AIMOVIG is indicated for the preventive treatment of migraine in adults.

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The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly.

If a dose of AIMOVIG is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.

AIMOVIG is for subcutaneous use only.

AIMOVIG is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer AIMOVIG using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique [see Instructions for Use]:

AIMOVIG is a sterile, clear to opalescent, colorless to light yellow solution available as follows:

{ "type": "p", "children": [], "text": "AIMOVIG is a sterile, clear to opalescent, colorless to light yellow solution available as follows:" }

{ "type": "ul", "children": [ " Injection: 70 mg/mL in a single-dose prefilled SureClick® autoinjector", " Injection: 140 mg/mL in a single-dose prefilled SureClick® autoinjector", " Injection: 70 mg/mL in a single-dose prefilled syringe", " Injection: 140 mg/mL in a single-dose prefilled syringe" ], "text": "" }

AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)]." }

Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with AIMOVIG in postmarketing experience. Most hypersensitivity reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy [see Contraindications (4), and Patient Counseling Information (17)].

Constipation with serious complications has been reported following the use of AIMOVIG in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose of AIMOVIG; however, patients have also presented with constipation later on in treatment. AIMOVIG was discontinued in most reported cases of constipation with serious complications. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies [see Adverse Reactions (6.1)].

Monitor patients treated with AIMOVIG for severe constipation and manage as clinically appropriate [see Patient Counseling Information (17)]. The concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Development of hypertension and worsening of pre-existing hypertension have been reported following the use of AIMOVIG in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. AIMOVIG was discontinued in many of the reported cases.

Monitor patients treated with AIMOVIG for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of AIMOVIG is warranted if evaluation fails to establish an alternative etiology.

Development of Raynaud's phenomenon and recurrence or worsening of pre-existing Raynaud's phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AIMOVIG. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

AIMOVIG should be discontinued if signs or symptoms of Raynaud's phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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

The safety of AIMOVIG has been evaluated in 2537 patients with migraine who received at least one dose of AIMOVIG, representing 3040.2 patient-years of exposure. Of these, 2271 patients were exposed to 70 mg or 140 mg once monthly for at least 6 months, 1305 patients were exposed for at least 12 months, and 216 patients were exposed through 5 years.

In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2184 patients, 787 patients received at least one dose of AIMOVIG 70 mg once monthly, 507 patients received at least one dose of AIMOVIG 140 mg once monthly, and 890 patients received placebo during 3 months or 6 months of double-blind treatment [see Clinical Studies (14)]. Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry.

The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation. Table 1 summarizes the adverse reactions that occurred during the first 3 months in the migraine studies (Studies 1, 2, and 3).

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1: Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3</span> </caption> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="25%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Adverse Reaction</th><th align="center" class="Rrule">AIMOVIG<br/>70 mg Once Monthly<br/>N = 787<br/>%</th><th align="center" class="Rrule">AIMOVIG <br/>140 mg Once Monthly<br/>N = 507<br/>%</th><th align="center" class="Rrule">Placebo<br/> <br/>N = 890<br/>%</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>The rate of injection site reactions reported in Table 1 is with the prefilled syringe. </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">Injection site reactions<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a><span class="Sup">,</span><a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a></td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">5</td><td align="center" class="Rrule">3</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">Constipation</td><td align="center" class="Rrule">1</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">1</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">Cramps, muscle spasms</td><td align="center" class="Rrule">&lt; 1</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">&lt; 1</td> </tr> </tbody> </table></div>

In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG 70 mg or 140 mg discontinued double-blind treatment because of adverse events. The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus.

The following adverse reactions have been identified during postapproval use of AIMOVIG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis [see Warnings and Precautions (5.1)].

Gastrointestinal Disorders: Constipation with serious complications [see Warnings and Precautions (5.2)], oral mucosal ulceration.

Skin and Subcutaneous Tissue Disorders: Rash, alopecia.

Vascular Disorders: Hypertension [see Warnings and Precautions (5.3)], Raynaud's Phenomenon [see Warnings and Precautions (5.4)].

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy. Patients should be encouraged to enroll by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/.

Risk Summary

There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation [see Data]. Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses.

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. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

Data

Animal Data

In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20-22 to parturition), no adverse effects on offspring were observed. Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly.

Risk Summary

There are no data on the presence of erenumab-aooe in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Erenumab-aooe is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide receptor. Erenumab-aooe is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa.

{ "type": "p", "children": [], "text": "Erenumab-aooe is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide receptor. Erenumab-aooe is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa." }

AIMOVIG (erenumab-aooe) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous administration. Each 1 mL 70 mg single-dose prefilled autoinjector and 70 mg single-dose prefilled glass syringe contains 70 mg erenumab-aooe, acetate (1.5 mg), polysorbate 80 (0.10 mg), and sucrose (73 mg). Each 1 mL 140 mg single-dose prefilled autoinjector and 140 mg single-dose prefilled glass syringe contains 140 mg erenumab-aooe, acetate (2.0 mg), polysorbate 80 (0.10 mg), and sucrose (65 mg). Enclosed within the autoinjector is a single-dose, prefilled glass syringe. The solution of AIMOVIG has a pH of 5.2.

{ "type": "p", "children": [], "text": "AIMOVIG (erenumab-aooe) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous administration. Each 1 mL 70 mg single-dose prefilled autoinjector and 70 mg single-dose prefilled glass syringe contains 70 mg erenumab-aooe, acetate (1.5 mg), polysorbate 80 (0.10 mg), and sucrose (73 mg). Each 1 mL 140 mg single-dose prefilled autoinjector and 140 mg single-dose prefilled glass syringe contains 140 mg erenumab-aooe, acetate (2.0 mg), polysorbate 80 (0.10 mg), and sucrose (65 mg). Enclosed within the autoinjector is a single-dose, prefilled glass syringe. The solution of AIMOVIG has a pH of 5.2." }

Erenumab-aooe is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function.

In a randomized, double-blind, placebo-controlled study in healthy volunteers, concomitant administration of erenumab-aooe (140 mg intravenous, single-dose) with sumatriptan (12 mg subcutaneous, given as two 6 mg doses separated by one hour) had no effect on resting blood pressure compared with sumatriptan alone. AIMOVIG is for subcutaneous use only.

Erenumab-aooe exhibits non-linear kinetics as a result of binding to the CGRP receptor. The Cmax mean and AUClast mean following subcutaneous administration of a 70 mg once monthly and a 140 mg once monthly dose in healthy volunteers or migraine patients are included in Table 2.

Less than 2-fold accumulation was observed in trough serum concentrations (Cmin) for episodic and chronic migraine patients following subcutaneous administration of 70 mg once monthly and 140 mg once monthly doses (see Table 2). Serum trough concentrations approached steady state by 3 months of dosing. The effective half-life of erenumab-aooe is 28 days.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2: Pharmacokinetic Parameters of AIMOVIG</span> </caption> <col align="left" valign="bottom" width="30%"/> <col align="center" valign="bottom" width="35%"/> <col align="center" valign="bottom" width="35%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">AIMOVIG 70 mg<br/>Subcutaneously Once Monthly</th><th align="center" class="Rrule">AIMOVIG 140 mg<br/>Subcutaneously Once Monthly</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-3" name="footnote-3">*</a> </dt> <dd>SD = standard deviation </dd> <dt> <a href="#footnote-reference-4" name="footnote-4">†</a> </dt> <dd>from a single-dose study</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">C<span class="Sub">max</span> mean (SD)<a class="Sup" href="#footnote-3" name="footnote-reference-3">*</a><span class="Sup">,</span><a class="Sup" href="#footnote-4" name="footnote-reference-4">†</a></td><td align="center" class="Rrule">6.1 (2.1) mcg/mL</td><td align="center" class="Rrule">15.8 (4.8) mcg/mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">AUC<span class="Sub">last</span> mean (SD)<a class="Sup" href="#footnote-3">*</a><span class="Sup">,</span><a class="Sup" href="#footnote-4">†</a></td><td align="center" class="Rrule">159 (58) day*mcg/mL</td><td align="center" class="Rrule">505 (139) day*mcg/mL</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3">C<span class="Sub">min </span>(SD)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Episodic migraine</td><td align="center" class="Rrule">5.7 (3.1) mcg/mL</td><td align="center" class="Rrule">12.8 (6.5) mcg/mL</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  Chronic migraine</td><td align="center" class="Rrule">6.2 (2.9) mcg/mL</td><td align="center" class="Rrule">14.9 (6.5) mcg/mL</td> </tr> </tbody> </table></div>

Absorption

Following a single subcutaneous dose of 70 mg or 140 mg erenumab-aooe administered to healthy adults, median peak serum concentrations were attained in approximately 6 days, and estimated absolute bioavailability was 82%.

Distribution

Following a single 140 mg intravenous dose, the mean (SD) volume of distribution during the terminal phase (Vz) was estimated to be 3.86 (0.77) L.

Metabolism and Excretion

Two elimination phases were observed for erenumab-aooe. At low concentrations, the elimination is predominantly through saturable binding to target (CGRP receptor), while at higher concentrations the elimination of erenumab-aooe is largely through a non-specific, non-saturable proteolytic pathway.

Specific Populations

The pharmacokinetics of erenumab-aooe were not affected by age, gender, race, or subtypes of migraine spectrum (episodic or chronic migraine) based on population pharmacokinetics analysis.

Patients with Renal or Hepatic Impairment

Population pharmacokinetic analysis of integrated data from the AIMOVIG clinical studies did not reveal a difference in the pharmacokinetics of erenumab-aooe in patients with mild or moderate renal impairment relative to those with normal renal function. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) have not been studied. No dedicated clinical studies were conducted to evaluate the effect of hepatic impairment or renal impairment on the pharmacokinetics of erenumab-aooe. Renal or hepatic impairment is not expected to affect pharmacokinetics of erenumab-aooe.

Drug Interaction Studies

P450 Enzymes

Erenumab-aooe is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Oral Contraceptives

In an open-label drug interaction study in healthy female volunteers, erenumab-aooe (140 mg subcutaneous, single-dose) did not affect the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate.

Sumatriptan

In a study in healthy volunteers, concomitant administration of erenumab-aooe with sumatriptan had no effect on the pharmacokinetics of sumatriptan [see Clinical Pharmacology (12.2)].

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

The immunogenicity of AIMOVIG has been evaluated using an immunoassay for the detection of binding anti-erenumab-aooe antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.

In controlled studies with AIMOVIG [see Clinical Studies (14)], the incidence of anti-erenumab-aooe antibody development was 6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitro neutralizing activity). In a long-term study, including 12 weeks of double-blind treatment and up to 256 weeks of open-label treatment, the incidence of anti-erenumab-aooe antibody development was 11.1% (25/225) among patients whose AIMOVIG dose was 70 mg or 140 mg (2 of whom had in vitro neutralizing activity). The neutralizing anti-erenumab-aooe antibody positive rate may be underestimated because of limitations of the assay. Although these data do not demonstrate an impact of anti-erenumab-aooe antibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited to make definitive conclusions.

Carcinogenesis

The carcinogenic potential of erenumab-aooe has not been assessed.

Mutagenesis

Genetic toxicology studies of erenumab-aooe have not been conducted.

Impairment of Fertility

Mating studies have not been conducted on erenumab-aooe. No histopathological changes in male or female reproductive organs were observed in monkeys administered erenumab-aooe (0, 25, or 150 mg/kg) by subcutaneous injection twice weekly for up to 6 months. Serum erenumab-aooe exposures (AUC) at the higher dose tested were more than 100 times that in humans at a dose of 140 mg once monthly.

Episodic Migraine

Study 1 (NCT 02456740) was a randomized, multi-center, 6-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. A total of 955 patients with a history of episodic migraine were randomized to receive either AIMOVIG 70 mg (N = 317), AIMOVIG 140 mg (N = 319), or placebo (N = 319) by subcutaneous injection once monthly (QM) for 6 months. Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study.

The study excluded patients with medication overuse headache as well as patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.

The primary efficacy endpoint was the change from baseline in mean monthly migraine days over months 4 to 6. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in mean monthly migraine days over months 4 to 6 ("≥ 50% MMD responders"), the change from baseline in mean monthly acute migraine-specific medication days over months 4 to 6, and the change from baseline in mean Migraine Physical Function Impact Diary (MPFID) over months 4 to 6. The MPFID measures the impact of migraine on everyday activities (EA) and physical impairment (PI) using an electronic diary administered daily. Monthly MPFID scores are averaged over 28 days, including days with and without migraine; scores are scaled from 0 to 100. Higher scores indicate worse impact on EA and PI. Reductions from baseline in MPFID scores indicate improvement.

A total of 858 (90%) patients completed the 6-month double-blind study. Patients had a median age of 42 years (range: 18 to 65 years), 85% were female, and 89% were white. Three percent of patients were taking concomitant preventive treatments for migraine. The mean migraine frequency at baseline was approximately 8 migraine days per month and was similar across treatment groups.

AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints compared to placebo, as summarized in Table 3.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 3: Efficacy Endpoints Over Months 4 to 6 in Study 1</span> </caption> <col align="left" valign="top" width="30%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">AIMOVIG<br/>70 mg Once Monthly</th><th align="center" class="Rrule">AIMOVIG<br/>140 mg Once Monthly</th><th align="center" class="Rrule">Placebo</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" valign="bottom">N = 312</th><th align="center" class="Rrule" valign="bottom">N = 318</th><th align="center" class="Rrule" valign="bottom">N = 316</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Monthly Migraine Days (MMD)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−3.2</td><td align="center" class="Rrule">−3.7</td><td align="center" class="Rrule">−1.8</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−1.4</td><td align="center" class="Rrule">−1.9</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">≥ 50% MMD responders</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  % Responders</td><td align="center" class="Rrule">43.3%</td><td align="center" class="Rrule">50.0%</td><td align="center" class="Rrule">26.6%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">16.7%</td><td align="center" class="Rrule">23.4%</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Odds ratio relative to placebo</td><td align="center" class="Rrule">2.1</td><td align="center" class="Rrule">2.8</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Monthly acute migraine-specific medication days</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−1.1</td><td align="center" class="Rrule">−1.6</td><td align="center" class="Rrule">−0.2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−0.9</td><td align="center" class="Rrule">−1.4</td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 1: Change from Baseline in Monthly Migraine Days in Study 1<a class="Sup" href="#footnote-5" name="footnote-reference-5">*</a></span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" colspan="1"> <dl class="Footnote"> <dt> <a href="#footnote-reference-5" name="footnote-5">*</a> </dt> <dd>Least-square means and 95% confidence intervals are presented.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 1" src="/dailymed/image.cfm?name=aimovig-01.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

Figure 2 shows the distribution of change from baseline in mean monthly migraine days over months 4 to 6 in bins of 2 days by treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of changes from baseline in monthly migraine days.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days Over Months 4 to 6 by Treatment Group in Study 1</span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" valign="top">Figure excludes patients with missing data.</td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 2" src="/dailymed/image.cfm?name=aimovig-02.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

Compared to placebo, patients treated with AIMOVIG 70 mg once monthly and 140 mg once monthly showed greater reductions from baseline in mean monthly MPFID everyday activity scores averaged over months 4 to 6 [difference from placebo: −2.2 for AIMOVIG 70 mg and −2.6 for AIMOVIG 140 mg; p-value < 0.001 for both], and in mean monthly MPFID physical impairment scores averaged over months 4 to 6 [difference from placebo: −1.9 for AIMOVIG 70 mg and −2.4 for AIMOVIG 140 mg; p-value < 0.001 for both].

Study 2 (NCT 02483585) was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. A total of 577 patients with a history of episodic migraine were randomized to receive either AIMOVIG 70 mg (N = 286) or placebo (N = 291) by subcutaneous injection once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study.

The study excluded patients with medication overuse headache as well as patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.

The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days ("≥ 50% MMD responders"), the change from baseline in monthly acute migraine-specific medication days at month 3, and the proportion of patients with at least a 5-point score reduction from baseline in MPFID at month 3.

A total of 546 (95%) patients completed the 3-month double-blind study. Patients had a median age of 43 years (range: 18 to 65 years), 85% were female, and 90% were white. Six to seven percent of patients were taking concomitant preventive migraine treatment. The mean migraine frequency at baseline was approximately 8 migraine days per month and was similar between treatment groups.

AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints compared to placebo, as summarized in Table 4.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 4: Efficacy Endpoints at Month 3 for Study 2</span> </caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="30%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">AIMOVIG<br/>70 mg Once Monthly</th><th align="center" class="Rrule">Placebo</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" valign="bottom">N = 282</th><th align="center" class="Rrule" valign="bottom">N = 288</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Bold">Monthly Migraine Days (MMD)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−2.9</td><td align="center" class="Rrule">−1.8</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−1.0</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Bold">≥ 50% MMD responders</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  % Responders</td><td align="center" class="Rrule">39.7%</td><td align="center" class="Rrule">29.5%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">10.2%</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Odds ratio relative to placebo</td><td align="center" class="Rrule">1.6</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">0.010</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="3"><span class="Bold">Monthly acute migraine-specific medication days</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−1.2</td><td align="center" class="Rrule">−0.6</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−0.6</td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">0.002</td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 3: Change from Baseline in Monthly Migraine Days in Study 2<a class="Sup" href="#footnote-6" name="footnote-reference-6">*</a></span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" colspan="1"> <dl class="Footnote"> <dt> <a href="#footnote-reference-6" name="footnote-6">*</a> </dt> <dd>Least-square means and 95% confidence intervals are presented.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 3" src="/dailymed/image.cfm?name=aimovig-03.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

Figure 4 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 2 days by treatment group. A treatment benefit over placebo for AIMOVIG is seen across a range of changes from baseline in monthly migraine days.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 4: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by Treatment Group in Study 2</span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" valign="top">Figure excludes patients with missing data.</td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 4" src="/dailymed/image.cfm?name=aimovig-04.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

The pre-specified analysis for the MPFID was based on at least a 5-point reduction within-patient responder definition. AIMOVIG 70 mg once monthly was not significantly better than placebo for the proportion of responders for everyday activity [difference from placebo: 4.7%; odds ratio = 1.2; p-value = 0.26] and physical impairment [difference from placebo: 5.9%; odds ratio = 1.3; p-value = 0.13]. In an exploratory analysis of the change from baseline in the mean MPFID scores at month 3, patients treated with AIMOVIG 70 mg, as compared to placebo, showed nominally greater reductions of physical impairment scores [difference from placebo: -1.3; p-value = 0.021], but not of everyday activities scores [difference from placebo: -1.1; p-value = 0.061].

Chronic Migraine

Study 3 (NCT 02066415) was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG as a preventive treatment of chronic migraine. A total of 667 patients with a history of chronic migraine with or without aura were randomized to receive AIMOVIG 70 mg (N = 191), AIMOVIG 140 mg (N = 190), or placebo (N = 286) by subcutaneous injections once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study.

The study excluded patients with medication overuse headache caused by opiate overuse and patients with concurrent use of migraine preventive treatments. Patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening were also excluded.

The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days ("≥ 50% MMD responders") and change from baseline in monthly acute migraine-specific medication days at month 3.

A total of 631 (95%) patients completed the 3-month double-blind study. Patients had a median age of 43 years (range: 18 to 66 years), 83% were female, and 94% were white. The mean migraine frequency at baseline was approximately 18 migraine days per month and was similar across treatment groups.

AIMOVIG treatment demonstrated statistically significant improvements for key efficacy outcomes compared to placebo, as summarized in Table 5.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 5: Efficacy Endpoints at Month 3 in Study 3</span> </caption> <col align="left" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">AIMOVIG<br/>70 mg Once Monthly</th><th align="center" class="Rrule">AIMOVIG<br/>140 mg Once Monthly</th><th align="center" class="Rrule">Placebo</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule" valign="bottom">N = 188</th><th align="center" class="Rrule" valign="bottom">N = 187</th><th align="center" class="Rrule" valign="bottom">N = 281</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Monthly Migraine Days (MMD)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−6.6</td><td align="center" class="Rrule">−6.6</td><td align="center" class="Rrule">−4.2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−2.5</td><td align="center" class="Rrule">−2.5</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">≥ 50% MMD responders</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  % Responders</td><td align="center" class="Rrule">39.9%</td><td align="center" class="Rrule">41.2%</td><td align="center" class="Rrule">23.5%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">16.4%</td><td align="center" class="Rrule">17.7%</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Odds ratio relative to placebo</td><td align="center" class="Rrule">2.2</td><td align="center" class="Rrule">2.3</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Monthly acute migraine-specific medication days</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Change from baseline</td><td align="center" class="Rrule">−3.5</td><td align="center" class="Rrule">−4.1</td><td align="center" class="Rrule">−1.6</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">  Difference from placebo</td><td align="center" class="Rrule">−1.9</td><td align="center" class="Rrule">−2.6</td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">  <span class="Italics">p-</span>value</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule">&lt; 0.001</td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 5: Change from Baseline in Monthly Migraine Days in Study 3<a class="Sup" href="#footnote-7" name="footnote-reference-7">*</a></span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" colspan="1"> <dl class="Footnote"> <dt> <a href="#footnote-reference-7" name="footnote-7">*</a> </dt> <dd>Least-square means and 95% confidence intervals are presented.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 5" src="/dailymed/image.cfm?name=aimovig-05.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

Figure 6 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 3 days by treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of changes from baseline in migraine days.

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span>Figure 6: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by Treatment Group in Study 3</span> </caption> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" valign="top">Figure excludes patients with missing data.</td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Figure 6" src="/dailymed/image.cfm?name=aimovig-06.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

AIMOVIG (erenumab-aooe) injection is a sterile, clear to opalescent, colorless to light yellow solution for subcutaneous administration.

AIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex. Each single-dose prefilled SureClick® autoinjector or single-dose prefilled syringe of AIMOVIG contains a Type 1 glass syringe and stainless steel needle and delivers 1 mL of 70 mg/mL or 140 mg/mL solution.

AIMOVIG is supplied as follows:

SureClick® Autoinjector

Syringe

Information on Preparation and Administration

Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled autoinjector or single-dose prefilled syringe [see Dosage and Administration (2.2)]. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AIMOVIG.

Advise patients to let AIMOVIG sit at room temperature for at least 30 minutes prior to administration [see Dosage and Administration (2.2)].

Hypersensitivity Reactions

Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions [see Warnings and Precautions (5.1)].

Constipation with Serious Complications

Advise patients that constipation with serious complications can occur with AIMOVIG and that they should contact their healthcare providers if they experience severe constipation [see Warnings and Precautions (5.2)].

Hypertension

Advise patients that development of hypertension and worsening of pre-existing hypertension can occur with AIMOVIG and that they should contact their healthcare providers if they experience elevation in their blood pressure [see Warnings and Precautions (5.3)].

Pregnancy

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy [see Use in Specific Populations (8.1)].

Raynaud's Phenomenon

Inform patients that Raynaud's phenomenon can develop or worsen with AIMOVIG. Advise patients to discontinue AIMOVIG and contact their healthcare provider if they experience signs or symptoms of Raynaud's phenomenon [see Warnings and Precautions (5.4)].

For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).

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AIMOVIG® (erenumab-aooe)

{ "type": "p", "children": [], "text": "AIMOVIG® (erenumab-aooe)" }

Manufactured by: Amgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799 U.S.A.U.S. License No. 1080

{ "type": "p", "children": [], "text": "\nManufactured by:\nAmgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799 U.S.A.U.S. License No. 1080" }

Patent: http://pat.amgen.com/aimovig/ © 2018-2025 Amgen Inc. All rights reserved. [part number] V12

{ "type": "p", "children": [], "text": "Patent: http://pat.amgen.com/aimovig/ © 2018-2025 Amgen Inc. All rights reserved. [part number] V12" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="85%"/> <col align="left" valign="top" width="15%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" colspan="2">Patient Information <br/>AIMOVIG<span class="Sup">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration.<br/>[part number] v10</td><td align="right" valign="top">Revised: 3/2025    </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is AIMOVIG?</span> <br/>AIMOVIG is a prescription medicine used for the preventive treatment of migraine in adults. <br/>It is not known if AIMOVIG is safe and effective in children under 18 years of age.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Who should not use AIMOVIG?</span> <br/> <span class="Bold">Do not</span> use AIMOVIG if you are allergic to erenumab-aooe or any of the ingredients in AIMOVIG. See the end of this Patient Information for a complete list of ingredients in AIMOVIG.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2">Before you start using AIMOVIG, tell your healthcare provider about all your medical conditions, including if you: <ul class="Disc"> <li>have high blood pressure</li> <li>have circulation problems in your fingers and toes</li> <li> <span class="Bold">are pregnant or plan to become pregnant.</span> It is not known if AIMOVIG will harm your unborn baby.<ul class="Circle"> <li>Pregnancy Registry: There is a pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your baby's health. You may enroll yourself by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Or you may talk to your healthcare provider about how you can take part in this registry.</li> </ul> </li> <li> <span class="Bold">are breastfeeding or plan to breastfeed.</span> It is not known if AIMOVIG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AIMOVIG.</li> </ul>Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How should I take AIMOVIG?</span> <ul> <li> <span class="Bold">See the detailed "Instructions for Use" on complete information on how to take AIMOVIG.</span> </li> <li>Take AIMOVIG exactly as your healthcare provider tells you to take it. </li> <li>Before you inject, always check the label of your single-dose prefilled autoinjector or single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG.</li> <li>Also, before you inject, leave AIMOVIG at room temperature for at least 30 minutes protected from direct sunlight.</li> <li>AIMOVIG is injected under your skin (subcutaneously) 1 time each month.</li> <li>AIMOVIG comes in 2 different types of devices: a single-dose (1 time) prefilled autoinjector or a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.</li> <li>If you forget to take AIMOVIG or are not able to take the dose at the regular time, take your missed dose as soon as you remember. After that, you can continue to take AIMOVIG 1 time each month from the date of your last dose.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are possible side effects of AIMOVIG?<br/>AIMOVIG may cause serious side effects, including:</span> <ul> <li> <span class="Bold">Allergic reactions.</span> Allergic reactions, including rash or swelling can happen after receiving AIMOVIG. This can happen within hours to days after using AIMOVIG. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: <ul class="Circle"> <li>swelling of the face, mouth, tongue, or throat</li> <li>trouble breathing</li> </ul> </li> <li> <span class="Bold">Constipation with serious complications.</span> Severe constipation can happen after receiving AIMOVIG. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly or bloating.</li> <li> <span class="Bold">High blood pressure.</span> High blood pressure or worsening of high blood pressure can happen after receiving AIMOVIG. Contact your healthcare provider if you have an increase in blood pressure.</li> <li> <span class="Bold">Raynaud's phenomenon.</span> A type of circulation problem can worsen or happen after receiving AIMOVIG. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.</li> </ul>The most common side effects of AIMOVIG include: pain, redness, or swelling at the injection site and constipation.<br/>Tell your healthcare provider if you have any side effect that bothers you or that does not go away.<br/>These are not all of the possible side effects of AIMOVIG. Ask your pharmacist or healthcare provider for more information.<br/>Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">How should I store AIMOVIG?</span> <ul> <li>Store AIMOVIG in the refrigerator between 36°F to 46°F (2°C to 8°C). </li> <li>Keep AIMOVIG in the original carton. This will protect the medicine from light. </li> <li>After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.</li> <li>Throw away AIMOVIG that has been left at room temperature for more than 7 days. </li> <li> <span class="Bold">Do not</span> freeze. </li> <li> <span class="Bold">Do not</span> shake. </li> </ul> <span class="Bold">Keep AIMOVIG and all medicines out of the reach of children.</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of AIMOVIG.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. <span class="Bold">Do not</span> use AIMOVIG for a condition for which it is not prescribed. <span class="Bold">Do not</span> give AIMOVIG to other people, even if they have the same symptoms that you have. It can harm them. You can ask your pharmacist or healthcare provider for information about AIMOVIG that is written for healthcare professionals. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in AIMOVIG?</span> <ul> <li> <span class="Bold">Active Ingredient:</span> erenumab-aooe</li> <li> <span class="Bold">Inactive Ingredients:</span> acetate, polysorbate 80, and sucrose</li> </ul> AIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex. </td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2"> AIMOVIG<span class="Sup">®</span> (erenumab-aooe)<br/> <span class="Bold">Manufactured by:</span> <br/>Amgen Inc.<br/>One Amgen Center Drive<br/>Thousand Oaks, CA 91320-1799 U.S.A.<br/>U.S. License No. 1080<br/>Patent: http://pat.amgen.com/aimovig/<br/>© 2018-2025 Amgen Inc. All rights reserved.<br/>For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"85%\"/>\n<col align=\"left\" valign=\"top\" width=\"15%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">Patient Information <br/>AIMOVIG<span class=\"Sup\">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration.<br/>[part number] v10</td><td align=\"right\" valign=\"top\">Revised: 3/2025    </td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is AIMOVIG?</span>\n<br/>AIMOVIG is a prescription medicine used for the preventive treatment of migraine in adults. <br/>It is not known if AIMOVIG is safe and effective in children under 18 years of age.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Who should not use AIMOVIG?</span>\n<br/>\n<span class=\"Bold\">Do not</span> use AIMOVIG if you are allergic to erenumab-aooe or any of the ingredients in AIMOVIG. See the end of this Patient Information for a complete list of ingredients in AIMOVIG.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">Before you start using AIMOVIG, tell your healthcare provider about all your medical conditions, including if you: \t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>have high blood pressure</li>\n<li>have circulation problems in your fingers and toes</li>\n<li>\n<span class=\"Bold\">are pregnant or plan to become pregnant.</span> It is not known if AIMOVIG will harm your unborn baby.<ul class=\"Circle\">\n<li>Pregnancy Registry: There is a pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your baby's health. You may enroll yourself by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Or you may talk to your healthcare provider about how you can take part in this registry.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">are breastfeeding or plan to breastfeed.</span> It is not known if AIMOVIG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AIMOVIG.</li>\n</ul>Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I take AIMOVIG?</span>\n<ul>\n<li>\n<span class=\"Bold\">See the detailed \"Instructions for Use\" on complete information on how to take AIMOVIG.</span>\n</li>\n<li>Take AIMOVIG exactly as your healthcare provider tells you to take it. </li>\n<li>Before you inject, always check the label of your single-dose prefilled autoinjector or single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG.</li>\n<li>Also, before you inject, leave AIMOVIG at room temperature for at least 30 minutes protected from direct sunlight.</li>\n<li>AIMOVIG is injected under your skin (subcutaneously) 1 time each month.</li>\n<li>AIMOVIG comes in 2 different types of devices: a single-dose (1 time) prefilled autoinjector or a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.</li>\n<li>If you forget to take AIMOVIG or are not able to take the dose at the regular time, take your missed dose as soon as you remember. After that, you can continue to take AIMOVIG 1 time each month from the date of your last dose.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are possible side effects of AIMOVIG?<br/>AIMOVIG may cause serious side effects, including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Allergic reactions.</span> Allergic reactions, including rash or swelling can happen after receiving AIMOVIG. This can happen within hours to days after using AIMOVIG. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: <ul class=\"Circle\">\n<li>swelling of the face, mouth, tongue, or throat</li>\n<li>trouble breathing</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Constipation with serious complications.</span> Severe constipation can happen after receiving AIMOVIG. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly or bloating.</li>\n<li>\n<span class=\"Bold\">High blood pressure.</span> High blood pressure or worsening of high blood pressure can happen after receiving AIMOVIG. Contact your healthcare provider if you have an increase in blood pressure.</li>\n<li>\n<span class=\"Bold\">Raynaud's phenomenon.</span> A type of circulation problem can worsen or happen after receiving AIMOVIG. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.</li>\n</ul>The most common side effects of AIMOVIG include: pain, redness, or swelling at the injection site and constipation.<br/>Tell your healthcare provider if you have any side effect that bothers you or that does not go away.<br/>These are not all of the possible side effects of AIMOVIG. Ask your pharmacist or healthcare provider for more information.<br/>Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">How should I store AIMOVIG?</span>\n<ul>\n<li>Store AIMOVIG in the refrigerator between 36°F to 46°F (2°C to 8°C). </li>\n<li>Keep AIMOVIG in the original carton. This will protect the medicine from light. </li>\n<li>After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.</li>\n<li>Throw away AIMOVIG that has been left at room temperature for more than 7 days. </li>\n<li>\n<span class=\"Bold\">Do not</span> freeze. </li>\n<li>\n<span class=\"Bold\">Do not</span> shake. </li>\n</ul>\n<span class=\"Bold\">Keep AIMOVIG and all medicines out of the reach of children.</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of AIMOVIG.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. <span class=\"Bold\">Do not</span> use AIMOVIG for a condition for which it is not prescribed. <span class=\"Bold\">Do not</span> give AIMOVIG to other people, even if they have the same symptoms that you have. It can harm them. You can ask your pharmacist or healthcare provider for information about AIMOVIG that is written for healthcare professionals. </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in AIMOVIG?</span>\n<ul>\n<li>\n<span class=\"Bold\">Active Ingredient:</span> erenumab-aooe</li>\n<li>\n<span class=\"Bold\">Inactive Ingredients:</span> acetate, polysorbate 80, and sucrose</li>\n</ul>\t\t\t\t\t\t\t\t\t\tAIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex. \t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">\t\t\t\t\t\t\t\t\t\tAIMOVIG<span class=\"Sup\">®</span> (erenumab-aooe)<br/>\n<span class=\"Bold\">Manufactured by:</span>\n<br/>Amgen Inc.<br/>One Amgen Center Drive<br/>Thousand Oaks, CA 91320-1799 U.S.A.<br/>U.S. License No. 1080<br/>Patent: http://pat.amgen.com/aimovig/<br/>© 2018-2025 Amgen Inc. All rights reserved.<br/>For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector.

{ "type": "p", "children": [], "text": "This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector." }

If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.

{ "type": "p", "children": [], "text": "If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse." }

The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG.

{ "type": "p", "children": [], "text": "The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center">Getting to know your prefilled autoinjector<img alt="Image" src="/dailymed/image.cfm?name=aimovig-07.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\">Getting to know your prefilled autoinjector<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-07.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="left"><span class="Bold">1. Important Information You Need to Know Before Injecting AIMOVIG</span> <ul class="Disc"> <li>It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.</li> <li> <span class="Bold">Do not</span> use the autoinjector if the carton is damaged or the seal is broken.</li> <li> <span class="Bold">Do not</span> use the autoinjector after the expiration date on the label.</li> <li> <span class="Bold">Do not</span> shake the autoinjector.</li> <li> <span class="Bold">Do not</span> remove the white cap from the autoinjector until you are ready to inject.</li> <li> <span class="Bold">Do not</span> use the autoinjector if it has been frozen.</li> <li> <span class="Bold">Do not</span> use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).</li> <li>The autoinjector is not made with natural rubber latex.</li> </ul> </td> </tr> <tr> <td align="left"><span class="Bold">Frequently asked questions:</span> <br/>For additional information and answers to frequently asked questions, visit <span class="Bold">www.aimovig.com</span>.</td> </tr> <tr class="Botrule"> <td align="left"><span class="Bold">Where to get help:</span> <br/>If you want more information or help using AIMOVIG: <ul class="Disc"> <li>Contact your healthcare provider,</li> <li>Visit <span class="Bold">www.aimovig.com</span>, or</li> <li>Call 1-800-77-AMGEN (1-800-772-6436)</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">1. Important Information You Need to Know Before Injecting AIMOVIG</span>\n<ul class=\"Disc\">\n<li>It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if the carton is damaged or the seal is broken.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector after the expiration date on the label.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the autoinjector.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the white cap from the autoinjector until you are ready to inject.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if it has been frozen.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).</li>\n<li>The autoinjector is not made with natural rubber latex.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Frequently asked questions:</span>\n<br/>For additional information and answers to frequently asked questions, visit <span class=\"Bold\">www.aimovig.com</span>.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">Where to get help:</span>\n<br/>If you want more information or help using AIMOVIG: \t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>Contact your healthcare provider,</li>\n<li>Visit <span class=\"Bold\">www.aimovig.com</span>, or</li>\n<li>Call 1-800-77-AMGEN (1-800-772-6436)</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2. Storing and Preparing to Inject AIMOVIG

{ "type": "p", "children": [], "text": "\n2. Storing and Preparing to Inject AIMOVIG\n" }

2a Refrigerate the autoinjector carton until you are ready to use it.

{ "type": "p", "children": [], "text": "\n2a\tRefrigerate the autoinjector carton until you are ready to use it.\n" }

{ "type": "ul", "children": [ "Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).", "Keep the autoinjector in the original carton to protect it from light or physical damage.", "\nDo not freeze the autoinjector.", "\nDo not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Keep the autoinjector and all medicines out of the sight and reach of children.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Keep the autoinjector and all medicines out of the sight and reach of children.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">WAIT</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-09.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr class="Botrule"> <td align="left"><span class="Bold">2b Wait 30 minutes for the autoinjector to reach room temperature.</span> <ul class="Disc"> <li>Let the autoinjector warm up naturally.</li> <li> <span class="Bold">Do not</span> heat the autoinjector with hot water, a microwave, or direct sunlight.</li> <li> <span class="Bold">Do not</span> shake the autoinjector at any time.</li> <li>Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">WAIT</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-09.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">2b\tWait 30 minutes for the autoinjector to reach room temperature.</span>\n<ul class=\"Disc\">\n<li>Let the autoinjector warm up naturally.</li>\n<li>\n<span class=\"Bold\">Do not</span> heat the autoinjector with hot water, a microwave, or direct sunlight.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the autoinjector at any time.</li>\n<li>Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2c You may keep AIMOVIG at room temperature for up to 7 days, if needed.

{ "type": "p", "children": [], "text": "\n2c\tYou may keep AIMOVIG at room temperature for up to 7 days, if needed.\n" }

{ "type": "ul", "children": [ "For example, when you are traveling, you may keep AIMOVIG at room temperature. \t\t\t\t\t\t\t\nKeep it at room temperature between 68°F to 77°F (20°C to 25°C).\n\nDo not put it back in the refrigerator.\nRecord the date you removed it from the refrigerator and use it within 7 days.\n\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Place the autoinjector in a sharps disposal container if it has reached room temperature and has not been used within <span class="Bold">7</span> days.</td> </tr> <tr class="Botrule"> <td align="left"> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Place the autoinjector in a sharps disposal container if it has reached room temperature and has not been used within <span class=\"Bold\">7</span> days.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"> </td>\n</tr>\n</tbody>\n</table></div>" }

2d Inspect the medicine. It should be clear and colorless to slightly yellow.

{ "type": "p", "children": [], "text": "\n2d\tInspect the medicine. It should be clear and colorless to slightly yellow.\n" }

{ "type": "ul", "children": [ "It is okay to see air bubbles in the autoinjector.", "\nDo not use AIMOVIG if the medicine is cloudy, discolored, or has flakes or particles." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> If the medicine is cloudy, discolored, or has flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).</td> </tr> <tr class="Botrule"> <td align="left"> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> If the medicine is cloudy, discolored, or has flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"> </td>\n</tr>\n</tbody>\n</table></div>" }

2e Check the expiration date (Exp.) and inspect the autoinjector for damage.

{ "type": "p", "children": [], "text": "\n2e\tCheck the expiration date (Exp.) and inspect the autoinjector for damage.\n" }

{ "type": "ul", "children": [ "\nDo not use the autoinjector if the expiration date has passed.", "\nDo not use the autoinjector if: \t\t\t\t\t\t\t\nthe white cap is missing or loose.\nit has cracks or broken parts.\nit has been dropped on a hard surface.\n\n", "Make sure you have the right medicine and dose." ], "text": "" }

3. Getting Ready for Your Injection

{ "type": "p", "children": [], "text": "\n3. Getting Ready for Your Injection\n" }

3a Gather and place the following items for your injection on a clean, flat, and well-lit surface:

{ "type": "p", "children": [], "text": "\n3a\tGather and place the following items for your injection on a clean, flat, and well-lit surface:\n" }

{ "type": "ul", "children": [ "AIMOVIG autoinjector (room temperature)", "Sharps disposal container [see Disposing of AIMOVIG and Checking the Injection Site]", "Alcohol wipe", "Adhesive bandage", "Cotton ball or gauze pad" ], "text": "" }

3b Inject into 1 of these sites.

{ "type": "p", "children": [], "text": "\n3b\tInject into 1 of these sites.\n" }

{ "type": "ul", "children": [ "Inject into the front of your thigh or stomach (except for 2 inches around your belly button).", "Someone else can inject in your thigh, stomach, or back of the upper arm." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, hard, raised, thick or scaly skin patch or lesion.</td> </tr> <tr class="Botrule"> <td align="left"> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, hard, raised, thick or scaly skin patch or lesion.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"> </td>\n</tr>\n</tbody>\n</table></div>" }

3c Wash hands thoroughly with soap and water.

{ "type": "p", "children": [], "text": "\n3c Wash hands thoroughly with soap and water.\n" }

3d Clean the injection site with an alcohol wipe.

{ "type": "p", "children": [], "text": "\n3d\tClean the injection site with an alcohol wipe.\n" }

{ "type": "ul", "children": [ "Let the skin dry on its own.", "\nDo not touch this area again before injecting." ], "text": "" }

4. Injecting AIMOVIG

{ "type": "p", "children": [], "text": "\n4. Injecting AIMOVIG\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Only remove the white cap when you can inject right away (within 5 minutes) because the medicine can dry out. <span class="Bold">Do not</span> recap.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Only remove the white cap when you can inject right away (within 5 minutes) because the medicine can dry out. <span class=\"Bold\">Do not</span> recap.</td>\n</tr>\n</tbody>\n</table></div>" }

4a Grasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.

{ "type": "p", "children": [], "text": "\n4a\tGrasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.\n" }

{ "type": "ul", "children": [ "\nDo not twist, bend or wiggle the white cap to pull it off.", "\nNever put the white cap back on. It may damage the needle.", "\nDo not put your finger inside the dark green safety guard.", "It is normal to see a drop of medicine at the end of the needle or dark green safety guard." ], "text": "" }

4b Stretch or pinch the skin to create a firm surface at the injection site. Place the dark green safety guard straight against the skin.

{ "type": "p", "children": [], "text": "\n4b\tStretch or pinch the skin to create a firm surface at the injection site. Place the dark green safety guard straight against the skin.\n" }

{ "type": "ul", "children": [ "Keep the skin stretched or pinched until the injection is finished.", "Make sure you can see the window.", "Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle)." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">PUSH<br/>and hold against skin</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-19.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">PUSH<br/>and hold against skin</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-19.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4c Firmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.

{ "type": "p", "children": [], "text": "\n4c\tFirmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.\n" }

{ "type": "ul", "children": [ "The dark green safety guard pushes in and unlocks the purple start button." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">PRESS<br/>purple start button</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-20.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">PRESS<br/>purple start button</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-20.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4d Keep pushing the autoinjector down and press the purple start button to start the injection.

{ "type": "p", "children": [], "text": "\n4d\tKeep pushing the autoinjector down and press the purple start button to start the injection.\n" }

{ "type": "ul", "children": [ "You may hear or feel a click.", "The window starts to turn yellow.", "It is okay to let go of the purple start button." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">WATCH and CONFIRM<br/>that the window turns fully yellow</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-21.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">WATCH and CONFIRM<br/>that the window turns fully yellow</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-21.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4e Keep pushing the autoinjector down. When the window is fully yellow, the injection is complete.

{ "type": "p", "children": [], "text": "\n4e\tKeep pushing the autoinjector down. When the window is fully yellow, the injection is complete.\n" }

{ "type": "ul", "children": [ "The injection may take up to 15 seconds to complete.", "You may hear or feel a click.", "Lift the autoinjector away from your skin.", "The dark green safety guard locks around the needle." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> If the window has not turned fully yellow, or it looks like the medicine is still coming out, you have not received a full dose. Call your healthcare provider right away.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> If the window has not turned fully yellow, or it looks like the medicine is still coming out, you have not received a full dose. Call your healthcare provider right away.</td>\n</tr>\n</tbody>\n</table></div>" }

5. Disposing of AIMOVIG and Checking the Injection Site

{ "type": "p", "children": [], "text": "\n5. Disposing of AIMOVIG and Checking the Injection Site\n" }

5a Place the used autoinjector and white cap in an FDA-cleared sharps disposal container right away after use.

{ "type": "p", "children": [], "text": "\n5a\tPlace the used autoinjector and white cap in an FDA-cleared sharps disposal container right away after use.\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important</span>: Do not throw away the autoinjector in your household trash.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important</span>: Do not throw away the autoinjector in your household trash.</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "\nDo not reuse the autoinjector.", "\nDo not touch the dark green safety guard." ], "text": "" }

5b Check the injection site.

{ "type": "p", "children": [], "text": "\n5b\tCheck the injection site.\n" }

{ "type": "ul", "children": [ "\nDo not rub the injection site.", "If there is blood, press a cotton ball or gauze pad on your injection site. Apply an adhesive bandage if necessary." ], "text": "" }

Additional information about your sharps disposal containerIf you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "\nAdditional information about your sharps disposal containerIf you do not have an FDA-cleared sharps disposal container, you may use a household container that is:\n" }

{ "type": "ul", "children": [ "made of a heavy-duty plastic,", "can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,", "upright and stable during use,", "leak-resistant, and", "properly labeled to warn of hazardous waste inside the container." ], "text": "" }

Disposing of sharps disposal containers: 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.

{ "type": "p", "children": [], "text": "\nDisposing of sharps disposal containers:\nWhen 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.

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

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

{ "type": "p", "children": [], "text": "\nhttp://www.fda.gov/safesharpsdisposal\n" }

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

{ "type": "p", "children": [], "text": "\nDo 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.

{ "type": "p", "children": [], "text": "\nDo not recycle your used sharps disposal container.\n" }

Important: Keep the autoinjector and sharps disposal container out of the sight and reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep the autoinjector and sharps disposal container out of the sight and reach of children.\n" }

For more information or help call 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "\nFor more information or help call 1-800-77-AMGEN (1-800-772-6436).\n" }

AIMOVIG® (AIM-oh-vig)

{ "type": "p", "children": [], "text": "\nAIMOVIG® (AIM-oh-vig)\n" }

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License Number 1080© 2018 - 2024 Amgen Inc.All rights reserved.Nnnnnnnnnn

{ "type": "p", "children": [], "text": "Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799US License Number 1080© 2018 - 2024 Amgen Inc.All rights reserved.Nnnnnnnnnn" }

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

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

Revised: 8/2024v11

{ "type": "p", "children": [], "text": "Revised: 8/2024v11" }

<div class="scrollingtable"><table class="Noautorules" width="70%"> <col align="center" valign="middle" width="10%"/> <col align="left" valign="middle" width="50%"/> <col align="center" valign="middle" width="40%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2"><span class="Bold">Side 1</span></td><td align="left" class="Botrule Rrule Toprule" rowspan="2"><span class="Bold">Reference Guide</span> <br/>Aimovig<span class="Sup">®</span> (AIM-oh-vig) <br/>(erenumab-aooe)<br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class="Sup">®</span> Autoinjector <br/>70 mg/mL </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold">Read all instructions in carton before use.</span></td> </tr> <tr> <td align="center"><span class="Bold">Questions? Call 1-800-77-AMGEN <br/> (1-800-772-6436)</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"70%\">\n<col align=\"center\" valign=\"middle\" width=\"10%\"/>\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\"><span class=\"Bold\">Side 1</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" rowspan=\"2\"><span class=\"Bold\">Reference Guide</span>\n<br/>Aimovig<span class=\"Sup\">®</span> (AIM-oh-vig) <br/>(erenumab-aooe)<br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class=\"Sup\">®</span> Autoinjector <br/>70 mg/mL </td><td align=\"center\" class=\"Botrule Rrule Toprule\"><span class=\"Bold\">Read all instructions in carton before use.</span></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Questions? Call 1-800-77-AMGEN <br/> (1-800-772-6436)</span></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="30%"/> <col align="center" valign="middle" width="5%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="5%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="17%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Guide to parts</span></td><td align="left" class="Botrule Rrule Toprule" colspan="2" rowspan="3" valign="middle"><span class="Bold">Wait at least 30 minutes</span> for the autoinjector to come to room temperature before giving your injection.</td><td align="left" class="Botrule Rrule Toprule" colspan="3" rowspan="2">Pull the white cap straight off only when you are ready to inject. <span class="Bold">Do not</span> leave the white cap off for <span class="Bold">more than 5 minutes</span>. This can dry out the medicine.</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="7"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-24.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr> <td align="center" class="Botrule Rrule"><span class="Bold">2</span></td><td align="center" class="Rrule" colspan="2"> </td> </tr> <tr> <td align="center" class="Botrule Rrule" colspan="2"> </td><td align="center"> </td><td align="center" class="Botrule Rrule" colspan="2" rowspan="4"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-25.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr> <td align="left" class="Botrule Rrule" colspan="2">Prepare and clean your injection site.</td><td align="center"></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><span class="Bold">1</span></td><td align="center" class="Botrule Rrule" rowspan="3"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-26.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="center"> </td> </tr> <tr> <td align="center"> </td><td align="center" class="Botrule"> </td> </tr> <tr> <td align="center" class="Botrule"> </td><td align="center" class="Rrule" colspan="2"> </td><td align="right" class="Botrule Rrule"><span class="Bold">Turn over to continue</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"30%\"/>\n<col align=\"center\" valign=\"middle\" width=\"5%\"/>\n<col align=\"center\" valign=\"middle\" width=\"25%\"/>\n<col align=\"center\" valign=\"middle\" width=\"5%\"/>\n<col align=\"center\" valign=\"middle\" width=\"18%\"/>\n<col align=\"center\" valign=\"middle\" width=\"17%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Guide to parts</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" colspan=\"2\" rowspan=\"3\" valign=\"middle\"><span class=\"Bold\">Wait at least 30 minutes</span> for the autoinjector to come to room temperature before giving your injection.</td><td align=\"left\" class=\"Botrule Rrule Toprule\" colspan=\"3\" rowspan=\"2\">Pull the white cap straight off only when you are ready to inject. <span class=\"Bold\">Do not</span> leave the white cap off for <span class=\"Bold\">more than 5 minutes</span>. This can dry out the medicine.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"7\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-24.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\"><span class=\"Bold\">2</span></td><td align=\"center\" class=\"Rrule\" colspan=\"2\"> </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\"> </td><td align=\"center\"> </td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" rowspan=\"4\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-25.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">Prepare and clean your injection site.</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><span class=\"Bold\">1</span></td><td align=\"center\" class=\"Botrule Rrule\" rowspan=\"3\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-26.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"center\"> </td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"center\" class=\"Botrule\"> </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule\"> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\"> </td><td align=\"right\" class=\"Botrule Rrule\"><span class=\"Bold\">Turn over to continue</span></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="15%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" colspan="2" rowspan="2"><span class="Bold">Side 2</span></td><td align="left" class="Rrule Toprule" colspan="3" rowspan="2"><span class="Bold">Reference Guide</span> <br/>Aimovig<span class="Sup">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class="Sup">®</span> Autoinjector <br/>70 mg/mL</td><td align="left" class="Rrule" colspan="2"><span class="Bold">AMGEN</span></td><td align="right" class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Read other side first </span></td> </tr> <tr> <td align="left" class="Botrule" colspan="4"> <p class="First">Manufactured by: <br/>Amgen, Inc. <br/>Thousand Oaks, CA 91320<br/>© 2020-2022, 2024 Amgen Inc. All rights reserved.<br/> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-27.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/>This printed material is recyclable. <br/>&lt;part number&gt; Revised: 8/2024 v4</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule Toprule" colspan="3">Stretch <span class="Bold">or</span> pinch your injection site to create a firm surface.</td><td align="left" class="Rrule Toprule" colspan="2"><span class="Bold">Put</span> the green safety guard (needle inside) on your skin at 90 degrees.</td><td align="left" class="Rrule Toprule" colspan="2">Firmly<span class="Bold"> push </span>down the autoinjector onto your skin until it stops moving.</td><td align="left" class="Rrule Toprule" colspan="2">Keep <span class="Bold">pushing</span> down on your skin for <span class="Bold">about 15 seconds.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">3</span></td><td align="left" class="Rrule" colspan="2"></td><td align="left" class="Botrule Rrule"><span class="Bold">4</span></td><td align="left" class="Rrule"></td><td align="left" class="Botrule Rrule"><span class="Bold">5</span></td><td align="left" class="Rrule"></td><td align="left" class="Botrule Rrule"><span class="Bold">6</span></td><td align="left" class="Rrule"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-28.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="left" class="Botrule Rrule" colspan="2"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-29.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="left" class="Botrule Rrule" colspan="2">When you are ready to inject, <span class="Bold">press</span> the purple start button. You will hear a click.<br/>"click"<br/> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-30.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td><td align="left" class="Botrule Rrule" colspan="2"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-31.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/><br/> <span class="Bold"> 15 seconds</span> <br/>Window turns from clear to yellow when the injection is done.<br/>"click"<br/> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-32.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"15%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Lrule Rrule Toprule\" colspan=\"2\" rowspan=\"2\"><span class=\"Bold\">Side 2</span></td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"3\" rowspan=\"2\"><span class=\"Bold\">Reference Guide</span>\n<br/>Aimovig<span class=\"Sup\">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class=\"Sup\">®</span> Autoinjector <br/>70 mg/mL</td><td align=\"left\" class=\"Rrule\" colspan=\"2\"><span class=\"Bold\">AMGEN</span></td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Read other side first </span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\" colspan=\"4\">\n<p class=\"First\">Manufactured by: <br/>Amgen, Inc. <br/>Thousand Oaks, CA 91320<br/>© 2020-2022, 2024 Amgen Inc. All rights reserved.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-27.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/>This printed material is recyclable. <br/>&lt;part number&gt; Revised: 8/2024 v4</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\" colspan=\"3\">Stretch <span class=\"Bold\">or</span> pinch your injection site to create a firm surface.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Put</span> the green safety guard (needle inside) on your skin at 90 degrees.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\">Firmly<span class=\"Bold\"> push </span>down the autoinjector onto your skin until it stops moving.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\">Keep <span class=\"Bold\">pushing</span> down on your skin for <span class=\"Bold\">about 15 seconds.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">3</span></td><td align=\"left\" class=\"Rrule\" colspan=\"2\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">4</span></td><td align=\"left\" class=\"Rrule\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">5</span></td><td align=\"left\" class=\"Rrule\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">6</span></td><td align=\"left\" class=\"Rrule\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-28.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-29.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">When you are ready to inject, <span class=\"Bold\">press</span> the purple start button. You will hear a click.<br/>\"click\"<br/>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-30.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-31.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/><br/>\n<span class=\"Bold\"> 15 seconds</span>\n<br/>Window turns from clear to yellow when the injection is done.<br/>\"click\"<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-32.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector.

{ "type": "p", "children": [], "text": "This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector." }

If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.

{ "type": "p", "children": [], "text": "If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse." }

The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG.

{ "type": "p", "children": [], "text": "The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center">Getting to know your prefilled autoinjector<img alt="Image" src="/dailymed/image.cfm?name=aimovig-33.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\">Getting to know your prefilled autoinjector<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-33.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="left"><span class="Bold">1. Important Information You Need to Know Before Injecting AIMOVIG</span> <ul class="Disc"> <li>It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.</li> <li> <span class="Bold">Do not</span> use the autoinjector if the carton is damaged or the seal is broken.</li> <li> <span class="Bold">Do not</span> use the autoinjector after the expiration date on the label.</li> <li> <span class="Bold">Do not</span> shake the autoinjector.</li> <li> <span class="Bold">Do not</span> remove the orange cap from the autoinjector until you are ready to inject.</li> <li> <span class="Bold">Do not</span> use the autoinjector if it has been frozen.</li> <li> <span class="Bold">Do not</span> use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).</li> <li>The autoinjector is not made with natural rubber latex.</li> </ul> </td> </tr> <tr> <td align="left"><span class="Bold">Frequently asked questions:</span> <br/>For additional information and answers to frequently asked questions, visit <span class="Bold">www.aimovig.com</span>.</td> </tr> <tr class="Botrule"> <td align="left"><span class="Bold">Where to get help:</span> <br/>If you want more information or help using AIMOVIG: <ul class="Disc"> <li>Contact your healthcare provider,</li> <li>Visit <span class="Bold">www.aimovig.com</span>, or</li> <li>Call 1-800-77-AMGEN (1-800-772-6436)</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">1. Important Information You Need to Know Before Injecting AIMOVIG</span>\n<ul class=\"Disc\">\n<li>It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if the carton is damaged or the seal is broken.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector after the expiration date on the label.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the autoinjector.</li>\n<li>\n<span class=\"Bold\">Do not</span> remove the orange cap from the autoinjector until you are ready to inject.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if it has been frozen.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).</li>\n<li>The autoinjector is not made with natural rubber latex.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Frequently asked questions:</span>\n<br/>For additional information and answers to frequently asked questions, visit <span class=\"Bold\">www.aimovig.com</span>.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">Where to get help:</span>\n<br/>If you want more information or help using AIMOVIG: \t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>Contact your healthcare provider,</li>\n<li>Visit <span class=\"Bold\">www.aimovig.com</span>, or</li>\n<li>Call 1-800-77-AMGEN (1-800-772-6436)</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2. Storing and Preparing to Inject AIMOVIG

{ "type": "p", "children": [], "text": "\n2. Storing and Preparing to Inject AIMOVIG\n" }

2a Refrigerate the autoinjector carton until you are ready to use it.

{ "type": "p", "children": [], "text": "\n2a\tRefrigerate the autoinjector carton until you are ready to use it.\n" }

{ "type": "ul", "children": [ "Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).", "Keep the autoinjector in the original carton to protect it from light or physical damage.", "\nDo not freeze the autoinjector.", "\nDo not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Keep the autoinjector and all medicines out of the sight and reach of children.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Keep the autoinjector and all medicines out of the sight and reach of children.</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">WAIT</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-35.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr class="Botrule"> <td align="left"><span class="Bold">2b Wait 30 minutes for the autoinjector to reach room temperature.</span> <ul class="Disc"> <li>Let the autoinjector warm up naturally.</li> <li> <span class="Bold">Do not</span> heat the autoinjector with hot water, a microwave, or direct sunlight.</li> <li> <span class="Bold">Do not</span> shake the autoinjector at any time.</li> <li>Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">WAIT</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-35.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\"><span class=\"Bold\">2b\tWait 30 minutes for the autoinjector to reach room temperature.</span>\n<ul class=\"Disc\">\n<li>Let the autoinjector warm up naturally.</li>\n<li>\n<span class=\"Bold\">Do not</span> heat the autoinjector with hot water, a microwave, or direct sunlight.</li>\n<li>\n<span class=\"Bold\">Do not</span> shake the autoinjector at any time.</li>\n<li>Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

2c You may keep AIMOVIG at room temperature for up to 7 days, if needed.

{ "type": "p", "children": [], "text": "\n2c You may keep AIMOVIG at room temperature for up to 7 days, if needed.\n" }

{ "type": "ul", "children": [ "For example, when you are traveling, you may keep AIMOVIG at room temperature. \t\t\t\t\t\t\t\nKeep it at room temperature between 68°F to 77°F (20°C to 25°C).\n\nDo not put it back in the refrigerator.\nRecord the date you removed it from the refrigerator and use it within 7 days.\n\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Place the autoinjector in a sharps disposal container if it has reached room temperature and has not been used within <span class="Bold">7</span> days.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Place the autoinjector in a sharps disposal container if it has reached room temperature and has not been used within <span class=\"Bold\">7</span> days.</td>\n</tr>\n</tbody>\n</table></div>" }

2d Inspect the medicine. It should be clear and colorless to slightly yellow.

{ "type": "p", "children": [], "text": "\n2d\tInspect the medicine. It should be clear and colorless to slightly yellow.\n" }

{ "type": "ul", "children": [ "It is okay to see air bubbles in the autoinjector.", "\nDo not use AIMOVIG if the medicine is cloudy, discolored, or has flakes or particles." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> If the medicine is cloudy, discolored, or has flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> If the medicine is cloudy, discolored, or has flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436).</td>\n</tr>\n</tbody>\n</table></div>" }

2e Check the expiration date (Exp.) and inspect the autoinjector for damage.

{ "type": "p", "children": [], "text": "\n2e\tCheck the expiration date (Exp.) and inspect the autoinjector for damage.\n" }

{ "type": "ul", "children": [ "\nDo not use the autoinjector if the expiration date has passed.", "\nDo not use the autoinjector if: \t\t\t\t\t\t\t\nthe orange cap is missing or loose.\nit has cracks or broken parts.\nit has been dropped on a hard surface.\n\n", "Make sure you have the right medicine and dose." ], "text": "" }

3. Getting Ready for Your Injection

{ "type": "p", "children": [], "text": "\n3. Getting Ready for Your Injection\n" }

3a Gather and place the following items for your injection on a clean, flat, and well-lit surface:

{ "type": "p", "children": [], "text": "\n3a\tGather and place the following items for your injection on a clean, flat, and well-lit surface:\n" }

{ "type": "ul", "children": [ "AIMOVIG autoinjector (room temperature)", "Sharps disposal container [see Disposing of AIMOVIG and Checking the Injection Site]", "Alcohol wipe", "Adhesive bandage", "Cotton ball or gauze pad" ], "text": "" }

3b Inject into 1 of these sites.

{ "type": "p", "children": [], "text": "\n3b\tInject into 1 of these sites.\n" }

{ "type": "ul", "children": [ "Inject into the front of your thigh or stomach (except for 2 inches around your belly button).", "Someone else can inject in your thigh, stomach, or back of the upper arm." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, hard, raised, thick or scaly skin patch or lesion.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, hard, raised, thick or scaly skin patch or lesion.</td>\n</tr>\n</tbody>\n</table></div>" }

3c Wash hands thoroughly with soap and water.

{ "type": "p", "children": [], "text": "\n3c Wash hands thoroughly with soap and water.\n" }

3d Clean the injection site with an alcohol wipe.

{ "type": "p", "children": [], "text": "\n3d\tClean the injection site with an alcohol wipe.\n" }

{ "type": "ul", "children": [ "Let the skin dry on its own.", "\nDo not touch this area again before injecting." ], "text": "" }

4. Injecting AIMOVIG

{ "type": "p", "children": [], "text": "\n4. Injecting AIMOVIG\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> Only remove the orange cap when you can inject right away (within 5 minutes) because the medicine can dry out. <span class="Bold">Do not</span> recap.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> Only remove the orange cap when you can inject right away (within 5 minutes) because the medicine can dry out. <span class=\"Bold\">Do not</span> recap.</td>\n</tr>\n</tbody>\n</table></div>" }

4a Grasp the autoinjector so you can see the window. Pull the orange cap straight off. You may need to pull hard.

{ "type": "p", "children": [], "text": "\n4a\tGrasp the autoinjector so you can see the window. Pull the orange cap straight off. You may need to pull hard.\n" }

{ "type": "ul", "children": [ "\nDo not twist, bend or wiggle the orange cap to pull it off.", "\nNever put the orange cap back on. It may damage the needle. ", "\nDo not put your finger inside the yellow safety guard.", "It is normal to see a drop of medicine at the end of the needle or yellow safety guard." ], "text": "" }

4b Stretch or pinch the skin to create a firm surface at the injection site. Place the yellow safety guard straight against the skin.

{ "type": "p", "children": [], "text": "\n4b\tStretch or pinch the skin to create a firm surface at the injection site. Place the yellow safety guard straight against the skin.\n" }

{ "type": "ul", "children": [ "Keep the skin stretched or pinched until the injection is finished.", "Make sure you can see the window.", "Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle)." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">PUSH<br/>and hold against skin</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-45.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">PUSH<br/>and hold against skin</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-45.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4c Firmly push the autoinjector down until the yellow safety guard stops moving. Hold the autoinjector down, do not lift.

{ "type": "p", "children": [], "text": "\n4c\tFirmly push the autoinjector down until the yellow safety guard stops moving. Hold the autoinjector down, do not lift.\n" }

{ "type": "ul", "children": [ "The yellow safety guard pushes in and unlocks the gray start button." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">PRESS<br/>gray start button</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-46.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">PRESS<br/>gray start button</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-46.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4d Keep pushing the autoinjector down and press the gray start button to start the injection.

{ "type": "p", "children": [], "text": "\n4d\tKeep pushing the autoinjector down and press the gray start button to start the injection.\n" }

{ "type": "ul", "children": [ "You may hear or feel a click.", "The window starts to turn yellow.", "It is okay to let go of the gray start button." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><span class="Bold">WATCH and CONFIRM<br/>that the window turns fully yellow</span><img alt="Image" src="/dailymed/image.cfm?name=aimovig-47.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><span class=\"Bold\">WATCH and CONFIRM<br/>that the window turns fully yellow</span><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-47.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n</tbody>\n</table></div>" }

4e Keep pushing the autoinjector down. When the window is fully yellow, the injection is complete.

{ "type": "p", "children": [], "text": "\n4e\tKeep pushing the autoinjector down. When the window is fully yellow, the injection is complete.\n" }

{ "type": "ul", "children": [ "The injection may take up to 15 seconds to complete. ", "You may hear or feel a click.", "Lift the autoinjector away from your skin.", "The yellow safety guard locks around the needle." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important:</span> If the window has not turned fully yellow, or it looks like the medicine is still coming out, you have not received a full dose. Call your healthcare provider right away.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important:</span> If the window has not turned fully yellow, or it looks like the medicine is still coming out, you have not received a full dose. Call your healthcare provider right away.</td>\n</tr>\n</tbody>\n</table></div>" }

5. Disposing of AIMOVIG and Checking the Injection Site

{ "type": "p", "children": [], "text": "\n5. Disposing of AIMOVIG and Checking the Injection Site\n" }

5a Place the used autoinjector and orange cap in an FDA-cleared sharps disposal container right away after use.

{ "type": "p", "children": [], "text": "\n5a\tPlace the used autoinjector and orange cap in an FDA-cleared sharps disposal container right away after use.\n" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Important</span>: Do not throw away the autoinjector in your household trash.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Important</span>: Do not throw away the autoinjector in your household trash.</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "\nDo not reuse the autoinjector.", "\nDo not touch the yellow safety guard." ], "text": "" }

5b Check the injection site.

{ "type": "p", "children": [], "text": "\n5b\tCheck the injection site.\n" }

{ "type": "ul", "children": [ "\nDo not rub the injection site. ", "If there is blood, press a cotton ball or gauze pad on your injection site. Apply an adhesive bandage if necessary." ], "text": "" }

Additional information about your sharps disposal containerIf you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "\nAdditional information about your sharps disposal containerIf you do not have an FDA-cleared sharps disposal container, you may use a household container that is:\n" }

{ "type": "ul", "children": [ "made of a heavy-duty plastic,", "can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,", "upright and stable during use,", "leak-resistant, and", "properly labeled to warn of hazardous waste inside the container." ], "text": "" }

Disposing of sharps disposal containers: 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.

{ "type": "p", "children": [], "text": "\nDisposing of sharps disposal containers:\nWhen 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.

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

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

{ "type": "p", "children": [], "text": "\nhttp://www.fda.gov/safesharpsdisposal\n" }

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

{ "type": "p", "children": [], "text": "\nDo 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.

{ "type": "p", "children": [], "text": "\nDo not recycle your used sharps disposal container.\n" }

Important: Keep the autoinjector and sharps disposal container out of the sight and reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Keep the autoinjector and sharps disposal container out of the sight and reach of children.\n" }

For more information or help call 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "\nFor more information or help call 1-800-77-AMGEN (1-800-772-6436).\n" }

AIMOVIG® (AIM-oh-vig)

{ "type": "p", "children": [], "text": "\nAIMOVIG® (AIM-oh-vig)\n" }

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799U.S. License Number 1080© 2019 - 2024 Amgen Inc. All rights reserved.nnnnnnnnnn

{ "type": "p", "children": [], "text": "Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799U.S. License Number 1080© 2019 - 2024 Amgen Inc. All rights reserved.nnnnnnnnnn " }

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

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

Revised: 8/2024v10

{ "type": "p", "children": [], "text": "Revised: 8/2024v10" }

<div class="scrollingtable"><table class="Noautorules" width="70%"> <col align="center" valign="middle" width="10%"/> <col align="left" valign="middle" width="50%"/> <col align="center" valign="middle" width="40%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2"><span class="Bold">Side 1</span></td><td align="left" class="Botrule Rrule Toprule" rowspan="2"><span class="Bold">Reference Guide</span> <br/>Aimovig<span class="Sup">®</span> (AIM-oh-vig) <br/>(erenumab-aooe)<br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class="Sup">®</span> Autoinjector <br/>140 mg/mL </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold">Read all instructions in carton before use.</span></td> </tr> <tr> <td align="center"><span class="Bold">Questions? Call 1-800-77-AMGEN <br/> (1-800-772-6436)</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"70%\">\n<col align=\"center\" valign=\"middle\" width=\"10%\"/>\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"center\" valign=\"middle\" width=\"40%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\"><span class=\"Bold\">Side 1</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" rowspan=\"2\"><span class=\"Bold\">Reference Guide</span>\n<br/>Aimovig<span class=\"Sup\">®</span> (AIM-oh-vig) <br/>(erenumab-aooe)<br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class=\"Sup\">®</span> Autoinjector <br/>140 mg/mL </td><td align=\"center\" class=\"Botrule Rrule Toprule\"><span class=\"Bold\">Read all instructions in carton before use.</span></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Questions? Call 1-800-77-AMGEN <br/> (1-800-772-6436)</span></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="30%"/> <col align="center" valign="middle" width="5%"/> <col align="center" valign="middle" width="25%"/> <col align="center" valign="middle" width="5%"/> <col align="center" valign="middle" width="18%"/> <col align="center" valign="middle" width="17%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Guide to parts</span></td><td align="left" class="Botrule Rrule Toprule" colspan="2" rowspan="3" valign="middle"><span class="Bold">Wait at least 30 minutes</span> for the autoinjector to come to room temperature before giving your injection.</td><td align="left" class="Botrule Rrule Toprule" colspan="3" rowspan="2">Pull the orange cap straight off only when you are ready to inject. <span class="Bold">Do not</span> leave the orange cap off for <span class="Bold">more than 5 minutes</span>. This can dry out the medicine.</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" rowspan="7"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-50.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr> <td align="center" class="Botrule Rrule"><span class="Bold">2</span></td><td align="center" class="Rrule" colspan="2"> </td> </tr> <tr> <td align="center" class="Botrule Rrule" colspan="2"> </td><td align="center"> </td><td align="center" class="Botrule Rrule" colspan="2" rowspan="4"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-51.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr> <td align="left" class="Botrule Rrule" colspan="2">Prepare and clean your injection site.</td><td align="center"></td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"><span class="Bold">1</span></td><td align="center" class="Botrule Rrule" rowspan="3"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-52.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="center"> </td> </tr> <tr> <td align="center"> </td><td align="center" class="Botrule"> </td> </tr> <tr> <td align="center" class="Botrule"> </td><td align="center" class="Rrule" colspan="2"> </td><td align="right" class="Botrule Rrule"><span class="Bold">Turn over to continue</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"30%\"/>\n<col align=\"center\" valign=\"middle\" width=\"5%\"/>\n<col align=\"center\" valign=\"middle\" width=\"25%\"/>\n<col align=\"center\" valign=\"middle\" width=\"5%\"/>\n<col align=\"center\" valign=\"middle\" width=\"18%\"/>\n<col align=\"center\" valign=\"middle\" width=\"17%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Guide to parts</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" colspan=\"2\" rowspan=\"3\" valign=\"middle\"><span class=\"Bold\">Wait at least 30 minutes</span> for the autoinjector to come to room temperature before giving your injection.</td><td align=\"left\" class=\"Botrule Rrule Toprule\" colspan=\"3\" rowspan=\"2\">Pull the orange cap straight off only when you are ready to inject. <span class=\"Bold\">Do not</span> leave the orange cap off for <span class=\"Bold\">more than 5 minutes</span>. This can dry out the medicine.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" rowspan=\"7\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-50.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\"><span class=\"Bold\">2</span></td><td align=\"center\" class=\"Rrule\" colspan=\"2\"> </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\"> </td><td align=\"center\"> </td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" rowspan=\"4\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-51.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">Prepare and clean your injection site.</td><td align=\"center\"></td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"><span class=\"Bold\">1</span></td><td align=\"center\" class=\"Botrule Rrule\" rowspan=\"3\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-52.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"center\"> </td>\n</tr>\n<tr>\n<td align=\"center\"> </td><td align=\"center\" class=\"Botrule\"> </td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule\"> </td><td align=\"center\" class=\"Rrule\" colspan=\"2\"> </td><td align=\"right\" class=\"Botrule Rrule\"><span class=\"Bold\">Turn over to continue</span></td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="15%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="5%"/> <col align="left" valign="middle" width="20%"/> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" colspan="2" rowspan="2"><span class="Bold">Side 2</span></td><td align="left" class="Rrule Toprule" colspan="3" rowspan="2"><span class="Bold">Reference Guide</span> <br/>Aimovig<span class="Sup">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class="Sup">®</span> Autoinjector <br/>140 mg/mL</td><td align="left" class="Rrule" colspan="2"><span class="Bold">AMGEN</span></td><td align="right" class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Read other side first </span></td> </tr> <tr> <td align="left" class="Botrule" colspan="4"> <p class="First">Manufactured by: <br/>Amgen, Inc. <br/>Thousand Oaks, CA 91320<br/>© 2020-2022, 2024 Amgen Inc. All rights reserved.<br/> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-53.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/>This printed material is recyclable. <br/>&lt;part number&gt; Revised: 8/2024 v4</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule Toprule" colspan="3">Stretch <span class="Bold">or</span> pinch your injection site to create a firm surface.</td><td align="left" class="Rrule Toprule" colspan="2"><span class="Bold">Put</span> the yellow safety guard (needle inside) on your skin at 90 degrees.</td><td align="left" class="Rrule Toprule" colspan="2">Firmly<span class="Bold"> push </span>down the autoinjector onto your skin until it stops moving.</td><td align="left" class="Rrule Toprule" colspan="2">Keep <span class="Bold">pushing</span> down on your skin for <span class="Bold">about 15 seconds.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">3</span></td><td align="left" class="Rrule" colspan="2"></td><td align="left" class="Botrule Rrule"><span class="Bold">4</span></td><td align="left" class="Rrule"></td><td align="left" class="Botrule Rrule"><span class="Bold">5</span></td><td align="left" class="Rrule"></td><td align="left" class="Botrule Rrule"><span class="Bold">6</span></td><td align="left" class="Rrule"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-54.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="left" class="Botrule Rrule" colspan="2"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-55.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="left" class="Botrule Rrule" colspan="2">When you are ready to inject, <span class="Bold">press</span> the gray start button. You will hear a click.<br/>"click"<br/> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-56.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td><td align="left" class="Botrule Rrule" colspan="2"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-57.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/><br/> <span class="Bold">15 seconds</span> <br/>Window turns from clear to yellow when the injection is done.<br/>"click"<br/> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-58.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"15%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"5%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Lrule Rrule Toprule\" colspan=\"2\" rowspan=\"2\"><span class=\"Bold\">Side 2</span></td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"3\" rowspan=\"2\"><span class=\"Bold\">Reference Guide</span>\n<br/>Aimovig<span class=\"Sup\">®</span> (AIM-oh-vig) (erenumab-aooe) <br/>injection, for subcutaneous use <br/>Single-Dose Prefilled SureClick<span class=\"Sup\">®</span> Autoinjector <br/>140 mg/mL</td><td align=\"left\" class=\"Rrule\" colspan=\"2\"><span class=\"Bold\">AMGEN</span></td><td align=\"right\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Read other side first </span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule\" colspan=\"4\">\n<p class=\"First\">Manufactured by: <br/>Amgen, Inc. <br/>Thousand Oaks, CA 91320<br/>© 2020-2022, 2024 Amgen Inc. All rights reserved.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-53.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/>This printed material is recyclable. <br/>&lt;part number&gt; Revised: 8/2024 v4</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule Toprule\" colspan=\"3\">Stretch <span class=\"Bold\">or</span> pinch your injection site to create a firm surface.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Put</span> the yellow safety guard (needle inside) on your skin at 90 degrees.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\">Firmly<span class=\"Bold\"> push </span>down the autoinjector onto your skin until it stops moving.</td><td align=\"left\" class=\"Rrule Toprule\" colspan=\"2\">Keep <span class=\"Bold\">pushing</span> down on your skin for <span class=\"Bold\">about 15 seconds.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">3</span></td><td align=\"left\" class=\"Rrule\" colspan=\"2\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">4</span></td><td align=\"left\" class=\"Rrule\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">5</span></td><td align=\"left\" class=\"Rrule\"></td><td align=\"left\" class=\"Botrule Rrule\"><span class=\"Bold\">6</span></td><td align=\"left\" class=\"Rrule\"></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"3\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-54.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-55.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">When you are ready to inject, <span class=\"Bold\">press</span> the gray start button. You will hear a click.<br/>\"click\"<br/>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-56.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td><td align=\"left\" class=\"Botrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-57.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/><br/> <span class=\"Bold\">15 seconds</span>\n<br/>Window turns from clear to yellow when the injection is done.<br/>\"click\"<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-58.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Important: Needle is inside the gray needle cap.

{ "type": "p", "children": [], "text": "\nImportant: Needle is inside the gray needle cap." }

Important

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

Before you use AIMOVIG prefilled syringe, read this important information:

{ "type": "p", "children": [], "text": "\nBefore you use AIMOVIG prefilled syringe, read this important information:\n" }

Storing your AIMOVIG prefilled syringe

{ "type": "p", "children": [], "text": "\nStoring your AIMOVIG prefilled syringe\n" }

{ "type": "ul", "children": [ "Keep the syringe out of the reach of children.", "Keep the syringe in the original carton to protect from light.", "The syringe should be kept in the refrigerator at 36°F to 46°F (2°C to 8°C). ", "After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.", "Throw away AIMOVIG that has been left at room temperature for more than 7 days. ", "\nDo not freeze." ], "text": "" }

Using your AIMOVIG prefilled syringe

{ "type": "p", "children": [], "text": "\nUsing your AIMOVIG prefilled syringe\n" }

{ "type": "ul", "children": [ "It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.", "\nDo not use a syringe after the expiration date on the label.", "\nDo not shake the syringe.", "\nDo not remove the gray needle cap from the syringe until you are ready to inject.", "\nDo not use the syringe if it has been frozen.", "\nDo not use a syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436). ", "The prefilled syringe is not made with natural rubber latex." ], "text": "" }

Step 1: Prepare

{ "type": "p", "children": [], "text": "\nStep 1: Prepare\n" }

AIMOVIG comes as a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the dose that is best for you.

{ "type": "p", "children": [], "text": "AIMOVIG comes as a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the dose that is best for you." }

Before you inject, always check the label of your single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG.

{ "type": "p", "children": [], "text": "Before you inject, always check the label of your single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG." }

A Remove AIMOVIG prefilled syringe from the carton.

{ "type": "p", "children": [], "text": "\nA Remove AIMOVIG prefilled syringe from the carton." }

Grab the syringe barrel to remove the syringe from the tray.

{ "type": "p", "children": [], "text": "Grab the syringe barrel to remove the syringe from the tray." }

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="10%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-60.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td><td align="left"></td><td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=aimovig-61.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></p> </td> </tr> <tr> <td align="left">Place finger or thumb on edge of tray to secure it while you remove the syringe.</td><td align="left"></td><td align="left">          <span class="Bold">Grab Here</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"75%\">\n<col align=\"left\" valign=\"top\" width=\"40%\"/>\n<col align=\"left\" valign=\"top\" width=\"10%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-60.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td><td align=\"left\"></td><td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-61.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\">Place finger or thumb on edge of tray to secure it while you remove the syringe.</td><td align=\"left\"></td><td align=\"left\">          <span class=\"Bold\">Grab Here</span></td>\n</tr>\n</tbody>\n</table></div>" }

For safety reasons:

{ "type": "p", "children": [], "text": "For safety reasons:" }

{ "type": "ul", "children": [ "\nDo not grab the plunger rod.", "\nDo not grab the gray needle cap.", "\nDo not remove the gray needle cap until you are ready to inject.", "\nDo not remove the finger flange. This is part of the syringe." ], "text": "" }

Leave the syringe at room temperature for at least 30 minutes before injecting.

{ "type": "p", "children": [], "text": "Leave the syringe at room temperature for at least 30 minutes before injecting." }

{ "type": "ul", "children": [ "\nDo not put the syringe back in the refrigerator after it has reached room temperature.", "\nDo not try to warm the syringe by using a heat source such as hot water or microwave.", "\nDo not leave the syringe in direct sunlight.", "\nDo not shake the syringe." ], "text": "" }

Important: Always hold the prefilled syringe by the syringe barrel.

{ "type": "p", "children": [], "text": "Important: Always hold the prefilled syringe by the syringe barrel." }

B Inspect the AIMOVIG prefilled syringe.

{ "type": "p", "children": [], "text": "\nB Inspect the AIMOVIG prefilled syringe." }

Always hold the syringe by the syringe barrel.

{ "type": "p", "children": [], "text": "\nAlways hold the syringe by the syringe barrel.\n" }

Make sure the medicine in the syringe is clear and colorless to slightly yellow.

{ "type": "p", "children": [], "text": "\nMake sure the medicine in the syringe is clear and colorless to slightly yellow.\n" }

{ "type": "ul", "children": [ "\nDo not use the syringe if the medicine is cloudy or discolored or contains flakes or particles.", "\nDo not use the syringe if any part appears cracked or broken.", "\nDo not use the syringe if the syringe has been dropped.", "\nDo not use the syringe if the gray needle cap is missing or not securely attached.", "\nDo not use the syringe if the expiration date printed on the label has passed." ], "text": "" }

In all cases, use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "In all cases, use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436)." }

C Gather all materials needed for your injection.

{ "type": "p", "children": [], "text": "\nC Gather all materials needed for your injection." }

Wash your hands thoroughly with soap and water.

{ "type": "p", "children": [], "text": "Wash your hands thoroughly with soap and water. " }

On a clean, well-lit work surface, place the:

{ "type": "p", "children": [], "text": "On a clean, well-lit work surface, place the:" }

{ "type": "ul", "children": [ "New syringe ", "Alcohol wipes", "Cotton balls or gauze pads", "Adhesive bandages", "Sharps disposal container" ], "text": "" }

D Prepare and clean your injection site.

{ "type": "p", "children": [], "text": "\nD Prepare and clean your injection site." }

Only use these injection sites:

{ "type": "p", "children": [], "text": "\nOnly use these injection sites:\n" }

{ "type": "ul", "children": [ "Your thigh", "Stomach area (abdomen), except for a two inch area right around your navel", "Outer area of upper arm (only if someone else is giving you the injection)" ], "text": "" }

Clean your injection site with an alcohol wipe. Let your skin dry.

{ "type": "p", "children": [], "text": "Clean your injection site with an alcohol wipe. Let your skin dry." }

{ "type": "ul", "children": [ "\nDo not touch this area again before injecting.", "\nDo not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks.\n\n\n" ], "text": "" }

Step 2: Get ready

{ "type": "p", "children": [], "text": "\nStep 2: Get ready\n" }

E Pull gray needle cap straight out and away from your body, only when you are ready to inject. Do not leave the gray needle cap off for more than five minutes. This can dry out the medicine.

{ "type": "p", "children": [], "text": "\nE Pull gray needle cap straight out and away from your body, only when you are ready to inject. Do not leave the gray needle cap off for more than five minutes. This can dry out the medicine." }

It is normal to see a drop of liquid at the end of the needle.

{ "type": "p", "children": [], "text": "It is normal to see a drop of liquid at the end of the needle." }

{ "type": "ul", "children": [ "\nDo not twist or bend the gray needle cap.", "\nDo not put the gray needle cap back onto the syringe.", "\nDo not remove the gray needle cap from the syringe until you are ready to inject." ], "text": "" }

Important: Throw the gray needle cap into the sharps disposal container.

{ "type": "p", "children": [], "text": "\nImportant: Throw the gray needle cap into the sharps disposal container." }

F Pinch your injection site to create a firm surface.

{ "type": "p", "children": [], "text": "\nF Pinch your injection site to create a firm surface." }

Pinch skin firmly between your thumb and fingers, creating an area about two inches wide.

{ "type": "p", "children": [], "text": "Pinch skin firmly between your thumb and fingers, creating an area about two inches wide." }

Important: Keep skin pinched while injecting.

{ "type": "p", "children": [], "text": "\nImportant: Keep skin pinched while injecting." }

Step 3: Inject

{ "type": "p", "children": [], "text": "\nStep 3: Inject\n" }

G Hold the pinch. With the gray needle cap off, insert the syringe into your skin at 45 to 90 degrees.

{ "type": "p", "children": [], "text": "\nG Hold the pinch. With the gray needle cap off, insert the syringe into your skin at 45 to 90 degrees." }

Do not place your finger on the plunger rod while inserting the needle.

{ "type": "p", "children": [], "text": "\nDo not place your finger on the plunger rod while inserting the needle." }

H Place your finger on the plunger rod. Using slow and constant pressure, push the plunger rod all the way down until the prefilled syringe stops moving.

{ "type": "p", "children": [], "text": "\nH Place your finger on the plunger rod. Using slow and constant pressure, push the plunger rod all the way down until the prefilled syringe stops moving." }

I When done, release your thumb, and gently lift the syringe off of your skin.

{ "type": "p", "children": [], "text": "\nI When done, release your thumb, and gently lift the syringe off of your skin." }

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider immediately.

{ "type": "p", "children": [], "text": "\nImportant: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider immediately." }

Step 4: Finish

{ "type": "p", "children": [], "text": "\nStep 4: Finish\n" }

J Discard the used syringe and the gray needle cap.

{ "type": "p", "children": [], "text": "\nJ Discard the used syringe and the gray needle cap. " }

Put the used AIMOVIG syringe and gray needle cap in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash.

{ "type": "p", "children": [], "text": "Put the used AIMOVIG syringe and gray needle cap in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash." }

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

{ "type": "p", "children": [], "text": "If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:" }

{ "type": "ul", "children": [ "Made of a heavy-duty plastic", "Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out", "Upright and stable during use", "Leak-resistant", "Properly labeled to warn of hazardous waste inside the container " ], "text": "" }

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.

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

{ "type": "ul", "children": [ "\nDo not reuse the syringe.", "\nDo not recycle the syringe or sharps disposal container or throw them into household trash." ], "text": "" }

Important: Always keep the sharps disposal container out of the reach of children.

{ "type": "p", "children": [], "text": "\nImportant: Always keep the sharps disposal container out of the reach of children." }

K Examine the injection site.

{ "type": "p", "children": [], "text": "\nK Examine the injection site. " }

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

{ "type": "p", "children": [], "text": "If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed." }

For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436)." }

AIMOVIG® (erenumab-aooe)

{ "type": "p", "children": [], "text": "AIMOVIG® (erenumab-aooe)" }

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799 USAU.S. License No. 1080

{ "type": "p", "children": [], "text": "Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799 USAU.S. License No. 1080" }

© 2018-2022, 2024 Amgen Inc. All rights reserved.

{ "type": "p", "children": [], "text": "© 2018-2022, 2024 Amgen Inc. All rights reserved." }

<div class="scrollingtable"><table width="55%"> <caption> <span>Symbol table</span> </caption> <col align="center" valign="top" width="33%"/> <col align="center" valign="top" width="33%"/> <col align="center" valign="top" width="34%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-71.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="center" class="Rrule"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-72.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td><td align="center" class="Rrule"><img alt="Image" src="/dailymed/image.cfm?name=aimovig-73.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8"/></td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">Do not reuse</td><td align="center" class="Rrule">CAUTION, Prior to use, read the enclosed Instructions For Use for administration information and see package insert for full Prescribing Information</td><td align="center" class="Rrule">Lot number</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"55%\">\n<caption>\n<span>Symbol table</span>\n</caption>\n<col align=\"center\" valign=\"top\" width=\"33%\"/>\n<col align=\"center\" valign=\"top\" width=\"33%\"/>\n<col align=\"center\" valign=\"top\" width=\"34%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-71.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"center\" class=\"Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-72.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td><td align=\"center\" class=\"Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=aimovig-73.jpg&amp;setid=b998ed05-94b0-47fd-b28f-cddd1e128fd8\"/></td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\">Do not reuse</td><td align=\"center\" class=\"Rrule\">CAUTION, Prior to use, read the enclosed Instructions For Use for administration information and see package insert for full Prescribing Information</td><td align=\"center\" class=\"Rrule\">Lot number</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 8/2024 [partnumber] v7

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 8/2024 [partnumber] v7" }

AMGEN®

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

1 x 70 mg/mL Prefilled SyringeNDC 55513-840-01Rx Only

{ "type": "p", "children": [], "text": "1 x 70 mg/mL Prefilled SyringeNDC 55513-840-01Rx Only" }

aimovig® (erenumab-aooe)Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe)Injection" }

70mg/mL

{ "type": "p", "children": [], "text": "70mg/mL" }

70 mg/mL

{ "type": "p", "children": [], "text": "70 mg/mL" }

Single-dose Prefilled Syringe

{ "type": "p", "children": [], "text": "Single-dose Prefilled Syringe" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake." }

Before injecting, allow AIMOVIG to sitat room temperature for at least 30 minuteswith cap on, protected from direct sunlight.

{ "type": "p", "children": [], "text": "Before injecting, allow AIMOVIG to sitat room temperature for at least 30 minuteswith cap on, protected from direct sunlight." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436)." }

CAUTION, Prior to use,read the enclosedInstructions for Use for administration informationand see package insert for full PrescribingInformation

{ "type": "p", "children": [], "text": "CAUTION, Prior to use,read the enclosedInstructions for Use for administration informationand see package insert for full PrescribingInformation" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

Not made withnatural rubber latex

{ "type": "p", "children": [], "text": "Not made withnatural rubber latex" }

AMGEN

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

1 x 70 mg/mL Prefilled Autoinjector NDC 55513-841-01 Rx Only

{ "type": "p", "children": [], "text": "1 x 70 mg/mL Prefilled Autoinjector NDC 55513-841-01 Rx Only" }

aimovig® (erenumab-aooe) Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe) Injection" }

70 mg/mL

{ "type": "p", "children": [], "text": "70 mg/mL" }

70 mg/mL

{ "type": "p", "children": [], "text": "70 mg/mL" }

Prefilled Autoinjector

{ "type": "p", "children": [], "text": "Prefilled Autoinjector" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com or call 1-800-77-AMGEN (1-800-772-6436)." }

CAUTION, Consult Accompanying Documents

{ "type": "p", "children": [], "text": "CAUTION, Consult Accompanying Documents" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

No U.S. standard of potency

{ "type": "p", "children": [], "text": "No U.S. standard of potency" }

Aimovig.com/demo

{ "type": "p", "children": [], "text": "Aimovig.com/demo" }

AMGEN

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

1 x 70 mg/mL Prefilled Autoinjector NDC 55513-841-00 Rx Only

{ "type": "p", "children": [], "text": "1 x 70 mg/mL Prefilled Autoinjector NDC 55513-841-00 Rx Only" }

aimovig® (erenumab-aooe) Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe) Injection" }

Not for Sale

{ "type": "p", "children": [], "text": "Not for Sale" }

70 mg/mL

{ "type": "p", "children": [], "text": "70 mg/mL" }

70 mg/mL

{ "type": "p", "children": [], "text": "70 mg/mL" }

Prefilled Autoinjector

{ "type": "p", "children": [], "text": "Prefilled Autoinjector" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com or call 1-800-77-AMGEN (1-800-772-6436)

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com or call 1-800-77-AMGEN (1-800-772-6436)" }

CAUTION, Consult Accompanying Documents

{ "type": "p", "children": [], "text": "CAUTION, Consult Accompanying Documents" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

No U.S. standard of potency

{ "type": "p", "children": [], "text": "No U.S. standard of potency" }

Aimovig.com/demo

{ "type": "p", "children": [], "text": "Aimovig.com/demo" }

AMGEN

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

1 x 140 mg/mL Prefilled Autoinjector NDC 55513-843-01 Rx Only

{ "type": "p", "children": [], "text": "1 x 140 mg/mL Prefilled Autoinjector NDC 55513-843-01 Rx Only" }

aimovig® (erenumab-aooe) Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe) Injection" }

140 mg/mL = 1 dose

{ "type": "p", "children": [], "text": "140 mg/mL = 1 dose" }

140 mg/mL

{ "type": "p", "children": [], "text": "140 mg/mL" }

Prefilled Autoinjector

{ "type": "p", "children": [], "text": "Prefilled Autoinjector" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436)." }

CAUTION, ConsultAccompanying Documents

{ "type": "p", "children": [], "text": "CAUTION, ConsultAccompanying Documents" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

No U.S. standard of potency

{ "type": "p", "children": [], "text": "No U.S. standard of potency" }

Aimovig.com/demo

{ "type": "p", "children": [], "text": "Aimovig.com/demo" }

AMGEN

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

1 x 140 mg/mL Prefilled Autoinjector NDC 55513-843-00 Rx Only

{ "type": "p", "children": [], "text": "1 x 140 mg/mL Prefilled Autoinjector NDC 55513-843-00 Rx Only" }

aimovig® (erenumab-aooe) Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe) Injection" }

Not for Sale

{ "type": "p", "children": [], "text": "Not for Sale" }

140 mg/mL = 1 dose

{ "type": "p", "children": [], "text": "140 mg/mL = 1 dose" }

140 mg/mL

{ "type": "p", "children": [], "text": "140 mg/mL" }

Prefilled Autoinjector

{ "type": "p", "children": [], "text": "Prefilled Autoinjector" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake. Discard Any Unused Portion." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436)." }

CAUTION, ConsultAccompanying Documents

{ "type": "p", "children": [], "text": "CAUTION, ConsultAccompanying Documents" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

No U.S. standard of potency

{ "type": "p", "children": [], "text": "No U.S. standard of potency" }

Aimovig.com/demo

{ "type": "p", "children": [], "text": "Aimovig.com/demo" }

AMGEN®

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

1 x 140 mg/mL Prefilled SyringeNDC 55513-842-01Rx Only

{ "type": "p", "children": [], "text": "1 x 140 mg/mL Prefilled SyringeNDC 55513-842-01Rx Only" }

aimovig® (erenumab-aooe)Injection

{ "type": "p", "children": [], "text": "aimovig®\n(erenumab-aooe)Injection" }

140mg/mL = 1dose

{ "type": "p", "children": [], "text": "140mg/mL = 1dose" }

140 mg/mL

{ "type": "p", "children": [], "text": "140 mg/mL" }

Single-dose Prefilled Syringe

{ "type": "p", "children": [], "text": "Single-dose Prefilled Syringe" }

For Subcutaneous Use Only

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

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake.

{ "type": "p", "children": [], "text": "Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake." }

Before injecting, allow AIMOVIG to sit at room temperature for at least 30 minuteswith cap on, protected from direct sunlight.

{ "type": "p", "children": [], "text": "Before injecting, allow AIMOVIG to sit at room temperature for at least 30 minuteswith cap on, protected from direct sunlight." }

Keep out of the sight and reach of children.

{ "type": "p", "children": [], "text": "Keep out of the sight and reach of children." }

For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436).

{ "type": "p", "children": [], "text": "For more information, go to Aimovig.com orcall 1-800-77-AMGEN (1-800-772-6436)." }

CAUTION, Prior to use,read the enclosedInstructions for Use for administration informationand see package insert forfull Prescribing Information

{ "type": "p", "children": [], "text": "CAUTION, Prior to use,read the enclosedInstructions for Use for administration informationand see package insert forfull Prescribing Information" }

Do Not Reuse

{ "type": "p", "children": [], "text": "Do Not Reuse" }

Not made withnatural rubber latex

{ "type": "p", "children": [], "text": "Not made withnatural rubber latex" }