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Patient Profiles


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Support Services

  1. Download the Prescription and Service Request Form (PSRF)
  2. Fax the completed form to Shared Solutions® at 1-844-257-6127

Patients can call 1-800-887-8100, Monday–Friday, 8 am–6 pm CT.

Safety profile in clinical trials for AJOVY

The most common side effects of AJOVY as reported in the pivotal phase 3 trials were injection-site reactions.

Adverse reactions reported by ≥2% of patients and greater than placebo

HALO-CM and HALO-EM (pivotal clinical trials) AJOVY 675 mg
Quarterly
(n=667)
AJOVY 225 mg
Monthly
(n=290)
Placebo
Monthly
(n=668)
Injection-site reactions1* 45% 43% 38%

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

Adverse reactions reported by ≥6% of patients in the long-term extension study

CM AJOVY 675 mg Quarterly (n=550) AJOVY 225 mg Monthly (n=558)
Injection-site reactions* 19% 23%
EM AJOVY 675 mg Quarterly (n=394) AJOVY 225 mg Monthly (n=386)
Injection-site reactions* 18% 23%

*Rates of injection-site reactions are averaged. Injection-site reactions include multiple adverse reactions-related terms, such as injection-site pain, induration, and erythema.

Adverse reactions reported by ≥2% of patients and greater than placebo in the FOCUS trial3

FOCUS trial AJOVY 675 mg Quarterly (n=276) AJOVY 225 mg Monthly (n=285) Placebo Monthly (n=277)
Injection site reactions1* 15% 14% 12%

*Injection-site reactions include multiple related adverse reaction terms, including 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 AJOVY

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

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
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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

Need help answering a question?

Support Services

  1. Download the Prescription and Service Request Form (PSRF)
  2. Fax the completed form to Shared Solutions® at 1-844-257-6127

Patients can call 1-800-887-8100, Monday–Friday, 8 am–6 pm CT.

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