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Forzinity
elamipretide
Adult Dosing .
Dosage forms: INJ
Barth syndrome
- [>30 kg]
- Dose: 40 mg SC qd
renal dosing
- [adjust dose amount]
- eGFR <30: 20 mg qd
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ
Barth syndrome
- [>1 mo, >30 kg]
- Dose: 40 mg SC qd
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
Drug Interactions .
Overview
elamipretide
mitochondrial cardiolipin binder
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn, severe
Common Reactions
- injection site rxn
Safety/Monitoring .
Monitoring Parameters
eGFR at baseline
Benzyl Alcohol Content
contains 20 mg benzyl alcohol per mL; risk of serious, potentially fatal gasping syndrome in preterm neonates and low-birth wt infants receiving benzyl alcohol-containing drugs; not approved in neonates
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at 6x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: enzymatic degradation; CYP450: unknown
Excretion: urine; Half-life: unknown
Subclass: Barth Syndrome
Mechanism of Action
binds to mitochondrial cardiolipin, improving mitochondrial morphology and function
Formulary .
No Formulary Selected
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