Aimovig

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.
• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2184 patients, 787 patients received at least one dose of AIMOVIG 70 mg once monthly, 507 patients received at least one dose of AIMOVIG 140 mg once monthly, and 890 patients received placebo during 3 months or 6 months of double-blind treatment [see Clinical Studies (14) ] .
• Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry.
• The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation.
• Table 1 summarizes the adverse reactions that occurred during the first 3 months in the migraine studies (Studies 1, 2, and 3).
• Table 1:
• Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3 Adverse Reaction AIMOVIG 70 mg Once Monthly N = 787 % AIMOVIG 140 mg Once Monthly N = 507 % Placebo N = 890 % Injection site reactions Injection 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 1 is with the prefilled syringe. 6 5 3 Constipation 1 3 1 Cramps, muscle spasms < 1 2 < 1 In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG 70 mg or 140 mg discontinued double-blind treatment because of adverse events.
• The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of AIMOVIG.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Immune System Disorders:
• Hypersensitivity reactions, including rash, angioedema, and anaphylaxis [see Warnings and Precautions (5.1) ].
• Gastrointestinal Disorders:
• Constipation with serious complications [see Warnings and Precautions (5.2) ] , oral mucosal ulceration .
• Skin and Subcutaneous Tissue Disorders: Rash, alopecia.
• Vascular Disorders:
• Hypertension [see Warnings and Precautions (5.3) ] , Raynaud's Phenomenon [see Warnings and Precautions (5.4) ].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Information on Preparation and Administration Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled autoinjector or single-dose prefilled syringe [see Dosage and Administration (2.2) ] .
• Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AIMOVIG.
• Advise patients to let AIMOVIG sit at room temperature for at least 30 minutes prior to administration [see Dosage and Administration (2.2) ] .
• Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions [see Warnings and Precautions (5.1) ] .
• Constipation with Serious Complications Advise patients that constipation with serious complications can occur with AIMOVIG and that they should contact their healthcare providers if they experience severe constipation [see Warnings and Precautions (5.2) ] .
• Hypertension Advise patients that development of hypertension and worsening of pre-existing hypertension can occur with AIMOVIG and that they should contact their healthcare providers if they experience elevation in their blood pressure [see Warnings and Precautions (5.3) ] .
• Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy [see Use in Specific Populations (8.1) ].
• Raynaud's Phenomenon Inform patients that Raynaud's phenomenon can develop or worsen with AIMOVIG.
• Advise patients to discontinue AIMOVIG and contact their healthcare provider if they experience signs or symptoms of Raynaud's phenomenon [see Warnings and Precautions (5.4) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

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

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 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.
• AIMOVIG is supplied as follows:
• SureClick ® Autoinjector Pack of 1 autoinjector:
• 70 mg/mL single-dose prefilled autoinjector NDC 55513-841-01 Pack of 1 autoinjector:
• 140 mg/mL single-dose prefilled autoinjector NDC 55513-843-01 Syringe Pack of 1 syringe:
• 70 mg/mL single-dose prefilled syringe NDC 55513-840-01 Pack of 1 syringe:
• 140 mg/mL single-dose prefilled syringe NDC 55513-842-01
• 16.2 Storage and Handling 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.

Quoted from the official label, section “How Supplied”.

How to store it

• 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.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Erenumab-aooe is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the calcitonin gene-related peptide receptor.
• Erenumab-aooe is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
• It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa.
• AIMOVIG (erenumab-aooe) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous administration.
• Each 1 mL 70 mg single-dose prefilled autoinjector and 70 mg single-dose prefilled glass syringe contains 70 mg erenumab-aooe, acetate (1.5 mg), polysorbate 80 (0.10 mg), and sucrose (73 mg).
• Each 1 mL 140 mg single-dose prefilled autoinjector and 140 mg single-dose prefilled glass syringe contains 140 mg erenumab-aooe, acetate (2.0 mg), polysorbate 80 (0.10 mg), and sucrose (65 mg).
• Enclosed within the autoinjector is a single-dose, prefilled glass syringe.
• The solution of AIMOVIG has a pH of 5.2.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Erenumab-Aooe