INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
QULIPTA® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS
QULIPTA 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 the use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.

ADVERSE REACTIONS
The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

DRUG INTERACTIONS
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 the 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.

Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

Please see full Prescribing Information.

Phase 2b/3 dose-finding study results:
Primary endpoints:
QULIPTA 60 mg: -3.6 MMD across 12 weeks (baseline MMD was 7.7) (n=177) (P=0.039).¹
QULIPTA 30 mg: -3.8 MMD across 12 weeks (baseline MMD was 7.6) (n=182) (P=0.039).¹
QULIPTA 10 mg: -4.0 MMD across 12 weeks (baseline MMD was 7.6) (n=92) (P=0.024).¹
Placebo: -2.8 MMD across 12 weeks (baseline MMD was 7.8) (n=178).¹

Study designs
EM study design: Two randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the efficacy and safety of QULIPTA for 12 weeks in patients who were experiencing 4 to 14 migraine days per month.^1,2

CM study design: A randomized, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy and safety of QULIPTA for 12 weeks in patients who were experiencing 15 or more migraine days per month.¹

^*Data from Phase 3 ADVANCE EM pivotal study.

^†Data from Phase 3 PROGRESS CM pivotal study.

CM=chronic migraine; EM=episodic migraine; MMD=Monthly Migraine Days.

References: 1. QULIPTA (atogepant). Package insert. AbbVie Inc; 2023. 2. Protocol for: Ailani J, Lipton RB, Goadsby PJ, et al; ADVANCE Study Group. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695-706. doi:10.1056/NEJMoa2035908

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