Erenumab

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

• AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults.ICD-10: G43.909

• 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) ] .contraindicated

For subcutaneous use only ( 2.1 , 2.2 ) Recommended dosage is 70 mg once monthly; some patients may benefit from a 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 ) 2.1 Recommended Dosing 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. 2.2 Important 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 a heat source such as hot water or a 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.

Hypersensitivity Reactions: If a 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 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. ( 5.4 ) 5.1 Hypersensitivity 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 a serious or severe hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy [see Contraindications (4) , and Patient Counseling Information (17) ] . 5.2 Constipation 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 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.

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) ] Raynaud's 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 . 6.1 Clinical Trials Experience 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.

8.1 Pregnancy 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.

Metabolism

Erenumab-aooe exhibits non-linear kinetics as a result of binding to the CGRP receptor. The C max mean and AUC last 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.

• May 17, 2018BLABLA761077Amgen Inc

1. 1Accidental Exposure To Product10,10319%
2. 2Device Difficult To Use9,91618%
3. 3Wrong Technique In Product Usage Process9,47918%
4. 4Drug Dose Omission By Device6,58512%
5. 5Migraine4,9439.2%
6. 6Drug Ineffective4,3108.0%
7. 7Headache3,3426.2%
8. 8Constipation3,1795.9%
9. 9Product Storage Error2,9745.5%
10. 10Injection Site Pain2,8485.3%
11. 11Off Label Use2,7065.0%
12. 12Nausea2,3744.4%
13. 13Fatigue2,2324.1%
14. 14Alopecia2,1804.0%
15. 15Therapeutic Product Effect Incomplete1,9373.6%

The 10 most recently updated of 83 ClinicalTrials.gov registrations naming Erenumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
  Recruiting · Phase 2 · Interventional · 40 enrolled · Massachusetts General Hospital
  NCT05684692updated 2026-04-23
• Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
  Completed · Phase 4 · Interventional · 512 enrolled · Amgen
  NCT04252742updated 2026-03-31
• Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action
  Completed · Phase 4 · Interventional · 64 enrolled · Beth Israel Deaconess Medical Center
  NCT04271202updated 2026-03-24
• Fremanezumab, Migraine and Sleep
  Terminated · Phase 4 · Interventional · 22 enrolled · Beth Israel Deaconess Medical Center
  NCT04693533updated 2026-02-27
• Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
  Active not recruiting · Phase 4 · Interventional · 72 enrolled · Brigham and Women's Hospital
  NCT06173661updated 2026-02-27
• Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
  Completed · Phase 3 · Interventional · 284 enrolled · Amgen
  NCT03832998updated 2026-01-20
• China HeadAche DIsorders RegiStry
  Recruiting · Observational · 10,000 enrolled · Beijing Tiantan Hospital
  NCT05334927updated 2026-01-15
• Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
  Recruiting · Early phase 1 · Interventional · 10 enrolled · Xuanwu Hospital, Beijing
  NCT07323927updated 2026-01-07
• Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
  Active not recruiting · Phase 3 · Interventional · 457 enrolled · Amgen
  NCT03836040updated 2025-12-23

Frequently asked questions

How does Erenumab work?

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

What is Erenumab used for?

According to FDA labeling, Erenumab carries indications including: AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Erenumab?

Erenumab is classified as Calcitonin gene-related peptide (CGRP) antagonists, Decreased Calcitonin Secretion.

What are the brand names for Erenumab?

Erenumab is marketed under brand names including Aimovig.

What are the contraindications for Erenumab?

Erenumab labeling lists contraindications including: 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) ] .. Always consult the full prescribing information and a clinician.