Temozol 20

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What Is Temozol?

Temozol is an oral capsule from Cipla containing temozolomide (20 mg). Temozolomide is an oral alkylating cytotoxic agent of the imidazotetrazine class. It crosses the blood-brain barrier (CSF concentration ~30% of plasma) and is the only oral cytotoxic with proven survival benefit in glioblastoma multiforme. Standard combination with radiotherapy (the “Stupp protocol”, 2005) extended median GBM survival from 12 months to 15 months and 2-year survival from 11% to 27%.

— det forstærker den normale fysiologiske respons snarere end at udløse en kunstigt.

• Newly-diagnosed glioblastoma multiforme (GBM) — concurrent with radiotherapy then maintenance (Stupp protocol)
• Anaplastic astrocytoma after recurrence
• Recurrent high-grade glioma
• Off-label: melanoma brain metastases, neuroendocrine tumours

Dosage (Stupp protocol)

• Concurrent phase: 75 mg/m²/day continuously during 6 weeks of radiotherapy (total ~42 days)
• 4-week break after radiotherapy completion
• Maintenance phase: 150 mg/m²/day for days 1–5 of a 28-day cycle (cycle 1); escalate to 200 mg/m²/day if tolerated for cycles 2–6 (total 6 cycles, with newer evidence supporting up to 12 cycles in younger MGMT-methylated patients)

1. Take on an empty stomach at the same time each day — food slows absorption and reduces peak concentration. Most patients take it at bedtime, ≥ 2 hours after the last meal.
2. Antiemetic: ondansetron 8 mg orally 1 hour before each temozolomide dose, especially during the maintenance phase 5-day pulse.
3. Swallow capsules whole with water. Do NOT open or chew — powder is cytotoxic.
4. PCP prophylaxis with co-trimoxazole 480 mg three times weekly during the concurrent phase — lymphopenia risk. Continue until CD4 > 200 cells/µL.
5. Mandatory monitoring: FBC weekly during concurrent phase; before each maintenance cycle (day 22 of previous cycle and day 1 of each new cycle); LFTs monthly. Hold cycle for ANC < 1,500/µL or platelets < 100,000/µL.
6. If a dose is vomited within 1 hour, do NOT re-dose. Resume next day per schedule.

Bivirkninger

Almindelige: nausea, vomiting (mostly preventable with ondansetron), fatigue, anorexia, constipation, headache, alopecia.

Vigtigt:

• Myelosuppression — especially thrombocytopenia (the dose-limiting toxicity); lymphopenia with PCP risk
• Pneumocystis jirovecii pneumonia — lymphopenia-driven; mandatory prophylaxis during concurrent phase
• Hepatotoxicity, including rare reactivation of hepatitis B
• Severe skin reactions including SJS/TEN (rare)
• Secondary myelodysplastic syndrome / acute leukaemia (rare, long-term)
• Severe lymphopenia > 6 months

Advarsler

• Graviditet: teratogenic. Reliable contraception throughout treatment + 6 months after.
• Amning: avoid.
• Svær leversvigt: avoid.
• Hepatitis B carrier status: screen and consider antiviral prophylaxis — reactivation risk.
• Live vaccines: contraindicated.
• Severe lymphopenia / CD4 < 200: continue PCP prophylaxis until lymphocyte recovery.

Lægemiddelinteraktioner

Opbevaring

• Room temperature, 15–30°C, original blister.
• Out of reach of children, women of childbearing potential, and pets — cytotoxic powder.

Relaterede alternativer på MedsBase

Other oncology medications stocked alongside this product:

• Endoxan (cyclophosphamide 50 mg)
• Celkeran (chlorambucil 2 / 5 mg)
• Temotero (temozolomide 20 / 100 mg)
• Lomoother (lomustine 40 mg)
• Endace (megestrol 40 / 160 mg)

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Ofte stillede spørgsmål

What is the Stupp protocol?

The Stupp protocol (2005) is the standard combined chemoradiotherapy regimen for newly-diagnosed glioblastoma multiforme: radiotherapy (60 Gy in 30 fractions) + concurrent temozolomide (75 mg/m²/day) for 6 weeks, then 4-week break, then maintenance temozolomide (150–200 mg/m²/day for days 1–5 of each 28-day cycle) for 6 cycles. The protocol extended median survival from 12 to 15 months and remains the global standard in 2026.

Why must I take Temozol on an empty stomach?

Food slows temozolomide absorption and reduces peak plasma concentration. For consistent dosing, take temozolomide at the same time each day with no food for at least 2 hours before. Most patients take it at bedtime ≥ 2 hours after the last meal. Take ondansetron 8 mg orally 1 hour before each dose to prevent nausea.

Why do I need PCP prophylaxis?

The continuous 6-week concurrent phase causes prolonged lymphopenia — particularly low CD4 counts — that creates a real risk of Pneumocystis jirovecii pneumonia (PCP), a potentially fatal opportunistic infection. Standard prophylaxis: co-trimoxazole 480 mg three times weekly throughout concurrent phase, continued until CD4 recovery (often takes 6+ months).

What does “MGMT methylation” mean for my treatment?

MGMT (O6-methylguanine-DNA methyltransferase) is a DNA repair enzyme that undoes temozolomide's alkylation damage. MGMT-methylated tumours have low MGMT expression — they cannot repair the damage, so respond much better to temozolomide. MGMT-unmethylated tumours have high MGMT expression and are relatively temozolomide-resistant. MGMT status is determined on the surgical biopsy and influences treatment intensity (longer maintenance, more aggressive regimens) and prognosis.

What blood tests do I need?

FBC weekly during the concurrent radiotherapy phase. Before each maintenance cycle: FBC on day 22 of the previous cycle and day 1 of the new cycle. LFTs monthly. Hold cycle for ANC < 1,500/µL or platelets < 100,000/µL — thrombocytopenia is the dose-limiting toxicity.

What if I vomit a dose?

If you vomit within 1 hour of taking Temozol, do NOT re-dose — the safety risk of double-dosing is greater than the modest loss of efficacy from one missed dose. Resume the next dose at the scheduled time. Speak to your oncology team about pre-medication adjustment if vomiting recurs.

Can I drink alcohol on Temozol?

Avoid during active treatment. Both alcohol and temozolomide are hepatotoxic, and alcohol increases nausea. Even after treatment finishes, limit alcohol given the hepatic and bone marrow recovery period.

Will Temozol cure my brain tumour?

Glioblastoma multiforme remains one of the most aggressive cancers. The Stupp protocol is the established standard and improves median survival, but cure is uncommon at present. Specific situations carry better prognosis: younger age, MGMT methylation, complete surgical resection, IDH mutation. Discuss prognosis honestly with your neuro-oncologist — treatment goals depend on individual disease characteristics.

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Related Anti-Cancer Medications

Other oncology medications stocked alongside this product:

• Temotero (temozolomide 100/250 mg)
• Lomoother (lomustine 40 mg)
• Endoxan (cyclophosphamide 50 mg)
• Hydrosar (hydroxyurea 500 mg)
• Folitrax (methotrexate 2.5/7.5/10 mg)

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