QULIPTA was generally well tolerated1*
Clinical trial adverse reactions
In the three placebo-controlled trials, the frequently reported adverse reactions (>1%) with QULIPTA were constipation, nausea, fatigue/somnolence, and decreased appetite.
Most adverse reactions were mild to moderate in intensity, and no serious adverse reactions were identified with QULIPTA.
Treatment-emergent adverse events
Adverse events occurring in ≥5% for QULIPTA in three studies1
Adapted from the QULIPTA Product Monograph.
The overall safety profile in the open-label, long-term safety studies was consistent with that demonstrated in the placebo-controlled trials.1
Select abnormal laboratory findings – Decrease in body weight1*
●In the placebo-controlled studies, patients had a mean weight of 79.3 kg and mean BMI of 28.86 kg/m2.
●There was a dose-dependent decrease in mean body weight of patients who received QULIPTA 30 mg (-0.40 kg) and 60 mg (-0.90 kg).
●Patients receiving placebo gained a mean body weight of 0.23 kg during the course of these studies.
●The proportion of patients with a weight decrease ≥7% at any point during the studies was 2.5% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 5.3% for QULIPTA 60 mg.
●No patients in these studies discontinued treatment due to an adverse event of decreased weight.
Safety information
Click here for additional safety information and for a link to the Product Monograph discussing:
●Relevant warnings and precautions regarding patients with severe hepatic impairment, driving and operating machinery, pregnant and nursing women, and geriatrics.
●Conditions of clinical use, adverse reaction, drug interactions and dosing instructions.
Reference:
1. QULIPTA Product Monograph. AbbVie Corporation.
BMI: body mass index.
*In pooled placebo-controlled trials (Studies 1, 2, and 3), 2500 patients with episodic and chronic migraine received various doses of QULIPTA (n=1837) and placebo (n=663).1
For more information
For any questions related to QULIPTA, you can contact AbbVie Medical Information at 1 844 241-5011.
QULIPTA and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.
© 2024 AbbVie. All rights reserved.
BMI: body mass index.
*In pooled placebo-controlled trials (Studies 1, 2, and 3), 2500 patients with episodic and chronic migraine received various doses of QULIPTA (n=1837) and placebo (n=663).1
For more information
For any questions related to QULIPTA, you can contact AbbVie Medical Information at
1 888 241-5011.
QULIPTA and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.
© 2024 AbbVie. All rights reserved.
CA-QLP-240063A / OC24