Temozolomide

The recommended dose of 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 temozolomide may change depending on the test results.

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, temozolomide is given daily along with radiation for 42 days. 4 weeks after radiation is complete, 6 cycles of 28 days of treatment with temozolomide are started.

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 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 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 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause nausea and vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each green and white, size 3, EHG capsule, imprinted "TMZ" on cap and "5" on body, contains 5 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, FD & C Blue No. 2, and yellow iron oxide.

20 mg
Each yellow and white, size 5, EHG capsule, imprinted "TMZ" on cap and "20" on body, contains 20 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and yellow iron oxide.

100 mg
Each pink and white, size 3, EHG capsule, imprinted "TMZ" on cap and "100" on body, contains 100 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and red iron oxide.

140 mg
Each transparent blue and white, size 1, EHG capsule, imprinted "TMZ" on cap and "140" on body, contains 140 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and FD & C Blue No. 2.

180 mg
Each maroon and white, size 1, EHG capsule, imprinted "TMZ" on cap and "180" on body, contains 180 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and yellow and red iron oxides.

250 mg
Each white and white, size 0, EHG capsule, imprinted "TMZ" on cap and "250" on body, contains 250 mg of temozolomide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose anhydrous, sodium starch glycolate, stearic acid, and tartaric acid; capsule shells: gelatin and titanium dioxide; ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.

Do not use Temozolomide if you:

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

There may be an interaction between 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 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 Temozolomide.

Birth defects: 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 temozolomide, you should not father a child during treatment and for up to 6 months after treatment.

Blood disorders: 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 Temozolomide. Your doctor will arrange periodic blood testing to monitor various blood components.

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

Kidney function: The safety and effectiveness of using 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: Temozolomide may reduce liver function and can cause liver failure, including death. If you have liver problems, discuss with your doctor how Temozolomide may affect your medical condition, how your medical condition may affect the dosing and effectiveness of 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 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 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 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 temozolomide daily along with radiation, your doctor will prescribe medication to help prevent PCP.

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

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

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

Children: The safety and effectiveness of using 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.

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. This medication is generally administered in a cyclical regimen that includes a period of use followed by a period of rest. To obtain the full benefits, it is important to complete each treatment cycle unless otherwise directed by your healthcare professional. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. The capsule of this medication should not be opened, crushed or chewed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication should not be taken with food. It is best taken on an empty stomach, one hour before or 2 hours after a meal.