Elamipretide

Elamipretide is pending FDA approval for Barth syndrome and primary mitochondrial myopathy.

Elamipretide is available under the following different brand names: Bendavia; ELA 4; Elamipretide-hydrochloride; Elamipretide-hydrochloride - Stealth Biotherapeutics; MTP 131; Ocuvia; SBT-31; SPI-31; and SS-31.

Dosages of Elamipretide:

• Phase III dose treatment is set to be explored at a dose of 40 mg administered as a 0.5-mL injection for 24 weeks.

Dosage Considerations – Should be Given as Follows:

Primary Mitochondrial Diseases

• Pending FDA approval for Barth syndrome and primary mitochondrial myopathy

Side effects of elamipretide include:

• Mild redness or itching at the injection site
• Headache
• Dizziness

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Elamipretide is pending FDA approval and has no listed interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains elamipretide. Do not take Bendavia; ELA 4; Elamipretide-hydrochloride; Elamipretide-hydrochloride - Stealth Biotherapeutics; MTP 131; Ocuvia; SBT-31; SPI-31; or SS-31 if you are allergic to elamipretide or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• No information available

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Elamipretide?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Elamipretide?”

Cautions

• No information available

Pregnancy and Lactation

• Elamipretide is pending FDA approval and no information is available regarding use during pregnancy or while breastfeeding.