QULIPTA® (atogepant) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
QULIPTA® (atogepant) is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.
WARNINGS AND PRECAUTIONS
Cases, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.
The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
Dose modifications are recommended when using the following:
- Episodic migraine: Strong CYP3A4 inhibitors; CYP3A4 inducers; or OATP inhibitors
- Chronic migraine: OATP inhibitors
In chronic migraine, avoid use with strong CYP3A4 inhibitors or with CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Severe renal impairment or end-stage renal disease: In episodic migraine, 10 mg once daily. In chronic migraine, avoid use.
Avoid use in patients with severe hepatic impairment.