Temozolomide

Temozolomide is used for:

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Treating certain types of brain tumors in certain patients. It may also be used for other conditions as determined by your doctor.

Temozolomide is an antineoplastic agent. It works by stopping cancer cells from growing and reproducing.

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, 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 have kidney or liver problems
• if you have low white blood cell counts or low blood platelet levels

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

• Corticosteroids (eg, prednisone) because the risk of severe infection may be increased
• Valproic acid because it may increase the risk of Temozolomide 's side effects

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.

• An extra patient leaflet is available with Temozolomide . Talk to your pharmacist if you have questions about this information.
• Temozolomide is usually given as an infusion at your doctor's office, hospital, or clinic. If you will be using Temozolomide at home, a health care provider will teach you how to use it. Be sure you understand how to use Temozolomide . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Temozolomide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Temozolomide , contact your doctor right away.

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. These effects may be worse if you take it with alcohol or certain medicines. Use Temozolomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Nausea, vomiting, and loss of appetite are common with Temozolomide . Ask your doctor or pharmacist for ways to decrease these effects if they occur.
• Temozolomide 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.
• Temozolomide may increase your risk of developing a second cancer. Talk to your doctor if you have any questions or concerns.
• Temozolomide may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Tell your doctor or dentist that you take Temozolomide before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including complete blood cell counts, may be performed while you use Temozolomide . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Temozolomide with caution in the ELDERLY; they may be more sensitive to its effects.
• Temozolomide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Men who take Temozolomide should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Temozolomide .
• PREGNANCY and BREAST-FEEDING: Temozolomide may cause harm to the fetus. Do not become pregnant while you are using it. Use an effective form of birth control while you are taking Temozolomide . If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Temozolomide while you are pregnant. It is not known if Temozolomide is found 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:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mouth sores; muscle aches; nausea; stomach pain; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; coughing up blood; depression; difficulty swallowing; increased or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness and tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; severe tiredness or weakness; shortness of breath; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

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 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), or emergency room immediately. Symptoms may include severe bleeding or persistent fever.

Temozolomide is usually handled and stored by a health care provider. If you are using Temozolomide at home, store Temozolomide as directed by your pharmacist or health care provider. 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.

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