When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to vorinostat, if you are pregnant, or if you have severe liver disease.

How to Use This Medicine:
Capsule

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not open, crush, break, or chew it.
• Drink at least 68 ounces (2 liters) of fluids every day to prevent dehydration.
• You may also receive medicines to help prevent nausea and vomiting.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

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

• Make sure your doctor knows if you use valproic acid (Depakene®) or a blood thinner (such as warfarin, Coumadin®).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding or if you have kidney disease, liver disease, anemia, diabetes, stomach or bowel problems, a mineral imbalance (such as low potassium, calcium, or magnesium in your blood), or a history of blood clots.
• This medicine may increase your risk for blood clots. Tell your doctor right away if you have chest pain, trouble breathing, or pain in your lower leg (calf) or if you cough up blood.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may increase blood sugar levels. Tell your doctor if you have increased hunger or thirst, changes in how much you urinate, or unusual weight loss. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Cancer medicines can cause diarrhea, nausea, or vomiting. Make sure to drink enough liquids so you do not get dehydrated. Ask your doctor about ways to control these side effects.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Changes in how much or how often you urinate, increased thirst or hunger, or muscle cramps
• Chest pain, trouble breathing, or coughing up blood
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Red or black stools
• Severe diarrhea, nausea, or vomiting
• Sudden or severe headache, or problems with vision, speech, or walking
• Unusual bleeding, bruising, or tiredness

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

• Change or loss of taste
• Loss of appetite
• Mild diarrhea or nausea
• Weight loss

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