Temodar

Temodar is used to treat specific types of brain cancer (eg, glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed. It belongs to the group of medicines known as antineoplastics (cancer medicines).

Temodar interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by temozolomide, other side effects may occur. 

Some of these may be serious and must be reported to your doctor. Some side effects may not occur for months or years after the medicine is used.

Before you begin treatment with temozolomide, you and your doctor should talk about the risks and benefits of this medicine. This medicine is available only with your doctor's prescription.

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 conditions:

• Metastatic melanoma (a 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 in children as the treatment for brain tumors that are getting worse or not responding to treatment).

This product is available in the following dosage forms:

• Capsule

Before using Temodar, you must know all about the risks and complications associated with it. 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.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of temozolomide in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Although appropriate studies on the relationship of age to the effects of temozolomide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of temozolomide in the elderly. 

However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temozolomide.

Pregnancy: All Trimesters: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease may outweigh the potential risk.

Breastfeeding: 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.

Drug Interactions: 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 problems (eg, anemia, leukemia, myelodysplastic syndrome, pancytopenia, thrombocytopenia) 
• Liver problems—Use with caution. May make these conditions worse
• Chickenpox (including recent exposure) 
• Herpes zoster (shingles)—May increase risk of severe disease affecting other parts of the body
• Kidney disease, severe 
• Liver disease, severe—Use with caution

To use Temodar properly, you must follow all instructions given 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. 

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

Swallow the capsules whole with a full glass of water. Do not be a crush, break, chew, or open 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 given as a single dose for 42 days. This is given together with a radiation treatment followed by a maintenance treatment for 6 cycles. 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 for 5 days, and then you stop taking it for the next 23 days. This dosing cycle may be repeated every 28 days, for up to 2 years. Your doctor may adjust your dose as needed.
  • 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.

Before using Temodar, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 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 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.
• 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.

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.

As with many medications, there are several potential side effects associated with Temodar. Although not all of these side effects may occur, 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
• convulsions
• a 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
• swelling of the feet or lower legs
• unusual bleeding or bruising

Incidence not known:

• abdominal or stomach pain or tenderness
• blistering, peeling or loosening of the skin
• chest pain
• clay colored stools
• cough
• decreased appetite
• diarrhea
• difficulty 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
• tightness in the chest
• troubled 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 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

Less common or rare:

• anxiety
• blurred or double vision
• breast pain (in females)
• burning or prickling feeling on the skin
• confusion
• diarrhea
• the difficulty with speaking
• drowsiness
• increased the 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.