Class Name(s):

• 92:92 Other Miscellaneous Therapeutic Agents

Brand Name(s):

• Dubyzat^®

WHY is this medicine prescribed?

Givinostat is used to treat Duchenne muscular dystrophy (DMD; a progressive disease in which the muscles do not function properly) in adults and children 6 years of age and older. Givinostat is in a class of medications called histone deacetylase inhibitors. How it works to help symptoms of DMD is unknown.

HOW should this medicine be used?

Givinostat comes as a suspension (liquid) to take by mouth. It is usually taken with food twice a day. Take givinostat at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take givinostat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly by turning the bottle upside down and shaking for at least 30 seconds. Look at the suspension (liquid) and make sure it looks the same all over. Using an oral syringe, measure the correct amount of liquid to give the dose prescribed by your doctor.

Your doctor may have to adjust your dose of givinostat based on side effects or changes in your blood work. It is important for you to communicate side effects with your doctor and attend all ordered lab visits.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking givinostat,

• tell your doctor and pharmacist if you are allergic to givinostat, any other medications, or any of the ingredients in givinostat suspension. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with givinostat. Make sure you have discussed any medications you are currently taking or plan to take before starting givinostat with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking givinostat, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had low platelets, anemia (low red blood cells), low white blood cells, high triglycerides, heart disease or a fast or slow heartbeat, a long QT interval (a heart problem that may cause irregular heartbeat, fainting, or sudden death), or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking givinostat, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking givinostat.
• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Givinostat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• nausea or vomiting
• fever
• muscle or joint aches or pains
• rash
• fatigue
• constipation
• reduced appetite

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• unusual bruising or bleeding (like nose or gum bleeding) or heavy or prolonged bleeding
• feel faint or dizzy, racing or fast or irregular heartbeat, or lose consciousness

Givinostat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Discard any unused liquid 60 days after first opening the bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to givinostat.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking givinostat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 20, 2024.