DACARBAZINE FOR INJECTION USP 200MG/VIAL

DACARBAZINE FOR INJECTION USP 200MG/VIAL

DACARBAZINE FOR INJECTION USP 200MG/VIAL

ATC Code: L01AX04

Dacarbazine is a cytostatic agent: The antineoplastic effect is due to an inhibition of cell growth which is independent of the cell cycle and due to an inhibition of DNA synthesis. An alkylating effect has also been shown and other cytostatic mechanisms may also be influenced by dacarbazine.

Dacarbazine is considered not to show an antineoplastic effect by itself. However, by microsomal N-demethylation it is quickly converted to 5-aminoimidazole- 4- carboxamide and a methyl cation, which is responsible for the alkylating effect of the drug.

Therapeutic Indications

Dacarbazine is indicated for the treatment of patients with metastasized malignant melanoma.

Further indications for dacarbazine as part of a combination chemotherapy are:

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  • advanced Hodgkin’s disease,
  • advanced adult soft tissue sarcomas (except mesothelioma, Kaposi sarcoma).

Posology and method of administration

Malignant Melanoma: The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may berepeated at 4-week intervals.An alternate recommended dosage is 250 mg/square meter body surface/day I.V injectionfor 5 days. Treatment may be repeated every 3 weeks.

Hodgkin’s Disease: The recommended dosage of dacarbazine in the treatment of Hodgkin’s disease is 150mg/square meter body surface/day for 5 days, in combination with other effective drugs.Treatment may be repeated every 4 weeks. An alternative recommended dosage is 375mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days.

Contraindications

Dacarbazine is contraindicated in patients: –

  • who have a history of hypersensitivity reactions to dacarbazine or to any of the excipients.
  • in pregnant or breastfeeding women
  • in patients with leucopenia and/or thrombocytopenia
  • in patients with severe liver or kidney diseases.

Warning and Precautions

It is recommended that dacarbazine should only be administered under the supervision of a

physician specialized in oncology, having the facilities for regular monitoring of clinical, biochemical and hematological effects, during and after therapy.

Interactions with other medicinal products and other forms of interactions

In case of previous or concomitant treatment having adverse effects on the bone marrow (particularly cytostatic agents, irradiation) myelotoxic interactions are possible. Studies to investigate the presence of phenotypic metabolism have not been undertaken but hydroxylation of the parent compound to metabolites with anti-tumor activity has been identified. Dacarbazine is metabolised by cytochrome P450 (CYP1A1, CYP1A2, and CYP2E1). This has to be taken into account if other drugs are co-administered which are metabolised by the same hepatic enzymes.

Pregnancy and Lactation

Dacarbazine has been shown to be mutagenic, teratogenic and carcinogenic in animals. It must be assumed that an increased risk for teratogenic effects exists in humans. Therefore, dacarbazine must not be used during pregnancy and during breastfeeding.

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Women of child bearing potential: Women of child bearing age must avoid pregnancy during dacarbazine treatment.

Effect of ability to drive and use medicines

Dacarbazine may influence the ability to drive or operate machines because of its central nervous side effects or because of nausea and vomiting.

Overdose

Severe bone marrow suppression, bone marrow aplasia occurs due to overdose. Give supportive treatment and monitor blood cell counts.

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