INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
QULIPTA
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.
Please see full Prescribing Information.
*Source: Online survey conducted by Ipsos Healthcare on behalf of AbbVie Inc., between June 16, 2024, and July 16, 2024, among 425 adults aged 18-64, of which 129 were using QULIPTA at the time of the survey.
†Survey respondents could choose from the following to indicate their agreement with the provided statement: strongly disagree, disagree, somewhat disagree, neither disagree nor agree, somewhat agree, agree, or strongly agree. The percentage represents those who answered strongly agree, agree, and somewhat agree.
‡Survey respondents could choose from the following to indicate whether they plan to continue using QULIPTA: “Yes, I plan to continue using QULIPTA” or “No, I do not plan to continue using QULIPTA.” The percentage represents those who answered “Yes, I plan to continue using QULIPTA.”
Reference: 1. Data on file. AbbVie Inc.
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US-QLP-250035 04/25