Temodar (Intravenous)

Temozolomide injection is used to treat certain types of brain cancer, such as glioblastoma multiforme and anaplastic astrocytoma, in patients whose tumors have come back or are newly 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. Since normal body cells may also be affected by temozolomide injection, there may be other side effects. Some of these side effects can be serious and should be reported to your doctor. Some side effects might not appear for months or years after using the medicine.

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

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

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to look 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 perform tests to confirm that 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, inform your doctor right away.

Temozolomide injection can temporarily reduce the number of white blood cells in your blood, which increases the risk of getting an infection (for example, 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 experience 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 or tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other methods to clean your teeth and gums. Consult your medical doctor before having any dental procedures 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 between.
• Be careful not to cut yourself when using sharp objects such as safety razors or fingernail or toenail clippers.
• Avoid contact sports or other situations 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 problem.

This medicine may cause serious lung or breathing issues (for example, pneumonia). Contact 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 the risk of blood problems and secondary cancer (for example, 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, speak 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 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 need to consider the risks of the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Let your doctor know if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how temozolomide injection affects children. Safety and effectiveness have not been confirmed.

Geriatric

There have not been appropriate studies on how temozolomide injection affects older adults, but there are no expected age-related problems that would limit its use in the elderly. However, older patients are more likely to have kidney, liver, or heart issues related to age, which may require careful monitoring and possible dose adjustments when using 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 and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It’s especially important for your healthcare professional to know if you are taking any of the medicines listed below when receiving this medicine. The following interactions have been chosen for their potential significance and may not cover all possible interactions.

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

• 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 generally not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both 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 certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues, especially:

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