What is the recommended dosage and treatment plan for Qulipta (atogepant) in adults with episodic migraine?

Recommended Dosage and Treatment Plan for Qulipta (Atogepant) in Adults with Episodic Migraine

For adults with episodic migraine, Qulipta (atogepant) should be administered at a dosage of 10 mg, 30 mg, or 60 mg taken once daily with or without food. 1

Dosing Guidelines

Qulipta is FDA-approved for the preventive treatment of migraine in adults. The specific dosing recommendations are:

• Episodic migraine (1-14 headache days per month):

  • 10 mg, 30 mg, or 60 mg taken once daily 1

• Chronic migraine (≥15 headache days per month):

  • 60 mg taken once daily 1

Dosage Modifications

Certain clinical scenarios require dosage adjustments:

Clinical Scenario	Recommended Dosage for Episodic Migraine	Recommendation for Chronic Migraine
Concomitant use of strong CYP3A4 inhibitors	10 mg once daily	Avoid use
Concomitant use of CYP3A4 inducers (strong, moderate, or weak)	30 mg or 60 mg once daily	Avoid use
Concomitant use of OATP inhibitors	10 mg or 30 mg once daily	30 mg once daily
Severe renal impairment (CLcr <30 mL/min) or end-stage renal disease	10 mg once daily	Avoid use

Efficacy and Treatment Duration

Atogepant demonstrates progressive improvement in migraine prevention with continued use:

• Initial efficacy is observed within the first month of treatment 2
• Sustained response rates increase over time, with improved efficacy at 52 weeks compared to 12 weeks 3, 2
• Long-term data shows mean reduction in monthly migraine days of -3.8 at weeks 1-4, improving to -5.2 at weeks 49-52 3

Clinical Considerations

1. Treatment Position in Guidelines:

   • The American College of Physicians (ACP) includes atogepant among CGRP antagonist-gepants evaluated for episodic migraine prevention 4
   • The U.S. Department of Veterans Affairs and Department of Defense (VA/DoD) suggests atogepant for the prevention of episodic migraine (weak for recommendation) 4

2. Monitoring and Follow-up:

   • Monitor for hypersensitivity reactions, which can include anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema 1
   • Hypersensitivity reactions can occur days after administration and require discontinuation if they develop 1

3. Common Side Effects:

   • Most common adverse events include upper respiratory tract infection (10.3%), constipation (7.2%), nausea (6.3%), and urinary tract infection (5.2%) 3
   • In clinical trials, treatment-related adverse events ranged from 18% to 26% across different doses 5

4. Quality of Life Improvements:

   • Atogepant treatment is associated with sustained improvements in migraine-specific quality of life and reductions in activity impairment 6
   • Headache Impact Test-6 (HIT-6) improvements of ≥5 points were observed in 59.9% of participants at week 4, increasing to 80.8% by week 52 6

Special Populations

Atogepant has shown efficacy in difficult-to-treat populations:

• In patients who failed 2-4 classes of conventional oral preventive treatments, atogepant 60 mg once daily demonstrated significant reduction in monthly migraine days compared to placebo (-4.2 vs -1.9, difference of -2.4) 7

Treatment Algorithm

1. Initial Treatment:

   • Start with 10 mg, 30 mg, or 60 mg once daily based on clinical judgment
   • Consider starting at lower doses (10 mg) in patients with potential drug interactions or renal impairment
   • Consider higher doses (60 mg) for patients with more severe or frequent migraines

2. Evaluation of Response:

   • Assess response after 4 weeks of treatment
   • If inadequate response, consider dose escalation up to 60 mg daily
   • Continue treatment for at least 12 weeks to evaluate full efficacy

3. Long-term Management:

   • For patients with good response, continue treatment with regular monitoring
   • Sustained efficacy improves over time, with better response rates at 52 weeks compared to initial treatment periods 3, 2

Contraindications

Qulipta is contraindicated in patients with a history of hypersensitivity to atogepant or any components of the medication 1.