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Overview: Amondys 45 is used to treat Duchenne muscular dystrophy (DMD) in people who have a specific mutation in the DMD gene. This medicine helps these people to make a shorter but working protein called dystrophin that is needed for muscles to work. Common side effects include headache and joint pain. Tell your health care provider right away if you have nausea, confusion, unusual swelling, or a reduced need to pee. Amondys 45 is injected into your vein (IV) by your health care provider.

Uses

What is Amondys 45 used for?

Amondys 45 (casimersen) is commonly used to treat Duchenne muscular dystrophy (DMD) in certain people.

Amondys 45 may also be used for other conditions as determined by your health care provider.

How does Amondys 45 work (mechanism of action)?

Dystrophin is a protein that is needed for muscles to work. Some people with Duchenne muscular dystrophy have a specific change in the DMD gene that can be treated with a process called exon 45 skipping. Amondys 45 is a medicine that helps these people to make a shorter but working dystrophin protein. 

How is Amondys 45 supplied (dosage forms)?

Amondys 45 is available in an injectable form that is given by a health care provider.

How should I store Amondys 45?

Amondys 45 is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Amondys 45?

The most common side effects of Amondys 45 are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, cough, or common cold symptoms
  • Fever 
  • Headache
  • Joint pain

There may be other side effects of Amondys 45 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. 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 Amondys 45?

While less common, the most serious side effects of Amondys 45 are described below, along with what to do if they happen.

Severe Allergic Reactions. Amondys 45 may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Kidney Damage. Kidney damage may happen when using Amondys 45. Call your health care provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Difficulty catching your breath or chest pain/pressure
  • Confusion
  • Nausea
  • Seizures

Warnings & Precautions

Who should not use Amondys 45?

Allergies to Ingredients. People who are allergic to any of the following should not use Amondys 45.

  • Amondys 45
  • Casimersen
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Amondys 45.

What should I know about Amondys 45 before using it?

Amondys 45 will be injected into your vein (intravenous) by a health care provider in a hospital or clinic.

Keep all your appointments with your health care provider, including lab appointments. They will use these appointments to check how well your kidneys are working and other health care markers while using Amondys 45. 

What should I tell my health care provider before using Amondys 45?

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 determine if Amondys 45 is right for you.

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

Kidney Problems. Tell your health care provider if you have kidney problems.

Pregnancy. It is not known if or how Amondys 45 could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Amondys 45 passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Amondys 45?

For more information about Amondys 45, you can visit the drugmaker’s website at www.amondys45.com or call them at 888-727-3782.

Interactions

Does Amondys 45 interact with foods or drinks?

There are no known interactions between Amondys 45 and foods or drinks.

It is unknown if drinking alcohol will affect Amondys 45. 

Does Amondys 45 interact with other medicines (drug interactions)?

There are no known interactions between Amondys 45 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 Amondys 45?

If you or someone else has used too much Amondys 45, 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 Amondys 45?

If you miss an appointment to get your Amondys 45 dose, call to make another appointment as soon as possible.