Brand name: Duvyzat (doo' vi zat)
Dosage form: oral suspension (8.86 mg/mL)
Drug class: Histone deacetylase inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 15, 2024.

What is givinostat?

Givinostat is used to treat Duchenne muscular dystrophy (DMD) to delay symptoms and disease progression. Givinostat works by inhibiting enzymes called HDACs that are involved in muscle damage. By inhibiting the HDAC, Givinostat slows down muscle deterioration in this muscle-wasting disorder, DMD. Givinostat can be used in all genetic variants of DMD in patients 6 years and older.  Givinostat is given as an oral suspension twice daily with food.

Givinostat brand name is Duvyzat, manufactured by Italfarmaco.

Givinostat FDA approval was received on March 21, 2024, based on positive results from the phase 3 EPIDYS clinical trial (NCT02851797). Givinostat Lancet trial results showed that patients using Givinostat had a statistically significant and clinically meaningful difference in time to complete the four-stair climb assessment compared to the placebo group. Givinostat approval indications are for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. 

Givinostat drug class is a novel histone deacetylase (HDAC) inhibitor.

What is Duchenne Muscular Dystrophy?

Duchenne muscular dystrophy (DMD) is the most common type of muscular dystrophy, which is a genetic disease that causes progressive muscle weakness and damage. DMD is caused by mutations in a gene responsible for properly making a protein called dystrophin.  Without the proper dystrophin, muscle fibers are easily injured, causing inflammation and problems with muscle regeneration, and muscle tissue may be replaced with fibrotic and fat tissue. Damage to the muscles causes symptoms to worsen over time, affecting the ability to walk, and eventually, heart and respiratory muscles are affected, which are the two main causes of early death. 

How does givinostat work?

In DMD, there is a deficiency in dystrophin, which causes an overactivity of the enzyme HDACs (histone deacetylases), which results in muscle problems and symptoms of DMD.  Givinostat mechanism of action (MOA) is by blocking the enzyme HDAC, which reduces overactivity to help slow down muscle deterioration to slow and DMD disease progression.

Givinostat Side Effects

Common givinostat side effects

The most common givinostat side effects include diarrhea, nausea, vomiting, fever, stomach pain, low platelet blood counts, and increased fat levels in the blood. These side effects occur in 10% or more of patients treated with this medicine.

Serious givinostat side effects

Givinostat can cause serious side effects including changes in the electrical activity of your heart called QT Prolongation. QT Prolongation can increase the risk of developing a type of irregular heart rhythm known as Torsades de Pointes. Call your healthcare provider right away if you feel faint, have an irregular heartbeat, feel dizzy, or lose consciousness.

These are not all of the possible side effects of this medicine. For more information, ask your healthcare provider or pharmacist. Talk to your healthcare provider if you have any side effects that bother you or do not go away. Contact your doctor for medical advice. You may report side effects to the FDA at 1-800-FDA-1088.

Also, see the Warnings section for more serious side effects.

Related/similar drugs

Warnings

Low platelet counts in your blood (thrombocytopenia). Platelets are important for blood clotting, and a decrease in their numbers can lead to an increased risk of bleeding or bruising. Your healthcare provider will check your blood count before you start and regularly during treatment for any signs of thrombocytopenia. Call your healthcare provider right away if you notice any unusual bleeding or small red or purple spots on the skin called petechiae.

Increased levels of fat (triglycerides) in your blood. Although you may not have any symptoms of high triglycerides, your healthcare provider will do blood tests before you start this medicine and regularly during treatment to check your triglyceride levels. 

Frequent watery loose stools (diarrhea) and vomiting. Givinostat can cause vomiting and moderate to severe diarrhea. If diarrhea occurs, you should track the frequency and severity of your symptoms, drink plenty of fluids, and contact your healthcare provider. 

Your healthcare provider may change your dose or stop treatment if any of the above side effect symptoms cannot be managed.

Before taking this medicine

Before taking this medicine, it is important to tell your healthcare provider about all of your medical conditions, including:

• any heart problems or if you take any medicines that could increase your chance of irregular heart rhythms.
• have any bleeding problems.

Before starting this medicine, you will have blood tests to check your baseline platelet counts and triglycerides level, these will also be monitored during treatment.

Patients who have underlying cardiac disease or are taking other medications that cause QT prolongation will have ECGs when starting treatment with givinostat during concomitant use and as clinically indicated. 

Pregnancy and breastfeeding

Based on animal data, givinostat may cause fetal harm. Givinostat is used for the treatment of DMD, which is a disease of mainly young male patients; this means there is no adequate data available to assess the use of it in pregnant women. In animal studies, oral administration during pregnancy and lactation resulted in increased embryofetal and offspring mortality and neurobehavioral changes in the offspring. 

How should I take givinostat?

Givinostat is a liquid (oral suspension) that is taken by mouth twice a day with food. 

Shake the bottle for at least 30 seconds by continuously turning the bottle up and down. Stop shaking when the medicine looks well mixed and the same throughout.

Your healthcare provider will tell you how much to take and when to take it.

Take the prescribed dose of givinostat by mouth (orally) using the oral syringe that came with your medicine. Keep the oral syringe to be used again.

Givinostat should not be mixed with water or other liquids.

Your healthcare provider may change your dose if needed. Do not change your dose of this medicine without talking to your healthcare provider.

Please refer to the Instructions for Use that came with your givinostat medicine for detailed instructions on how to take it correctly.

Givinostat Dosing Information

The recommended dose of givinostat for DMD is based on body weight.

Givinostat is available as an oral suspension containing givinostat 8.86 mg/mL.

Givinostat label

Review the Givinostat Label  (Duvyzat Label) for more detailed information about this medicine. The Givinostat Label contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Duvyzat Label is sometimes called Duvyzat Prescribing Information (PI) or Duvyzat Package Insert.

What is the Cost of Givinostat?

Givinostat price will depend on your insurance plan and which pharmacy you use.

Coupons or a savings card may be available that you could be eligible for. Ask your doctor or pharmacist if you qualify, or see our Givinostat Price guide (Duvyzat price guide) for information on coupons, copay cards and patient assistance.

What happens if I miss a dose?

If you miss a dose of medicine, skip the missed dose and take your next dose of givinostat as scheduled.

Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking givinostat with certain other medicines may affect each other and can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Not all possible interactions are listed here.

Storage

• Store at 20°C to 25°C (68°F to 77°F)
• Do not freeze. 
• Store upright.
• Discard any unused suspension 60 days after the first opening of the bottle.

Ingredients

Active ingredient: givinostat

Duvyzat Inactive ingredients: cream flavor, glycerin, non-crystallizing sorbitol solution, peach flavor, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, tartaric acid, and tragacanth

Givinostat Manufacturer

Duvyzat Manufacturer Givinostat Italfarmaco S.A. Madrid, Spain

Distributed by ITF Therapeutics, LLC Concord, MA 01742.

Further information

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

Medical Disclaimer