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Overview: Forzinity is used for certain people with a rare genetic condition called Barth syndrome. It may help certain cell structures, called mitochondria, work better. Forzinity comes as a liquid that is injected under the skin. Common side effects include pain, itching, swelling, bruising, or redness near the injection site. Serious side effects are rare but may include severe allergic reactions. Get help right away if you have symptoms of an allergic reaction, such as breathing problems, wheezing, cough, itching, skin rash, or hives.

Uses

What is Forzinity used for?

Forzinity (elamipretide) is commonly used to help improve muscle strength in certain people with Barth syndrome. Barth syndrome is a rare genetic condition that can affect the heart, muscles, immune system, and growth and development.

Forzinity may also be used for other conditions as determined by your health care provider.

How does Forzinity work (mechanism of action)?

Barth syndrome is a rare genetic condition that affects how certain cell structures, called mitochondria, work. Mitochondria are often called the “powerhouses of the cell.” They make energy for cells in our bodies, especially in certain organs, such as the heart and muscles. By binding to an inner part of the mitochondria, Forzinity may help mitochondria work better and improve their structure.

How is Forzinity supplied (dosage forms)?

Forzinity is available in 280 mg/3.5 mL (80 mg/mL) vials.

How should I store Forzinity?

Forzinity may be given by a health care provider in a hospital or clinic, or you or a caregiver may be able to inject it at home after proper training. If you will store Forzinity at home, it should be stored in a refrigerator, between 36 F and 46 F (2 C and 8 C). Do not freeze.

After the first dose, the open vial can be stored either in the refrigerator, between 36 F and 46 F (2 C and 8 C), or at room temperature, between 68 F and 77 F (20 C and 25 C). Throw the vial away eight days after opening it, even if it still has some medicine in it. After opening each vial, write the “discard after” date on the vial so you know when to throw it away.

Side Effects

What are the most common side effects of Forzinity?

The most common side effects of Forzinity are pain, itching, swelling, bruising, or redness near the injection site. Tell your health care provider if you have any side effects that bother you.

There may be other side effects of Forzinity that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Forzinity?

While less common, the most serious side effects of Forzinity are described below, along with what to do if they happen.

Severe Allergic Reactions. Forzinity may cause allergic reactions, which can be serious. These reactions may happen right away or within months after starting treatment. Stop using Forzinity and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems, wheezing, or cough
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Forzinity?

Allergies to Ingredients. People who are allergic to any of the following should not use Forzinity.

  • Elamipretide
  • Forzinity
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Forzinity.

What should I know about Forzinity before using it?

Do not use Forzinity unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Forzinity with other people, even if they have the same condition as you. It may harm them.

Keep Forzinity out of the reach of children. As this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

This medicine is injected under the skin (subcutaneously) in the belly (at least 2 inches away from the belly button) or in the outer thigh. After proper training, you or a caregiver may be able to inject Forzinity at home. If you inject Forzinity at home, read and follow the instructions and make sure that you or a caregiver understands how to properly prepare, use, and throw it away. For example, you should change (rotate) the injection site each day. Do not inject into scars, stretch marks, or skin that is bruised, hard, tender, or discolored. If you have any questions, talk to your health care provider. Keep all follow-up appointments with your health care provider.

Forzinity vials have enough medicine for more than one dose. Use the exact amount of medicine recommended by your health care provider.

If you have a mild skin reaction (such as itching, swelling, or redness) where the medicine is injected, your health care provider may tell you to use certain medicines to help relieve these symptoms. Follow your health care provider’s instructions.

What should I tell my health care provider before using Forzinity?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Forzinity is right for you.

In particular, make sure that you discuss any of the following.

Kidney Problems. Tell your health care provider if you have any kidney problems. Your dose of Forzinity may need to be adjusted.

Pregnancy. People who can become pregnant are not usually prescribed Forzinity. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. People who can breastfeed are not usually prescribed Forzinity. It is not known if Forzinity passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Forzinity?

For more information about Forzinity, you can visit the drugmaker’s website at stealthbt.com/for-patients-providers or call them at 844-444-6486.

 

Interactions

Does Forzinity interact with foods or drinks?

There are no known interactions between Forzinity and foods or drinks.

It is unknown if drinking alcohol will affect Forzinity.

Does Forzinity interact with other medicines (drug interactions)?

There are no known interactions between Forzinity and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Forzinity?

If you or someone else has used too much Forzinity, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Forzinity?

If you miss a dose, skip the missed dose and only use the next dose at the regular scheduled time. Do not use double or extra doses.