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Temonix (Temodar) Temozolomide 100 mg by beacon pharma is used to treat certain types of brain cancer.

Temonix is the alternative & generic version of Temodar by Merck & Co.. Temonix is manufactured by Beacon Pharmaceuticals Bangladesh which is the biggest pharmaceutical company in Bangladesh.

Therapeutic Class

Cytotoxic Chemotherapy

Pharmacology

Temozolomide, a triazene, is an inactive prodrug. It is chemically hydrolysed to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC), the active metabolite of dacarbazine. The cytotoxicity of MTIC is believed to be due alkylation of DNA, mainly at the O⁶ and N⁷ positions of guanine.

Dosage

Newly diagnosed glioblastoma multiforme: 75 mg/m² for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m² once daily for Days 1-5 of a 28-day cycle of Temozolomide for 6 cycles

Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m² once daily for 5 consecutive days per 28-day treatment cycle.

The recommended dose for Temodar as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when Temodar for Injection was given over 90 minutes

Administration

Should be taken on an empty stomach. Take at least 1 hr before meals.

Interaction

Reduced effectiveness of vaccines and generalised infection may occur in patients immunised with live vaccines. Decreased Temodar clearance with valproic acid.

Contraindications

Hypersensitivity to dacarbazine. Severe myelosupression. Pregnancy.

Side Effects

Nausea, vomiting, taste perversion, constipation, diarrhoea, abdominal pain, stomatitis, anorexia, headache, fatigue, convulsions, dizziness, memory impairment, impaired concentration, tremors, blurred vision, hearing impairment.

coughing, neutropenia, thrombocytopenia, leucopenia, anaemia, hyperglycemia, decreased wt, insomnia, anxiety, alopecia, muscle weakness, urinary incontinence, increased alanine aminotransferase. Rarely, myelodysplastic syndrome and secondary malignancies.

Pregnancy & Lactation

Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for Temodar in animal studies

Precautions & Warnings

Severe hepatic and renal impairment. Elderly >70 yr, children. Women of childbearing potential should avoid becoming pregnant during therapy.

Unknown if distributed into breastmilk, discontinue nursing due to potential risk. May impair ability to drive or operate machinery. Swallow capsules whole with a full glass of water on an empty stomach or at bedtime.

Do not take a 2nd dose if capsules are vomited. Monitor CBC wkly during concomitant therapy and on day 22 of each 28-day treatment cycle, followed by wkly blood count until recovery.

Use in Special Populations

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies of Temodar did not include enough numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment: Caution should be exercised when Temodar is administered to patients with severe renal impairment

Hepatic Impairment: Caution should be exercised when Temodar is administered to patients with severe hepatic impairment

Overdose Effects

Doses of 500, 750, 1000, and 1250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses.

There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death.

Storage Conditions

Store at 15-30° C.