A generally
well-tolerated
treatment choice1-6

Adverse events with AJOVY® have been reported in phase III trials:1–6,8

Click below to select the data:

The safety profile of AJOVY® has been assessed in

>2,500

patients1

>1,400

patients were treated with
AJOVY® for at least 12 months1

The safety profile of AJOVY® was generally comparable with placebo1–6

*The safety and efficacy of AJOVY® were not affected by anti-drug antibody development.

 

HALO EPISODIC MIGRAINE

ADVERSE EVENTS2

 

aAdverse events were collected at each visit via inquiry and clinical laboratory tests. The safety population included all patients who were randomised and received at least 1 dose of study drug. If a patient had multiple types of adverse events, he/she was counted once for each type. One patient randomised to receive placebo inadvertently received 1 dose of AJOVY®, 225mg. Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

bOne death occurred in the AJOVY® quarterly group as a result of diphenhydramine overdose (suicide); assessment by the investigator determined that the death was unrelated to treatment.

cLocal injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

dAspartate aminotransferase or alanine aminotransferase ≥3 x ULN.

eTotal bilirubin ≥2 x ULN.

fPresence of 3 components: aspartate aminotransferase or alanine aminotransferase ≥3 x ULN; total bilirubin ≥2 x ULN; and no other reason to explain these increases (eg, viral hepatitis A, B, or C; liver disease; or drug capable of causing injury).

gOne patient in the placebo group had a serious adverse event of drug hypersensitivity that was assessed as severe; the event was considered to be a generalised allergic reaction to ceftriaxone.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

 

HALO CHRONIC MIGRAINE

ADVERSE EVENTS3

 

*Shown are data collected during the double-blind, placebo-controlled intervention period. The safety population included all the patients who underwent randomisation and received at least one dose of a trial regimen. Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

One serious adverse event led to discontinuation of the trial; an event of suicidal ideation (assessed by the investigator as being moderate in severity and unrelated to the trial regimen) was reported in a patient in the AJOVY® monthly group who had a history of depression.

One death occurred in the AJOVY® quarterly group as a result of chronic obstructive pulmonary disease; this was determined by the investigator and sponsor to be unrelated to the trial regimen.

§Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

Patients could have more than one type of possible trial-agent–induced liver injury.

**An event was reported in one additional patient but was inadvertently omitted as an adverse event of special interest.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

HALO LT EPISODIC MIGRAINE

Adverse events8

 

*Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

HALO LT CHRONIC MIGRAINE

Adverse events8

 

*Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

FOCUS

Adverse events5

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

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Continue to Efficacy page of AJOVY

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Flexibility to help you meet your patients’ needs1,5

Felxibility of ajovy®