Forzinity (elamipretide HCl)
Subcutaneous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Elamipretide hydrochloride is a mitochondrial cardiolipin binder.
Elamipretide is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.
Elamipretide maximum concentrations are reached 0.5-1 hour post subcutaneous administration. The absolute bioavailability after subcutaneous administration is approximately 92%. Elamipretide is 39% protein bound.
Elamipretide is metabolized by sequential C-terminal degradation to the M1 tripeptide and M2 dipeptide inactive metabolites. Elamipretide and its metabolites are excreted in urine. At 48 hours post-dose, approximately 100% of the dose was recovered in urine as either elamipretide, M1, or M2 in patients with normal renal function.
USES: This medication is used to improve muscle strength in people with a certain rare genetic problem (Barth syndrome). Elamipretide works by helping the body make more energy.
Generic name: elamipretide HCl
Pronunciation: (El-a-MIP-re-tide)
Therapeutic class: Locomotor System
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Forzinity
Indications
The following indications are listed for Forzinity:
- Muscle Weakness In Barth Syndrome
Also known as: Muscle Weakness In 3-Methylglutaconic Aciduria Type 2.
Dosing
Dosage of elamipretide hydrochloride is expressed in terms of elamipretide.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Forzinity 280 Mg/3.5 Ml Vial | Maintenance | Inject 0.5 milliliter (40 mg) by subcutaneous route once daily. |
No dosing information is available for this tab.
Drug interactions
Elamipretide does not inhibit cytochrome P-450 (CYP) 1A, CYP2D6, CYP2E1, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A. Elamipretide does not induce CYP1A2, CYP2B6, or CYP3A4.
Elamipretide does not inhibit the activity of organic cation transporter (OCT) 2, breast cancer resistance protein (BCRP), organic anion transporter (OAT) 1, OAT3, organic anion transporting polypeptide (OATP) 1B1, OATP1B3, P-glycoprotein (P-gp), or multidrug and toxin extrusion transporter (MATE) 2K. Elamipretide is an inhibitor of MATE1.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Serious hypersensitivity to elamipretide or any of the excipients in the formulation.
There are no contraindication contraindications for this drug.
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions reported with elamipretide in clinical studies were injection site reactions.
There are no severe adverse reactions for this drug.
More Frequent
- Hypersensitivity drug reaction
- Injection site erythema
Less Frequent
- Injection site inflammation
- Injection site pain
Rare or Very Rare
- Eosinophilia
- Injection site sequelae
- Skin rash
Precautions
No enhanced messaging available.
The safety and effectiveness of elamipretide have been established in pediatric patients with Barth syndrome weighing >=30 kg. Use of elamipretide for improving muscle strength is supported by results of an open-label extension study that included 7 pediatric patients >=12 years of age. The safety and effectiveness of elamipretide have not been established in pediatric patients weighing <30 kg.
Elamipretide is not approved for use in neonates. Serious adverse reactions, including fatal reactions associated with new onset or worsening metabolic acidosis have been reported in low-birth weight neonates and preterm neonates who received benzyl alcohol-containing drugs intravenously (see Risk of Benzyl Alcohol Toxicity in Neonates under Cautions.)
There are no data with elamipretide use in pregnant women to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse developmental outcomes occurred in animal reproduction studies at any dose tested. Elamipretide contains benzyl alcohol as a preservative; due to its rapid metabolism during pregnancy, exposure to the fetus is unlikely.
Barth syndrome is a rare, X-linked, recessive, genetic disorder and is not likely to affect females.
It is not known whether elamipretide is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Elamipretide contains benzyl alcohol as a preservative; due to its rapid metabolism by a lactating female, benzyl alcohol exposure in the breastfed infant is unlikely. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for elamipretide and any potential adverse effects on the breastfed infant from elamipretide or from the underlying maternal condition.
Barth syndrome is an X-linked, recessive genetic disorder and is not likely to affect females.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Clinical studies of elamipretide did not enroll patients >=65 years of age.
ICD codes
| Code | Type | Description |
|---|---|---|
| Muscle weakness in barth syndrome | ||
| E78.71 | ICD10CM | Barth syndrome |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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