Intas Pharmaceuticals


Alliance Pharma
Concise Prescribing Info
As monotherapy or concomitantly w/ radiotherapy in adult patients w/ newly diagnosed glioblastoma multiforme. Malignant glioma (eg, glioblastoma multiforme or anaplastic astrocytoma), showing recurrence or progression after standard therapy in childn 3 yr, adolescents & adult patients.
Dosage/Direction for Use
Adult w/ newly-diagnosed glioblastoma multiforme In combination w/ focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide monotherapy. Concomitant phase 75 mg/m2 temozolomide daily for 42 days w/ focal radiotherapy 60 Gγ administered in 30 fractions. Continue throughout the 42 day concomitant period (up to 49 days) if: ANC ≥1.5 x 109/L, thrombocyte count ≥100 x 109/L, common toxicity criteria non-haematological toxicity ≤Grade 1 (except alopecia, nausea, vomiting). Monotherapy phase Administer temozolamide for up to 6 cycles. Cycle 1 (monotherapy): 150 mg/m2 once daily for 5 days followed by 23 days without treatment. Cycle 2: Escalate to 200 mg/m2 if CTC non-haematological toxicity for Cycle 1 is ≤Grade 2 (except for alopecia, nausea & vomiting), ANC ≥1.5 x 109/L, thrombocyte count ≥100 x 109/L. Once escalated, the dose remains at 200 mg/m2/day for the first 5 days of each subsequent cycle except if toxicity occurs. If dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. Recurrent or progressive malignant glioma Adult & ped patient ≥3 yr Treatment cycle: 28 days. Patients previously untreated w/ chemotherapy 200 mg/m2 once daily for the first 5 days followed by a 23-day treatment interruption. Patients previously treated w/ chemotherapy Initially, 150 mg/m2 once daily, to be increased in the 2nd cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity.
Should be taken on an empty stomach: Swallow whole, do not open/chew cap.
Hypersensitivity to temozolamide, dacarbazine (DTIC). Severe myelosuppression.
Special Precautions
Renal & hepatic impairment. Administer prophylaxis against Pneumocystitis carinii pneumonia for all patients receiving concomitant temozolomide & radiotherapy for the 42-day regimen; risk in developing Pneumocystitis carinii pneumonia during longer dosing regimen. Myelodysplastic syndrome & secondary malignancies. Administer anti-emetic therapy prior to therapy especially in concomitant phase in adult patients w/ newly diagnosed glioblastoma multiforme; strongly recommended during monotherapy phase; patients w/ recurrent or progressive malignant glioma who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. Interrupt treatment if: During concomitant radiotherapy & temozolomide: ANC ≥0.5 & <1.5 x 109/L, thrombocyte count ≥10 & <100 x 109/L, & CTC Grade 2; during monotherapy: ANC <1 x 109/L, thrombocyte count <50 x 109/L, CTC Grade 3. Discontinue therapy if: During concomitant radiotherapy & temozolomide: ANC <0.5 x 109/L, thrombocyte count <10 x 109/L, CTC Grade 3 or 4; during monotherapy: Dose level -1 (100 mg/m2) still results in unacceptable toxicity, same Grade 3 non-haematological toxicity (except alopecia, nausea, vomiting) recurs after dose reduction, CTC Grade 4. Obtain CBC on Day 22 (21 days after 1st dose) or w/in 48 hr & wkly until ANC >1.5 x 109/L & platelet count >100 x 109/L. Male patients should not father a child up to 6 mth after receiving last dose. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Childn <3 yr. Elderly >70 yr.
Adverse Reactions
Anorexia; headache; constipation, nausea & vomiting; rash, alopecia; fatigue. Infection, Herpes simplex, wound infection, pharyngitis, oral candidiasis; neutropenia, thrombocytopenia, lymphopenia, leukopenia; hyperglycaemia, decreased wt; anxiety, emotional lability, depression, insomnia; convulsions, consciousness, decreased somnolence, aphasia, impaired balance, dizziness, confusion, memory impairment, impaired concentration; neuropathy, paresthesia, speech disorder, tremor, hemiparesis, dysphasia, neurological disorder, peripheral neuropathy; blurred vision, visual field defect, diplopia; hearing impairment, tinnitus; haemorrhage, oedema, leg oedema, DVT; dyspnoea, coughing; stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia, dry mouth; dermatitis, dry skin, erythema, pruritus; muscle weakness, arthralgia, musculoskeletal pain, myalgia; micturition frequency, urinary incontinence; allergic reaction, fever, radiation, injury, face oedema, pain, taste perversion; increased ALT.
Drug Interactions
Decreased clearance w/ valproic acid. Increased risk of  myelosuppression w/ other myelosuppressive agents.
ATC Classification
L01AX03 - temozolomide ; Belongs to the class of other alkylating agents. Used in the treatment of cancer.
Zolotem cap 20 mg
1 × 5's
Zolotem cap 100 mg
1 × 5's
Zolotem cap 250 mg
1 × 5's
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