Safety profile in clinical trials for AJOVY

*Injection-site reactions include multiple adverse reactions–related terms, such as injection-site pain, induration, and erythema.

In the HALO phase 3 clinical trials²:

• <1% of patients experienced constipation vs <1% for placebo
• <1% of patients experienced hypertension vs <1% with placebo
• ≤2% of patients discontinued due to adverse events in the AJOVY and placebo treatment arms
• <1% of patients in both phase 3 trials developed antibodies to AJOVY¹

^†Rates of injection-site reactions are averaged. Injection-site reactions included injection-site induration, pain, erythema, hemorrhage, and pruritus.

In the Long-Term Extension study²:

• No new safety signals were identified
• 6% of patients discontinued due to lack of efficacy or adverse events
• Discontinuation rates were comparable for both quarterly (7%) and monthly (5%) dosing

^‡Injection-site reactions include multiple related adverse event terms, such as injection-site pain, induration, and erythema.⁴

In the FOCUS phase 3b clinical trial:

• Most injection-site reactions were rated as mild to moderate²
• Discontinuation rate due to adverse events was <1%²
• The most common adverse event experienced among patients receiving AJOVY included injection-site reactions (14%)²
• Injection-site reactions were evaluated differently in HALO phase 3 and FOCUS studies²
• In the phase 3 trials, injection-site reactions were assessed for erythema, induration, ecchymosis, and pain immediately and 1 hour after study drug administration. If a patient had severe injection-site induration, erythema, and/or ecchymosis and/or grade 3 (severe) or grade 4 (worst possible) injection-site pain at 1 hour after completion of study drug administration, the patient was reassessed 3 hours after study drug administration and hourly thereafter until the reaction/pain was of moderate or less severity²

AJOVY is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.¹

AJOVY has a long half-life. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. Teva has a pregnancy exposure registry for pregnant women; healthcare providers are encouraged to register pregnant patients by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.