Finished product reference
Dacarbazine
Injection, Powder, for Solution · Parenteral · 200 mg
- List code
- 377
- Pharmacologic class
- Alkylating Drug
WARNING It is recommended that dacarbazine for injection be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Hemopoietic depression is the most common toxicity with dacarbazine for injection. (See WARNINGS .) Hepatic necrosis has been reported.
What it is and how it works
Mechanism class: Alkylating Activity
Indications
INDICATIONS AND USAGE Dacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Malignant Melanoma The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals. 2 An alternate recommended dosage is 250 mg/square meter body surface/day IV for 5 days. Treatment may be repeated every 3 weeks. 3, 4 Hodgkin's Disease The recommended dosage of dacarbazine for injection in the treatment of Hodgkin's Disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. 5 An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days.
Contraindications
CONTRAINDICATIONS Dacarbazine for injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.
Warnings and precautions
WARNINGS Hemopoietic depression is the most common toxicity with dacarbazine for injection and involves primarily the leukocytes and platelets, although anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with dacarbazine for injection.
Pregnancy
Pregnancy Teratogenic Effects, Pregnancy Category C Dacarbazine for injection has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation.
Storage and supply
Store in a refrigerator 2° to 8°C (36° to 46°F). Use within 8 hours of reconstitution. Protect from light. DISCARD UNUSED PORTION. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Source: Dacarbazine (Dacarbazine) — US FDA prescribing information, 2024-03-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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