Aimovig

— THERAPEUTIC CATEGORIES —
  • Migraine and headache
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Aimovig Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Erenumab-aooe 70mg/mL, 140mg/mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Calcitonin gene-related peptide (CGRP) receptor antagonist.

    How Supplied

    Single-dose prefilled SureClick autoinjector—1; Single-dose prefilled syringe—1

    How Supplied

    • 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.

      • SureClick Autoinjector: Pack of 1 autoinjector containing 70mg/mL or 140mg/mL.

      • Syringe: Pack of 1 syringe containing 70mg/mL or 140mg/mL.

    Storage

    • Store refrigerated at 2°C to 8°C (36°F to 46°F) 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 25°C [77°F]) in the original carton and must be used within 7 days. Throw away Aimovig that has been left at room temperature for more than 7 days.  

    • Do not freeze. Do not shake.

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

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

    Aimovig Indications

    Indications

    Prophylaxis of migraine.

    Aimovig Dosage and Administration

    Adult

    Give by SC inj into abdomen, thigh, or upper arm. 70mg once monthly; some patients may benefit from 140mg once monthly.

    Children

    Not established.

    Aimovig Contraindications

    Not Applicable

    Aimovig Boxed Warnings

    Not Applicable

    Aimovig Warnings/Precautions

    Warnings/Precautions

    Do not inj into tender, bruised, red, or hard areas. Discontinue if serious hypersensitivity reaction occurs; treat appropriately. Monitor for severe constipation, new-onset hypertension, or worsening of preexisting hypertension; manage appropriately. Latex allergy (needle shield/cap). Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Hypersensitivity Reactions  

    • Hypersensitivity reactions have been reported. These reactions include rash, angioedema, and anaphylaxis.

    • Most reactions were not serious and occurred within hours of administration; some have occurred more than 1 week after administration.

    • Discontinue Aimovig and initiate treatment if a serious or severe hypersensitivity reaction occurs.

    Constipation with Serious Complications

    • Constipation with serious complication have been reported, some of these cases have required hospitalization.

    • A majority of these cases have been reported after the first dose.

    • Monitor for severe constipation and manage appropriately.

    • Concomitant use with medications associated with decreased GI motility may increase the risk for more severe constipation and constipation-related complications.

    Hypertension

    • 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. 

    Pregnancy Considerations

    Risk Summary

    • No adequate data on the risk associated with use of Aimovig in pregnant women.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of erenumab-aooe in human milk, the effects on the breastfed infant, or the effects on milk production.

    • Consider the developmental and health benefits of breastfeeding 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.

    Pediatric Considerations

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

     

    Geriatric Considerations

    • 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.

    Aimovig Pharmacokinetics

    Absorption

    • Median peak serum concentrations were attained in approximately 6 days.

    • Estimated absolute bioavailability: 82%.

    Distribution

    • Mean volume of distribution: ~3.86 (0.77) L.

    Elimination

    • Half-life: 28 days.

    Aimovig Interactions

    Interactions

    Concomitant drugs that decrease GI motility may increase risk for severe constipation and related-complications.

    Aimovig Adverse Reactions

    Adverse Reactions

    Inj site reactions, constipation (may be severe), cramps, muscle spasms.

    Aimovig Clinical Trials

    Clinical Trials

    The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4–14 migraine days per month) (Study 1 and Study 2) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month) (Study 3). The studies enrolled patients with a history of migraine, with or without aura, according to the International Classification of Headache Disorders diagnostic criteria. 

    Episodic Migraine – Study 1

    • The randomized, multicenter, 6-month, placebo-controlled, double-blind study evaluated Aimovig for the preventive treatment of episodic migraine in 955 patients with a history of episodic migraine. Patients were randomly assigned to receive either Aimovig 70 mg, 140 mg, or placebo subcutaneously once monthly for 6 months. Patients were allowed to use acute headache treatments including migraine-specific medications and NSAIDs.

    • Aimovig 70 mg and 140 mg achieved a reduction of 3.2 and 3.7 monthly migraine days (MMD), respectively, over months 4 to 6 from baseline compared with a reduction of 1.8 MMD for placebo (P <.001 for both).

    • 43.3% and 50% of patients treated with Aimovig 70 mg and 140 mg, respectively, achieved at least a 50% reduction from baseline in mean monthly migraine days over months 4 to 6 from baseline compared with 26.6% of those treated with placebo (P <.001 for both).

    • Aimovig 70 mg and 140 mg achieved a reduction of 1.1 and 1.6, respectively, mean monthly acute migraine-specific medication days over months 4 to 6 from baseline compared with a reduction of 0.2 for placebo (P <.001 for both).

    Episodic Migraine – Study 2

    • The randomized, multicenter, 3-month, placebo-controlled, double-blind study evaluated Aimovig for the preventive treatment of episodic migraine in 577 patients with a history of episodic migraine. Patients were randomly assigned to receive either Aimovig 70 mg or placebo subcutaneously once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications and NSAIDs.

    • Aimovig 70 mg achieved a reduction of 2.9 monthly migraine days (MMD) at month 3 from baseline compared with a reduction of 1.8 MMD for placebo (P <.001).

    • 39.7% of patients treated with Aimovig 70 mg achieved at least a 50% reduction from baseline in mean MMD at month 3 from baseline compared with 29.5% of those treated with placebo (P =.01).

    • Aimovig 70 mg achieved a reduction of 1.2 mean monthly acute migraine-specific medication days at month 3 from baseline compared with a reduction of 0.6 for placebo (P =.002).

    Chronic Migraine – Study 3

    • The randomized, multicenter, 3-month, placebo-controlled, double-blind study evaluated Aimovig for the preventive treatment of chronic migraine in 667 patients with a history of chronic migraine with or without aura. Patients were randomly assigned to receive either Aimovig 70 mg, 140 mg, or placebo subcutaneously once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications and NSAIDs.

    • Aimovig 70 mg and 140 mg achieved a reduction of 6.6 and 6.6 monthly migraine days (MMD), respectively, at month 3 from baseline compared with a reduction of 4.2 MMD for placebo (P <.001 for both).

    • 39.9% and 41.2% of patients treated with Aimovig 70 mg and 140 mg, respectively, achieved at least a 50% reduction from baseline in mean MMD at month 3 from baseline compared with 23.5% of those treated with placebo (P <.001 for both).

    • Aimovig 70 mg and 140 mg achieved a reduction of 3.5 and 4.1, respectively, mean monthly acute migraine-specific medication days at month 3 from baseline compared with a reduction of 1.6 for placebo (P <.001 for both).

    Aimovig Note

    Not Applicable

    Aimovig Patient Counseling

    Patient Counseling

    • Advise patients to let Aimovig sit at room temperature for at least 30 minutes prior to administration.

    • Advise patients to seek immediate medical attention if symptoms of serious or severe hypersensitivity reactions occur. 

    • Advise patients that constipation with serious complications can occur with Aimovig and should contact their healthcare providers if severe constipation occurs.

    • Advise patients that hypertension and worsening of pre-existing hypertension may occur and should contact their healthcare providers if elevated blood pressure occurs.

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