Minimum Age for Ubrelvy (Ubrogepant)
Ubrelvy is not approved for use in pediatric patients; safety and effectiveness have not been established in individuals under 18 years of age. 1
FDA-Approved Age Indication
- The FDA label explicitly states: "Safety and effectiveness in pediatric patients have not been established." 1
- All pivotal clinical trials (ACHIEVE I and ACHIEVE II) enrolled only adults, with no pediatric data available to support safety or efficacy in children or adolescents. 2, 3
- You must be an adult (≥18 years) to take Ubrelvy. 1, 4
Clinical Trial Population
- The ACHIEVE I trial randomized 1,672 adult participants (mean age 41.5 years, 90% female) with migraine with or without aura, demonstrating efficacy at 50 mg and 100 mg doses. 2
- The ACHIEVE II trial similarly enrolled 1,686 adult participants, confirming pain freedom at 2 hours in 21.8% (50 mg) and 20.7% (25 mg) versus 14.3% (placebo). 3
- No participants under 18 years were included in any registration trial, leaving a complete absence of pediatric safety and pharmacokinetic data. 2, 3
Guideline Context for Acute Migraine Treatment
- The 2024 VA/DoD Headache Management Guideline suggests ubrogepant for short-term treatment of migraine in adults (weak recommendation), but does not address pediatric use. 5
- The 2022 CDC Pain Guideline mentions ubrogepant as an FDA-approved acute migraine treatment in adults, noting its nonvasoconstrictive mechanism as an advantage over triptans in patients with cardiovascular risk factors, but again provides no pediatric guidance. 5
Why Pediatric Use Is Not Supported
- Ubrogepant's pharmacokinetics, safety profile, and dosing have been studied exclusively in adults; hepatic and renal adjustments are defined only for adult populations. 1
- The FDA requires dedicated pediatric trials to establish age-appropriate dosing, safety, and efficacy before approval in children—none have been completed for ubrogepant. 1
- Off-label use in adolescents or children is not recommended due to the absence of any data on developmental effects, appropriate dosing, or adverse event profiles in younger populations. 1, 4
Common Pitfalls to Avoid
- Do not prescribe Ubrelvy to patients under 18 years, even if they have severe migraine, as there is no evidence base for safety or efficacy. 1
- For pediatric migraine, consider age-appropriate alternatives such as NSAIDs (ibuprofen, naproxen), acetaminophen, or triptans (e.g., sumatriptan nasal spray approved ≥12 years), which have established pediatric safety data. 5
- Avoid assuming that adult dosing can be extrapolated to adolescents; pharmacokinetics, hepatic metabolism, and receptor sensitivity differ significantly in developing individuals. 1