Rizatriptan (Maxalt) for a 9-Year-Old Girl Weighing 63 Pounds
Yes, rizatriptan is FDA-approved and appropriate for this 9-year-old girl weighing 63 pounds (28.6 kg), at a dose of 5 mg orally disintegrating tablet, taken at migraine onset. 1
FDA Approval and Dosing
- Rizatriptan benzoate tablets are FDA-approved for acute treatment of migraine with or without aura in pediatric patients 6 to 17 years old. 1
- For children weighing less than 40 kg (88 pounds), the appropriate dose is 5 mg. 1, 2, 3
- Since this patient weighs 63 pounds (approximately 29 kg), she falls into the <40 kg weight category and should receive the 5 mg dose. 2, 3
- The medication should be administered as a single dose at migraine onset, with a maximum of one dose in a 24-hour period. 2
Evidence Supporting Efficacy in Children
- A randomized, double-blind, placebo-controlled crossover trial in children ages 6 to 17 years demonstrated that rizatriptan 5 mg (for those 20-39 kg) achieved headache relief in 74% of patients at 2 hours, compared to 36% with placebo (p < 0.001). 4
- At 1 hour post-dose, 50% of children achieved headache relief with rizatriptan 5 mg versus 29% with placebo (p = 0.004). 4
- A long-term safety study in pediatric patients ages 12-17 years showed that rizatriptan maintained consistent efficacy over time, with a mean pain-free response at 2 hours of 46.3% across all treated attacks. 2
- The pharmacokinetic profile of rizatriptan 5 mg in children weighing <40 kg produces plasma concentrations similar to the effective 10 mg adult dose, supporting the weight-based dosing strategy. 3
Safety Profile
- Rizatriptan was generally safe and well tolerated in pediatric patients, with no serious adverse effects observed in the primary efficacy trial. 4
- In a long-term open-label study treating up to 8 attacks per month for 12 months, only 2.3% of patients discontinued due to adverse events, and only 3 of 16 serious adverse events were drug-related (all associated with overdose from using >1 dose in 24 hours). 2
- Adverse effects in children are similar to those in adults and are generally mild and transient. 5
Critical Frequency Limitation to Prevent Medication-Overuse Headache
- Limit rizatriptan use to no more than 2 days per week (approximately 8-10 days per month) to prevent medication-overuse headache. 6, 2
- If this child requires acute migraine treatment more than twice weekly, she should be evaluated for preventive therapy rather than relying solely on acute treatment. 6
- Medication-overuse headache can paradoxically increase headache frequency and lead to daily headaches when acute medications are used too frequently. 6
Important Prescribing Considerations
- Rizatriptan should only be used when a clear diagnosis of migraine has been established. 1
- If the patient has no response to the first migraine attack treated with rizatriptan, the diagnosis should be reconsidered before treating subsequent attacks. 1
- Rizatriptan is not indicated for migraine prevention, only for acute treatment. 1
- The orally disintegrating tablet (ODT) formulation is particularly convenient for pediatric patients and does not require water. 2, 3
When to Escalate or Reassess
- If rizatriptan fails after treating 2-3 migraine episodes, consider trying a different triptan, as failure of one does not predict failure of others. 6
- Alternative acute treatment options include nasal sumatriptan (approved in Europe for children ≥12 years) or almotriptan tablets (FDA-approved for adolescents ≥12 years in the USA). 5
- If headaches occur more than twice weekly despite optimal acute treatment, initiate preventive therapy with propranolol as first-line (avoiding valproate due to teratogenic risk in girls of childbearing potential). 6