PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. In 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 mg doses separated by one hour) had no effect on resting blood pressure compared with sumatriptan alone. AIMOVIG is for subcutaneous use only.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. AIMOVIG is sterile, clear to opalescent, colorless to light yellow solution available as follows: Injection: 70 mg/mL in single-dose prefilled SureClick(R) autoinjector Injection: 140 mg/mL in single-dose prefilled SureClick(R) autoinjector Injection: 70 mg/mL in single-dose prefilled syringe Injection: 140 mg/mL in single-dose prefilled syringe. Injection: 70 mg/mL in single-dose prefilled SureClick(R) autoinjector. Injection: 140 mg/mL in single-dose prefilled SureClick(R) autoinjector. Injection: 70 mg/mL in single-dose prefilled syringe. Injection: 140 mg/mL in single-dose prefilled syringe. Injection: 70 mg/mL solution in single-dose prefilled SureClick(R) autoinjector (3)Injection: 140 mg/mL solution in single-dose prefilled SureClick(R) autoinjector (3)Injection: 70 mg/mL solution in single-dose prefilled syringe (3)Injection: 140 mg/mL solution in single-dose prefilled syringe (3). Injection: 70 mg/mL solution in single-dose prefilled SureClick(R) autoinjector (3). Injection: 140 mg/mL solution in single-dose prefilled SureClick(R) autoinjector (3). Injection: 70 mg/mL solution in single-dose prefilled syringe (3). Injection: 140 mg/mL solution in single-dose prefilled syringe (3).

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following serious adverse reactions are described below and elsewhere in the labeling:Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Constipation with Serious Complications [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3)] Raynauds Phenomenon [see Warnings and Precautions (5.4)] Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Constipation with Serious Complications [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3)] Raynauds Phenomenon [see Warnings and Precautions (5.4)] The most common adverse reactions in AIMOVIG clinical studies (occurring in at least 3% of treated patients and more often than placebo) are injection site reactions and constipation. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.. 6.1Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of 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 months, 1305 patients were exposed for at least 12 months, and 216 patients were exposed through 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 months or 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 summarizes the adverse reactions that occurred during the first months in the migraine studies (Studies 1, 2, and 3).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 Months in Studies 1, 2, and 3Adverse ReactionAIMOVIG70 mg Once MonthlyN 787%AIMOVIG 140 mg Once MonthlyN 507%Placebo = 890%Injection site reactionsInjection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema. The rate of injection site reactions reported in Table is with the prefilled syringe. 653Constipation131Cramps, muscle spasms< 12< 1In 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.. 6.2 Postmarketing Experience. The following adverse reactions have been identified during postapproval use of AIMOVIG. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish 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)], Raynauds Phenomenon [see Warnings and Precautions (5.4)].

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. CarcinogenesisThe carcinogenic potential of erenumab-aooe has not been assessed.. MutagenesisGenetic toxicology studies of erenumab-aooe have not been conducted.. Impairment of FertilityMating 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 months. Serum erenumab-aooe exposures (AUC) at the higher dose tested were more than 100 times that in humans at dose of 140 mg once monthly.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Erenumab-aooe is human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function.. 12.2 Pharmacodynamics. In 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 mg doses separated by one hour) had no effect on resting blood pressure compared with sumatriptan alone. AIMOVIG is for subcutaneous use only.. 12.3 Pharmacokinetics. Erenumab-aooe exhibits non-linear kinetics as result of binding to the CGRP receptor. The Cmax mean and AUClast mean following subcutaneous administration of 70 mg once monthly and 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 months of dosing. The effective half-life of erenumab-aooe is 28 days.Table 2: Pharmacokinetic Parameters of AIMOVIGAIMOVIG 70 mgSubcutaneously Once MonthlyAIMOVIG 140 mgSubcutaneously Once MonthlyCmax mean (SD)SD standard deviation from single-dose study 6.1 (2.1) mcg/mL15.8 (4.8) mcg/mLAUClast mean (SD) 159 (58) daymcg/mL505 (139) daymcg/mLCmin (SD) Episodic migraine5.7 (3.1) mcg/mL12.8 (6.5) mcg/mL Chronic migraine6.2 (2.9) mcg/mL14.9 (6.5) mcg/mL. AbsorptionFollowing single subcutaneous dose of 70 mg or 140 mg erenumab-aooe administered to healthy adults, median peak serum concentrations were attained in approximately days, and estimated absolute bioavailability was 82%.. DistributionFollowing 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 ExcretionTwo 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 non-specific, non-saturable proteolytic pathway.. Specific PopulationsThe 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 ImpairmentPopulation pharmacokinetic analysis of integrated data from the AIMOVIG clinical studies did not reveal 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 EnzymesErenumab-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 ContraceptivesIn an open-label drug interaction study in healthy female volunteers, erenumab-aooe (140 mg subcutaneous, single-dose) did not affect the pharmacokinetics of combined oral contraceptive containing ethinyl estradiol and norgestimate.. SumatriptanIn study in healthy volunteers, concomitant administration of erenumab-aooe with sumatriptan had no effect on the pharmacokinetics of sumatriptan [see Clinical Pharmacology (12.2)].. 12.6 Immunogenicity. 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 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.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. The efficacy of AIMOVIG was evaluated as preventive treatment of episodic or chronic migraine in three randomized, double-blind, placebo-controlled studies: two studies in patients with episodic migraine (4 to 14 migraine days per month) (Study and Study 2) and one study in patients with chronic migraine (>= 15 headache days per month with >= migraine days per month) (Study 3). The studies enrolled patients with history of migraine, with or without aura, according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.. Episodic MigraineStudy (NCT 02456740) was randomized, multi-center, 6-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. total of 955 patients with 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 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 to 6. Secondary endpoints included the achievement of >= 50% reduction from baseline in mean monthly migraine days over months to (>= 50% MMD responders), the change from baseline in mean monthly acute migraine-specific medication days over months to 6, and the change from baseline in mean Migraine Physical Function Impact Diary (MPFID) over months 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 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 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 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.Table 3: Efficacy Endpoints Over Months to in Study 1AIMOVIG70 mg Once MonthlyAIMOVIG140 mg Once MonthlyPlaceboN 312N 318N 316Monthly Migraine Days (MMD) Change from baseline-3.2-3.7-1.8 Difference from placebo-1.4-1.9 p-value< 0.001< 0.001>= 50% MMD responders Responders43.3%50.0%26.6% Difference from placebo16.7%23.4% Odds ratio relative to placebo2.12.8 p-value< 0.001< 0.001Monthly acute migraine-specific medication days Change from baseline-1.1-1.6-0.2 Difference from placebo-0.9-1.4 p-value< 0.001< 0.001Figure 1: Change from Baseline in Monthly Migraine Days in Study 1Least-square means and 95% confidence intervals are presented. Figure shows the distribution of change from baseline in mean monthly migraine days over months to in bins of days by treatment group. treatment benefit over placebo for both doses of AIMOVIG is seen across range of changes from baseline in monthly migraine days.Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days Over Months to by Treatment Group in Study 1Figure excludes patients with missing data.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 to [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 to [difference from placebo: -1.9 for AIMOVIG 70 mg and -2.4 for AIMOVIG 140 mg; p-value 0.001 for both].Study (NCT 02483585) was randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. total of 577 patients with history of episodic migraine were randomized to receive either AIMOVIG 70 mg (N 286) or placebo (N 291) by subcutaneous injection once monthly for 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 >= 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 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 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 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.Table 4: Efficacy Endpoints at Month for Study 2AIMOVIG70 mg Once MonthlyPlaceboN 282N 288Monthly Migraine Days (MMD) Change from baseline-2.9-1.8 Difference from placebo-1.0 p-value< 0.001>= 50% MMD responders Responders39.7%29.5% Difference from placebo10.2% Odds ratio relative to placebo1.6 p-value0.010Monthly acute migraine-specific medication days Change from baseline-1.2-0.6 Difference from placebo-0.6 p-value0.002Figure 3: Change from Baseline in Monthly Migraine Days in Study 2Least-square means and 95% confidence intervals are presented. Figure shows the distribution of change from baseline in monthly migraine days at month in bins of days by treatment group. treatment benefit over placebo for AIMOVIG is seen across range of changes from baseline in monthly migraine days.Figure 4: Distribution of Change from Baseline in Monthly Migraine Days at Month by Treatment Group in Study 2Figure excludes patients with missing data.The pre-specified analysis for the MPFID was based on at least 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].. Figure 1. Figure 2. Figure 3. Figure 4. Chronic MigraineStudy (NCT 02066415) was randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG as preventive treatment of chronic migraine. total of 667 patients with 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 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 >= 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 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.Table 5: Efficacy Endpoints at Month in Study 3AIMOVIG70 mg Once MonthlyAIMOVIG140 mg Once MonthlyPlaceboN 188N 187N 281Monthly Migraine Days (MMD) Change from baseline-6.6-6.6-4.2 Difference from placebo-2.5-2.5 p-value< 0.001< 0.001>= 50% MMD responders Responders39.9%41.2%23.5% Difference from placebo16.4%17.7% Odds ratio relative to placebo2.22.3 p-value< 0.001< 0.001Monthly acute migraine-specific medication days Change from baseline-3.5-4.1-1.6 Difference from placebo-1.9-2.6 p-value< 0.001< 0.001Figure 5: Change from Baseline in Monthly Migraine Days in Study 3Least-square means and 95% confidence intervals are presented. Figure shows the distribution of change from baseline in monthly migraine days at month in bins of days by treatment group. treatment benefit over placebo for both doses of AIMOVIG is seen across range of changes from baseline in migraine days.Figure 6: Distribution of Change from Baseline in Monthly Migraine Days at Month by Treatment Group in Study 3Figure excludes patients with missing data.. Figure 5. Figure 6.

CLINICAL TRIALS EXPERIENCE SECTION.

6.1Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of 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 months, 1305 patients were exposed for at least 12 months, and 216 patients were exposed through 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 months or 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 summarizes the adverse reactions that occurred during the first months in the migraine studies (Studies 1, 2, and 3).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 Months in Studies 1, 2, and 3Adverse ReactionAIMOVIG70 mg Once MonthlyN 787%AIMOVIG 140 mg Once MonthlyN 507%Placebo = 890%Injection site reactionsInjection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema. The rate of injection site reactions reported in Table is with the prefilled syringe. 653Constipation131Cramps, muscle spasms< 12< 1In 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.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. 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)].. AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. (4).

DESCRIPTION SECTION.

11 DESCRIPTION. Erenumab-aooe is 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 heavy chains, each containing 456 amino acids, and 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 sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous administration. Each 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 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 single-dose, prefilled glass syringe. The solution of AIMOVIG has pH of 5.2.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For subcutaneous use only (2.1, 2.2)Recommended dosage is 70 mg once monthly; some patients may benefit from dosage of 140 mg once monthly (2.1)Administer in the abdomen, thigh, or upper arm subcutaneously (2.2)See Dosage and Administration for important administration instructions (2.2). For subcutaneous use only (2.1, 2.2). Recommended dosage is 70 mg once monthly; some patients may benefit from dosage of 140 mg once monthly (2.1). Administer in the abdomen, thigh, or upper arm subcutaneously (2.2). See Dosage and Administration for important administration instructions (2.2). 2.1Recommended Dosing. The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from dosage of 140 mg injected subcutaneously once monthly.If dose of AIMOVIG is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.. 2.2Important Administration Instructions. 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]:Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight [see How Supplied/Storage and Handling (16.2)]. This is important for administering the entire dose and helps minimize discomfort. Do not warm by using heat source such as hot water or microwave. Do not shake the product. Inspect visually for particulate matter and discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if the solution is cloudy or discolored or contains flakes or particles. Administer AIMOVIG in the abdomen, thigh, or upper arm subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard. Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.. Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight [see How Supplied/Storage and Handling (16.2)]. This is important for administering the entire dose and helps minimize discomfort. Do not warm by using heat source such as hot water or microwave.. Do not shake the product.. Inspect visually for particulate matter and discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if the solution is cloudy or discolored or contains flakes or particles.. Administer AIMOVIG in the abdomen, thigh, or upper arm subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard.. Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.

GERIATRIC USE SECTION.

8.5 Geriatric Use. 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.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. 16.1How Supplied. AIMOVIG (erenumab-aooe) injection is 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(R) autoinjector or single-dose prefilled syringe of AIMOVIG contains Type glass syringe and stainless steel needle and delivers mL of 70 mg/mL or 140 mg/mL solution.AIMOVIG is supplied as follows:SureClick(R) AutoinjectorPack of autoinjector: 70 mg/mL single-dose prefilled autoinjector NDC 55513-841-01Pack of autoinjector: 140 mg/mL single-dose prefilled autoinjector NDC 55513-843-01SyringePack of syringe: 70 mg/mL single-dose prefilled syringe NDC 55513-840-01Pack of syringe: 140 mg/mL single-dose prefilled syringe NDC 55513-842-01. Pack of autoinjector: 70 mg/mL single-dose prefilled autoinjector NDC 55513-841-01. Pack of autoinjector: 140 mg/mL single-dose prefilled autoinjector NDC 55513-843-01. Pack of syringe: 70 mg/mL single-dose prefilled syringe NDC 55513-840-01. Pack of syringe: 140 mg/mL single-dose prefilled syringe NDC 55513-842-01. 16.2Storage and Handling. Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light until time of use. If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25C [77F]) in the original carton and must be used within days. Throw away AIMOVIG that has been left at room temperature for more than days. Do not freeze. Do not shake.. Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light until time of use.. If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25C [77F]) in the original carton and must be used within days. Throw away AIMOVIG that has been left at room temperature for more than days.. Do not freeze.. Do not shake.

IMMUNOGENICITY.

12.6 Immunogenicity. 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 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.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. AIMOVIG is indicated for the preventive treatment of migraine in adults.. AIMOVIG is calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).. Information on Preparation and AdministrationProvide 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 ReactionsAdvise 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 ComplicationsAdvise 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)].. HypertensionAdvise 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)].. PregnancyAdvise patients that there is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy [see Use in Specific Populations (8.1)]. Raynauds PhenomenonInform patients that Raynauds phenomenon can develop or worsen with AIMOVIG. Advise patients to discontinue AIMOVIG and contact their healthcare provider if they experience signs or symptoms of Raynauds phenomenon [see Warnings and Precautions (5.4)].

INSTRUCTIONS FOR USE SECTION.

INSTRUCTIONS FOR USEAIMOVIG(R) [AIM-oh-vig](erenumab-aooe)injection, for subcutaneous use70 mg/mLsingle-dose prefilled SureClick(R) autoinjector. This Instructions for Use contains information on how to inject AIMOVIG with SureClick autoinjector.If your healthcare provider decides that you or 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. Getting to know your prefilled autoinjector Important Information You Need to Know Before Injecting AIMOVIGIt is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.Check the autoinjector label and prescription to make sure you have the correct medicine and dose.Do not use the autoinjector if the carton is damaged or the seal is broken.Do not use the autoinjector after the expiration date on the label.Do not shake the autoinjector.Do not remove the white cap from the autoinjector until you are ready to inject.Do not use the autoinjector if it has been frozen.Do not use the autoinjector if it has been dropped on hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).The autoinjector is not made with natural rubber latex.Frequently asked questions:For additional information and answers to frequently asked questions, visit www.aimovig.com.Where to get help:If you want more information or help using AIMOVIG: Contact your healthcare provider,Visit www.aimovig.com, orCall 1-800-77-AMGEN (1-800-772-6436)Storing and Preparing to Inject AIMOVIG1Refrigerate the autoinjector carton until you are ready to use it.Keep the autoinjector in the refrigerator between 36F to 46F (2C to 8C).Keep the autoinjector in the original carton to protect it from light or physical damage.Do not freeze the autoinjector.Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicles glove box or trunk.Important: Keep the autoinjector and all medicines out of the sight and reach of children. WAIT2Wait 30 minutes for the autoinjector to reach room temperature.Let the autoinjector warm up naturally.Do not heat the autoinjector with hot water, microwave, or direct sunlight.Do not shake the autoinjector at any time.Using the autoinjector at room temperature makes sure the full dose is delivered and allows for more comfortable injection.3You may keep AIMOVIG at room temperature for up to days, if needed.For example, when you are traveling, you may keep AIMOVIG at room temperature. Keep it at room temperature between 68F to 77F (20C to 25C).Do not put it back in the refrigerator.Record the date you removed it from the refrigerator and use it within days. Important: Place the autoinjector in sharps disposal container if it has reached room temperature and has not been used within days. 4Inspect the medicine. It should be clear and colorless to slightly yellow.It is okay to see air bubbles.Do not use the autoinjector if the medicine is cloudy, discolored, or contains flakes or particles.Important: If the medicine is cloudy, discolored, contains flakes or particles, or if the autoinjector is damaged or expired, call 1-800-77-AMGEN (1-800-772-6436). 5Check the expiration date (Exp.) and inspect the autoinjector for damage.Do not use the autoinjector if the expiration date has passed.Do not use the autoinjector if: the white cap is missing or loose in carton.it has cracks or broken parts, orit has been dropped on hard surface. Getting Ready to Inject AIMOVIG6Gather and place the following texts for your injection on clean, flat, and well-lit surface:AIMOVIG autoinjector (room temperature),Sharps disposal container [see Completing the Injection and Disposal],Alcohol wipe,Adhesive bandage, andCotton balls or gauze pads. 7Select of these injection sites.Select the thigh or stomach (except for inches around the belly button). Someone else can inject in your thigh, stomach, or back of the upper arm.Important: Avoid areas with scars or stretch marks, or where the skin is tender, bruised, red, hard, raised, thick or scaly skin patch, or lesion. Wash your hands thoroughly with soap and water. 9Clean the injection site with an alcohol wipe.Let the skin dry on its own.Do not touch this area again before injecting. Injecting AIMOVIGImportant: Only remove the white cap when you can inject right away (within minutes) because the medicine can dry out. Do not recap.10Grasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.Do not twist, bend, or wiggle the white cap to pull it off.Never put the white cap back on. It may damage the needle.Do not put your finger inside the dark green safety guard.It is normal to see drop of medicine come out of the needle or dark green safety guard. 11Stretch or pinch the skin to create firm surface at the injection site until the injection is finished. Place the dark green safety guard straight against the skin.Make sure you can see the window.Make sure the autoinjector is positioned straight on the injection site (at 90-degree angle). PUSHand hold against skin12Firmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.The dark green safety guard pushes in and unlocks the purple start button. PRESSpurple start button13Keep pushing the autoinjector down and press the purple start button to start the injection.You may hear or feel click.The window starts to turn yellow.It is okay to let go of the purple start button. WATCH window will turn fully yellow14Keep pushing the autoinjector down. Wait for the window to turn fully yellow.The injection may take up to 15 seconds to complete.You may hear or feel click.After the window turns fully yellow, lift the autoinjector away from the skin.The dark green safety guard locks around the needle. Completing the Injection and DisposalCONFIRM15Confirm full dose of medicine was injected.Do not touch the dark green safety guard. small drop of liquid on the injection site is okay. Important: If the window has not turned fully yellow or if it looks like the medicine is still coming out, full dose was not injected. Call your healthcare provider right away. 16Check the injection site.Do not rub the injection site.If there is blood, press cotton ball or gauze pad on your injection site. Apply an adhesive bandage if necessary.For more information or help call 1-800-77-AMGEN (1-800-772-6436). 17Place the used autoinjector and white cap in an FDA-cleared sharps disposal.Important: Do not throw away the autoinjector in your household trash.Do not reuse the autoinjector. Do not touch the dark green safety guard. Additional information about your sharps disposal container If you do not have an FDA-cleared sharps disposal container, you may use household container that is:made of heavy-duty plastic,can be closed with tight-fitting, puncture-resistant lid, without sharps being able to come out,upright and stable during use,leak-resistant, andproperly labeled to warn of hazardous waste inside the container.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.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 FDAs website at:http://www.fda.gov/safesharpsdisposalDo 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.Keep the autoinjector and sharps disposal container out of the sight and reach of children. AIMOVIG(R) (AIM-oh-vig)Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799U.S. License Number 1080(C) 2018 2025 Amgen Inc.All rights reserved.1XXXXXXThis Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 6/2025v12. It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.. Check the autoinjector label and prescription to make sure you have the correct medicine and dose.. Do not use the autoinjector if the carton is damaged or the seal is broken.. Do not use the autoinjector after the expiration date on the label.. Do not shake the autoinjector.. Do not remove the white cap from the autoinjector until you are ready to inject.. Do not use the autoinjector if it has been frozen.. Do not use the autoinjector if it has been dropped on hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).. The autoinjector is not made with natural rubber latex.. Contact your healthcare provider,. Visit www.aimovig.com, or. Call 1-800-77-AMGEN (1-800-772-6436). Keep the autoinjector in the refrigerator between 36F to 46F (2C to 8C).. Keep the autoinjector in the original carton to protect it from light or physical damage.. Do not freeze the autoinjector.. Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicles glove box or trunk.. Let the autoinjector warm up naturally.. Do not heat the autoinjector with hot water, microwave, or direct sunlight.. Do not shake the autoinjector at any time.. Using the autoinjector at room temperature makes sure the full dose is delivered and allows for more comfortable injection.. For example, when you are traveling, you may keep AIMOVIG at room temperature. Keep it at room temperature between 68F to 77F (20C to 25C).Do not put it back in the refrigerator.Record the date you removed it from the refrigerator and use it within days. Keep it at room temperature between 68F to 77F (20C to 25C).. Do not put it back in the refrigerator.. Record the date you removed it from the refrigerator and use it within days.. It is okay to see air bubbles.. Do not use the autoinjector if the medicine is cloudy, discolored, or contains flakes or particles.. Do not use the autoinjector if the expiration date has passed.. Do not use the autoinjector if: the white cap is missing or loose in carton.it has cracks or broken parts, orit has been dropped on hard surface. the white cap is missing or loose in carton.. it has cracks or broken parts, or. it has been dropped on hard surface.. AIMOVIG autoinjector (room temperature),. Sharps disposal container [see Completing the Injection and Disposal],. Alcohol wipe,. Adhesive bandage, and. Cotton balls or gauze pads.. Select the thigh or stomach (except for inches around the belly button). Someone else can inject in your thigh, stomach, or back of the upper arm.. Let the skin dry on its own.. Do not touch this area again before injecting.. Do not twist, bend, or wiggle the white cap to pull it off.. Never put the white cap back on. It may damage the needle.. Do not put your finger inside the dark green safety guard.. It is normal to see drop of medicine come out of the needle or dark green safety guard.. Make sure you can see the window.. Make sure the autoinjector is positioned straight on the injection site (at 90-degree angle).. The dark green safety guard pushes in and unlocks the purple start button.. You may hear or feel click.. The window starts to turn yellow.. It is okay to let go of the purple start button.. The injection may take up to 15 seconds to complete.. You may hear or feel click.. After the window turns fully yellow, lift the autoinjector away from the skin.. The dark green safety guard locks around the needle.. Do not touch the dark green safety guard. A small drop of liquid on the injection site is okay. Do not rub the injection site.. If there is blood, press cotton ball or gauze pad on your injection site. Apply an adhesive bandage if necessary.. Do not reuse the autoinjector. Do not touch the dark green safety guard.. made of heavy-duty plastic,. can be closed with 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.. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image. Image.

LACTATION SECTION.

8.2 Lactation. Risk SummaryThere 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 mothers clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition.

MECHANISM OF ACTION SECTION.

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

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. CarcinogenesisThe carcinogenic potential of erenumab-aooe has not been assessed.. MutagenesisGenetic toxicology studies of erenumab-aooe have not been conducted.. Impairment of FertilityMating 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 months. Serum erenumab-aooe exposures (AUC) at the higher dose tested were more than 100 times that in humans at dose of 140 mg once monthly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 70 mg/mL Syringe Carton. AMGEN(R) x 70 mg/mL Prefilled SyringeNDC 55513-840-01Rx Onlyaimovig(R) (erenumab-aooe)Injection70mg/mL70 mg/mLSingle-dose Prefilled SyringeFor Subcutaneous Use OnlyStore refrigerated at 2C to 8C (36F to 46F) 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.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).CAUTION, Prior to use,read the enclosedInstructions for Use for administration informationand see package insert for full PrescribingInformationDo Not ReuseNot made withnatural rubber latex. PRINCIPAL DISPLAY PANEL 70 mg/mL Syringe Carton.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. Erenumab-aooe exhibits non-linear kinetics as result of binding to the CGRP receptor. The Cmax mean and AUClast mean following subcutaneous administration of 70 mg once monthly and 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 months of dosing. The effective half-life of erenumab-aooe is 28 days.Table 2: Pharmacokinetic Parameters of AIMOVIGAIMOVIG 70 mgSubcutaneously Once MonthlyAIMOVIG 140 mgSubcutaneously Once MonthlyCmax mean (SD)SD standard deviation from single-dose study 6.1 (2.1) mcg/mL15.8 (4.8) mcg/mLAUClast mean (SD) 159 (58) daymcg/mL505 (139) daymcg/mLCmin (SD) Episodic migraine5.7 (3.1) mcg/mL12.8 (6.5) mcg/mL Chronic migraine6.2 (2.9) mcg/mL14.9 (6.5) mcg/mL. AbsorptionFollowing single subcutaneous dose of 70 mg or 140 mg erenumab-aooe administered to healthy adults, median peak serum concentrations were attained in approximately days, and estimated absolute bioavailability was 82%.. DistributionFollowing 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 ExcretionTwo 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 non-specific, non-saturable proteolytic pathway.. Specific PopulationsThe 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 ImpairmentPopulation pharmacokinetic analysis of integrated data from the AIMOVIG clinical studies did not reveal 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 EnzymesErenumab-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 ContraceptivesIn an open-label drug interaction study in healthy female volunteers, erenumab-aooe (140 mg subcutaneous, single-dose) did not affect the pharmacokinetics of combined oral contraceptive containing ethinyl estradiol and norgestimate.. SumatriptanIn study in healthy volunteers, concomitant administration of erenumab-aooe with sumatriptan had no effect on the pharmacokinetics of sumatriptan [see Clinical Pharmacology (12.2)].

POSTMARKETING EXPERIENCE SECTION.

6.2 Postmarketing Experience. The following adverse reactions have been identified during postapproval use of AIMOVIG. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish 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)], Raynauds Phenomenon [see Warnings and Precautions (5.4)].

PREGNANCY SECTION.

8.1 Pregnancy. Pregnancy Exposure RegistryThere is 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 SummaryThere 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 RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.. Data. Animal DataIn 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 dose of 140 mg once monthly.

RECENT MAJOR CHANGES SECTION.

Warnings and Precautions (5.4)3/2025.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Information AIMOVIG(R) (AIM-oh-vig) (erenumab-aooe) injection, for subcutaneous useThis Patient Information has been approved by the U.S. Food and Drug Administration.[part number] v10Revised: 3/2025 What is AIMOVIGAIMOVIG is prescription medicine used for the preventive treatment of migraine in adults. It is not known if AIMOVIG is safe and effective in children under 18 years of age.Who should not use AIMOVIGDo not use AIMOVIG if you are allergic to erenumab-aooe or any of the ingredients in AIMOVIG. See the end of this Patient Information for complete list of ingredients in AIMOVIG.Before you start using AIMOVIG, tell your healthcare provider about all your medical conditions, including if you: have high blood pressurehave circulation problems in your fingers and toesare pregnant or plan to become pregnant. It is not known if AIMOVIG will harm your unborn baby.Pregnancy Registry: There is pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your babys 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. are breastfeeding or plan to breastfeed. 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.Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.How should take AIMOVIGSee the detailed Instructions for Use on complete information on how to take AIMOVIG.Take AIMOVIG exactly as your healthcare provider tells you to take it. 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.Also, before you inject, leave AIMOVIG at room temperature for at least 30 minutes protected from direct sunlight.AIMOVIG is injected under your skin (subcutaneously) time each month.AIMOVIG comes in different types of devices: single-dose (1 time) prefilled autoinjector or single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.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 time each month from the date of your last dose.What are possible side effects of AIMOVIGAIMOVIG may cause serious side effects, including:Allergic reactions. 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: swelling of the face, mouth, tongue, or throattrouble breathing Constipation with serious complications. 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.High blood pressure. 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.Raynauds phenomenon. type of circulation problem can worsen or happen after receiving AIMOVIG. Raynauds 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.The most common side effects of AIMOVIG include: pain, redness, or swelling at the injection site and constipation.Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all of the possible side effects of AIMOVIG. Ask your pharmacist or healthcare provider for more information.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).How should store AIMOVIGStore AIMOVIG in the refrigerator between 36F to 46F (2C to 8C). Keep AIMOVIG in the original carton. This will protect the medicine from light. After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68F to 77F (20C to 25C) for up to days.Throw away AIMOVIG that has been left at room temperature for more than days. Do not freeze. Do not shake. Keep AIMOVIG and all medicines out of the reach of children.General information about the safe and effective use of AIMOVIG.Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use AIMOVIG for condition for which it is not prescribed. Do not 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. What are the ingredients in AIMOVIGActive Ingredient: erenumab-aooeInactive Ingredients: acetate, polysorbate 80, and sucroseAIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex. AIMOVIG(R) (erenumab-aooe) Manufactured by: Amgen Inc.One Amgen Center DriveThousand Oaks, CA 91320-1799 U.S.A.U.S. License No. 1080Patent: http://pat.amgen.com/aimovig/(C) 2018-2025 Amgen Inc. All rights reserved.For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).. have high blood pressure. have circulation problems in your fingers and toes. are pregnant or plan to become pregnant. It is not known if AIMOVIG will harm your unborn baby.Pregnancy Registry: There is pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your babys 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. Pregnancy Registry: There is pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your babys 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.. are breastfeeding or plan to breastfeed. 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.. See the detailed Instructions for Use on complete information on how to take AIMOVIG.. Take AIMOVIG exactly as your healthcare provider tells you to take it. 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.. Also, before you inject, leave AIMOVIG at room temperature for at least 30 minutes protected from direct sunlight.. AIMOVIG is injected under your skin (subcutaneously) time each month.. AIMOVIG comes in different types of devices: single-dose (1 time) prefilled autoinjector or single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.. 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 time each month from the date of your last dose.. Allergic reactions. 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: swelling of the face, mouth, tongue, or throattrouble breathing swelling of the face, mouth, tongue, or throat. trouble breathing. Constipation with serious complications. 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.. High blood pressure. 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.. Raynauds phenomenon. type of circulation problem can worsen or happen after receiving AIMOVIG. Raynauds 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.. Store AIMOVIG in the refrigerator between 36F to 46F (2C to 8C). Keep AIMOVIG in the original carton. This will protect the medicine from light. After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68F to 77F (20C to 25C) for up to days.. Throw away AIMOVIG that has been left at room temperature for more than days. Do not freeze. Do not shake. Active Ingredient: erenumab-aooe. Inactive Ingredients: acetate, polysorbate 80, and sucrose.

SPL UNCLASSIFIED SECTION.

2.1Recommended Dosing. The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from dosage of 140 mg injected subcutaneously once monthly.If dose of AIMOVIG is missed, administer as soon as possible. Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.

STORAGE AND HANDLING SECTION.

16.2Storage and Handling. Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light until time of use. If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25C [77F]) in the original carton and must be used within days. Throw away AIMOVIG that has been left at room temperature for more than days. Do not freeze. Do not shake.. Store refrigerated at 2C to 8C (36F to 46F) in the original carton to protect from light until time of use.. If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25C [77F]) in the original carton and must be used within days. Throw away AIMOVIG that has been left at room temperature for more than days.. Do not freeze.. Do not shake.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Pregnancy Exposure RegistryThere is 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 SummaryThere 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 RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.. Data. Animal DataIn 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 dose of 140 mg once monthly.. 8.2 Lactation. Risk SummaryThere 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 mothers clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition.. 8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. 8.5 Geriatric Use. 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.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity Reactions: If serious hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy. Hypersensitivity reactions can occur within hours to more than one week after administration. (5.1)Constipation with Serious Complications: Serious complications of constipation may occur. (5.2)Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.3) Raynauds Phenomenon: New-onset or worsening of pre-existing Raynauds phenomenon may occur. (5.4). Hypersensitivity Reactions: If serious hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy. Hypersensitivity reactions can occur within hours to more than one week after administration. (5.1). Constipation with Serious Complications: Serious complications of constipation may occur. (5.2). Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.3) Raynauds Phenomenon: New-onset or worsening of pre-existing Raynauds phenomenon may occur. (5.4). 5.1Hypersensitivity Reactions. 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 serious or severe hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy [see Contraindications (4), and Patient Counseling Information (17)].. 5.2Constipation with Serious Complications. 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 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.. 5.3Hypertension. 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.. 5.4Raynauds Phenomenon. Development of Raynauds phenomenon and recurrence or worsening of pre-existing Raynauds 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 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 Raynauds phenomenon develop, and patients should be evaluated by healthcare provider if symptoms do not resolve. Patients with history of Raynauds phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.