Why is this medicine prescribed?
Elamipretide injection is used to improve muscle strength in patients with Barth syndrome (rare inherited disorder in males that result in dysfunction in a lipid necessary for energy production that results in damage to heart, muscles and immune system). Elamipretide injection is in a class of medications called mitochondrial cardiolipin binders. It works by improving the mitochondrial function needed for the lipid production.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Elamipretide injection comes as a solution (liquid) to be injected subcutaneously (under the skin). It is injected once a daily. Inject elamipretide injection at around the same time every day.
Use elamipretide injection exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You or your caregiver may be able to perform the injections at home. Your doctor or nurse will show you or your caregiver how to inject the medicine. You will also receive instructions for use. Read these carefully and ask your doctor or nurse if there is any part of the instructions you do not understand.
Before injecting elamipretide injection, inspect the solution in the vial to make sure it is clear and free of particles. If there are any particles or the solution is cloudy, do not inject. Given elamipretide into the abdomen, at least 2 inches from the belly button, or outer thighs. Injection site should be rotated daily. Do not inject in areas where the skin is bruised, tender, red or hard or in areas with scars or stretch marks.
What special precautions should I follow?
Before using elamipretide injection,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using elamipretide injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you forget to inject a dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Elamipretide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness, itching, pain, bruising, or swelling at the site of injection
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- rash; itchy, dry skin; cough; shortness of breath
Elamipretide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep elamipretide vials in the refrigerator until use. Once the vial is opened, it can be stored at room temperature or in the refrigerator. Discard vials and any unused medication 8 days after opening.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to elamipretide injection.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.