Temotero

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What Is Temotero?

Temotero is an oral capsule from Glenmark containing temozolomide (20 mg and 100 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%.

Käyttö ja indikaatiot

• 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
• Ylläpitovaihe: 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-profilaksia with co-trimoxazole 480 mg three times weekly during the concurrent phase — lymphopenia risk. Continue until CD4 > 200 cells/µL.
5. Pakollinen seuranta: 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.

Haittavaikutukset

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

Tärkeää:

• Mielosuppressio — especially thrombocytopenia (the dose-limiting toxicity); lymphopenia with PCP risk
• Pneumocystis jirovecii -keuhkokuume — 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

Varoitukset

• Raskaus: teratogenic. Reliable contraception throughout treatment + 6 months after.
• Imetyksen aikana: vältä.
• Vakava maksan vajaatoiminta: vältä.
• Hepatitis B carrier status: screen and consider antiviral prophylaxis — reactivation risk.
• Elävät rokotteet: vastaa-aiheinen.
• Severe lymphopenia / CD4 < 200: continue PCP prophylaxis until lymphocyte recovery.

Lääkeaineenvaihdunta

Säilytys

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

Aiheeseen liittyvät vaihtoehdot MedsBasessa

Muut tämän tuotteen rinnalla varastossa olevat syöpälääkkeet:

• Endoxan (syklofosfamidi 50 mg)
• Celkeran (chlorambucil 2 / 5 mg)
• Temozol (temozolomiili 20 mg)
• Lomoother (lomustini 40 mg)
• Endace (megestroli 40/160 mg)

Selaa kaikkia syöpälääkkeitä →

Usein Kysytyt Kysymykset

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 Temotero 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.

Mitä verikokeita tarvitsen?

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 Temotero, 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 Temotero?

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 Temotero 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.

Miksi tilata MedsBasesta

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Aiheeseen liittyvät syöpälääkkeet

Muut tämän tuotteen rinnalla varastossa olevat syöpälääkkeet:

• Temozol 20 (temozolomide 20 mg)
• Lomoother (lomustini 40 mg)
• Endoxan (syklofosfamidi 50 mg)
• Hydrosar (hydroksikarbamidi 500 mg)
• Folitrax (metotreksaatti 2.5/7.5/10 mg)

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