Temovex-20/Temovex-100

Temovex-20/Temovex-100

temozolomide

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Temozolomide
Indications/Uses
Treatment of newly diagnosed glioblastoma multiforme concomitantly w/ radiotherapy & also as adjuvant treatment. Malignant glioma eg, glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Dosage/Direction for Use
Adult w/ newly diagnosed glioblastoma multiforme Concomitant 75 mg/m2 once daily for 42 days w/ focal radiotherapy; monotherapy 4 wk after completing concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment. Cycle 1 150 mg/m2 once daily for 5 days followed by 23 days w/o treatment; cycle 2 escalate dose to 200 mg/m2 once daily. Once escalated, the dose remains at 200 mg/m2 once daily for the 1st 5 days of each subsequent cycle except if toxicity occurs. Adult & childn ≥3 yr w/ recurrent or progressive malignant glioma Treatment cycle is 28 days. Patient previously untreated w/ chemotherapy 200 mg/m2 once daily for the 1st 5 days followed by 23 day treatment interruption. Patient previously treated w/ chemotherapy Initially 150 mg/m2 once daily. Dose may be increased in the 2nd cycle to 200 mg/m2 once daily for 5 days if there is no hematological toxicity.
Administration
Should be taken on an empty stomach: Swallow whole, do not open/chew cap.
Contraindications
Hypersensitivity to dacarbazine & temozolomide. Severe myelosuppression.
Special Precautions
Prior to dosing, patients must have an absolute neutrophil count (ANC) of ≥1.5 x 109/L & platelet count of ≥100 x 109/L. A complete blood count should be obtained on day 22 (21 days after the 1st dose) or w/in 48 hr of that day & wkly until ANC is above 1.5 x 109/L & platelet count exceeds 100 x 109/L.
Adverse Reactions
Nausea, vomiting, headache, fatigue; myelosuppression.
Drug Interactions
ATC Classification
L01AX03 - temozolomide ; Belongs to the class of other alkylating agents. Used in the treatment of cancer.
Presentation/Packing
Form
Temovex-100 cap 100 mg
Packing/Price
5's
Form
Temovex-20 cap 20 mg
Packing/Price
5's
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