Temovex 20/Temovex 100 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

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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.

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Overdosage

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Administration

Should be taken on an empty stomach: Swallow whole, do not open/chew cap.

Contraindications

Hypersensitivity to dacarbazine & temozolomide. Severe myelosuppression.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Temovex 20/Temovex 100 detailed prescribing information

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.

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Drug Interactions

Decrease oral clearance of valproic acid.

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Storage

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Description

View Temovex 20/Temovex 100 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Temovex 100 cap 100 mg

Packing/Price

5's

Form

Temovex 20 cap 20 mg

Packing/Price

5's

Temovex 20/Temovex 100

temozolomide

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma