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| Drug class description : | Alkylating cytotoxics. |
| Generic Name : | Temozolomide |
| Drug description : | Hard white opaque capsules with strength, SP logo and two stripes. |
| Presentation : | Capsules, temozolomide 5mg and 20mg , 100mg , 250mg . |
| Indications : | Malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
| Adult Dosage : | In patients previously untreated with chemotherapy, Temodal is administered orally at a dose of 200 mg/m2 once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 daily, providing the absolute neutrophil count (ANC) is more than or equal to 1.5 x 109/L and the thrombocyte count is more than or equal to 100 x 109/L on Day 1 of the next 109/L on Day 1 of the next cycle. Temodal should be administered in the fasting state. Temodal capsules must be swallowed whole with a glass of water and must not be opened or chewed. The prescribed dose should be administered using the minimum number of capsules possible. Anti-emetic therapy may be administered prior to or following administration of Temodal. If vomiting occurs after the dose is administered, a second dose should not be administered that day. |
| Child Dosage : | Paediatric patients: In patients 3 years of age or older, Temodal is administered orally at a dose of 200 mg/m 2 once daily for 5 days per 28-day cycle. Paediatric patients previously treated with chemotherapy should receive an initial dose of 150 mg/m2 once daily for 5 days, with escalation to 200 mg/m 2 once daily at the next cycle if there is no haematologic toxicity. Fasting, swallowing and antiemetic precautions as adult dose. |
| Contra Indications : | Contraindications: Women of childbearing potential should be advised to avoid pregnancy while they are receiving Temodal. Temodal should not be used by women who are breast-feeding. Male patients: Temozolomide can have genotoxic effects. Therefore, men being treated with temozolomide are advised not to father a child during up to 6 months after treatment and to seek advice on cryoconservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with temozolomide. Temodal is contraindicated in patients who have a history of hypersensitivity to its components or to dacarbazine (DTIC). Temodal is contraindicated in patients with severe The ability to drive and use machines may be impaired in patients treated with Temodal due to fatigue and somnolence. |
| Special Precautions : | Laboratory parameters Prior to dosing, the following laboratory parameters must be met: ANC more than or equal to 1.5 x 109/l and platelet count more than or equal to 100 x 109/ L. A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC is above 1.5 x 10 9/L and platelet count exceeds 100 x 109/L. If ANC falls to < 1.0 x 109/L or the platelet count is < 50 x 10 9/L during any cycle, the next cycle should be reduced one dose level. Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/ m2. The lowest recommended dose is 100 mg/m 2. Paediatric use There is no clinical experience with use of Temodal in children under the age of 3 years. Experience in older children is very limited. Use in elderly patients Elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients. Therefore, special care should be taken when Temodal is administered in elderly patients. |
| Interactions : | Administration of Temodal with food resulted in a 33% decrease in C and a 9% decrease in AUC. Temodal should be administered max without food. Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of temozolomide. Use of Temodal in combination with other myelosuppressive agents may increase the likelihood of myelosuppression. In trials co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H -receptor antagonists, or phenobarbital did 2 temozolomide |
| Adverse Reactions : | Nausea (42%) and vomiting (35%). The incidence of severe nausea and vomiting was 4%. Thrombocytopenia and neutropenia, Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and 28), and recovery was rapid, usually within 1 - 2 weeks. No evidence of cumulative myelosuppression was observed. Fatigue (21%), constipation (15%) , and headache (13%). Anorexia (11%), diarrhoea (8%), rash, fever and somnolence (6% each) were also reported. Less common (2% to 5%) and in descending order of frequency were asthenia; pain, including abdominal pain; dizziness; weight decrease; dyspnea; dyspepsia; alopecia; rigors; pruritus; malaise; taste perversion; and paresthesia. |
| Manufacturer : | Schering Plough |
| Drug Availability : | (POM) |
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