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