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|Zolinza

Zolinza

Zolinza is used for:

Treating certain patients with skin symptoms caused by a type of cancer (cutaneous T-cell lymphoma; CTCL).

Zolinza is a histone deacetylase (HDAC) inhibitor. It works by blocking the growth of some cancer cells.

Do NOT use Zolinza if:

• you are allergic to any ingredient in Zolinza without first checking with your doctor

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zolinza :

Some medical conditions may interact with Zolinza . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are dehydrated or have nausea, vomiting, or diarrhea
• if you have low blood magnesium or potassium levels, anemia, or low blood platelet levels
• if you have diabetes or high blood sugar, or are at risk for diabetes
• if you have a history of kidney or liver problems, blood clots (eg, in the lungs or legs), or heart problems (eg, irregular heartbeat, abnormal electrocardiogram [ECG], congenital long QT syndrome)
• if you are taking any medicine for irregular heartbeat

Some MEDICINES MAY INTERACT with Zolinza . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Valproic acid because the risk of low blood platelet levels, unusual bruising or bleeding, and serious stomach or bowel bleeding may be increased
• Warfarin because the risk of its side effects may be increased by Zolinza

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zolinza may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zolinza :

Use Zolinza as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Zolinza . Talk to your pharmacist if you have questions about this information.
• Take Zolinza by mouth with food.
• Swallow Zolinza whole. Do not open, break, crush, or chew before swallowing.
• If the capsule is accidentally crushed or broken, do NOT touch the powder. If you get the powder on your skin or in your eyes, wash immediately with water. Contact your doctor immediately.
• Drinking extra fluids (at least eight 8 oz glasses of liquid per day) while you are taking Zolinza is recommended. Check with your doctor for instructions.
• Be sure you know how to properly handle and dispose of Zolinza . Contact your doctor if you have questions.
• If you miss a dose of Zolinza , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zolinza .

Important safety information:

• Zolinza may cause dizziness or fatigue. These effects may be worse if you take it with alcohol or certain medicines. Use Zolinza with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• Zolinza may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Zolinza may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including complete blood cell counts, blood electrolyte levels, blood glucose levels, ECG, and creatinine levels, may be performed while you use Zolinza . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Zolinza should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Zolinza has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zolinza while you are pregnant. It is not known if Zolinza is found in breast milk. Do not breast-feed while taking Zolinza .

Possible side effects of Zolinza :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; constipation; cough; diarrhea; dizziness; dry mouth; fatigue; hair loss; headache; loss of appetite; muscle aches; nausea; taste changes; vomiting; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; calf or leg pain, swelling, redness, or warmth to the touch; chest pain; coughing up blood; fainting; fast or irregular heartbeat; muscle pain or spasms; severe nausea, vomiting, or diarrhea; shortness of breath; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased urination, thirst, or hunger; confusion; drowsiness; flushing; fast breathing; fruit-like breath odor); symptoms of infection (eg, fever; persistent or severe chills, cough, or sore throat); unusual bleeding or bruising; unusual sweating; unusual weakness or tiredness; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Zolinza at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zolinza out of the reach of children and away from pets.

General information:

• If you have any questions about Zolinza , please talk with your doctor, pharmacist, or other health care provider.
• Zolinza is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zolinza . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.