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|Temozolomide

Temozolomide

Temozolomide is used for:

Treating adults with recurrent malignant brain tumors that did not respond to other medicines. It is also used for treating new brain tumors along with radiotherapy and then as maintenance treatment. It may also be used for other conditions as determined by your doctor.

Temozolomide is an antineoplastic agent. It works by killing and stopping growth of cancer cells.

Do NOT use Temozolomide if:

• you are allergic to any ingredient in Temozolomide
• you are allergic to dacarbazine

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

Before using Temozolomide :

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

• if you are pregnant or planning to become pregnant
• 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 have kidney or liver problems
• if you have low white blood cell counts, decreased blood platelet levels, or other blood problems

Some MEDICINES MAY INTERACT with Temozolomide . However, no specific interactions with Temozolomide are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Temozolomide 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 Temozolomide :

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

• Take Temozolomide without food to lessen the chance of nausea.
• Take Temozolomide at bedtime unless otherwise directed by your doctor.
• Take Temozolomide with a full glass of water.
• Swallow Temozolomide whole. Do not break, crush, or chew before swallowing.
• If the capsule is opened accidentally, do not breathe in the contents. Do not let capsule contents get on your skin or inside your nose or mouth.
• If you miss a dose of Temozolomide , contact your doctor immediately.

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

Important safety information:

• Temozolomide may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Temozolomide . Using Temozolomide alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Temozolomide may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Temozolomide may increase your risk of developing a second cancer. Discuss any questions or concerns with your doctor.
• Temozolomide may lower your resistance to infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.
• LAB TESTS including, complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Temozolomide in the ELDERLY because they may be more sensitive to its effects.
• Use Temozolomide with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Temozolomide may cause harm to the fetus. Avoid becoming pregnant while using Temozolomide . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Temozolomide during pregnancy. It is unknown if Temozolomide is excreted in breast milk. Do not breast-feed while taking Temozolomide .

Possible side effects of Temozolomide :

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:

Abnormal skin sensations; anxiety; back pain; blurred vision; breast pain; constipation; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain or weakness; loss of appetite; muscle aches; nausea; sinus inflammation; stomach pain; taste change; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; confusion; depression; difficulty swallowing; increased or painful urination; infection (fever, chills, sore throat); loss of bladder control; loss of coordination; memory loss; muscle weakness on one side of the body; paralysis; persistent cough; seizures; severe or prolonged headache; severe tiredness or weakness; shortness of breath; speech changes; swelling of the ankle feet or hands; unusual bruising or bleeding; vision changes.

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. Symptoms may include death; infection; severe bleeding.

Store Temozolomide at 77 degrees F (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 Temozolomide out of the reach of children and away from pets.

General information:

• If you have any questions about Temozolomide , please talk with your doctor, pharmacist, or other health care provider.
• Temozolomide 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 Temozolomide . 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.