Description
Elamipretide injection is used to improve muscle strength in patients with Barth syndrome (a rare genetic disorder).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of elamipretide injection in children weighing less than 30 kilograms (kg). Safety and efficacy have not been established. Use is not recommended in babies.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of elamipretide injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease, severe (patients not on dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thigh.
This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Elamipretide may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, 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. This will help prevent skin problems. 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 the injection:
- 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.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For improvement of muscle strength:
- Adults and children weighing at least 30 kilograms (kg)—40 milligrams (mg) injected under the skin once a day at the same time each day.
- Children weighing less than 30 kg—Use and dose must be determined by your doctor.
- For improvement of muscle strength:
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.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store 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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine contains benzyl alcohol, which may cause serious reactions (eg, gasping syndrome) to newborn or premature babies. Discuss this with your doctor if you are concerned.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness. Your doctor may give you medicines (eg, topical steroid medicine, allergy medicine) to treat skin reactions.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Incidence not known
- Blistering, crusting, irritation, itching, or reddening of the skin
- chest tightness
- cough
- cracked, dry, scaly skin
- difficulty swallowing
- dizziness
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- swelling
- trouble breathing
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008522
