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Some commonly used brand names are:
In the U.S.—
Temozolomide (tem-oh-ZOHL-oh-mide) belongs to the general group of medicines known as antineoplastics. It is used to treat specific types of cancer of the brain in adults whose tumors have returned and whose tumors have just been diagnosed.
Temozolomide seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by temozolomide, other effects will also occur. Some of these may be serious and must be reported to your doctor.
Before you begin treatment with temozolomide, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
Temozolomide is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For temozolomide, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dacarbazine or temozolomide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—There is a chance that this medicine may cause birth defects if it is taken at the time of conception or if it is taken during pregnancy. You should wait for 6 months after the treatment is finished before becoming pregnant. Studies in rats and rabbits have shown that temozolomide causes birth defects in the fetus and other problems (including miscarriages).
Be sure that you have discussed these possible effects with your doctor before taking this medicine. Before taking temozolomide, make sure your doctor knows if you are pregnant or if you may become pregnant. It is best to use some kind of birth control while you are taking temozolomide. Tell your doctor right away if you think you have become pregnant while taking temozolomide.
If you are a man taking temozolomide you should be very careful not to father a child up to 6 months after treatment. Use a good form of birth control. Treatment with temozolomide may make you sterile. You may want to save and freeze your sperm before you start treatment with temozolomide in case this happens.
Breast-feeding—It is not known whether temozolomide passes into human breast milk. However, temozolomide is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.
Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of temozolomide in children with use in other age groups.
Older adults—Elderly patients may be more sensitive to the effects of temozolomide. Blood problems such as low platelet (the cell that helps blood to clot) counts and low white blood cell (the cell that helps fight off infections) counts may be especially likely to occur in patients 70 years of age or older.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking temozolomide it is especially important that your health care professional knows if you are taking any of the following:
Other medical problems—The presence of other medical problems may affect the use of temozolomide. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
Take this medicine only as directed . Do not take more or less of it and do not take it for a longer time than directed. To do so may increase the chance of unwanted side effects. This is especially important for elderly patients, who may be more sensitive to the effects of this medicine.
Temozolomide often causes nausea and vomiting. However, it is very important that you continue to take the medicine, even if you begin to feel ill . Taking the medicine on an empty stomach or at bedtime may help to lessen the nausea. Ask your health care professional for other ways to help lessen these effects.
Temozolomide should be taken at the same time each day in relation to meals.
Temozolomide capsules should be swallowed whole with a full glass of water. The capsules should not be chewed, crushed or broken open . If the capsules are opened accidentally, do not allow the powder to come into contact with your skin or into your mouth or nose. Be careful not to inhale the contents of the capsule.
Dosing—The dose of temozolomide will be different for different patients. The dose that is used will depend on a number of things, including the patient"s body size and various laboratory test results. If you are taking temozolomide at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of temozolomide, ask your doctor.
Missed dose—If you miss a dose of this medicine, do not double the next one. Check with your doctor for further instructions.
Storage—To store this medicine:
Precautions While Using This Medicine
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
While you are being treated with temozolomide, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Temozolomide may lower your body"s resistance, and there is a chance you might get the infection that the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Temozolomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Side Effects of This Medicine
Along with its needed effects, temozolomide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common or rare
Amnesia; black, tarry stools; blood in urine or stools; convulsions (seizures); cough or hoarseness; fever or chills; infection; lower back or side pain; muscle weakness or paralysis on one or both sides of the body; painful or difficult urination; pinpoint red spots on skin; swelling of feet or lower legs; unusual bleeding or bruising
Incidence not determined——Observed during clinical practice; estimates of frequency cannot be determined
Blistering, peeling, loosening of skin; chest pain ; cough; difficulty swallowing; dizziness; fast heartbeat; fever or chills; hives; itching; joint or muscle pain; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; sneezing ; shortness of breath; skin rash; sore throat; troubled breathing; tightness in chest; unusual tiredness or weakness; wheezing
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
Constipation; headache; nausea and vomiting; unusual tiredness or weakness
Less common or rare
Abdominal or stomach pain; anxiety; blurred or double vision; breast pain (in females); burning or prickling feeling on the skin; confusion; diarrhea; difficulty in speaking; dizziness; drowsiness; loss of appetite; loss of muscle coordination; mental depression; muscle pain; runny or stuffy nose; skin rash or itching; sore throat; trouble in sleeping; unusual weight gain; urinary incontinence or increased urge to urinate
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, temozolomide is used in certain patients with the following medical condition:
Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.
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