1. Clinical & Scientific Overview
Temozolomide (TIP-MED-000552, Reference Code [ONC-03]) is classified under
Oncology & Antineoplastic Medicines as a Alkylating / Methylating Agent • Imidazotetrazine Oral DNA Methylating Agent.
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Temodal (MSD Pharmaceuticals), Temoside (Cipla Ltd), Gliotem (Sun Pharma)
Hard Gelatin Capsule: 5 mg, 20 mg, 100 mg, 140 mg, 250 mg
Oncology Specialisation & Cytotoxic Safety Protocol
Alkylating / Methylating Agent
Antineoplastic Cytotoxic
Standard Regimen & Cycle Context: Stupp Concomitant Phase: 75 mg/m2 orally daily for 42 days with focal radiotherapy; Adjuvant Phase: 150–200 mg/m2 orally on Days 1–5 of each 28-day cycle for 6 cycles.
Signature Dose-Limiting Toxicities & Organ Monitoring: Myelosuppression (nadir at Days 21–28), lymphopenia-induced Pneumocystis jirovecii pneumonia (PCP — mandatory cotrimoxazole prophylaxis during concomitant chemoradiation), hepatotoxicity, and nausea/vomiting.
Extravasation, Premedication & Safe Cytotoxic Handling: Swallow capsules whole on an empty stomach at bedtime (1 hour before or 2 hours after food) with an antiemetic (ondansetron) 30–60 minutes prior; NEVER open or chew capsules (cytotoxic powder inhalation hazard).
3. Mechanism of Action & Pharmacodynamics
Undergoes spontaneous non-enzymatic hydrolysis at physiological pH (7.4) to active MTIC, which methylates DNA guanine at O6 (most cytotoxic lesion; repaired if MGMT enzyme is unmethylated) and N7 positions, triggering futile mismatch repair and apoptosis; crosses the blood-brain barrier (CSF = 20–30% of plasma).
4. Therapeutic Indications & Evidence-Supported Uses
- Newly diagnosed Glioblastoma Multiforme (GBM — Stupp protocol concomitant with radiotherapy, then adjuvant)
- Refractory anaplastic astrocytoma
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Educational Oncology Regimen Context (Specialist Reference Only): Stupp Concomitant Phase: 75 mg/m2 orally daily for 42 days with focal radiotherapy; Adjuvant Phase: 150–200 mg/m2 orally on Days 1–5 of each 28-day cycle for 6 cycles.
Administration & Meal Timing: Stupp Concomitant Phase: 75 mg/m2 orally daily for 42 days with focal radiotherapy; Adjuvant Phase: 150–200 mg/m2 orally on Days 1–5 of each 28-day cycle for 6 cycles.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Specialist oncology pharmacokinetic profile; dosing depends on Body Surface Area (BSA in m2), Calvert GFR formula, or flat targeted dosing with strict organ-function adjustments.
Hepatic enzymatic activation/inactivation or proteolytic degradation (for monoclonal antibodies); see specific polymorphism and interaction notes.
Verify serum creatinine and eGFR before every cycle; see drug-specific renal dosing and uroprotection rules.
Check total bilirubin, AST, and ALT prior to each cycle; taxanes, anthracyclines, and TKIs require strict hepatic dose modification.
7. Contraindications, Precautions & High-Risk Warnings
- Severe hypersensitivity to Temozolomide or formulation vehicle
- Pregnancy and lactation (potent teratogen/embryotoxic class warning unless explicitly evaluated by oncology specialist)
- Severe unrecovered bone marrow aplasia or decompensated organ failure per protocol thresholds
Key Clinical Precautions: Myelosuppression (nadir at Days 21–28), lymphopenia-induced Pneumocystis jirovecii pneumonia (PCP — mandatory cotrimoxazole prophylaxis during concomitant chemoradiation), hepatotoxicity, and nausea/vomiting.
8. Adverse Effects Profile
- Myelosuppression (nadir at Days 21–28), lymphopenia-induced Pneumocystis jirovecii pneumonia (PCP — mandatory cotrimoxazole prophylaxis during concomitant chemoradiation), hepatotoxicity, and nausea/vomiting.
- Myelosuppression (nadir at Days 21–28), lymphopenia-induced Pneumocystis jirovecii pneumonia (PCP — mandatory cotrimoxazole prophylaxis during concomitant chemoradiation), hepatotoxicity, and nausea/vomiting.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Myelosuppression (nadir at Days 21–28), lymphopenia-induced Pneumocystis jirovecii pneumonia (PCP — mandatory cotrimoxazole prophylaxis during concomitant chemoradiation), hepatotoxicity, and nausea/vomiting.
- Avoid live-attenuated vaccines during immunosuppressive chemotherapy; verify CYP3A4, UGT1A1, DPD, and QTc interactions before each cycle.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Swallow capsules whole on an empty stomach at bedtime (1 hour before or 2 hours after food) with an antiemetic (ondansetron) 30–60 minutes prior; NEVER open or chew capsules (cytotoxic powder inhalation hazard).
Pharmacist Patient Counselling Points:
- Swallow capsules whole on an empty stomach at bedtime (1 hour before or 2 hours after food) with an antiemetic (ondansetron) 30–60 minutes prior; NEVER open or chew capsules (cytotoxic powder inhalation hazard).
- Report fever >=38.0°C (100.4°F) immediately (medical emergency: possible febrile neutropenia).
- Follow strict reproductive contraception and safe cytotoxic oral handling instructions.
Storage, Stability & Dispensing Safeguards: Swallow capsules whole on an empty stomach at bedtime (1 hour before or 2 hours after food) with an antiemetic (ondansetron) 30–60 minutes prior; NEVER open or chew capsules (cytotoxic powder inhalation hazard).
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: National Cancer Grid (NCG) India Consensus Guidelines; NLEM 2022 Antineoplastic Section; Indian Pharmacopoeia (IP) & CDSCO Approved Oncology Prescribing Information.
Official Verification Portals: National Cancer Grid (NCG) India — Evidence-Based Oncology Guidelines • CDSCO — Central Drugs Standard Control Organization Approved Drug Data • Indian Pharmacopoeia Commission (IPC)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
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