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INDICATION

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: 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.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including QULIPTA. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. QULIPTA should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

ADVERSE REACTIONS

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

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

US-QLP-250104

Please see full Prescribing Information.

References

References: 1. QULIPTA [package insert]. North Chicago, IL: AbbVie Inc.; 2025. 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 3. Data on file. AbbVie Inc. 4. Russo AF. Calcitonin gene-related peptide (CGRP): a new target for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552. 5. Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol. 2018;14(6):338-350. doi:10.1038/s41582-018-0003-1 6. Edvinsson L. The trigeminovascular pathway: role of CGRP and CGRP receptors in migraine. Headache. 2017;57(suppl 2):47-55. 7. UBRELVY [package insert]. North Chicago, IL: AbbVie Inc.; 2025. 8. Data on file. AbbVie Inc. January 2020–November 2024.

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©2025 AbbVie. All rights reserved.
QULIPTA® and its design are registered trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.
All other trademarks are the property of their respective owners.

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. Patients in trials were 88% female, 80% White, 17% Black, and 12% Hispanic or Latino ethnicity and the mean age at study was 41 years (range 18-74 years).1

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. Patients in trials were 88% female, 80% White, 17% Black, and 12% Hispanic or Latino ethnicity and the mean age at study entry was 41 years (range 18-74 years).1,2

Phase 2b/3 Dose-finding Study Results:

QULIPTA 60 mg: -3.6 mothly migraine days across 12 weeks (n=177) (P=0.039).
QULIPTA 30 mg: -3.8 mothly migraine days across 12 weeks (n=182) (P=0.039).
QULIPTA 10 mg: -4.0 mothly migraine days across 12 weeks (n=92) (P=0.024). Placebo: -2.8 mothly migraine days across 12 weeks (n=178).1

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

INDICATION

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: 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.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including QULIPTA. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. QULIPTA should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

ADVERSE REACTIONS

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

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

US-QLP-250104