Temozolomide is an alkylating drug indicated for the treatment of adults with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment, among other approved uses. MedsAcross supplies Temozolomide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Anaplastic astrocytoma. Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. Treatment of adults with refractory anaplastic astrocytoma.
Source: US FDA prescribing information
Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to DNA alkylation, mainly at the O 6 and N 7 positions of guanine, which causes DNA double strand breaks and results in programmed cell death.
Source: US FDA prescribing information
Administer either orally or intravenously. Newly Diagnosed Glioblastoma: 75 mg/m 2 once daily for 42 to 49 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m 2 once daily for Days 1 to 5 of each 28-day cycle for 6 cycles. May increase maintenance dose to 200 mg/m 2 for Cycles 2 to 6 based on toxicity. Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to Grade 1 or less. Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma: Beginning 4 weeks after the end of radiotherapy, administer TEMODAR orally in a single dose on days 1-5 of a 28-day cycle for 12 cycles. The recommended dosage for Cycle 1 is 150 mg/m 2 per day and for Cycles 2 to 12 is 200 mg/m 2 if patient experienced no or minimal toxicity in Cycle 1.
Source: US FDA prescribing information
TEMODAR is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in TEMODAR, and dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMODAR have included anaphylaxis. History of serious hypersensitivity to temozolomide or any other ingredients in TEMODAR and dacarbazine.
Source: US FDA prescribing information
Myelosuppression: Monitor absolute neutrophil count (ANC) and platelet count prior to each cycle and during treatment. Geriatric patients and women have a higher risk of developing myelosuppression. Hepatotoxicity: Fatal and severe hepatotoxicity have been reported. Perform liver tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately 2 to 4 weeks after the last dose of TEMODAR. Pneumocystis Pneumonia (PCP): Closely monitor all patients, particularly those receiving steroids, for the development of lymphopenia and PCP. Secondary Malignancies: Myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression Hepatotoxicity Pneumocystis Pneumonia Secondary Malignancies The most common adverse reactions (≥20%) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions. The most common Grade 3 to 4 hematologic laboratory abnormalities (≥10%) in patients with anaplastic astrocytoma are: decreased lymphocytes, decreased platelets, decreased neutrophils, and decreased leukocytes.
Source: US FDA prescribing information
Store TEMODAR Capsules at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store TEMODAR for injection refrigerated at 2°C to 8°C (36°F to 46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
13 presentations of Temozolomide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Temozolomide 100 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temozolomide 140 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temozolomide 180 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temozolomide 20 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temozolomide 5 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temozolomide 250 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temodar 100 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 140 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 180 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 20 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 5 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 2.5 mg/mL powder for injectionIntravenous Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
| Temodar 250 mg capsuleOral Cold chain | Merck Sharp & Dohme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Temozolomide in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 13 presentations of Temozolomide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Temozolomide, including Temodar.
Yes. The US FDA first approved Temozolomide on 11 August 1999, according to Drugs@FDA.
Yes. Temozolomide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Temozolomide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Temozolomide is classified under ATC code L01AX03 (Temozolomide).
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