Temozolomide (Intravenous)

Temozolomide injection is used to treat certain types of brain cancer (such as glioblastoma multiforme and anaplastic astrocytoma) in patients whose tumors have returned or who have just been diagnosed. It is part of a group of medicines called antineoplastics (cancer medicines).

Temozolomide works by interfering with the growth of cancer cells, which are then destroyed by the body. Because temozolomide injection can also affect the growth of normal body cells, it may cause other side effects. Some of these side effects could be serious and need to be reported to your doctor. Some side effects might not show up for months or years after using the medicine.

Before starting treatment with temozolomide injection, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for side 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 perform tests to confirm you are not pregnant before you receive 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 can become pregnant should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you may be pregnant, tell your doctor right away.

Temozolomide injection can temporarily reduce the number of white blood cells in your blood, which increases the chance of getting an infection (such as pneumonia). It can also lower the number of platelets, which are needed for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, shortness of breath, or unusual bleeding or bruising.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Talk to your 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 cautious when using sharp objects such as a safety razor or fingernail or toenail cutters to avoid cutting yourself.
• Avoid contact sports or other activities where bruising or injury could happen.

Contact your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could be signs of a serious liver issue.

This medicine may cause serious lung or breathing problems (such as pneumonia). Contact your doctor immediately if you have chest pain or tightness, cough, fever or chills, sneezing, sore throat, or trouble breathing.

This medicine may increase the risk of blood issues and secondary cancer (such as myeloid leukemia). Contact 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 last dose of this medicine.

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

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of temozolomide injection in children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies on how age affects the use of temozolomide injection in older adults have not been performed, but age-related problems are not expected to limit its usefulness in the elderly. However, older patients are more likely to have kidney, liver, or heart issues, which may require caution and possible dose adjustments for those receiving temozolomide injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, others may be used together even if there is a possible interaction. In such cases, your doctor may need to adjust the dose or take other precautions. It's very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may influence how this medicine works. Make sure you inform your doctor about any other medical issues you have, especially:

• Bone marrow problems (e.g., anemia, leukemia, myelodysplastic syndrome, pancytopenia, thrombocytopenia) or
• Liver problems—Use with caution. May worsen these conditions.

• Infection—May reduce your body's ability to fight infections.

• Severe kidney disease or
• Severe liver disease—Use with caution.

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.

In the U.S.

• Temodar

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Imidazole Carboxamide

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.

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