Safety profile in clinical trials for AJOVY

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 reactions1

Adverse reactions reported by ≥2% of patients
and greater than placebo in the HALO trials1

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 reactions*

45%

43%

38%

*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

Adverse reactions reported by ≥6% of patients
in the long-term extension study3

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 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

Adverse reactions reported by ≥2% of patients
and greater than placebo in the FOCUS trial4

FOCUS trial

AJOVY 675mg Quarterly

(n=276)

AJOVY 225mg Monthly

(n=285)

Placebo Monthly

(n=277)

Injection-site reactions1‡

15%

14%

12%

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.

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