TM Owner Merck & Co.
Temodar 250mg Capsule
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Indications & Clinical Uses
- Temodar 250 mg capsules (temozolomide) is an alkylating chemotherapy of the imidazotetrazine class and is the brand name used in the United States for temozolomide; the same molecule is sold as Temodal in Europe and internationally, and as generic temozolomide capsules, including the brand Temomedac, once patents expired — these are the same active substance in different regional brand or generic form, not different drugs.
- Temodar is approved in adults for newly diagnosed glioblastoma, given concomitantly with radiotherapy and then as maintenance monotherapy, and for anaplastic astrocytoma as adjuvant treatment of newly diagnosed disease or for refractory disease after prior chemotherapy.
- It remains FDA-approved and on the US market, with no withdrawal to report.
- An intravenous formulation is also available for patients temporarily unable to swallow capsules, at the same total dose, but it is a different formulation requiring different handling and is not simply interchangeable at home.
- Temodar is prescribed only by oncology specialists and taken on specific days of each treatment cycle.
Side Effects
- The most frequently reported side effects include hair loss (alopecia), fatigue, nausea, vomiting, headache, constipation, loss of appetite and convulsions.
- Temodar carries no boxed warning, but myelosuppression is its dose-limiting toxicity — low white cells, platelets and red cells — and the FDA label notes that older patients and women have a higher risk of severe myelosuppression, so blood counts are checked regularly.
- Hepatotoxicity, including rare fatal liver damage, has been reported; liver tests are done at baseline, midway through the first cycle, before each later cycle and again 2 to 4 weeks after the last dose.
- Report fever, infection, unusual bruising or bleeding, yellowing of the skin or eyes, dark urine, or severe or persistent vomiting to your care team urgently rather than waiting for a scheduled visit.
- Secondary cancers, including leukaemia, have occurred months to years after treatment in some patients.
Precautions & Warnings
- Temodar is contraindicated in anyone with a known hypersensitivity to temozolomide or to dacarbazine, which shares the same active metabolite.
- It is prescribed only by clinicians experienced in treating brain tumours, with full blood counts monitored weekly during the combined radiotherapy phase and before every later cycle, and liver function tested at the intervals described above.
- Pneumocystis pneumonia prophylaxis is recommended for patients on the 42-day concomitant radiotherapy schedule.
- Temodar can cause fetal harm: women of reproductive potential must use effective contraception during treatment and for 6 months after the final dose, and males with female partners should use contraception for 3 months after their last dose.
- Capsules must be swallowed whole on an empty stomach and never opened, crushed or chewed, since the contents are hazardous if inhaled or if they contact skin or mucous membranes; caregivers should avoid direct contact with capsule contents.
Avoid Interactions
- Tell your oncology team about every prescription and over-the-counter medicine, herbal product and supplement you take.
- Food reduces temozolomide absorption by about a third, so capsules are taken on an empty stomach at a consistent time, ideally at bedtime.
- No clinically significant pharmacokinetic interaction has been established between temozolomide and valproic acid or other commonly used anticonvulsants, but this should still be reviewed case by case with your prescriber.
- Because Temodar already suppresses bone marrow function, combining it with other drugs that lower blood counts or increase bleeding risk needs closer monitoring.
- Avoid live vaccines during treatment and for a period afterwards, since the immune response to them may be blunted.
- Capsules must not be opened; anyone else handling a spilled or damaged capsule should wear gloves and wash the area thoroughly afterward.
References
Frequently Asked Questions
Temodar (temozolomide) is a chemotherapy capsule for adults with newly diagnosed glioblastoma, given with radiotherapy then alone, and for anaplastic astrocytoma. It is the US brand of temozolomide; the same drug is sold as Temodal in Europe. It only treats these specific brain tumours.
Swallow Temodar capsules whole with water on an empty stomach, at the same time each day, ideally at bedtime. Never open, chew or crush them. Your dose and the number of capsules can change by day within a treatment cycle, so follow your personalised schedule exactly.
Common side effects of Temodar (temozolomide) include hair loss, fatigue, nausea, vomiting, headache, constipation and low blood counts. Older adults and women have a higher risk of severe myelosuppression. Report fever, infection, bruising, bleeding, or yellowing skin or eyes to your care team right away.
No, Temodar (temozolomide) has no boxed warning. Its key risks are myelosuppression, monitored with regular blood counts, and rare but serious liver damage, checked with liver tests before, during and after each cycle. Secondary blood cancers have occurred years after treatment in some patients.
Temodar is usually given for about 6 weeks alongside radiotherapy for new glioblastoma, followed by up to 6 further monthly maintenance cycles, though your oncologist may extend or shorten this based on response and blood counts. For anaplastic astrocytoma, cycles typically repeat every 28 days.
No. Temodar (temozolomide) can harm an unborn baby, so women of reproductive potential need effective contraception during treatment and for 6 months after the last dose; male patients should use contraception for 3 months after theirs. Discuss fertility concerns with your oncology team before starting.
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