Givinostat (giv-IN-oh-stat)

Treats Duchenne muscular dystrophy.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine with food. Do not mix this medicine with water or other liquids.
• Oral liquid:
  • Shake the bottle well for at least 30 seconds by continuously turning it up and down. Stop when the oral liquid is mixed well and looks the same throughout.
  • Open the bottle by pressing down on the cap and turn the cap to the left (counter-clockwise).
  • If you are using the medicine for the first time, take the provided oral syringe and firmly insert the tip of the oral syringe into the bottle adapter opening. If it is not the first time, take the oral syringe and push the plunger all the way down (to remove the air) and firmly insert the tip of the oral syringe into the bottle adapter opening.
  • Hold the syringe in place and turn the bottle upside down. Slowly pull the plunger down to pull out a small amount of the oral liquid. Then push the plunger all the way up to remove any air bubbles.
  • Slowly pull the plunger down until you reach the prescribed dose. While keeping the plunger in the same position, turn the bottle upright and place it on a flat surface. Remove the oral syringe by gently twisting or pulling it out from the bottle adapter opening. Do not hold the plunger because it may come out.
  • Place the tip of the oral syringe against the inside of the cheek and slowly push the plunger all the way down until there is no medicine left in the syringe.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away any unused liquid after 60 days of opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how givinostat works. Tell your doctor if you are using clarithromycin, midazolam, or medicines that may cause heart rhythm problems.

Warnings While Using This Medicine:

• Tell you doctor if you are pregnant or breastfeeding, or if you have liver disease, heart disease, or bleeding problems.
• This medicine may cause the following problems:
  • Increased levels of fat (triglycerides) in your blood
  • Stomach or bowel problems
  • Heart rhythm problems, including QT prolongation
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, stomach pain, vomiting
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Muscle or joint pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, decreased appetite
• Fever
• Rash

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088