TM Owner Sun Pharma
Temozolomide 5mg Capsule
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Indications & Clinical Uses
- Temozolomide 5 mg capsules (generic temozolomide, manufactured by Sun Pharmaceutical Industries) is an alkylating chemotherapy of the imidazotetrazine class, approved as a generic equivalent of the originator brands Temodal (EU/international) and Temodar (US); these are the same active substance in different regional brand or generic form, not different drugs, though available strengths and pack sizes can differ between manufacturers.
- This generic is approved for adults with 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 disease that has failed prior chemotherapy.
- The 5 mg strength is one of six capsule strengths (5, 20, 100, 140, 180 and 250 mg) combined to make up an individually calculated daily dose based on body surface area, so patients often take more than one strength at once — the exact combination must never be assumed from the strength alone.
- It is prescribed only by oncology specialists.
Side Effects
- The most frequently reported side effects of temozolomide include hair loss, fatigue, nausea, vomiting, headache, constipation, loss of appetite and convulsions.
- This generic capsule carries no boxed warning, but myelosuppression — low white cells, platelets and red cells — is its dose-limiting toxicity, and older patients and women have a higher reported 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 skin or eyes, dark urine, or severe or persistent vomiting to your care team urgently.
- Secondary cancers, including leukaemia, have occurred months to years after treatment in some patients.
Precautions & Warnings
- This temozolomide capsule is contraindicated in anyone with known hypersensitivity to temozolomide or to dacarbazine, which shares the same active metabolite, and is prescribed only by clinicians experienced in treating brain tumours.
- Full blood counts are monitored weekly during any combined radiotherapy phase and before every later cycle, with liver function tested at the intervals described above.
- Pneumocystis pneumonia prophylaxis is recommended during the standard 42-day concomitant radiotherapy schedule.
- Temozolomide can cause fetal harm: women of reproductive potential must use effective contraception during treatment and for 6 months after the final dose, and male patients should use contraception for 3 months after their last dose.
- Because this 5 mg strength is normally combined with other strengths to reach the prescribed total dose, always check the full prescription before taking any capsules, swallow them whole on an empty stomach, and never open, crush or chew them.
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 with valproic acid or other commonly used anticonvulsants, but this should still be reviewed with your prescriber.
- Because temozolomide already suppresses bone marrow function, other drugs that lower blood counts or raise bleeding risk need closer monitoring when used together.
- Avoid live vaccines during treatment and for a period afterwards.
- Capsules must not be opened; anyone else handling a damaged capsule should avoid direct skin contact with the powder and wash the area thoroughly afterward.
References
Frequently Asked Questions
Generic temozolomide capsules treat adults with newly diagnosed glioblastoma, given with radiotherapy then alone, and anaplastic astrocytoma. They contain the same active substance as the brands Temodal and Temodar, made here by Sun Pharma as an approved generic version.
Swallow temozolomide capsules whole with water on an empty stomach, at a consistent time, ideally at bedtime. The 5mg strength is usually combined with other capsule strengths to reach your full prescribed dose, so always take every capsule listed on that day's prescription.
Common side effects of temozolomide include hair loss, fatigue, nausea, vomiting, headache, constipation and low blood counts. Report fever, infection, unusual bruising or bleeding, or yellowing of the skin or eyes to your care team urgently — these can signal serious blood or liver problems.
No, temozolomide capsules carry no boxed warning. The main risk is myelosuppression — low white cells, platelets and red cells — monitored with regular blood counts. Rare serious risks include liver damage, checked with liver tests, and secondary blood cancers occurring later.
Yes. This generic capsule contains the same temozolomide as the brands Temodar (US) and Temodal (EU/international). Strengths and pack sizes can differ between manufacturers, so always check the strength and quantity printed on your own pack against your prescription.
No. 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 any fertility concerns with your oncology team first.
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