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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

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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 development 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 http://www.tevamigrainepregnancyregistry.com/.

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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