Givinostat

Generic name: givinostat
Brand name: Duvyzat
Dosage form: oral suspension (8.86 mg/mL)
Drug class: Histone deacetylase inhibitors

Medically reviewed by Drugs.com on Aug 13, 2024. Written by Cerner Multum.

What is givinostat?

Givinostat is used to treat Duchenne muscular dystrophy in adults and children at least 6 years old.

Givinostat may also be used for purposes not listed in this medication guide.

Givinostat side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Givinostat can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

Givinostat may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing diarrhea;

• irregular heartbeats;

• long QT syndrome (in you or a family member);

• coronary artery disease (clogged arteries);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• dizziness, fainting; or

• loss of consciousness.

Your treatment with givinostat may be delayed or permanently discontinued if you have certain side effects.

Common side effects of givinostat may include:

• nausea, vomiting, stomach pain;

• loose stools or diarrhea that is watery;

• fever;

• high cholesterol or triglycerides; or

• low levels of platelets in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Givinostat can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

Givinostat can cause high triglycerides in your blood, diarrhea, and vomiting. Tell your doctor if you have diarrhea that is watery. Ask your doctor about your risk.

Before taking this medicine

Givinostat can cause a serious heart problem. Your treatment plan may change if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV. Tell your doctor about all other medicines you use.

Tell your doctor if you have or have ever had:

• heart problems, heart rhythm disorders; or

• bleeding problems.

It is not known if givinostat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using givinostat.

How should I take givinostat?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Doses are based on weight. Your dose may change if you gain or lose weight.

Givinostat is usually taken twice per day with food.

Do not mix this medicine with water or with any other liquids.

You may be given medication to prevent diarrhea or vomiting while you are receiving givinostat.

You may need medical tests before and during your treatment with this medicine, and your dose may be changed based on the results.

Gently swirl the oral suspension (liquid) for at least 30 seconds. Measure a dose with the supplied measuring device (not a kitchen spoon).

Store tightly closed in an upright position at room temperature, do not freeze. Throw the medicine away after 60 days of first opening the bottle, even if there is still medicine left inside.

Givinostat dosing information

Usual Adult Dose for Muscular Dystrophy:

18 years or older:
-Weight 10 to less than 20 kg: 22.2 mg orally twice a day
-Weight 20 to less than 40 kg: 31 mg orally twice a day
-Weight 40 to less than 60 kg: 44.3 mg orally twice a day
-Weight 60 kg or more: 53.2 mg orally twice a day

Comments:
-The drug is not recommended for patients with a platelet count below 150 x 10(9)/L.
-ECGs should be obtained before starting treatment in patients with underlying cardiac disease or those taking concurrent drugs that prolong QT.

Use: For the treatment of Duchenne muscular dystrophy

Usual Pediatric Dose for Muscular Dystrophy:

6 years or older:
-Weight 10 to less than 20 kg: 22.2 mg orally twice a day
-Weight 20 to less than 40 kg: 31 mg orally twice a day
-Weight 40 to less than 60 kg: 44.3 mg orally twice a day
-Weight 60 kg or more: 53.2 mg orally twice a day

Comments:
-The drug is not recommended for patients with a platelet count below 150 x 10(9)/L.
-ECGs should be obtained before starting treatment in patients with underlying cardiac disease or those taking concurrent drugs that prolong QT.

Use: For the treatment of Duchenne muscular dystrophy in patients 6 years of age and older

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking givinostat?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect givinostat?

Some drugs should not be used with givinostat. Givinostat can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect givinostat. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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