Temodal

The recommended dose of Temodal (Temozolomide) varies according to body surface area, and takes into account whether you have been previously treated with chemotherapy. Before each new cycle of treatment, your blood will be tested and your dose of Temodal (Temozolomide) may change depending on the test results.

Temodal (Temozolomide) is normally taken once a day for 5 days followed by a rest period of 23 days. This 28-day cycle is repeated until treatment is complete, as assessed by your doctor.

For a specific type of newly diagnosed brain tumour called glioblastoma multiforme, Temodal (Temozolomide) is given daily along with radiation for 42 days. 4 weeks after radiation is complete, 6 cycles of 28 days of treatment with Temodal (Temozolomide) are started.

Temodal (Temozolomide) capsules should be swallowed whole, with a full glass of water at least one hour before a meal. Do not open or chew the capsules. In case of accidental contact with the capsule contents, flush the area with water.

Antinausea medications can be taken just before or after Temodal (Temozolomide) to help reduce the risk of vomiting. If vomiting occurs after taking the medication, do not take a second dose. Contact your doctor for further instructions.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Temodal (Temozolomide) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, check with your doctor. Do not take a double dose to make up for a missed one, unless your doctor tells you to do so.

Store Temodal (Temozolomide) at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Capsules

5 mg
Each size 3 capsule, with opaque green cap and opaque white body, the cap imprinted in black ink with "TEMODAL", the body imprinted in black ink with 2 stripes, "5 mg", and the Schering-Plough logo, contains 5 mg of Temodal (Temozolomide). Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells: FD&C Blue No. 2, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide; ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide, and sometimes potassium hydroxide.

20 mg
Each size 2 capsule, with yellow cap and opaque white body, the cap imprinted in black ink with "TEMODAL", the body imprinted in black ink with 2 stripes, "20 mg", and Schering-Plough logo, contains 20 mg of Temodal (Temozolomide). Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells: gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide; ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide, and sometimes potassium hydroxide.

100 mg
Each size 1 capsule, with opaque pink cap and opaque white body, the cap imprinted in black ink with "TEMODAL", the body imprinted in black ink with 2 stripes, "100 mg", and the Schering-Plough logo, contains 100 mg of Temodal (Temozolomide). Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells: gelatin, sodium lauryl sulfate, red iron oxide and titanium dioxide; ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide, and sometimes potassium hydroxide.

140 mg
Each size 0 capsules with a blue cap and opaque white body, the cap imprinted in black ink with "TEMODAL'', the body imprinted in black ink with 2 stripes, "140 mg", and the Schering-Plough logo, contains 140 mg of Temodal (Temozolomide). Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells: FD&C blue No. 2, gelatin, sodium lauryl sulfate and titanium dioxide; ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide, and sometimes potassium hydroxide.

250 mg
Each size 0 capsule, with opaque white cap and opaque white body, the cap imprinted in black ink with "TEMODAL", the body imprinted in black ink with 2 stripes, "250 mg" and the Schering-Plough logo, contains 250 mg of Temodal (Temozolomide). Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid; capsule shells: gelatin, sodium lauryl sulfate and titanium dioxide; ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide, and sometimes potassium hydroxide.

Do not use Temodal (Temozolomide) if you:

• are allergic to Temodal (Temozolomide) or any ingredients of Temodal (Temozolomide)
• are allergic to Dacarbazine (DTIC)
• have severely reduced bone marrow function

There may be an interaction between Temodal (Temozolomide) and any of the following:

• amphotericin B
• bacillus Calmette-Guérin (BCG vaccine)
• Clozapine
• Deferiprone
• Denosumab
• dipyrone
• echinacea
• Fingolimod
• Leflunomide
• Natalizumab
• Nivolumab
• other medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Pimecrolimus
• Roflumilast
• Tacrolimus
• Trastuzumab
• vaccines
• Valproic acid

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Temodal (Temozolomide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Temodal (Temozolomide).

Birth defects: Temodal (Temozolomide) can have genotoxic effects, meaning that it may damage the genetic material contained in sperm. This could lead to birth defects. If you are a man being treated with Temodal (Temozolomide), you should not father a child during treatment and for up to 6 months after treatment.

Blood disorders: Temodal (Temozolomide) can cause the levels of certain blood cells to drop. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, chills, easy bruising, paleness, or bleeding (symptoms may include black and tarry stools, blood in the urine, or cuts that won't stop bleeding) while taking Temodal (Temozolomide). Your doctor will arrange periodic blood testing to monitor various blood components.

Hepatitis B infection: Temodal (Temozolomide) has been linked to reactivation of Hepatitis B infection. If you have had hepatitis B in the past discuss with your doctor how Temodal (Temozolomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Temodal (Temozolomide), and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of using Temodal (Temozolomide) have not been established for people with kidney problems. You should be closely monitored by your doctor if you have kidney problems.

Liver function: Temodal (Temozolomide) may reduce liver function and can cause liver failure, including death. If you have liver problems, discuss with your doctor how Temodal (Temozolomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Temodal (Temozolomide), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Temodal (Temozolomide).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain, or swelling, and itchy skin, contact your doctor immediately.

Male infertility: Irreversible infertility may result from treatment with Temodal (Temozolomide). Therefore, men who may want to father a child in the future should seek advice on cryoconservation (freezing for long-term storage) of sperm prior to starting treatment.

Pneumocystis carinii pneumonia (PCP): People who take Temodal (Temozolomide) daily along with radiation may be at a higher risk of developing a serious form of pneumonia called Pneumocystis carinii pneumonia (PCP). If you are taking Temodal (Temozolomide) daily along with radiation, your doctor will prescribe medication to help prevent PCP.

Vomiting: Nausea and vomiting are very common with Temodal (Temozolomide) treatment. Antinausea medications taken before or after taking Temodal (Temozolomide) may be recommended.

Pregnancy: Temodal (Temozolomide) may harm the baby if used during pregnancy. Women should avoid becoming pregnant while taking Temodal (Temozolomide). Use effective birth control while using Temodal (Temozolomide) and for 6 months after stopping the medication. Tell your doctor immediately if you become pregnant.

Breast-feeding: It is not known if Temodal (Temozolomide) passes into breast milk. It is recommended that women should stop breast-feeding while taking Temodal (Temozolomide).

Children: The safety and effectiveness of using Temodal (Temozolomide) have not been established for children.

Seniors: People over the age of 70 are more likely to experience a decrease in white blood cell counts or platelet cells. This can affect their body's ability to fight infection or their blood's ability to clot.