Temozolomide (Oral)

Temozolomide is used to treat certain types of brain cancer (for example, glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have come back or have just been diagnosed. It is part of a group of medicines called antineoplastics (cancer medicines).

Temozolomide works by interfering with the growth of cancer cells, which are then killed by the body. Since it can also affect the growth of normal body cells, other side effects may happen. Some of these side effects can be serious and should be reported to your doctor. Some side effects might not appear for months or even years after using the medicine.

Before starting treatment with temozolomide, you and your doctor should discuss the risks and benefits of this medicine.

This medicine is available only with a prescription from your doctor.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause birth defects if either partner is using it during conception or pregnancy. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for at least 6 months after your last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant, tell your doctor right away.

Temozolomide can temporarily lower the number of white blood cells in your blood, which increases 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 the 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 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious lung or breathing problems (e.g., pneumonia). Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, sneezing, sore throat, or trouble breathing.

This medicine may increase the risk of blood problems and secondary cancer (e.g., myeloid leukemia). Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Male patients should not donate semen during treatment and for at least 3 months after the final dose of this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the effects of temozolomide in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies on the effects of temozolomide in older adults have not been performed, but there are no expected age-related problems that would limit its usefulness in the elderly. However, older patients are more likely to have kidney, liver, or heart issues, which may require caution and possible dose adjustments for those taking temozolomide.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are using any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or the frequency of use for one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used near the time of eating or with certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Bone marrow problems (e.g., anemia, leukemia, myelodysplastic syndrome, pancytopenia, thrombocytopenia) or
• Liver problems—Use with caution. May worsen these conditions.

• Infection—May reduce your body's ability to fight infections.

• Severe kidney disease or
• Severe liver disease—Use with caution.

Along with its needed effects, Temozolomide (Oral) may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Amnesia
• black, tarry stools
• blood in the urine or stools
• cough or hoarseness
• fever or chills
• 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 the skin
• seizures
• swelling of the feet or lower legs
• unusual bleeding or bruising

Incidence not known

• Blistering, peeling, or loosening of the skin
• chest pain or tightness
• clay colored stools
• cough
• decreased appetite
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• headache
• hives, itching, or skin rash
• joint or muscle pain
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sneezing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or tenderness
• trouble breathing
• unusual tiredness or weakness
• yellow skin or eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Temozolomide (Oral). Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation

Less common or rare

• Anxiety
• blurred or double vision
• breast pain (in females)
• burning or prickling feeling on the skin
• confusion
• diarrhea
• difficulty with speaking
• drowsiness
• increased urge to urinate
• loss of appetite
• loss of muscle coordination
• mental depression
• runny or stuffy nose
• trouble sleeping
• unusual weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Temodar

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Imidazole Carboxamide

Take this medicine only as directed by your doctor. 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 medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time each day, either with or without food.

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. You may take the medicine on an empty stomach or at bedtime may help to lessen the nausea. Ask your doctor for other ways to help lessen these effects.

Swallow the capsules whole with a full glass of water. Do not open, chew, or dissolve it. If the capsule is opened accidentally, do not allow the powder to contact your skin, mouth, or nose. Be careful not to inhale the contents of the capsule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For newly diagnosed glioblastoma multiforme: Adults—Dose is based on body size and must be determined by your doctor. The dose is usually 75 milligrams (mg) per square meter (m[2]) of body size once day for 42 to 49 days together with radiation treatment. Followed by a maintenance treatment of 150 mg/m2 on Days 1 to 5 of each 28-day cycle for 6 cycles. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor. For newly diagnosed anaplastic astrocytoma: Adults—Dose is based on body size and must be determined by your doctor. The dose is usually 150 milligrams (mg) per square meter (m[2]) of body size once a day on Days 1 to 5 of each 28-day cycle for 12 cycles starting at 4 weeks after receiving radiation treatment. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor. For refractory anaplastic astrocytoma: Adults—Dose is based on body size and must be determined by your doctor. The starting dose is usually 150 milligrams (mg) per square meter (m[2]) of body size once a day on Days 1 to 5 of each 28-day cycle. Your doctor may adjust your dose as needed and tolerated. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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