Dacarbazine-Dacin

/ Pharmalogic

Unless specific dosage guidelines for combination therapy have been specified, the following dosage regimens are to be followed, particularly for monotherapy: 4–5 day cycles of 150 to 250 mg/m2 body surface area/day IV. This treatment can be repeated every 21 days. Alternatively, 2.0–4.5 mg/kg/day IV may be given for 1–10 days. This regimen can be repeated every 28 days.
DACARBAZINE-DACIN® is administered either as an intravenous injection over approximately one minute or as an intravenous infusion over 15–30 minutes. If necessary, DACARBAZINE-DACIN® can be given intra-arterially.
Combination Chemotherapy: Generally 4 to 5 day cycles of 100 mg/m2/day, with a 21 day interval between subsequent cycles starting from the last day of treatment.
Extravasation of DACARBAZINE-DACIN® during intravenous administration can induce tissue damage and severe pain.

Metastatic, malignant melanoma; Hodgkin’s disease as a second line therapy when used in combination with other agents.

• Hypersensitivity to dacarbazine or any of the excipients.
• Renal insufficiency.
• Bone marrow depression.
• DACARBAZINE-DACIN® should not be administered to women who are pregnant or breast-feeding.

See prescribing information for full details.

Anorexia, nausea, vomiting and fever. Impairment of hematopoiesis is the most severe toxic reaction to occur with therapy and primarily affects leukocytes and thrombocytes, although minor anemia may also occur. Leucopoenia and thrombocytopenia may be of a sufficiently severe nature as to be fatal. Bone marrow suppression requires careful monitoring of leukocytes, erythrocytes and thrombocytes. Photosensitivity reactions have been reported up to three days after administration. Influenza-like systemic disorders (asthenia, headache, myalgia, fever).These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments. Renal or hepatic toxicity have been reported. Eosinophilia has been reported. Epileptic fits and dementia (with high doses of dacarbazine), venous-occlusion (with very high doses of dacarbazine) have been reported.
See prescribing information for full details.

Drug interactions are the same as those observed with other cytostatic agents.
Caution should be exercised when using the following combinations:
• Cyclosporine: immunodepression is potentiated with risk of pseudolymphoma.
• Attenuated live vaccines: risk of possibly fatal systemic disease. The risk is potentiated in patients whose immunity has already been depressed by the underlying disease.
• Fotemustine: risk of pulmonary toxicity (ARDS) has been reported when dacarbazine is followed by fotemustine administered on the same day.

Pregnancy: Animal studies have shown dacarbazine to have undesirable effects on the foetus (teratogenic and embryotoxic effects). No controlled studies in humans have been performed. The use of dacarbazine is contraindicated during pregnancy.
Lactation: It is not known whether dacarbazine is excreted in breast milk. As many preparations are excreted in breast milk and dacarbazine has been shown in animal studies to possess tumorigenic potential, the preparation should not be used during lactation.

Supportive measures are to be applied. Blood cell count must be monitored carefully.