Aimovig

Aimovig is indicated for the preventive treatment of migraine in adults.

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

None.

8.1       Pregnancy

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 during pregnancy.

Data

Animal Data

In a 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 a dose of 140 mg once monthly.

8.2       Lactation

Risk Summary

There 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 mother’s 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.

13.1       Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

The carcinogenic potential of erenumab-aooe has not been assessed.

Mutagenesis

Genetic toxicology studies of erenumab-aooe have not been conducted.

Impairment of Fertility

Mating 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 6 months. Serum erenumab-aooe exposures (AUC) at the higher dose tested were more than 100 times that in humans at a dose of 140 mg once monthly.

16.1       How Supplied

Aimovig (erenumab-aooe) injection is a sterile, clear to opalescent, colorless to light yellow solution for subcutaneous administration. 

The needle shield within the white cap of the Aimovig prefilled autoinjector and gray needle cap of the Aimovig prefilled syringe contain dry natural rubber (a derivative of 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 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 2 autoinjectors: 140 mg/2 mL (2 x 70 mg/mL single-dose prefilled autoinjectors)
  NDC 55513-841-02

Syringe

• Pack of 1 syringe: 70 mg/mL single-dose prefilled syringe
  NDC 55513-840-01

• Pack of 2 syringes: 140 mg/2 mL (2 x 70 mg/mL single-dose prefilled syringes)
  NDC 55513-840-02

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.

• It is used to prevent migraine headaches.

• If you have an allergy to Aimovig (erenumab-aooe) or any part of Aimovig (erenumab-aooe).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aimovig (erenumab-aooe) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Aimovig (erenumab-aooe). This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Aimovig (erenumab-aooe) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data on the developmental risk associated with this drug in human pregnancy; in monkeys, adverse effects were not observed at doses approximately 20 times the human dose of 140 mg per month.

In monkeys administered this drug subcutaneously from gestation day 20 to 22 through birth, no adverse effects on offspring were observed. The dose administered (50 mg/kg twice a week) provided serum exposures expected to be 20 times that in humans at a dose of 140 mg per month.

Published data have suggested that pregnant women who experience migraines may be at increased risk of preeclampsia during pregnancy. The estimated rate of major birth defects among women with migraine are similar to rates reported in women without migraine.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.