><td align="center" class="Botrule Rrule" valign="top">21.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Sneezing</td><td align="center" class="Botrule Rrule" valign="top">19.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Itching of throat</td><td align="center" class="Botrule Rrule" valign="top">12.4</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Itching of ears</td><td align="center" class="Botrule Rrule" valign="top">3.3</td> </tr> </tbody> </table></div>

Adverse Reactions in Pediatric Patients Aged 4 Years and Above

A single dose of BAQSIMI was compared to weight-based doses of 0.5 mg or 1 mg of IMG in pediatric patients with type 1 diabetes in Study 3 [see Clinical Studies (14)].

Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of ≥2% in Study 3.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Adverse Reactions (≥2%) Occurring in Pediatric Patients with Type 1 Diabetes in Study 3 </span> </caption> <colgroup> <col align="left" width="62.150%"/> <col align="left" width="37.850%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="2" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">BAQSIMI 3 mg</span> <br/> <span class="Bold">(n=36)</span> <br/>%</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting</td><td align="center" class="Botrule Rrule" valign="middle">30.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Headache</td><td align="center" class="Botrule Rrule" valign="middle">25.0</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea</td><td align="center" class="Botrule Rrule" valign="middle">16.7</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Upper Respiratory Tract Irritation<span class="Sup">a</span></td><td align="center" class="Botrule Rrule" valign="middle">16.7</td> </tr> </tbody> </table></div>

Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in pediatric patients in Study 3 and these adverse reactions are presented in Table 4.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 4: Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients with Type 1 Diabetes in Study 3 </span> </caption> <colgroup> <col align="left" width="57.950%"/> <col align="left" width="42.050%"/> </colgroup> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="2" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span><span class="Bold"><span class="Sup">a</span></span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">BAQSIMI 3 mg</span> <br/> <span class="Bold">(n=36)</span> <br/> <span class="Bold">%</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Any increase in symptom severity</span><span class="Bold"><span class="Sup">a</span></span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Watery eyes</td><td align="center" class="Botrule Rrule" valign="top">47.2</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nasal congestion</td><td align="center" class="Botrule Rrule" valign="top">41.7</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nasal itching</td><td align="center" class="Botrule Rrule" valign="top">27.8</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Runny nose</td><td align="center" class="Botrule Rrule" valign="top">25.0</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Sneezing</td><td align="center" class="Botrule Rrule" valign="top">19.4</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Itchy eyes</td><td align="center" class="Botrule Rrule" valign="top">16.7</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Redness of eyes</td><td align="center" class="Botrule Rrule" valign="top">13.9</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Itching of throat</td><td align="center" class="Botrule Rrule" valign="top">2.8</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Itching of ears</td><td align="center" class="Botrule Rrule" valign="top">2.8</td> </tr> </tbody> </table></div>

Other Adverse Reactions in Adult and Pediatric Patients

Other observed adverse reactions with BAQSIMI-treated patients across clinical trials were, dysgeusia, pruritus, tachycardia, hypertension, and additional upper respiratory tract irritation events (nasal pruritus, throat irritation, and parosmia).

As with all therapeutic peptides, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to BAQSIMI with the incidences of antibodies to other products may be misleading.

In 3 clinical trials, 3/124 (2%) of BAQSIMI-treated patients had treatment-emergent anti-drug antibodies as detected by an affinity capture elution (ACE) ligand-binding immunogenicity assay. No neutralizing antibodies were detected.

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.

In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia.

BAQSIMI may increase the anticoagulant effect of warfarin.

Risk Summary

Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, based on body surface area (mg/m2) (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m2) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.

Risk Summary

There is no information available on the presence of glucagon in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.

The safety and effectiveness of BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use of BAQSIMI for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. [see Clinical Studies (14.2)].

The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 4 years of age.

Clinical studies of BAQSIMI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Limited clinical trial experience has not identified differences in responses between the elderly and younger patients.

If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium levels may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

{ "type": "p", "children": [], "text": "If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium levels may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed." }

BAQSIMI contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single-chain polypeptide containing 29 amino acid residues and has a molecular weight of 3483, and is identical to human glucagon.

{ "type": "p", "children": [], "text": "BAQSIMI contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single-chain polypeptide containing 29 amino acid residues and has a molecular weight of 3483, and is identical to human glucagon." }

Its molecular formula is C153H225N43O49S, with the following molecular structure:

{ "type": "p", "children": [], "text": "Its molecular formula is C153H225N43O49S, with the following molecular structure:" }

BAQSIMI is a preservative-free, white powder for intranasal administration in an intranasal device containing one dose of 3 mg glucagon. BAQSIMI contains glucagon as the active ingredient and betadex, and dodecylphosphocholine as the excipients.

{ "type": "p", "children": [], "text": "\nBAQSIMI is a preservative-free, white powder for intranasal administration in an intranasal device containing one dose of 3 mg glucagon. BAQSIMI contains glucagon as the active ingredient and betadex, and dodecylphosphocholine as the excipients.\n" }

Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.

After administration of BAQSIMI in adult patients with diabetes, the mean maximum glucose increase from baseline was 140 mg/dL (Figure 1).

In pediatric patients with type 1 diabetes (4 to <17 years), the mean maximum glucose increase from baseline was 138 mg/dL (4 to <8 years), 133 mg/dL (8 to <12 years), and 102 mg/dL (12 to <17 years) (Figure 2).

Sex and body weight had no clinically meaningful effects on the pharmacodynamics of BAQSIMI.

Common cold with nasal congestion tested with or without use of decongestant did not impact pharmacodynamics of BAQSIMI.

Figure 1 Mean glucose concentration over time after glucagon dose in adult Type 1 Diabetes patients with insulin-induced hypoglycemia.

Figure 2 Mean glucose concentration over time in pediatric Type 1 Diabetes patients administered BAQSIMI

Absorption

Glucagon absorption via the intranasal route, achieved mean peak plasma levels of 6130 pg/mL at around 15 minutes.

Distribution

The apparent volume of distribution was approximately 885 L.

Elimination

The median half-life was approximately 35 minutes.

Metabolism

Glucagon is known to be degraded in the liver, kidneys, and plasma.

Specific Populations

Pediatrics

In pediatric patients (4 to <17 years), glucagon via the intranasal route, achieved mean peak plasma levels between 15 and 20 minutes. The median half-life was 21 to 31 minutes.

Patients with Colds

Common cold with nasal congestion did not impact the pharmacokinetics of BAQSIMI.

Drug Interaction Studies

Common cold with use of decongestant did not impact the pharmacokinetics of BAQSIMI.

Long term studies in animals to evaluate carcinogenic potential have not been performed. Recombinant glucagon was positive in the bacterial Ames assay. It was determined that an increase in colony counts was related to technical difficulties in running this assay with peptides. Studies in rats have shown that glucagon does not cause impaired fertility.

Study 1 (NCT03339453) was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with type 1 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mg dose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to <60 mg/dL. Seventy patients were enrolled, with a mean age of 41.7 years and a mean diabetes duration of 20.1 years. Twenty-seven (39%) were female.

The primary efficacy outcome measure was the proportion of patients achieving treatment success, which was defined as either an increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level. Glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes, following glucagon administration.

The mean nadir blood glucose was 54.5 mg/dL for BAQSIMI and 55.8 mg/dL for IMG. BAQSIMI demonstrated non-inferiority to IMG in reversing insulin-induced hypoglycemia with 100% of BAQSIMI-treated patients and 100% of IMG-treated patients achieving treatment success. The mean time to treatment success was 11.6 and 9.9 minutes in the BAQSIMI and IMG 1 mg treatment groups, respectively.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 5: Adult Patients with Type 1 Diabetes Meeting Treatment Success and Other Glucose Criteria in Study 1 </span> </caption> <colgroup> <col align="left" width="70.290%"/> <col align="left" width="14.738%"/> <col align="left" width="14.972%"/> </colgroup> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with evaluable primary outcome.</p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">b</span> Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG).</p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">c</span> 2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="middle"><span class="Bold">Type 1 Diabetes<br/>(N=66)</span><span class="Bold"><span class="Sup">a</span></span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">BAQSIMI 3 mg</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">IMG</span> <br/> <span class="Bold">1 mg</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Treatment Success – n (%)</span></td><td align="center" class="Botrule Rrule" valign="middle">66 (100%)</td><td align="center" class="Botrule Rrule" valign="middle">66 (100%)</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle"><span class="Bold">Treatment Difference (2-sided 95% confidence limit)</span><span class="Bold"><span class="Sup">b, c</span></span></td><td align="center" class="Botrule Rrule" colspan="2" valign="middle">0% (-2.9%, 2.9%)</td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Glucose criterion met – n (%)</span></td><td align="center" class="Rrule" valign="middle"></td><td align="center" class="Rrule" valign="middle"></td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">      (i) ≥70 mg/dL<br/>      (ii) Increase by ≥20 mg/dL from nadir<br/>      Both (i) and (ii)</td><td align="center" class="Botrule Rrule" valign="middle">66 (100%)<br/>66 (100%)<br/>66 (100%)</td><td align="center" class="Botrule Rrule" valign="middle">66 (100%)<br/>66 (100%)<br/>66 (100%)</td> </tr> </tbody> </table></div>

Study 2 (NCT01994746) was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with type 1 diabetes or type 2 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mg dose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to the hypoglycemic range with a target blood glucose nadir of <50 mg/dL.

Study 2 enrolled 83 patients 18 to <65 years of age. The mean age of patients with type 1 diabetes (N=77) was 32.9 years and a mean diabetes duration of 18.1 years, and 45 (58%) patients were female. The mean age of patients with type 2 diabetes (N=6) was 47.8 years, with a mean diabetes duration of 18.8 years, and 4 (67%) patients were female.

The mean nadir blood glucose was 44.2 mg/dL for BAQSIMI and 47.2 mg/dL for IMG. BAQSIMI demonstrated non-inferiority to IMG in reversing insulin-induced hypoglycemia with 98.8% of BAQSIMI-treated patients and 100% of IMG-treated patients achieving treatment success within 30 minutes.

The mean time to treatment success was 15.9 and 12.1 minutes in the BAQSIMI and IMG 1 mg treatment groups, respectively.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 6: Adult Patients with Type 1 and Type 2 Diabetes Meeting Treatment Success and Other Glucose Criteria in Study 2 </span> </caption> <colgroup> <col align="left" width="54.151%"/> <col align="left" width="22.074%"/> <col align="left" width="23.775%"/> </colgroup> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with evaluable primary outcome.</p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">b</span> Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG).</p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">c</span> 2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%.</p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote"> <span class="Sup">d</span> Percentage based on number of patients.</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="middle"><span class="Bold">Type 1 and Type 2 Diabetes (N=80)</span><span class="Bold"><span class="Sup">a</span></span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">BAQSIMI</span> <br/> <span class="Bold">3 mg</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">IMG</span> <br/> <span class="Bold">1 mg</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Treatment Success – n (%)</span></td><td align="center" class="Botrule Rrule" valign="middle">79 (98.8%)</td><td align="center" class="Botrule Rrule" valign="middle">80 (100%)</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Treatment Difference (2-sided 95% confidence limit) </span><span class="Bold"><span class="Sup">b,c</span></span></td><td align="center" class="Botrule Rrule" colspan="2" valign="top">-1.3% (-4.6%, 2.2%)</td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Glucose criterion met – n (%)</span><span class="Bold"><span class="Sup">d</span></span></td><td align="center" class="Rrule" valign="middle"></td><td align="center" class="Rrule" valign="middle"></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">      (i) ≥70 mg/dL</td><td align="center" class="Rrule" valign="middle">77 (96%)</td><td align="center" class="Rrule" valign="middle">79 (99%)</td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">      (ii) Increase by ≥20 mg/dL from nadir</td><td align="center" class="Rrule" valign="middle">79 (99%)</td><td align="center" class="Rrule" valign="middle">80 (100%)</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">      Both (i) and (ii)</td><td align="center" class="Botrule Rrule" valign="middle">77 (96%)</td><td align="center" class="Botrule Rrule" valign="middle">79 (99%)</td> </tr> </tbody> </table></div>

Study 3 (NCT01997411) was a randomized, multicenter, clinical study that assessed BAQSIMI compared to intra-muscular glucagon (IMG) in pediatric patients aged 4 years and older with type 1 diabetes. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL. Efficacy was assessed based on percentage of patients with a glucose increase of ≥20 mg/dL from glucose nadir within 30 minutes following BAQSIMI administration.

Forty-eight patients were enrolled and received at least one dose of study drug. The mean age in the Young Children cohort (4 to <8 years) was 6.5 years. In the Children cohort (8 to <12 years), mean age was 11.1 years and in the Adolescents cohort (12 to <17 years) mean age was 14.6 years. In all age cohorts, the population was predominantly male and white.

Across all age groups, all (100%) patients in both treatment arms achieved an increase in glucose ≥20 mg/dL from glucose nadir within 20 minutes of glucagon administration. The mean time to reach a glucose increase of ≥20 mg/dL for BAQSIMI and IMG for all age groups is shown in Table 7.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 7: Mean Time to Reach Glucose Increase of ≥20 mg/dL from Nadir in Pediatric Patients with Type 1 Diabetes in Study 3 </span> </caption> <colgroup> <col align="left" width="28.418%"/> <col align="left" width="9.801%"/> <col align="left" width="12.745%"/> <col align="left" width="11.773%"/> <col align="left" width="12.745%"/> <col align="left" width="11.773%"/> <col align="left" width="12.745%"/> </colgroup> <thead> <tr class="First"> <th align="center" class="Botrule Lrule Rrule Toprule" rowspan="3" valign="middle"><span class="Bold">Increase from Nadir</span></th><th align="center" class="Botrule Rrule Toprule" colspan="6" valign="middle"><span class="Bold">Mean Time Post-Glucagon Administration (minutes)</span></th> </tr> <tr> <th align="center" class="Botrule Rrule" colspan="2" valign="top"><span class="Bold">Young Children</span> <br/> <span class="Bold">(4 to &lt;8 years old)</span></th><th align="center" class="Botrule Rrule" colspan="2" valign="top"><span class="Bold">Children</span> <br/> <span class="Bold">(8 to &lt;12 years old)</span></th><th align="center" class="Botrule Rrule" colspan="2" valign="top"><span class="Bold">Adolescents</span> <br/> <span class="Bold">(12 to &lt;17 years old)</span></th> </tr> <tr class="Last"> <th align="center" class="Botrule Rrule" valign="top"><span class="Bold">IMG</span><span class="Bold"><span class="Sup">a</span></span> <br/> <span class="Bold">N=6</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">BAQSIMI</span> <br/> <span class="Bold">3 mg</span> <br/> <span class="Bold">N=12</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">IMG</span><span class="Bold"><span class="Sup">a</span></span> <br/> <span class="Bold">N=6</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">BAQSIMI</span> <br/> <span class="Bold">3 mg</span> <br/> <span class="Bold">N=12</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">IMG</span><span class="Bold"><span class="Sup">a</span></span> <br/> <span class="Bold">N=12</span></th><th align="center" class="Botrule Rrule" valign="top"><span class="Bold">BAQSIMI</span> <br/> <span class="Bold">3 mg</span> <br/> <span class="Bold">N=12</span></th> </tr> </thead> <tfoot> <tr class="First First Last Last"> <td align="left" colspan="7" valign="top"> <p class="First First Footnote"> <span class="Sup">a</span> 0.5 mg or 1 mg of IMG (based upon body weight)</p> </td> </tr> </tfoot> <tbody> <tr class="First First Last Last"> <td align="center" class="Botrule Lrule Rrule" valign="middle">≥20 mg/dL</td><td align="center" class="Botrule Rrule" valign="middle">10.8</td><td align="center" class="Botrule Rrule" valign="middle">10.8</td><td align="center" class="Botrule Rrule" valign="middle">12.5</td><td align="center" class="Botrule Rrule" valign="middle">11.3</td><td align="center" class="Botrule Rrule" valign="middle">12.5</td><td align="center" class="Botrule Rrule" valign="middle">14.2</td> </tr> </tbody> </table></div>

BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, white powder.

{ "type": "p", "children": [], "text": "BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, white powder." }

{ "type": "ul", "children": [ "BAQSIMI One Pack® carton contains 1 intranasal device (NDC 0548-8351-01)", "BAQSIMI Two Pack® carton contains 2 intranasal devices (NDC 0548-8352-02)", "Store at temperatures up to 86°F (30°C) in the shrink wrapped tube provided.", "Keep BAQSIMI in the shrink wrapped tube until ready to use. If the tube has been opened, BAQSIMI may have been exposed to moisture and may not work as expected.", "Discard BAQSIMI and tube after use." ], "text": "" }

Recognition of Severe Hypoglycemia:

Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Administration:

Review the Patient Information and Instructions for Use with the patient and family members or caregivers.

Serious Hypersensitivity:

Inform patients that allergic reactions can occur with BAQSIMI. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

Literature revised: May, 2023

Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730, USA. Copyright © 2023, Amphastar Pharmaceuticals, Inc. All rights reserved.

698351AMA

<div class="scrollingtable"><table width="100%"> <colgroup> <col align="left" width="33.333%"/> <col align="left" width="33.333%"/> <col align="left" width="33.333%"/> </colgroup> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote">This Patient Information has been approved by the U.S. Food and Drug Administration</p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First First Footnote">Issued: May, 2023</p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"><span class="Bold">PATIENT INFORMATION</span> <br/> <span class="Bold">BAQSIMI<span class="Sup">®</span> (BAK-see-mee)</span> <br/> <span class="Bold">(glucagon)<br/> nasal powder</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">What is BAQSIMI?</span> <br/>BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.<br/>It is not known if BAQSIMI is safe and effective in children under 4 years of age.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Do not use BAQSIMI if you:</span> <br/> <ul class="Disc"> <li>have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.</li> <li>have a tumor in your pancreas called insulinoma.</li> <li>are allergic to glucagon, or any other ingredients in BAQSIMI. See the end of this Patient Information for a complete list of ingredients in BAQSIMI.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:</span> <br/> <ul class="Disc"> <li>have a tumor in your pancreas.</li> <li>have not had food or water for a long time (prolonged fasting or starvation).</li> <li>are pregnant or plan to become pregnant.</li> <li>are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your healthcare provider should decide if you can use BAQSIMI while breastfeeding.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top">Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">How should I use BAQSIMI?</span> <br/> <ul class="Disc"> <li>Read the detailed <span class="Bold"><a href="#s56">Instructions for Use</a></span> that comes with BAQSIMI.</li> <li>Use BAQSIMI exactly how your healthcare provider tells you to use it.</li> <li>Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way <span class="Underline">before</span> you need their help.</li> <li>Your healthcare provider will tell you how and when to use BAQSIMI.</li> <li>BAQSIMI contains only 1 dose of medicine and <span class="Bold">cannot</span> be reused.</li> <li>BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.</li> <li>BAQSIMI will work even if you have a cold or are taking cold medicine.</li> <li>After giving BAQSIMI, the caregiver should call for emergency medical help right away.</li> <li>If the person does not respond after 15 minutes, another dose may be given, if available.</li> <li>Tell your healthcare provider each time you use BAQSIMI.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">What are the possible side effects of BAQSIMI?</span> <br/> <span class="Bold">BAQSIMI may cause serious side effects, including:</span> <br/> <ul class="Disc"> <li> <span class="Bold">High blood pressure.</span> BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.</li> <li> <span class="Bold">Low blood sugar.</span> BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.</li> <li> <span class="Bold">Serious allergic reaction.</span> Call your healthcare provider or <span class="Bold">get medical help right away</span> if you have a serious allergic reaction including:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> <ul class="Disc"> <li>rash</li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>difficulty breathing</li> </ul> </td><td align="left" class="Rrule" valign="top"> <ul class="Disc"> <li>low blood pressure</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">The most common side effects of BAQSIMI include:</span></td> </tr> <tr> <td align="left" class="Lrule" valign="top"> <ul class="Disc"> <li>nausea</li> <li>vomiting</li> <li>headache</li> </ul> </td><td align="left" valign="top"> <ul class="Disc"> <li>runny nose</li> <li>discomfort in your nose</li> <li>stuffy nose</li> </ul> </td><td align="left" class="Rrule" valign="top"> <ul class="Disc"> <li>redness in your eyes</li> <li>itchy nose, throat and eyes</li> <li>watery eyes</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top">These are not all the possible side effects of BAQSIMI. For more information, ask your healthcare provider.<br/>Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">How should I store BAQSIMI?</span> <br/> <ul class="Disc"> <li>Store BAQSIMI at temperatures up to 86ºF (30ºC).</li> <li>Keep BAQSIMI in the shrink wrapped tube until you are ready to use it.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Keep BAQSIMI and all medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">General Information about the safe and effective use of BAQSIMI.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them.<br/>You can ask your pharmacist or healthcare provider for information about BAQSIMI that is written for healthcare professionals.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">What are the ingredients in BAQSIMI?</span> <br/> <span class="Bold">Active Ingredient:</span> glucagon<br/> <span class="Bold">Inactive Ingredients:</span> betadex and dodecylphosphocholine</td> </tr> <tr> <td align="center" class="Lrule Rrule" colspan="3" valign="top"><span class="Bold">Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga,</span><span class="Bold">CA 91730, U.S.A.</span> <br/> <span class="Bold">www.baqsimi.com</span> <br/>Copyright © 2023, Amphastar Pharmaceuticals, Inc. All rights reserved.</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top">For more information, call 1-800-423-4136 or go to the following website: www.baqsimi.com.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<colgroup>\n<col align=\"left\" width=\"33.333%\"/>\n<col align=\"left\" width=\"33.333%\"/>\n<col align=\"left\" width=\"33.333%\"/>\n</colgroup>\n<tfoot>\n<tr class=\"First\">\n<td align=\"left\" colspan=\"3\" valign=\"top\">\n<p class=\"First First Footnote\">This Patient Information has been approved by the U.S. Food and Drug Administration</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" colspan=\"3\" valign=\"top\">\n<p class=\"First First Footnote\">Issued: May, 2023</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">PATIENT INFORMATION</span>\n<br/>\n<span class=\"Bold\">BAQSIMI<span class=\"Sup\">®</span> (BAK-see-mee)</span>\n<br/>\n<span class=\"Bold\">(glucagon)<br/> nasal powder</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What is BAQSIMI?</span>\n<br/>BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.<br/>It is not known if BAQSIMI is safe and effective in children under 4 years of age.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Do not use BAQSIMI if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.</li>\n<li>have a tumor in your pancreas called insulinoma.</li>\n<li>are allergic to glucagon, or any other ingredients in BAQSIMI. See the end of this Patient Information for a complete list of ingredients in BAQSIMI.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>have a tumor in your pancreas.</li>\n<li>have not had food or water for a long time (prolonged fasting or starvation).</li>\n<li>are pregnant or plan to become pregnant.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your healthcare provider should decide if you can use BAQSIMI while breastfeeding.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">How should I use BAQSIMI?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Read the detailed <span class=\"Bold\"><a href=\"#s56\">Instructions for Use</a></span> that comes with BAQSIMI.</li>\n<li>Use BAQSIMI exactly how your healthcare provider tells you to use it.</li>\n<li>Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way <span class=\"Underline\">before</span> you need their help.</li>\n<li>Your healthcare provider will tell you how and when to use BAQSIMI.</li>\n<li>BAQSIMI contains only 1 dose of medicine and <span class=\"Bold\">cannot</span> be reused.</li>\n<li>BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.</li>\n<li>BAQSIMI will work even if you have a cold or are taking cold medicine.</li>\n<li>After giving BAQSIMI, the caregiver should call for emergency medical help right away.</li>\n<li>If the person does not respond after 15 minutes, another dose may be given, if available.</li>\n<li>Tell your healthcare provider each time you use BAQSIMI.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What are the possible side effects of BAQSIMI?</span>\n<br/>\n<span class=\"Bold\">BAQSIMI may cause serious side effects, including:</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">High blood pressure.</span> BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.</li>\n<li>\n<span class=\"Bold\">Low blood sugar.</span> BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.</li>\n<li>\n<span class=\"Bold\">Serious allergic reaction.</span> Call your healthcare provider or <span class=\"Bold\">get medical help right away</span> if you have a serious allergic reaction including:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>rash</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>difficulty breathing</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>low blood pressure</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">The most common side effects of BAQSIMI include:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>nausea</li>\n<li>vomiting</li>\n<li>headache</li>\n</ul>\n</td><td align=\"left\" valign=\"top\">\n<ul class=\"Disc\">\n<li>runny nose</li>\n<li>discomfort in your nose</li>\n<li>stuffy nose</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\">\n<ul class=\"Disc\">\n<li>redness in your eyes</li>\n<li>itchy nose, throat and eyes</li>\n<li>watery eyes</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">These are not all the possible side effects of BAQSIMI. For more information, ask your healthcare provider.<br/>Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">How should I store BAQSIMI?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Store BAQSIMI at temperatures up to 86ºF (30ºC).</li>\n<li>Keep BAQSIMI in the shrink wrapped tube until you are ready to use it.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Keep BAQSIMI and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">General Information about the safe and effective use of BAQSIMI.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them.<br/>You can ask your pharmacist or healthcare provider for information about BAQSIMI that is written for healthcare professionals.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">What are the ingredients in BAQSIMI?</span>\n<br/>\n<span class=\"Bold\">Active Ingredient:</span> glucagon<br/>\n<span class=\"Bold\">Inactive Ingredients:</span> betadex and dodecylphosphocholine</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\"><span class=\"Bold\">Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga,</span><span class=\"Bold\">CA 91730, U.S.A.</span>\n<br/>\n<span class=\"Bold\">www.baqsimi.com</span>\n<br/>Copyright © 2023, Amphastar Pharmaceuticals, Inc. All rights reserved.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">For more information, call 1-800-423-4136 or go to the following website: www.baqsimi.com.</td>\n</tr>\n</tbody>\n</table></div>" }

698351AMA

{ "type": "p", "children": [], "text": "698351AMA" }

INSTRUCTIONS FOR USE

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n" }

BAQSIMI®

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

(glucagon) nasal powder

{ "type": "p", "children": [], "text": "(glucagon) nasal powder" }

3 mg

{ "type": "p", "children": [], "text": "3 mg" }

Read the Instructions for Use for BAQSIMI before using it. BAQSIMI is used to treat very low blood sugar (severe hypoglycemia) that may cause you to need help from others. You should make sure you show your caregivers, family and friends where you keep BAQSIMI and explain how to use it by sharing these instructions. They need to know how to use BAQSIMI before an emergency happens.

{ "type": "p", "children": [], "text": "\nRead the Instructions for Use for BAQSIMI before using it. BAQSIMI is used to treat very low blood sugar (severe hypoglycemia) that may cause you to need help from others. You should make sure you show your caregivers, family and friends where you keep BAQSIMI and explain how to use it by sharing these instructions. They need to know how to use BAQSIMI before an emergency happens.\n" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First First Last Last"> <td align="center"> <p class="First"> <span class="Bold"> Tube and Device Parts</span> </p> <p> <img alt="ifu1" src="/dailymed/image.cfm?name=ifu1.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td align=\"center\">\n<p class=\"First\">\n<span class=\"Bold\"> Tube and Device Parts</span>\n</p>\n<p>\n<img alt=\"ifu1\" src=\"/dailymed/image.cfm?name=ifu1.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Important Information to Know

{ "type": "p", "children": [], "text": "\nImportant Information to Know\n" }

{ "type": "ul", "children": [ "\nDo not remove the Shrink Wrap or open the Tube until you are ready to use it.", "If the Tube has been opened, BAQSIMI could be exposed to moisture. This could cause BAQSIMI not to work as expected.\n", "Do not push the plunger or test BAQSIMI before you are ready to use it.", "BAQSIMI contains 1 dose of glucagon nasal powder and cannot be reused.", "BAQSIMI is for nasal (nose) use only.", "BAQSIMI will work even if you have a cold or are taking cold medicine." ], "text": "" }

Preparing the Dose

{ "type": "p", "children": [], "text": "\nPreparing the Dose\n" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><img alt="ifu2" src="/dailymed/image.cfm?name=ifu2.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></td><td> <br/> <ul> <li>Remove the Shrink Wrap by pulling on red stripe.</li> </ul> </td> </tr> <tr class="Last"> <td><img alt="ifu3" src="/dailymed/image.cfm?name=ifu3.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></td><td> <ul> <li>Open the Lid and remove the Device from the Tube.<br/> <span class="Bold">Caution: Do not press the Plunger until ready to give the dose.</span> </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><img alt=\"ifu2\" src=\"/dailymed/image.cfm?name=ifu2.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></td><td>\n<br/>\n<ul>\n<li>Remove the Shrink Wrap by pulling on red stripe.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Last\">\n<td><img alt=\"ifu3\" src=\"/dailymed/image.cfm?name=ifu3.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></td><td>\n<ul>\n<li>Open the Lid and remove the Device from the Tube.<br/>\n<span class=\"Bold\">Caution: Do not press the Plunger until ready to give the dose.</span>\n</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Giving the Dose

{ "type": "p", "children": [], "text": "\nGiving the Dose\n" }

<div class="scrollingtable"><table width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr class="First"> <td><img alt="ifu4" src="/dailymed/image.cfm?name=ifu4.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></td><td> <ul> <li> <span class="Bold">Hold Device</span> between fingers and thumb.</li> <li> <span class="Bold">Do not</span> push Plunger yet.</li> </ul> </td> </tr> <tr> <td><img alt="ifu5" src="/dailymed/image.cfm?name=ifu5.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></td><td> <ul> <li> <span class="Bold">Insert Tip</span> gently into one nostril until finger(s) touch the outside of the nose.</li> </ul> </td> </tr> <tr class="Last"> <td><img alt="ifu6" src="/dailymed/image.cfm?name=ifu6.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254"/></td><td> <ul> <li> <span class="Bold"> Push Plunger</span> firmly all the way in.</li> <li> <span class="Bold">Dose is complete when the Green Line disappears.</span> </li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><img alt=\"ifu4\" src=\"/dailymed/image.cfm?name=ifu4.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></td><td>\n<ul>\n<li>\n<span class=\"Bold\">Hold Device</span> between fingers and thumb.</li>\n<li>\n<span class=\"Bold\">Do not</span> push Plunger yet.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td><img alt=\"ifu5\" src=\"/dailymed/image.cfm?name=ifu5.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></td><td>\n<ul>\n<li>\n<span class=\"Bold\">Insert Tip</span> gently into one nostril until finger(s) touch the outside of the nose.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Last\">\n<td><img alt=\"ifu6\" src=\"/dailymed/image.cfm?name=ifu6.jpg&amp;setid=f1f5df9b-872f-44e5-a18f-f0b68e7e9254\"/></td><td>\n<ul>\n<li>\n<span class=\"Bold\"> Push Plunger</span> firmly all the way in.</li>\n<li>\n<span class=\"Bold\">Dose is complete when the Green Line disappears.</span>\n</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

After giving BAQSIMI

{ "type": "p", "children": [], "text": "\nAfter giving BAQSIMI\n" }

{ "type": "ul", "children": [ "Call for emergency medical help right away.", "If the person is unconscious turn the person on their side.", "\nThrow away the used Device and Tube.\n", "Encourage the person to eat as soon as possible. When they are able to safely swallow, give the person a fast acting source of sugar, such as juice. Then encourage the person to eat a snack, such as crackers with cheese or peanut butter.", "If the person does not respond after 15 minutes, another dose may be given, if available." ], "text": "" }

Storage and Handling

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

{ "type": "ul", "children": [ "\nDo not remove the Shrink Wrap or open the Tube until you are ready to use it.\n", "Store BAQSIMI in the shrink wrapped Tube at temperatures up to 86º F (30ºC ).", "Replace BAQSIMI before the expiration date printed on the Tube or carton." ], "text": "" }

Other Information

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

{ "type": "ul", "children": [ "\nCaution: Replace the used BAQSIMI right away so you will have a new BAQSIMI in case you need it.\n", "Keep BAQSIMI and all medicines out of the reach of children." ], "text": "" }

For Questions or More Information about BAQSIMI

{ "type": "p", "children": [], "text": "\nFor Questions or More Information about BAQSIMI\n" }

{ "type": "ul", "children": [ "Call your healthcare provider", "Call Amphastar Pharmaceuticals, inc. 1-800-423-4136", "Visit www.baqsimi.com" ], "text": "" }

BAQSIMI is a registered trademark of Amphastar Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "BAQSIMI is a registered trademark of Amphastar Pharmaceuticals, Inc." }

Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga,

{ "type": "p", "children": [], "text": "Marketed by: Amphastar Pharmaceuticals, Inc. Rancho Cucamonga," }

CA 91730, U.S.A

{ "type": "p", "children": [], "text": "CA 91730, U.S.A" }

Copyright © 2023, Amphastar Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "Copyright © 2023, Amphastar Pharmaceuticals, Inc." }

<div class="scrollingtable"><table width="100%"> <colgroup> <col align="left" width="100.000%"/> </colgroup> <tbody class="Headless"> <tr class="First First Last Last"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top">BAQSIMI Device meets all applicable requirements defined in ISO 20072</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<colgroup>\n<col align=\"left\" width=\"100.000%\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"First First Last Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">BAQSIMI Device meets all applicable requirements defined in ISO 20072</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use has been approved by the U.S. Food and Drug AdminstrationIssued: May, 2023

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug AdminstrationIssued: May, 2023" }

678351AMA/5-23

{ "type": "p", "children": [], "text": "678351AMA/5-23" }

NDC 0548-8351-01

{ "type": "p", "children": [], "text": "NDC 0548-8351-01" }

baqsimi®

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

(glucagon) nasal powder

{ "type": "p", "children": [], "text": "(glucagon) nasal powder" }

3 mg

{ "type": "p", "children": [], "text": "3 mg" }

For Treatment of Severe Low Blood Sugar

{ "type": "p", "children": [], "text": "For Treatment of Severe Low Blood Sugar" }

For Nasal Use Only

{ "type": "p", "children": [], "text": "For Nasal Use Only" }

Contains 1 nasal devices.

{ "type": "p", "children": [], "text": "Contains 1 nasal devices." }

Keep tubes sealed until ready to use.

{ "type": "p", "children": [], "text": "Keep tubes sealed until ready to use." }

Rx only

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

BAQSIMI One Pack®

{ "type": "p", "children": [], "text": "BAQSIMI One Pack®\n" }

www.baqsimi.com

{ "type": "p", "children": [], "text": "www.baqsimi.com" }

568351AMA/5-23

{ "type": "p", "children": [], "text": "568351AMA/5-23" }

NDC 0548-8352-02

{ "type": "p", "children": [], "text": "NDC 0548-8352-02" }

baqsimi®

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

(glucagon) nasal powder

{ "type": "p", "children": [], "text": "(glucagon) nasal powder" }

3 mg

{ "type": "p", "children": [], "text": "3 mg" }

For Treatment of Severe Low Blood Sugar

{ "type": "p", "children": [], "text": "For Treatment of Severe Low Blood Sugar" }

For Nasal Use Only

{ "type": "p", "children": [], "text": "For Nasal Use Only" }

Contains 2 nasal devices.

{ "type": "p", "children": [], "text": "Contains 2 nasal devices." }

Keep tubes sealed until ready to use.

{ "type": "p", "children": [], "text": "Keep tubes sealed until ready to use." }

Rx only

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

BAQSIMI two Pack®

{ "type": "p", "children": [], "text": "BAQSIMI two Pack®\n" }

www.baqsimi.com

{ "type": "p", "children": [], "text": "www.baqsimi.com" }

528351AMA/5-23

{ "type": "p", "children": [], "text": "528351AMA/5-23" }