Newly diagnosed glioblastoma multiforme (GBM)

  • In combination with radiotherapy, then as maintenance therapy

Dose:

  • Concomitant phase (with radiotherapy):
    • 75 mg/m² daily for 42 days (up to 49 days) with radiotherapy
  • Maintenance phase:

    • Start 4 weeks after radiotherapy
    • Cycle 1: OD 150 mg/m² for 5 days in a 28-day cycle
    • Cycles 2–6: May increase to 200 mg/m²/day for 5 days if tolerated

Refractory anaplastic astrocytoma

  • In patients whose disease has progressed after prior therapy

Dose:

  • 150 mg/m²/day for 5 days every 28 days
  • May increase to 200 mg/m²/day in subsequent cycles if tolerated

Capsules:5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg

  • Oral administration
  • Take on an empty stomach (1 hour before or 2 hours after food)
  • Swallow capsules whole with water
  • Do not open, crush, or chew capsules
  • Antiemetics may be given to reduce nausea/vomiting

Class: Alkylating agent

Mechanism of Action:

  • Prodrug → Converts to MTIC (monomethyl triazeno imidazole carboxamide)
  • MTIC alkylates DNA at guanine residues, leading to apoptosis of cancer cells

Pharmacokinetics:

  • Half-life: ~1.8 hours
  • Peak plasma: ~1 hour post-dose
  • Excretion: Primarily renal (urine)
  • Nausea, vomiting
  • Fatigue
  • Constipation
  • Headache
  • Loss of appetite
  • Alopecia
  • Hypersensitivity to temozolomide or dacarbazine
  • Severe myelosuppression
  • Myelosuppressive agents: Increased bone marrow suppression risk
  • Live vaccines: Avoid due to immunosuppression
  • Valproic acid: May alter hematologic toxicity

                                   Drug Status

Availability
Pregnancy
Breastfeeding
Schedule
BRAND NAME STRENGTH FORMULATION PACK SIZE MANUFACTURER DISTRIBUTOR
Temotero 20mg Capsule 5’s Hetero Labs Unisel Ltd
Temotero 100mg Capsule 5’s Hetero Labs Unisel Ltd
Temotero 250mg Capsule 5’s Hetero Labs Unisel Ltd
Temozol 100mg Capsule 5’s PSM Pharma PSM Pharma