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Temozolomide (Intravenous route)

Pronunciation:

tem-oh-ZOE-loe-mide

Brand Names:

  • Temodar

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Imidazole Carboxamide

Uses of This Medicine:

Temozolomide injection 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).

Temozolomide 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 benefits this medicine will do as well as the risks of using it.

This medicine is to be given only by or under the immediate supervision of your doctor.

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 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.

Older adults—

Although appropriate studies on the relationship of age to the effects of temozolomide injection 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 age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temozolomide injection.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

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. 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:

  • Bone marrow problems (eg, anemia, leukemia, myelodysplastic syndrome, pancytopenia, thrombocytopenia) or
  • Liver problems—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infections.
  • Kidney disease, severe or
  • Liver disease, severe—Use with caution.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. It must be injected slowly, so your IV tube will need to stay in place for 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.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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. 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 (eg, 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.

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.

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.

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

More common
Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chills
cold or flu-like symptoms
congestion
cough or hoarseness
difficult, burning, or painful urination
difficulty with breathing
dryness or soreness of the throat
ear congestion
fever
frequent urge to urinate
headache
loss of ability to use or understand speech or language
loss of bladder control
loss of voice
lower back or side pain
pain or tenderness around the eyes and cheekbones
partial or slight paralysis
rapid weight gain
seizures
shakiness and unsteady walk
shortness of breath or troubled breathing
sneezing
sore throat
stuffy or runny nose
tender, swollen glands in the neck
tightness of the chest
tingling of the hands or feet
trouble swallowing
unsteadiness, trembling, or other problems with muscle control or coordination
unusual tiredness or weakness
unusual weight gain or loss
voice changes
Less common
Black, tarry stools
bleeding gums
dizziness
fast heartbeat
flushing or redness of the skin
hives, itching, or skin rash
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
unusual bleeding or bruising
unusually warm skin
Incidence not known
Abdominal or stomach pain or tenderness
blistering, peeling, or loosening of the skin
clay colored stools
decreased appetite
deep, dark purple bruise
diarrhea
joint or muscle pain
nausea or vomiting
red skin lesions, often with a purple center
red, irritated eyes
small red or purple spots on the skin
sores, ulcers, or white spots in the mouth or on the lips
yellow eyes or 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
Back pain
being forgetful
blurred vision
breast pain
change in walking and balance
clumsiness or unsteadiness
constipation
discouragement
fear or nervousness
feeling sad or empty
hair loss or thinning of the hair
irritability
lack or loss of strength
loss of interest or pleasure
problems with memory
sleepiness or unusual drowsiness
tiredness
trouble concentrating
trouble sleeping
weight loss
Less common
Change in taste or bad unusual or unpleasant (after) taste
changes in vision
difficulty with moving
double vision
dry skin
increased weight
mood or mental changes
muscle aching or cramping
muscle stiffness
seeing double
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.


Last Updated: 11/4/2014

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