Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal RiskPublished data have suggested that women with migraine may be at increased risk of preeclampsia duringpregnancy.

Data

Animal Data

In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly bysubcutaneous 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 20times 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 theeffects 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 fromAIMOVIG or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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Reference ID: 4264882 

8.5 Geriatric Use

Clinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determinewhether 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 decreasedhepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

11 DESCRIPTION

Erenumab-aooe is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding tothe 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 2light 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 tolight yellow solution for subcutaneous administration. Each 1 mL single-dose prefilled autoinjector and

single-dose prefilled glass syringe contains 70 mg erenumab-aooe, acetate (1.5 mg), polysorbate 80 (0.10 mg),and sucrose (73 mg). Enclosed within the autoinjector is a single-dose, prefilled glass syringe. The solution of

AIMOVIG has a pH of 5.2.

12 CLINICAL PHARMACOLOGY

12.1 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.

12.2 Pharmacodynamics

In a randomized, double-blind, placebo-controlled study in healthy volunteers, concomitant administration oferenumab-aooe (140 mg intravenous, single-dose) with sumatriptan (12 mg subcutaneous, given as two 6 mg

doses separated by one hour) had no effect on resting blood pressure compared with sumatriptan alone.

AIMOVIG is for subcutaneous use only.

12.3 Pharmacokinetics

Erenumab-aooe exhibits non-linear kinetics as a result of binding to the CGRP receptor. The Cmax mean andAUClast mean following subcutaneous administration of a 70 mg once monthly and a 140 mg once monthly