Zolinza is a prescription medicine used to treat skin problems caused by cutaneous T-cell lymphoma.

Zolinza is usually given after other treatments did not work or have stopped working, or your cutaneous T-cell lymphoma gets worse or comes back after you have taken other medicines.

It is not known if Zolinza is safe and effective in children.

You should not use Zolinza if you are allergic to vorinostat, or if you have severe liver disease.

Do not use Zolinza if you are pregnant. It could harm the unborn baby.

You should not breast-feed while you are using Zolinza.

Drink at least 2 liters of water each day to keep from getting dehydrated while you are taking Zolinza. Tell your doctor if you have severe vomiting or diarrhea during treatment.

Do not crush or open a Zolinza capsule. Swallow it whole. The medicine inside the capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Stop using Zolinza and call your doctor at once if you have chest pain, sudden cough, wheezing, rapid breathing, coughing up blood, swelling or warmth in one or both legs, fever, chills, mouth sores, easy bruising or bleeding, bloody or tarry tools, or severe vomiting or diarrhea.

Before taking this medicine

To make sure Zolinza is safe for you, tell your doctor if you have:

• diabetes or high blood sugar;

• a blood clot;

• liver disease;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• any allergies.

Vorinostat can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Zolinza if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Zolinza.

Do not breast-feed while using this medicine, and for at least 1 week after your last dose.

Take Zolinza exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take with food. Drink at least 2 liters of water each day to keep from getting dehydrated.

Swallow the capsule whole and do not chew, break, or open it. The medicine inside the capsule can be dangerous if it gets in your eyes or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water, and then call your doctor.

Tell your doctor if you have trouble swallowing the capsule whole.

Your blood sugar will need to be checked often, and you may need other blood tests.

Call your doctor if you are sick with vomiting or diarrhea, especially if you are diabetic and cannot eat or drink normally.

You may be given other medications to help prevent nausea, vomiting, or diarrhea. Keep using these medicines for as long as your doctor has prescribed.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Cutaneous T-cell Lymphoma:

400 mg orally once a day; If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily; the dose may be further reduced to 300 mg once daily for 5 consecutive days each week if needed

-This drug should be taken with food.
-Swallow capsules whole; do not open or crush.
-Therapy may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Use: For the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or following 2 systemic therapies

To make sure Zolinza is safe for you, tell your doctor if you have:

• diabetes or high blood sugar;

• a blood clot;

• liver disease;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• any allergies.

Vorinostat can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Zolinza if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Zolinza.

Do not breast-feed while using this medicine, and for at least 1 week after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Get emergency medical help if you have signs of an allergic reaction to Zolinza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• dehydration symptoms - dizziness, drowsiness, feeling very thirsty or hot, being unable to urinate, hot and dry skin;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• low platelets or red blood cells - pale skin, easy bruising, unusual bleeding, purple or red spots under your skin, unusual tiredness, feeling light-headed, cold hands and feet;

• signs of a blood clot in the lung - chest pain, fast heartbeats, shortness of breath, sweating, coughing up blood; or

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Common Zolinza side effects may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• weight loss;

• swelling in your lower legs;

• dry mouth;

• fever, chills, headache, muscle pain;

• cold symptoms such as stuffy nose, sneezing, cough.

• dizziness, tiredness;

• itching, hair loss; or

• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• valproic acid; or

• a blood thinner (warfarin, Coumadin, Jantoven).

This list is not complete. Other drugs may interact with vorinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.