temozolomide - oral, Temodar
GENERIC NAME: TEMOZOLOMIDE - ORAL (TEM-oh-ZOL-oh-mide)
BRAND NAME(S): Temodar
USES: This medication is used to treat certain types of brain cancer. It is a chemotherapy drug that works by slowing cancer cell growth. In some patients, temozolomide decreases the size of brain tumors.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to treat other types of cancer (such as bone cancer).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using temozolomide and each time you get a refill. If you have any questions about the information or if you are not certain which days of the treatment cycle to take your medication, consult your doctor or pharmacist.Take this medication by mouth, usually once daily or as directed by your doctor. To reduce nausea and vomiting, take it on an empty stomach (1 hour before or 3 hours after a meal) or at bedtime, unless otherwise directed by your doctor. To make sure the amount of medicine in your body is kept at a constant level, take it at the same time every day in relation to a meal (e.g., always 1 hour before the evening meal or always 3 hours after the evening meal).Swallow the capsules whole with a full glass of water (8 ounces or 240 milliliters). The dosage is based on your medical condition, body size, and response to therapy.Do not crush, chew, or open the capsules. If the capsules are accidentally opened or damaged, avoid inhaling the medication, and do not let it touch the skin or mucous membranes (e.g., inside the nose). If contact occurs, flush the area with water. Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.
SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, and headache may occur. Nausea and vomiting can be quite severe. Drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: mouth sores, swelling of the ankles/feet, easy bleeding or bruising, shortness of breath.This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as: fever, chills, persistent sore throat, cough, burning/painful/frequent urination.Although temozolomide is used to treat cancer, very rarely in some patients it may increase the risk of developing another form of cancer (of the bone marrow). Consult your doctor for more details. Tell your doctor immediately if you develop: swollen glands, unexplained or sudden weight loss, night sweats.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, decreased bone marrow function, blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.Wash your hands well to prevent the spread of infections.The elderly may be more sensitive to the side effects of this drug, especially the increased risk of infection and easy bruising/bleeding.Women may be more sensitive to the side effects of this drug, especially the increased risk of infection and easy bruising/bleeding.This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use reliable forms of birth control (e.g., condoms and birth control pills) during treatment with this drug. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.It is not known if this drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because very serious interactions may occur: nalidixic acid.If you are currently using the medication listed above, tell your doctor or pharmacist before starting temozolomide.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood counts, brain scans) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: For the best benefits, it is important to take each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.
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