Temodal

Temozolomide

Treatment of newly diagnosed glioblastoma multiforme concomitantly w/ RT & then as adjuvant treatment. Treatment of malignant glioma (eg, glioblastoma multiforme or anaplastic astrocytoma) showing recurrence or progression after standard therapy. 1st-line treatment of advanced metastatic malignant melanoma.

Adult Newly diagnosed glioblastoma multiforme Concomitant phase: 75 mg/m² daily for 42 days w/ focal RT, followed by adjuvant Temodal. Adjuvant phase (6 cycles): 4 wk after completing Temodal + RT. Cycle 1: 150 mg/m² once daily for 5 days followed by 23 days w/o treatment. Cycle 2: Dose escalated to 200 mg/m². Dose remains at 200 mg/m² daily for the 1st 5 days of each subsequent cycle except if toxicity occurs. Recurrent or progressive malignant glioma Previously untreated w/ chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. Previously treated w/ chemotherapy: Initially 150 mg/m² once daily, increased to 200 mg/m² daily in the 2nd cycle. Metastatic malignant melanoma 200 mg/m² once daily for 5 days per 28-day cycle. Childn ≥3 yr Recurrent or progressive malignant glioma 200 mg/m² once daily for 5 days per 28-day cycle. Previously treated w/ chemotherapy: Initially 150 mg/m² once daily for 5 days, escalated to 200 mg/m² once daily at the next cycle if no hematologic toxicity.

Should be taken on an empty stomach: Take at least 1 hr before meals. Swallow whole, do not open/chew/crush.

Hypersensitivity to temozolomide or dacarbazine. Severe myelosuppression. Pregnancy & lactation.

Avoid contact of powd contents w/ skin or mucous membrane in case of damaged cap. Risk of Pneumocystis carinii pneumonia in patients receiving concomitant Temodal & RT. Institute antiemetic prophylaxis/therapy for nausea & vomiting. Reports of hepatic injury (including fatal hepatic failure). Perform baseline LFTs prior to treatment initiation. Reports of hepatitis due to HBV reactivation. Screen for HBV infection prior to treatment initiation. Discontinue therapy in case of active hepatitis B infection. Exercise caution in patients w/ severe hepatic impairment (Child-Pugh grade C) or w/ renal impairment. Female patients should use effective contraception during & for at least 6 mth after treatment. Men should not father a child for at least 3 mth after receiving the final dose. Semen donation is not advised during treatment & for at least 3 mth after the final dose. No clinical experience in childn <3 yr. Very limited experience in older childn & adolescents. Increased risk of neutropenia & thrombocytopenia in elderly >70 yr.

Anorexia; headache, convulsions; constipation, nausea, vomiting; alopecia, rash; fatigue. Oral candidiasis, herpes simplex, infection, pharyngitis, wound infection; leukopenia, lymphopenia, neutropenia, febrile neutropenia, thrombocytopenia, anemia; hyperglycemia, decreased wt; anxiety, emotional lability, insomnia, depression; dizziness, aphasia, impaired balance & concentration, confusion, decreased consciousness, memory impairment, neuropathy, paresthesia, somnolence, speech disorder, tremor, dysphasia, hemiparesis, neurological disorder (NOS), peripheral neuropathy; blurred vision, diplopia, visual field defect; hearing impairment, tinnitus; edema, leg edema, hemorrhage, DVT; coughing, dyspnea; abdominal pain, diarrhoea, dyspepsia, dysphagia, stomatitis, dry mouth; dermatitis, dry skin, erythema, pruritus; arthralgia, muscle weakness, musculoskeletal pain, myalgia; micturition frequency, urinary incontinence; fever, pain, allergic reaction, radiation injury, face edema, taste perversion; increased SGPT.

Decreased clearance w/ valproic acid. Increased likelihood of myelosuppression w/ other myelosuppressive agents.

Cytotoxic Chemotherapy

L01AX03 - temozolomide ; Belongs to the class of other alkylating agents. Used in the treatment of cancer.

P₁S₁S₃