Ubrelvy Age Indication
Ubrelvy (ubrogepant) is indicated for adults only, as safety and effectiveness in pediatric patients have not been established. 1
FDA-Approved Age Range
- Ubrelvy is approved exclusively for adults aged 18 years and older for the acute treatment of migraine with or without aura 1, 2
- The FDA drug label explicitly states: "Safety and effectiveness in pediatric patients have not been established" 1
Clinical Context for Age Restrictions
Why Adults Only?
- All pivotal phase III clinical trials (ACHIEVE I and ACHIEVE II) enrolled only adult participants, providing no safety or efficacy data for pediatric populations 2
- Clinical studies did not include sufficient numbers of elderly patients (≥65 years) to determine differential responses, though no clinically significant pharmacokinetic differences were observed between elderly and younger subjects 1
Pediatric Migraine Treatment Alternatives
For children and adolescents with migraine, the treatment approach differs significantly:
- Children: Ibuprofen is recommended as first-line medication at doses appropriate for body weight 3, 4
- Adolescents (12-17 years): Multiple NSAIDs and triptans are approved options; nasal spray formulations of sumatriptan and zolmitriptan may be particularly effective 4
- Bed rest alone may suffice in children with short-duration attacks 3
Positioning in Adult Treatment Algorithm
When ubrogepant is appropriate for adults:
- CGRP antagonists (gepants) including ubrogepant should be considered for moderate to severe acute episodic migraine in nonpregnant adults who do not tolerate or have inadequate response to combination therapy of a triptan with an NSAID or acetaminophen 3
- Gepants are positioned after NSAIDs and triptans in the stepped-care approach 3
Important Safety Considerations for Adults
- Pregnancy: Avoid in pregnant women; animal studies showed increased embryofetal mortality at high doses 1
- Severe hepatic impairment: Dose adjustment required (ubrogepant exposure increased by 115%) 1
- End-stage renal disease: Avoid use in patients with creatinine clearance <15 mL/min 1
- Maximum dosing: 200 mg within 48 hours 2