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Temodal

temozolomide
Alkylating Agent FDA Approved 1999 (EU) Schering-Plough/MSD (EU brand)
Route
Oral
Half-Life
~1.8 hrs
FDA Approved
1999 (EU)
Manufacturer
Schering-Plough/MSD (EU b
1. Indications and Usage

Temodal is the European brand name for temozolomide (Temodar). Indicated for: Newly diagnosed glioblastoma multiforme (GBM) in adults with initial concomitant chemoradiotherapy followed by 6 cycles of maintenance temozolomide. Recurrent/progressive malignant glioma (anaplastic astrocytoma) after standard therapy.

2. Dosage and Administration

Concomitant phase: 75 mg/m² daily for 42 days with radiotherapy. Maintenance phase: 150–200 mg/m² daily for 5 days of 28-day cycle for 6 cycles.

5. Warnings and Precautions

Myelosuppression: Monitor CBC. Pneumocystis jiroveci Pneumonia (PCP): Prophylaxis required during concomitant phase. Hepatotoxicity: Monitor LFTs. Embryo-Fetal Toxicity.

6. Adverse Reactions
Most Common Adverse Reactions

Nausea (49%), fatigue (45%), vomiting (29%), headache (25%), constipation (23%), anorexia (19%), thrombocytopenia (19%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

12. Clinical Pharmacology
Mechanism of Action

Temozolomide is an imidazotetrazine derivative that undergoes rapid chemical conversion at physiologic pH to the reactive alkylating agent MTIC. MTIC methylates DNA predominantly at the O6 and N7 positions of guanine, causing DNA strand breaks and triggering apoptosis. Methylation silencing of the MGMT gene promoter predicts benefit from temozolomide.

Pharmacokinetics

Half-life: ~1.8 hrs. Route: Oral. Refer to the full prescribing information for complete pharmacokinetic data.

14. Clinical Studies
Pivotal Clinical Trials
EORTC/NCIC GBM Trial
Temozolomide + RT vs RT alone in newly diagnosed GBM. Phase III, n=573.
NCT00006353 ↗

Clinical efficacy and safety data are available in the full prescribing information and referenced publications.

External Resources

Frequently Asked Questions

What is Temodal (temozolomide) approved for?

Temodal is the European brand name for temozolomide (Temodar). Indicated for: Newly diagnosed glioblastoma multiforme (GBM) in adults with initial concomitant chemoradiotherapy followed by 6 cycles of maintenance temozolomide. Recurrent/progressive malignant glioma (anaplastic astrocytoma) after standard therapy.

How does Temodal (temozolomide) work?

Temozolomide is an imidazotetrazine derivative that undergoes rapid chemical conversion at physiologic pH to the reactive alkylating agent MTIC. MTIC methylates DNA predominantly at the O6 and N7 positions of guanine, causing DNA strand breaks and triggering apoptosis. Methylation silencing of the MGMT gene promoter predicts benefit from temozolomide.

What are the most common side effects?

Nausea (49%), fatigue (45%), vomiting (29%), headache (25%), constipation (23%), anorexia (19%), thrombocytopenia (19%)

View by Tumor Type
Brain Cancer
Medical Disclaimer: This page is intended as a navigational reference to FDA prescribing information. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions.