Elamipretide (By injection)

Elamipretide (el-a-MIP-re-tide)

Improves muscle strength in patients with Barth syndrome.

Brand Name(s):

Forzinity

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is given as a shot under your skin, usually in the stomach or thigh.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks.
• Allow the medicine to warm to room temperature for 10 minutes before using it.
• Check the liquid in the vial. It should be clear, colorless to yellow. Do not use if it is discolored, cloudy, or has lumps, flakes, or particles in it. Do not use the vial if it has cracks or if the plastic cap is broken or missing.
• To use:
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the plastic cap on the vial if you are using a new one. Clean the top of the vial stopper with an alcohol wipe before each injection. Do not mix this medicine with other medicines in the same syringe.
  • Hold the syringe by the barrel with the needle cap pointing straight up and carefully pull the cap straight off. Fill the syringe with air by pulling back on the plunger to the prescribed dose.
  • With the vial on a flat surface and in upright position, insert the needle straight down into the center of the vial rubber stopper. Slowly inject all the air from the syringe into the vial. Keep the needle inside the vial.
  • Turn the vial and syringe upside down with one hand. Slowly pull back on the plunger to withdraw the prescribed dose. Keep the needle inside the vial. Check for air bubbles. If you see large air bubbles, gently tap the side of the syringe.
  • Slowly push the plunger up to push the large air bubbles back into the vial. Pull back on the plunger again more slowly to fill the syringe to your prescribed dose.
  • Return the vial into upright position and place it on a flat surface. While holding the vial with one hand and the barrel of the syringe between fingertips of your other hand, pull the needle straight out of the vial. Keep the syringe in your hand. Do not set it down.
  • Gently pinch the skin with the other hand. Insert the needle at a 90 degree angle into the pinched skin. Push the needle all the way into the skin. Pull the needle out.
• Use a new needle and syringe each time you inject your medicine.
• Your doctor may give you medicines (including topical steroid medicine, allergy medicine) to treat skin reactions.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store the opened vial in the refrigerator or at room temperature. Throw away unused medicine 8 days after opening.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 12/4/2025