This page provides information about your medicine and answers some common questions about treatment with TEMODAR® Capsules. If you are not sure about any aspect of your treatment, ask your
doctor, nurse, or pharmacist.

The information in this section does not take the place of talking with your healthcare provider about your medical condition and treatment. Your healthcare provider should be your primary source of information about your medical condition and treatment. In addition, please carefully read the patient package insert that accompanied your prescription or it can also be found on this Web site. If you have any questions, contact your health care provider.

What Is TEMODAR®?

TEMODAR® is used to treat certain cancerous brain tumors in adult patients (greater than 18 years of age).

Your doctor has prescribed TEMODAR® as part of your cancer treatment. TEMODAR® is a drug you take by mouth that interferes with cell growth, especially in cells that are growing rapidly, such as cancer cells. TEMODAR® has been shown to help slow the growth of certain tumors. When given to patients with brain cancer, TEMODAR® has been shown to reduce the size of the tumor in some patients. To monitor your response to TEMODAR®, you will need to have regular scans and blood tests.

You should not take TEMODAR® if you have had an allergic reaction to DTIC-Dome (dacarbazine), a different treatment for cancer. If you have had an allergic reaction before to drugs such as DTIC-Dome, be sure to tell your doctor before taking TEMODAR®. If you are allergic to drugs similar to TEMODAR®, you may also have an allergic reaction to TEMODAR®. The inactive ingredients in the capsules include lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules and the cap are made of gelatin. The capsule body and cap are imprinted with pharmaceutical ink. If you have had a reaction to any of these ingredients, or think you are allergic to any of them, you should check with your doctor before you start your treatment.

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How Does It Work?

TEMODAR® acts directly on the DNA in the cells in your body. DNA controls the growth of normal cells as well as brain tumor cells. Because these tumor cells grow much faster than normal cells, they are affected to a much greater extent by the effects of TEMODAR® Capsules.

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How Long Will the Treatment Continue?

Different dosing schedules are used for taking TEMODAR®. Be sure to follow the one that your doctor has prescribed for you. One schedule you may be prescribed is TEMODAR® taken for 42 days (up to 49 days) with radiotherapy. Another schedule you may be prescribed is TEMODAR® taken for 5 consecutive days only, then you must stop taking TEMODAR® for the next 23 days. Your dose is based on your height and weight, and the number of treatment cycles will depend on how you respond to and tolerate this treatment. Your doctor may have prescribed a treatment regimen that is different from the ones discussed in this section. If so, make sure you follow the specific instructions given to you by your doctor. If you are unsure about when you should be taking your TEMODAR®, check with your doctor, nurse, or pharmacist.

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When Will I Come Back to See the Doctor?

TEMODAR® may reduce the number of certain types of blood cells, which can cause side effects. For this reason, it is important that your blood be checked periodically while you are taking TEMODAR®. Periodic blood tests help determine if dose adjustment, interruption, or discontinuation is necessary. These tests may be needed weekly or before the start of each cycle, depending on your prescribed treatment regimen.

You may also have a brain scan. Depending on your response to TEMODAR®, your doctor may need to make adjustments to your treatment.

It is important that you continue to see your doctor regularly to check your progress. Your doctor can notice side effects of treatment that you may miss.

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When Should I Take It?

Plan to take TEMODAR® on an empty stomach at least 1 hour before a meal or at bedtime. This may help reduce the nausea associated with taking the medication. If your doctor has prescribed antinausea medication, you should take it as prescribed. TEMODAR® is used best by your body if you take it at the same time every day in relation to a meal.

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How Many Capsules Do I Take?

Your doctor will decide the correct dose of TEMODAR® for you to take, based on your height and weight. Your prescribed daily dose will determine how many capsules you take. TEMODAR® is available in capsules of different strengths, so your daily dose may be made up of more than one capsule.

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How Should I Take TEMODAR® Capsules?

Take each day's dose of capsules at one time with a full glass of water. Swallow the capsules whole; do NOT open or split the capsules. The TEMODAR® Capsules should be swallowed whole and NEVER chewed.

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What Should I Do if I Take Too Many Capsules?

TEMODAR® should be taken only as prescribed by your doctor. If you accidentally take more capsules than you were supposed to, contact your doctor, nurse, or pharmacist immediately.

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What Should I Do if I Miss a Dose?

If you miss a dose, contact your doctor or health care professional.
Do not make up the missed dose by taking another.

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How Should I Store My TEMODAR® at Home?

Store it in a cool, dry place (not above 77°F, or 25°C), well out of the reach of children and pets.

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What Should I Do if a Capsule Gets Damaged?

If a capsule is broken or damaged, it is very important to avoid inhalation of the powder or contact with the skin, eyes, or nose. If you accidentally get some in your eyes or nose, flush the area well with water. Then call your healthcare provider for further guidance and for information on how to properly dispose of the powder. It is important to keep TEMODAR® Capsules away from children and pets.

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How Will I Feel When I Take TEMODAR® Capsules and What Are Its Side Effects?

Nausea and vomiting are the most common side effects associated with TEMODAR®. Your doctor can prescribe medicines that may help reduce them. Other common side effects include headache, feeling tired, loss of appetite, hair loss, and constipation. TEMODAR® can also reduce the number of certain types of blood cells, which can have serious effects. It is important that your doctor check your blood periodically while you are taking TEMODAR® to see if these side effects are occurring. There are other side effects associated with TEMODAR®. They are included in a longer, more technical information leaflet written for health care providers that you can obtain from your doctor or pharmacist.

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What Can I Do if I Can't Fall Asleep?

If you have trouble sleeping, you should discuss this with your doctor or nurse. They may be able to suggest relaxation methods or prescribe a sleep aid to help you get sufficient rest.

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Will TEMODAR® React with My Other Medications?

TEMODAR® will probably not react with any other drugs you take. However, you should tell your doctor, nurse, or pharmacist about any other medications you are taking so that the possibility of drug interaction can be avoided.

No significant interactions have been seen when TEMODAR® was given along with most anticonvulsant drugs (phenytoin, carbamazepine, and phenobarbital). It is known that valproic acid decreases the clearance of TEMODAR® by about 5%, but the clinical effect of this is not known.

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Will I Lose My Hair?

If you receive radiation with TEMODAR®, you may experience hair loss.

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Will I Feel Sick and Fatigued All the Time?

Some patients do feel tired during treatment. Moderate exercise, frequent smaller meals, and regular sleep can help relieve fatigue. Nausea and vomiting are generally mild to moderate with TEMODAR®, and your doctor can prescribe medication to control these side effects.

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Will I Have to Change What I Eat and Drink?

Because of the way TEMODAR® Capsules work in your body, you don't have to change your diet or avoid certain foods while taking the medication.

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What Do I Do if I Vomit?

If you vomit within half an hour of taking TEMODAR®, notify your doctor immediately. He/she may prescribe a make-up dose. If you vomit before taking the medication because you are nervous about therapy, your doctor may be able to prescribe antinausea medications for you to take before therapy begins.

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Will TEMODAR® Make Me Constipated?

Unfortunately, like other chemotherapy drugs, TEMODAR® may cause constipation. By eating smaller meals more frequently and getting enough fiber in your diet, you should be able to reduce discomfort from this problem. If necessary, your doctor may recommend a laxative.

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Will I Have a Normal Sex Life?

TEMODAR® should have no effect on sex drive, so you should be able to continue sexual relations with your partner. TEMODAR® may cause birth defects. Therefore, male or female patients who take TEMODAR® should use effective birth control. Female patients should avoid becoming pregnant while receiving this drug.

You should not breast-feed an infant while taking TEMODAR®. It is not known whether TEMODAR® passes into breast milk. Because many drugs do pass into breast milk, there is the possibility of serious harm to nursing infants. Whether you are male or female, you may want to consult your doctor or specialist about preservation of future fertility before treatment.

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How Will I Pay for TEMODAR® Treatment?

Most insurers, including Medicare, will cover the cost of TEMODAR®. But for patients with financial need beyond insurance provisions, Schering Corporation has also developed Schering's COMMITMENT TO CARE® program. This service can help eligible patients find alternative sources of reimbursement, and may be contacted by calling 1-800-521-7157.

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