ELAMIPRETIDE HYDROCHLORIDE

Electrolyte / Mineral

Brand names: FORZINITY

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.

Indications

an intermediate clinical endpoint. ( 14 ) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Contraindications

• 4 CONTRAINDICATIONS Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY [see Warnings and Precautions (5.2) ]. Serious hypersensitivity to any of the ingredients ( 4
• 5.2 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Benzyl alcohol toxicity : Do not use in neonates
1 Risk of Benzyl Alcohol Toxicity in Neonates FORZINITY is not approved for use in neonates
Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol (BA)-containing drugs intravenously
Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity and is primarily characterized by multiorgan dysfunction secondary to metabolic acidosis, which leads to gasping respirations and death

Known Side Effects

0 documented side effects by frequency

No structured side effect data available.

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Compare With

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous