RELGAABI is indicated for:
In adults with postherpetic neuralgia, RELGAABI may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Patients 12 Years of Age and Above
The starting dose is 300 mg three times a day. The recommended maintenance dose of RELGAABI is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been administered in long-term clinical studies. Doses of 3,600 mg/day have also been administered to a small number of patients for a relatively short duration. Administer RELGAABI three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 Years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of RELGAABI in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of RELGAABI in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. RELGAABI may be administered as capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
Full Prescribing Information: DailyMed
