Givinostat

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.

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.

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

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.

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

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.

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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