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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 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.

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—

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—

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:

  • 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 of This Medicine:

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 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 (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 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 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
nasal congestion
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 or wheezing
tingling of the hands or feet
trouble with 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, redness of the skin
hives
itching
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash
unusual bleeding or bruising
unusually warm skin
Incidence not known
Deep, dark purple bruise
itching, pain, redness, or swelling
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
Abdominal or stomach pain
back pain
being forgetful
blurred vision
breast pain
change in walking and balance
clumsiness or unsteadiness
constipation
discouragement
dizziness
fear or nervousness
feeling sad or empty
hair loss or thinning of the hair
irritability
itching skin
lack or loss of strength
loss of appetite
loss of interest or pleasure
loss of memory
nausea or vomiting
problems with memory
sleepiness or unusual drowsiness
sleeplessness
tiredness
trouble concentrating
trouble sleeping
unable to sleep
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
joint pain
mood or mental changes
muscle aching or cramping
muscle pains or 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: 4/4/2014

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