Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Temodar

Descriptions


Temozolomide injection is an antineoplastic agent. It is used to treat specific types of cancer of the brain in patients whose tumors have returned or whose tumors have just been diagnosed.

Temozolomide injection 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 injection, 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 injection, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Temozolomide injection is to be administered only by or under the immediate supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temozolomide injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving temozolomide injection.

Pregnancy

Information about this temozolomide-intravenous-route
Pregnancy Category Explanation
All Trimesters 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Anemia (low red blood cells) or
  • Bone marrow problems or
  • Leukemia (type of cancer) or
  • Leukopenia (low white blood cells) or
  • Myelodysplastic syndrome or
  • Thrombocytopenia (low platelets)—May make these conditions worse.
  • Infection—May decrease your ability to fight infections.
  • Kidney disease, severe or
  • Liver disease, severe—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.

This medicine is given through a needle placed in one of your veins. Each treatment usually takes about 90 minutes.

This medicine may cause nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Precautions

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 injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (e.g. pneumonia). 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 have fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, shortness of breath, or unusual bleeding or bruising.
  • 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.

Side Effects

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.

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

More common

  1. Bladder pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. bloody or cloudy urine
  4. body aches or pain
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. chills
  7. cold flu-like symptoms
  8. congestion
  9. cough or hoarseness
  10. difficult, burning, or painful urination
  11. difficulty with breathing
  12. dryness or soreness of the throat
  13. ear congestion
  14. fever
  15. frequent urge to urinate
  16. headache
  17. loss of ability to use or understand speech or language
  18. loss of bladder control
  19. loss of voice
  20. lower back or side pain
  21. nasal congestion
  22. pain or tenderness around the eyes and cheekbones
  23. partial or slight paralysis
  24. rapid weight gain
  25. seizures
  26. shakiness and unsteady walk
  27. shortness of breath or troubled breathing
  28. sneezing
  29. sore throat
  30. stuffy or runny nose
  31. tender, swollen glands in the neck
  32. tightness of the chest or wheezing
  33. tingling of the hands or feet
  34. trouble with swallowing
  35. unsteadiness, trembling, or other problems with muscle control or coordination
  36. unusual tiredness or weakness
  37. unusual weight gain or loss
  38. voice changes

Less common

  1. Black, tarry stools
  2. bleeding gums
  3. dizziness
  4. fast heartbeat
  5. flushing, redness of the skin
  6. hives
  7. itching
  8. pinpoint red spots on the skin
  9. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  10. skin rash
  11. unusual bleeding or bruising
  12. unusually warm skin

Incidence not known

  1. Deep, dark purple bruise
  2. itching, pain, redness, or swelling
  3. small red or purple spots on the skin

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

  1. Abdominal or stomach pain
  2. back pain
  3. being forgetful
  4. blurred vision
  5. breast pain
  6. change in walking and balance
  7. clumsiness or unsteadiness
  8. constipation
  9. discouragement
  10. dizziness
  11. fear or nervousness
  12. feeling sad or empty
  13. hair loss or thinning of the hair
  14. irritability
  15. itching skin
  16. lack or loss of strength
  17. loss of appetite
  18. loss of interest or pleasure
  19. loss of memory
  20. nausea or vomiting
  21. problems with memory
  22. sleepiness or unusual drowsiness
  23. sleeplessness
  24. tiredness
  25. trouble concentrating
  26. trouble sleeping
  27. unable to sleep
  28. weight loss

Less common

  1. Change in taste or bad unusual or unpleasant (after) taste
  2. changes in vision
  3. difficulty with moving
  4. double vision
  5. dry skin
  6. increased weight
  7. joint pain
  8. mood or mental changes
  9. muscle aching or cramping
  10. muscle pains or stiffness
  11. seeing double
  12. swollen joints

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.