Elamipretide Hydrochloride (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: SUBCUTANEOUS.
Brand Names
- FORZINITY
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.
Contraindications
Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY [see Warnings and Precautions (5.2)].
Mechanism of Action
FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.
Overdosage
There were no reports of overdose during clinical trials with FORZINITY. Symptoms and signs of overdose are likely to be histamine-related (e.g., decreased blood pressure, presyncope) and should be managed according to standard of care. Interrupt treatment with FORZINITY if there is suspicion of overdose.