Pharmacokinetics and Tolerability of Rizatriptan in Pediatric Migraineurs in a Randomized Study

Abstract

In pediatric migraineurs, a weight-based dosing scheme generated plasma rizatriptan AUC((0-∞)) and C(max) values that were generally similar to those historically observed in adults administered a 10-mg dose of rizatriptan ODT (a proven effective dose). The data support further evaluation of the safety, tolerability, and efficacy of this rizatriptan dosing scheme in larger scale clinical trials in the pediatric migraineur population.

Long‐Term Open‐Label Safety Study of Rizatriptan Acute Treatment in Pediatric Migraineurs

“…7 According to the dosing regimen, patients weighing <40 kg are assigned to rizatriptan 5 mg, and those weighing Ն40 kg are assigned to rizatriptan 10 mg. This weight-based dosing regimen is also supported by data from a pharmacokinetic study in pediatric migraineurs 8 that demonstrated similar area under the curve and C max values with weight-based dosing to those historically observed in adults administered rizatriptan 10 mg orally disintegrating tablet. 9 The objective of the present study was to assess the long-term tolerability, safety, and efficacy of the rizatriptan weight-based dosing strategy in pediatric migraineurs aged 12-17 years.…”

Population Pharmacokinetic Analysis of Zolmitriptan and Its Metabolite in Adults and Adolescents to Support Dose Selection in Children With Migraine

“…Dose adjustment based on age and body weight was also implemented in the recommended posology for rizatriptan 44 to the rizatriptan AUC in adults after administration of a 10 mg rizatriptan oral disintegrating tablet; similar exposure was observed in children between 6 and 17 years old receiving single doses of 5 or 10 mg based on their body weight, that is, less or greater than 40 kg (AUC ratios of 0.85 and 1.17, respectively). 45 In the clinical efficacy study evaluating this rizatriptan weight-based dose schedule, 125 children aged 6-11 years and 337 patients aged 12 to 17 years were exposed to rizatriptan. Adverse events in 6-to 17-year-olds were similar for rizatriptan and placebo.…”

Pediatric migraine

“…21 Triptans have shown to be effective for relieving migraines in adolescent patients. 27,28 Rizatriptan is available as an oral disintegrating tablet that provides a good route for both children unable to swallow 27,28 Rizatriptan is available as an oral disintegrating tablet that provides a good route for both children unable to swallow…”