QULIPTA

AbsorptionFollowing oral administration of QULIPTA, atogepant is absorbed with peak plasma concentrations at approximately 1 to 2 hours. Atogepant displays dose-proportional pharmacokinetics up to 170 mg per day (approximately 3 times the highest recommended dosage), with no accumulation. Effect of Food When QULIPTA was administered with a high-fat meal, the food effect was not significant (AUC and C max were reduced by approximately 18% and 22%, respectively, with no effect on median time to m...

Figure 1: Change from Baseline in Monthly Migraine Days in

Study 1Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in

Study 1Diagram Description automatically generated Chart, bar chart Description automatically generated Figure 5: Change from Baseline in Monthly Migraine Days in

Study 3Figure 6: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 3 14.1 Episodic Migraine The efficacy of QULIPTA for the preventive treatment of episodic migraine in adults was demonstrated in two randomized, multicenter,...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-108...

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions ( 5.1 )] . Patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA. ( 4 )

Hypersensitivity Reactions: If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, ...

7 DRUG INTERACTIONS Recommended dosage modifications: Strong CYP3A4 Inhibitors ( 2.2 , 7.1 ): Episodic or chronic migraine: 10 mg once daily Strong CYP3A4 Inducers ( 2.2 , 7.2 ): Episodic migraine: 60 mg once daily (monitor for reduced efficacy). Chronic migraine: Not recommended. Moderate CYP3A4 Inducers ( 2.2 , 7.2 ): Episodic migraine: 60 mg once daily. Chronic migraine: Not recommended. Weak C...