FORZINITY (ELAMIPRETIDE HYDROCHLORIDE)
FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: FORZINITY; Generic name: ELAMIPRETIDE HYDROCHLORIDE; Manufacturer: Stealth Biotherapeutics Inc..
| Brand name | FORZINITY |
|---|---|
| Generic name | ELAMIPRETIDE HYDROCHLORIDE |
| Manufacturer | Stealth Biotherapeutics Inc. |
| Used for | 1 INDICATIONS AND USAGE FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ( 1 ) This indication is approved under accelerated approval based on an |
| Dosage | 2 DOSAGE AND ADMINISTRATION For patients weighing 30 kg and greater, the recommended dosage is 40 mg subcutaneously once daily. ( 2.1 ) Reduce the dose in adults with severe renal impairment. ( 2.2 , 8.6 ). 2.1 Recommended Dosage The recommended dosage of FORZINITY in patients weighing at least 30 kg is 40 mg subcutaneously once daily. Patients should receive the dose at the same time each day. Missed Dose If a dose is missed, skip the dose and take the next dose of FORZINITY at the scheduled ti |
| Active ingredient(s) | ELAMIPRETIDE HYDROCHLORIDE |
| Route | SUBCUTANEOUS |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=146bf34c-76f2-48db-ac07-fb29cce2cd75 |