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What is the drug TEMOZOLOMIDE

TEMOZOLOMIDE is an imidazotetrazine alkylating drug with antitumor activity. When released into the systemic circulation at physiological pH values, it undergoes rapid chemical transformation to form the active compound monomethyltriazenoimidazole carboxamide (MTIC). It is believed that the cytotoxicity of MTIC is primarily due to alkylation of guanine at position O6 and additional alkylation at position N7. Apparently, the cytotoxic damages that occur in this case include (trigger) the mechanism of aberrant reduction of the methyl residue.

Dosage form

The dosage is 20 mg. Solid gelatin capsules No. 2 with a white body and a green lid.

The dosage is 100 mg. Solid gelatin capsules No. 1 with a white body and a red cap.

The dosage is 140 mg. Solid gelatin capsules No. 1 with a white body and a blue lid.

The dosage is 180 mg. Solid gelatin capsules No. 0 with a white body and a yellow cap.

The dosage is 250 mg. Solid gelatin capsules No. 0 with a white body and an orange lid.

The contents of the capsules are white to light pink or light brown powder with a yellowish tinge of color.

Indications for use

- Newly diagnosed glioblastoma multiforme – combined treatment with radiation therapy followed by adjuvant monotherapy;

- Malignant glioma (glioblastoma multiforme or anaplastic astrocytoma), in the presence of recurrence or progression of the disease after standard therapy;

- Widespread metastatic malignant melanoma – as a first-line therapeutic agent.

Efficacy and safety studies

In accordance with current legislation, the drug has proven its effectiveness, safety and quality during state registration. For registration purposes, a bioequivalence study was conducted with the original (reference) medicinal product.