consecutive subcutaneous injections of 70 mg each.

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

2.2 Important Administration Instructions

AIMOVIG is for subcutaneous use only.

The needle shield within the white cap of the AIMOVIG prefilled autoinjector and gray needle cap of theAIMOVIG prefilled syringe contain dry natural rubber (a derivative of latex), which may cause allergic

reactions in individuals sensitive to latex.

AIMOVIG is intended for patient self-administration. Prior to use, provide proper training to patients and/orcaregivers 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 minutesprotected from direct sunlight [see How Supplied/Storage and Handling (16.2)]. 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 andStrengths (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 wherethe skin is tender, bruised, red, or hard.

Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.

3 DOSAGE 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: 70 mg/mL in a single-dose prefilled syringe

4 CONTRAINDICATIONS

None.

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical 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 eva luated in 2,537 patients with migraine who received at least one dose of

AIMOVIG, representing 2,310 patient-years of exposure. Of these, 2,057 patients were exposed to 70 mg or140 mg once monthly for at least 6 months, 1,198 patients were exposed for at least 12 months, and 287 patients

were exposed for at least 18 months.

In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2,184 patients, 787 patients received at least onedose 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 [seeClinical Studies (14)]. 

Approximately 84% were female, 91% were white, and the mean age was 42 years atstudy entry.