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—

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.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

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.

This medicine may cause birth defects if either partner is using it during conception or pregnancy. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment and for at least 6 months after your last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant, 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.

This medicine may cause serious lung or breathing problems (eg, pneumonia). Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, sneezing, sore throat, or trouble breathing.

This medicine may increase risk of blood problems and secondary cancer (eg, myeloid leukemia). Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Male patients should not donate semen during treatment and for at least 3 months after the final dose of this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

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

chest tightness

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

sneezing

sore throat

stuffy or runny nose

tender, swollen glands in the neck

tingling of the hands or feet

trouble swallowing

troubled breathing

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

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

stomach pain or tenderness

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

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.