At what age can you start taking Ubrelvy (Ubrogepant)?

Age Requirement for Starting Ubrelvy (Ubrogepant)

Ubrelvy (ubrogepant) is only approved for use in adults 18 years of age and older, and safety and effectiveness have not been established in pediatric patients. 1

FDA Approval Status and Age Requirements

• Ubrelvy (ubrogepant) received its first global approval in December 2019 in the USA for the acute treatment of migraine with or without aura specifically in adults 2
• The FDA label clearly states: "Safety and effectiveness in pediatric patients have not been established" 1
• Clinical trials that led to Ubrelvy's approval were conducted exclusively in adult populations 3

Safety Considerations for Different Age Groups

• For geriatric patients (65 years and older), the FDA label notes that clinical studies did not include sufficient numbers of elderly patients to determine if they respond differently from younger patients 1
• For elderly patients, dose selection should be cautious, usually starting at the lower end of the dosing range 1
• No specific dosing recommendations exist for pediatric populations as the medication has not been studied or approved in this age group 1

Clinical Evidence Supporting Adult Use

• The pivotal phase III clinical trials (ACHIEVE I and ACHIEVE II) that demonstrated the effectiveness and safety of ubrogepant were conducted only in adult participants 4
• Long-term safety evaluation of ubrogepant was conducted in adults with an average age of 42 years 5
• Real-world effectiveness studies have similarly focused on adult populations with a mean age of 41.9 years 6

Important Considerations When Prescribing

• Special dosing considerations may be needed for patients with:
  • Severe hepatic impairment (Child-Pugh Class C) - dose adjustment is recommended 1
  • Severe renal impairment (CLcr 15-29 mL/min) - dose adjustment is recommended 1
  • End-stage renal disease (ESRD) (CLcr <15 mL/min) - use should be avoided 1

Common Pitfalls to Avoid

• Do not prescribe Ubrelvy to patients under 18 years of age as safety and efficacy have not been established in this population 1
• Do not assume that weight-based dosing for children (as sometimes used with other medications) is appropriate for Ubrelvy 1
• Unlike some medications where children weighing over 40 kg might receive adult doses 7, this approach is not applicable to Ubrelvy as it has not been studied in pediatric populations

In summary, Ubrelvy should only be prescribed to patients 18 years of age and older, as this is the only population in which its safety and efficacy have been established through clinical trials and for which it has received FDA approval.