Minimum Age for Qulipta and Ubrelvy in Migraine Treatment
Qulipta (atogepant) is FDA-approved for preventive treatment of migraine in adults only, and Ubrelvy (ubrogepant) is FDA-approved for acute treatment of migraine in adults only—neither medication has established safety or efficacy data in pediatric populations, and therefore should not be prescribed to patients under 18 years of age. 1, 2
FDA-Approved Age Indications
Qulipta (Atogepant)
- Approved for adults only for the preventive treatment of both episodic and chronic migraine 1
- The prescribing information explicitly states the indication is "for the preventive treatment of migraine in adults" 1
- No pediatric dosing recommendations exist in the FDA label 1
Ubrelvy (Ubrogepant)
- Approved for adults only for the acute treatment of migraine with or without aura 2
- The FDA label specifies use "in adults" without any pediatric age provisions 2
- Clinical trials enrolled participants aged 18-75 years only 2
Clinical Trial Population Data
All pivotal trials for both medications excluded pediatric patients:
- Ubrogepant trials (ACHIEVE I and II) enrolled only adults aged 18-75 years, with a mean age of 41 years 2, 3
- Atogepant clinical studies included participants with a mean age of 41 years (range 18-74 years) 1
- The TANDEM study evaluating concomitant use of both medications enrolled only adults with episodic migraine 4
Guideline-Recommended Alternatives for Pediatric Migraine
For children and adolescents with migraine, evidence-based alternatives include:
- First-line acute treatment: Ibuprofen at weight-appropriate dosing 5
- Preventive medications: Propranolol, amitriptyline, or topiramate (though efficacy in pediatric trials has not been definitively proven) 5
- Non-pharmacologic approaches: Bed rest alone may suffice for short-duration attacks in children 5
- For adolescents 12-17 years: Multiple NSAIDs and triptans have been approved, with nasal spray formulations of sumatriptan and zolmitriptan showing the most effectiveness 5
Important Clinical Considerations
The absence of pediatric data for gepants reflects:
- Migraine typically begins at or around puberty, with mean onset younger than 8 years in children 6
- Clinical features differ in pediatric populations—attacks are shorter (2-72 hours vs 4-72 hours in adults), more often bilateral, and gastrointestinal symptoms are more prominent 5, 6
- The high placebo response rate in pediatric migraine trials confounds therapeutic gain assessment 5
Current guidelines do not mention gepants (including ubrogepant or atogepant) as treatment options for pediatric migraine, instead recommending traditional therapies with established pediatric safety profiles 5