Allina Health

Pronunciation:

tem-oh-ZOE-loe-mide

Brand Names:

• Temodar

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Imidazole Carboxamide

Uses of This Medicine:

Temozolomide 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.

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)
• Relapsed, refractory, or progressive malignant gliomas, as monotherapy in pediatric patients (used alone as treatment for brain tumors that are getting worse or not responding to treatment in children) .

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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.

Children—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of temozolomide in children .

Older adults—

Although appropriate studies on the relationship of age to the effects of temozolomide have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of temozolomide in the elderly. However, some studies have shown that blood problems, such as low platelet counts and low white blood cell counts, may be more likely to occur in patients 70 years of age or older, which may require an adjustment in the dose for patients receiving temozolomide .

Pregnancy—

Breast-feeding—

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

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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.

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 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.

Missed dose—

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine, do not double the next one.

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.

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:

• 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

Less common or rare

Amnesia

black, tarry stools

blood in the 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 the skin

swelling of the feet or lower legs

unusual bleeding or bruising

Incidence not known

Blistering, peeling, or loosening of the 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

shortness of breath

skin rash

sneezing

sore throat

tightness in the chest

troubled breathing

unusual tiredness or weakness

wheezing

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 the medicine. 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

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 with 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 with sleeping

unusual weight gain

urinary incontinence or increased urge to urinate

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.