Vorinostat (vor-IN-oh-stat)

Treats cutaneous T-cell lymphoma (CTCL).

Brand Name(s):

Zolinza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• 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 fluid 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.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 may affect how vorinostat works. Tell your doctor if you are using valproic acid or a blood thinner (including warfarin).

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant.
• Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
• Tell your doctor if you have liver disease, heart problems, diabetes, stomach or bowel problems (including nausea, vomiting, diarrhea), fluid or electrolyte imbalance, or a history of blood clots.
• This medicine may cause the following problems:
  • Increased risk of blood clots in the lungs or blood vessels
  • High blood sugar
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• 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.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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
• Changes in how much or how often you urinate, increased thirst or hunger, blurred vision, weight loss
• Chest pain, trouble breathing, coughing up blood
• Fever, chills, cough, runny or stuffy nose, sore throat, 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 stomach pain, constipation, vomiting of blood or material that looks like coffee grounds
• Severe diarrhea, nausea, or vomiting, dizziness, lightheadedness, dry skin or mouth
• Sudden or severe headache, problems with vision, speech, or walking
• Tiny red dots on the skin, especially on the lower legs
• 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
• Thinning or loss of hair

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