At what age can Nurtec (rimegepant) be started for migraine treatment?

Age Requirements for Starting Nurtec (Rimegepant)

Nurtec (rimegepant) is FDA-approved for use in adults aged 18 years and older for both acute treatment and prevention of migraine, with recent pediatric dosing recommendations now available for children as young as 6 years of age based on body weight. 1, 2

FDA-Approved Age Indications

• Adults ≥18 years: Rimegepant 75 mg orally disintegrating tablet is approved for acute treatment of migraine and preventive treatment of episodic migraine in adults. 1

• Pediatric patients 6 to <18 years: Recent population pharmacokinetic modeling supports weight-based dosing in children and adolescents, though formal FDA approval for pediatric use is based on exposure-matching studies rather than completed efficacy trials. 2

Weight-Based Pediatric Dosing Recommendations

For children aged 6 to <12 years, dosing is determined by body weight rather than age alone: 2

• Body weight >40 kg: 75 mg orally disintegrating tablet
• Body weight >25 to ≤40 kg: 50 mg orally disintegrating tablet
• Body weight >15 to ≤25 kg: 35 mg orally disintegrating tablet

For adolescents aged 12 to <18 years: 75 mg orally disintegrating tablet (standard adult dose) 2

Clinical Trial Safety Data by Age

• The pivotal adult trials enrolled participants aged 18-75 years, with mean age of 40-42 years across acute and preventive treatment studies. 1

• Long-term safety data (up to 52 weeks) in adults showed rimegepant was well tolerated with no signal of hepatotoxicity, medication-overuse headache, or drug abuse potential. 3

• The pediatric pharmacokinetic study included 20 participants and used exposure-matching to adult data to support dose selection, with predicted pediatric/adult exposure ratios maintained close to 1 and ≤2. 2

Positioning in Treatment Algorithm

For adults, rimegepant is recommended as a third-line option after failure of combination therapy with a triptan plus NSAID or acetaminophen. 4, 5

• First-line treatment should be NSAIDs (ibuprofen, naproxen, aspirin) or acetaminophen for mild-to-moderate migraine. 4

• Second-line treatment adds a triptan to the NSAID regimen for moderate-to-severe attacks or when NSAIDs fail. 4

• Rimegepant is considered only after inadequate response or intolerance to triptan-NSAID combinations in nonpregnant adults. 4, 5

Critical Safety Considerations

• Hypersensitivity reactions: Delayed serious hypersensitivity (dyspnea, rash) can occur days after administration; discontinue immediately if hypersensitivity develops. 1

• Pregnancy: There is a pregnancy exposure registry (1-877-366-0324 or nurtecpregnancyregistry.com) for monitoring outcomes in women exposed during pregnancy. 1

• Drug interactions: Avoid concomitant use with strong CYP3A4 inhibitors; avoid another dose within 48 hours when used with moderate CYP3A4 inhibitors or potent P-gp inhibitors. 1

Medication-Overuse Headache Prevention

• Limit rimegepant use to no more than 8 migraine attacks per 30-day period to prevent medication-overuse headache. 4

• If acute treatment is needed more than twice weekly, initiate preventive therapy immediately rather than increasing frequency of acute medication use. 4