Elamipretide (Subcutaneous)
Elamipretide is used to help improve muscle strength in adults and children who weigh at least 30 kg with Barth syndrome.
Elamipretide may also be used for purposes not listed in this medication guide.
uses
What is Elamipretide (Subcutaneous) used for?
- Barth Syndrome
warnings
What is the most important information I should know about Elamipretide (Subcutaneous)?
You should not use elamipretide if you are allergic to it or any of its ingredients.
Tell your doctor if you have or have ever had:
- kidney disease.
Elamipretide may contain an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.
It is not known if elamipretide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Elamipretide (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Less serious side effects may be more likely, or you may have none at all.
Common side effects may include:
- pain, bruising, swelling, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Elamipretide (Subcutaneous) if I’m pregnant or breastfeeding?
It is not known if elamipretide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Elamipretide (Subcutaneous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Elamipretide (Subcutaneous)?
Use Elamipretide (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Elamipretide is injected under the skin in the stomach or thigh, usually once a day at the same time each day. A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Do not inject within 2 inches of your navel (belly button), or areas where the skin is hard, tender, red, bruised, or has scars or stretch marks. Do not inject into the same place two times in a row.
Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
You may be given other medications to treat certain allergic reactions or serious side effects. Keep taking these medicines for as long as your doctor has prescribed.
Store an unopened vial (bottle) in the refrigerator. Do not freeze. After the first dose, you may store the opened vial in the refrigerator or at room temperature.
If the vial is stored in the refrigerator, let it reach room temperature for 10 minutes before using.
Throw away the vial 8 days after you first opened it, even if there is still medicine left inside.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.