What are the contraindications for Qulipta (atogepant) in patients with a history of hypersensitivity reactions, impaired renal function, or those taking other medications?

Qulipta Contraindications

Qulipta (atogepant) is contraindicated in patients with a history of hypersensitivity to atogepant or any component of the formulation, including reactions such as anaphylaxis and dyspnea. 1

Primary Contraindication

• History of hypersensitivity reactions to atogepant or any excipient in the formulation is an absolute contraindication 1
• Documented hypersensitivity reactions with Qulipta have included anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema 1
• These reactions can occur days after administration, not just immediately, requiring vigilance even after initial tolerance 1

Critical Dosing Restrictions (Not Absolute Contraindications, But Require Avoidance in Specific Contexts)

Severe Renal Impairment

• Chronic migraine patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease should avoid Qulipta entirely 1
• Episodic migraine patients with severe renal impairment can use a reduced dose of 10 mg once daily 1
• The distinction between episodic and chronic migraine is critical—chronic migraine patients have no safe dosing option with severe renal dysfunction 1

Drug Interaction-Based Avoidance

• Chronic migraine patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) should avoid Qulipta 1
• All patients (episodic or chronic migraine) taking strong, moderate, or weak CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) with chronic migraine should avoid Qulipta 1
• Episodic migraine patients on CYP3A4 inhibitors can use 10 mg once daily, while those on inducers can use 30-60 mg once daily 1

Management of Hypersensitivity Reactions

• If hypersensitivity occurs, immediately discontinue Qulipta and institute appropriate therapy 1
• Do not rechallenge patients who have experienced hypersensitivity reactions, as this represents an absolute contraindication to future use 1
• Monitor patients for delayed hypersensitivity reactions that may manifest days after initial administration 1

Populations Requiring Caution (Not Contraindications)

• Severe hepatic impairment: Avoid use due to lack of safety data 1
• Pregnancy: May cause fetal harm based on animal data; use only if benefit justifies potential risk 1
• Patients with weight loss concerns should be monitored, as 5.3% of patients on 60 mg experienced ≥7% weight decrease 1

Common Pitfalls to Avoid

• Do not confuse episodic versus chronic migraine dosing restrictions—chronic migraine has stricter limitations with renal impairment and drug interactions 1
• Do not assume all CGRP antagonists have identical contraindications—atogepant's specific chemical structure differs from earlier CGRP antagonists that had hepatotoxicity concerns 2, 3
• Do not overlook delayed hypersensitivity reactions that occur days after starting therapy 1