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Overview: Duvyzat is used to treat Duchenne muscular dystrophy (DMD), a genetic condition that causes muscles to become weak over time. Duvyzat may work by reducing inflammation and supporting muscle repair. Common side effects include diarrhea, stomach pain, nausea, and vomiting. Keep all appointments for bloodwork while you are taking Duvyzat. And tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Uses

What is Duvyzat used for?

Duvyzat (givinostat) is commonly used to treat Duchenne muscular dystrophy (DMD).  DMD is a genetic condition that affects muscles, causing them to become weaker over time.

Your Guide to Duvyzat for Duchenne Muscular Dystrophy

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

How does Duvyzat work (mechanism of action)?

People with Duchenne muscular dystrophy (DMD) have a change (mutation) in their genes that affects a muscle protein called dystrophin. Without the right amount of functioning dystrophin, muscles are unable to repair themselves as they should. People with DMD also have overactive histone deacetylase (HDAC) enzymes, which may lead to inflammation (swelling) and interfere with muscle repair. With less dystrophin and more inflammation, muscles become weak over time. 

Duvyzat is a histone deacetylase inhibitor. It blocks overactive HDAC enzymes. This may help reduce inflammation, slow down muscle breakdown, and make the body more able to repair muscles in people with DMD.

How is Duvyzat supplied (dosage forms)?

Brands and other names

  • Duvyzat

Dosage forms and strengths

  • 8.86 mg/mL oral suspension

How should I store Duvyzat?

Duvyzat should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you're transporting it. Store it in a cool, dry place. Do not freeze it, and keep the bottle upright. 

Side Effects

What are the most common side effects of Duvyzat?

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

  • Stomach problems, such as diarrhea, stomach pain, nausea, and vomiting (see below)
  • Low platelet levels (see below)
  • High blood fat levels (see below)
  • Fever

There may be other side effects of Duvyzat 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 Duvyzat?

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

Severe Allergic Reactions. Duvyzat may cause allergic reactions, which can be serious. Stop taking Duvyzat and 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

Stomach Problems. Duvyzat can commonly cause stomach problems, such as diarrhea, stomach pain, nausea, or vomiting. Sometimes these side effects can be severe. Track how often you have these symptoms and how bad they are. Stay hydrated by drinking plenty of water. Tell your health care provider right away if these symptoms bother you or do not go away. Your health care provider may need to adjust the dose of Duvyzat or may recommend other ways to manage these side effects.

Low Platelet Levels. Duvyzat can cause low platelet levels (thrombocytopenia). It can also cause other blood problems, such as low hemoglobin (anemia) or low white blood cell levels (neutropenia). Keep all appointments for bloodwork before and while you are taking Duvyzat. Stop taking Duvyzat and get help right away if you have any of the following symptoms of blood disorders.

  • Easy bruising or bleeding, including nosebleeds
  • Blood in your poop
  • Small purple or red spots on your skin
  • Unusual weakness or tiredness
  • Fever, chills, or sweating
  • Sore throat, coughing, or shortness of breath
  • Pale or yellowish skin
  • Mouth or throat sores
  • Frequent infection
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

High Blood Fat Levels. Duvyzat can increase the levels of a certain type of fat in your blood, called triglycerides. Keep all appointments with your health care provider to check your bloodwork before and during treatment with Duvyzat. Follow your health care provider's advice about what to do if your triglycerides are high. 

Heart Rhythm Changes. Duvyzat may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint, feel dizzy or lightheaded, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Warnings & Precautions

Who should not use Duvyzat?

Allergies to Ingredients. People who are allergic to any of the following should not take Duvyzat.

  • Duvyzat
  • Givinostat
  • Any of the ingredients in the specific product dispensed

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

What should I know about Duvyzat before using it?

Do not take Duvyzat unless it has been prescribed to you by a health care provider. Take it as prescribed.

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

Keep Duvyzat out of the reach of children.

Read and follow the instructions for Duvyzat, and make sure you know how to use it properly. If you have any questions, talk to your health care provider.

Duvyzat is a liquid that you take by mouth. Do not mix Duvyzat with water or any other liquid. Before taking each dose of Duvyzat, shake the bottle to evenly mix the medicine. Turn the bottle up and down for at least 30 seconds. The medicine should look evenly mixed before measuring each dose. 

Use the oral syringe that comes with Duvyzat to measure the correct dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist for instructions on how to use the syringe.

Throw away any Duvyzat left in the bottle after 60 days of opening it. 

Keep all appointments with your health care provider before and during treatment with Duvyzat. Your health care provider may order tests or bloodwork to make sure it is safe for you to take this medicine or to see if you need a different dose.

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

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 Duvyzat is right for you.

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

Heart Rhythm Problems. Tell your health care provider if you or anyone in your family has had heart problems, including heart disease or a heart attack, an irregular heartbeat (arrhythmia), or a condition called "QT prolongation" or "long QT syndrome."

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Bleeding problems
  • Liver problems

Other Medicines and Supplements. Duvyzat may interact with other medicines and supplements. Before taking Duvyzat, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Duvyzat 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 Duvyzat passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Duvyzat while breastfeeding.

How can I get more information about Duvyzat?

For more information about Duvyzat, you can visit the drugmaker's website at www.duvyzat.com or call them at 855-448-3272.

Interactions

Does Duvyzat interact with foods or drinks?

There are no known interactions between Duvyzat and foods or drinks. Duvyzat should be taken with food.

It is unknown if drinking alcohol will affect Duvyzat.

Does Duvyzat interact with other medicines (drug interactions)?

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.

In particular, make sure that you discuss if you are using any of the following before taking Duvyzat.

  • Medicines within the past two weeks that can cause QT prolongation, which is a potentially dangerous heart rhythm problem, such as OTC medicines like diphenhydramine, herbal products like echinacea, or prescription medicines like certain antibiotics
  • An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots

Duvyzat may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Duvyzat. Always check with your health care provider.

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 Duvyzat?

If you or someone else has used too much Duvyzat, 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 Duvyzat?

If you miss a dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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