In the U.S.—

In Canada—

• Antineoplastic

Temozolomide ( tem-oh-ZOHL-oh-mide) belongs to the general group of medicines known as antineoplastics. It is used to treat a specific type of cancer of the brain in adults whose tumors have returned.

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:

Oral
• Capsules (U.S. and Canada)

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:

• Acyclovir (e.g., Zovirax) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine taken by mouth) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Antipsychotics (medicine for mental illness) or
• Captopril (e.g., Capoten) or
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Imipenem or
• Inflammation or pain medicine, except narcotics or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tiopronin (e.g., Thiola) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril)—Concurrent use of these agents with temozolomide may cause blood disorders
• Alpha Interferons (e.g., Intron A, Roferon-A) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Zidovudine (e.g., AZT, Retrovir)—Concurrent use of these agents with temozolomide increases the risk of infection
• If you have ever been treated with radiation or cancer medicines—Temozolomide may increase the effects that these medicines or radiation therapy may have on the blood

• Bone marrow depression, existing or
• Infection—There may be an increased risk of infections or worsening infections because of the body's reduced ability to fight them

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Kidney disease or
• Liver disease— Temozolomide should be used with caution

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:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

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:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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.

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 
  
  

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:

• More common
  • 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:

• Metastatic melanoma (a certain type of skin cancer that has spread to other areas of the body, including the brain)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.