Temodar

DRUG DESCRIPTION

TEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:

TEMODAR (temozolomide) Structural Formula Illustration

The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH ( < 5) and labile at pH > 7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.

TEMODAR Capsules

Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for TEMODAR Capsules are as follows:

TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg).

TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg).

TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg).

TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartarlc acid (4.2 mg), and stearlc acid (8.4 mg).

TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartarlc acid (5.4 mg), and stearlc acid (10.8 mg).

TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearicacid (13.5 mg).

The body of the capsules are made of gelatin, and are opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide.

TEMODAR 5 mg: The green cap contains gelatin, titanium dioxide, iron oxide yellow, sodium lauryl sulfate, and FD&C Blue #2.

TEMODAR 20 mg: The yellow cap contains gelatin, sodium lauryl sulfate, and iron oxide yellow.

TEMODAR 100 mg: The pink cap contains gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide red.

TEMODAR 140 mg: The blue cap contains gelatin, sodium lauryl sulfate, and FD&C Blue #2.

TEMODAR 180 mg: The orange cap contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, and sodium lauryl sulfate.

TEMODAR 250 mg: The white cap contains gelatin, titanium dioxide, and sodium lauryl sulfate.

TEMODAR for Injection: Each vial contains 100 mg of sterile and pyrogen-free temozolomide lyophilized powder for intravenous injection. The inactive ingredients are: mannitol (600 mg), L-threonine (160 mg), polysorbate 80 (120 mg), sodium citrate dihydrate (235 mg), and hydrochloric acid (160mg).

What are the possible side effects of temozolomide (Temodar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • numbness or tingling on one side of your body;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, unusual weakness;
  • dry cough,...

Read All Potential Side Effects and See Pictures of Temodar

What are the precautions when taking temozolomide (Temodar)?

Before taking temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, decreased bone marrow function, blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or...

Read All Potential Precautions of Temodar


Temodar Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, and headache may occur. Nausea and vomiting can be quite severe. Drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mouth sores, swelling of the ankles/feet, easy bleeding or bruising, shortness of breath.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as: fever, chills, persistent sore throat, cough, burning/painful/frequent urination.

Although temozolomide is used to treat cancer, very rarely in some patients it may increase the risk of developing another form of cancer (of the bone marrow). Consult your doctor for more details. Tell your doctor immediately if you develop: swollen glands, unexplained or sudden weight loss, night sweats.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, decreased bone marrow function, blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.

Wash your hands well to prevent the spread of infections.

The elderly may be more sensitive to the side effects of this drug, especially the increased risk of infection and easy bruising/bleeding.

Women may be more sensitive to the side effects of this drug, especially the increased risk of infection and easy bruising/bleeding.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use two effective forms of birth control (e.g., condoms and birth control pills) during treatment with this drug and for some time afterwards. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known if this drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Temodar Patient Information Including Side Effects

Brand Names: Temodar

Generic Name: temozolomide (oral) (Pronunciation: TEM oh ZOE loe mide)

  • What is temozolomide (Temodar)?
  • What are the possible side effects of temozolomide (Temodar)?
  • What is the most important information I should know about temozolomide (Temodar)?
  • What should I discuss with my healthcare provider before taking temozolomide (Temodar)?
  • How should I take temozolomide (Temodar)?
  • What happens if I miss a dose (Temodar)?
  • What happens if I overdose (Temodar)?
  • What should I avoid while taking temozolomide (Temodar)?
  • What other drugs will affect temozolomide (Temodar)?
  • Where can I get more information?

What is temozolomide (Temodar)?

Temozolomide interferes with the development of cancer cells, slowing their growth and spread in the body.

Temozolomide is used together with radiation therapy to treat certain types of brain tumor in adults.

Temozolomide is sometimes given after other cancer medications have been tried without successful treatment of the tumor.

Temozolomide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of temozolomide (Temodar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • numbness or tingling on one side of your body;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, unusual weakness;
  • dry cough, feeling short of breath, weight loss, night sweats;
  • pain or burning when you urinate; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • hair loss;
  • tired feeling;
  • diarrhea, constipation;
  • mild skin rash;
  • dizziness, blurred vision;
  • sleep problems (insomnia); or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about temozolomide (Temodar)?

Do not this medication if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome). Before taking temozolomide, tell your doctor if you have liver or kidney disease.

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not open the temozolomide capsule, or use a capsule that has been accidentally broken. The powder inside the capsule can be dangerous if you accidentally inhale it or if it gets in your eyes, mouth, or nose, or on your skin. If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of it. Rinse off any medicine that gets on your skin or in your eyes, nose, or mouth.

Temozolomide is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends. There may be periods of time when you will take temozolomide for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor's instructions carefully.

Your doctor may occasionally change your dose to make sure you get the best results from this medication. The size, color, and number of temozolomide capsules you take may be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact your doctor or pharmacist if you have any questions.

Taking temozolomide may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk.

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