Adult Dosing

Metastatic malignant melanoma

• 2 to 4.5 mg/kg/day IV x 10 days, may be repeated in 4 wks intervals
• Alt: 250 mg/m²/day IV x 5 days, may be repeated q3 wks

Hodgkin's disease

• 150 mg/m²/day IV (in combination with other agents) x 5 days, may be repeated q4 wks
• Alt: 375 mg/m²/day IV q15 days

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of metastatic malignant melanoma
• Second-line therapy of Hodgkin’s disease (with other agents)

• Known hypersensitivity to dacarbazine or any of its components
• Severe myelosuppression

• Dacarbazine should be administered only under supervision of a physician experienced in cancer chemotherapy
• Myelosuppression is the most common toxicity with dacarbazine; primarily leukopenia and thrombocytopenia, may be fatal. Anemia may also occur. Monitor WBC, RBC and platelets; temporarily suspend or discontinue treatment if required
• Hepatic toxicity with hepatic vein thrombosis and hepatic necrosis resulting in death has occurred in 0.01% of patients. This is more common with concomitant antineoplastic drugs, also reported with monotherapy
• Weigh possible therapeutic benefits vs. risks of toxicity for each potential patient
• Dacarbazine is carcinogenic and teratogenic in animals
• Physician must weight carefully the possibility of achieving benefit against the risk of toxicity

Renal Dose Adjustment

• Renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic Impairment: Caution advised; dose adjustments not defined

• Myelosuppression is the most common toxicity of dacarbazine. Leukopenia and thrombocytopenia, may be fatal. Anemia may also occur. Monitor WBC, RBC and platelets; temporarily suspend or discontinue treatment if required
• Monitor patient for signs and symptoms of bacterial, viral, or fungal infection
• Implement infection control measures if WBC drops; implement bleeding precautions if platelet count drops
• Assess injection site frequently for signs or symptoms of extravasation (eg, burning, pain, induration)
• Dacarbazine may cause hepatic vein thrombosis and hepatocellular necrosis
• Monitor CBC, WBC and platelet counts; hepatic and renal function periodically during treatment

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Bone marrow depression
• Pediatric population (safety not established)

Pregnancy Category:C

Breastfeeding: Most sources consider breastfeeding to be contraindicated with antineoplastic therapy. Due to the potential to cause serious adverse events, it is recommended that patients receiving dacarbazine should not breastfeed.

• GI: Anorexia, nausea and vomiting (common), diarrhea
• HEPA: Hepatic necrosis, hepatic vein thrombosis
• HEMA: Bone marrow suppression, anemia, leukopenia, thrombocytopenia
• ENDO: Gonadal suppression
• DERM: Alopecia, facial flushing, photosensitivity, erythematous and urticarial rashes
• LABTESTS: Abnormal liver or renal function tests
• LOCAL: Pain/phlebitis at IV site, extravasation, tissue necrosis
• MUSC: Myalgia
• MISC: Flu-like syndrome, malaise, facial paresthesia

• Alkylating agent; exact mechanism of action unknown; may disrupt DNA and RNA synthesis; interacts with SH groups; causes death of rapidly growing tumor tissue cell
• IV administration results in complete bioavailability
• Partially metabolized by the liver; CYP450: Unknown
• Renally excreted: 40%
• Half-life: Biphasic
• Initial phase: 19 mins
• Terminal phase: 5 hrs

US Trade Name(s)

• DTIC-Dome

US Availability

dacarbazine (generic)

• PWDR for INJ: 100 mg/vial
• PWDR for INJ: 200 mg/vial
• PWDR for INJ: 500 mg/vial

DTIC-Dome

• INJ: 100 mg/vial
• INJ: 200 mg/vial

Canadian Trade Name(s)

• Only generic available

Canadian Availability

dacarbazine (generic)

• PWDR for INJ: 200 mg/vial
• PWDR for INJ: 600 mg/vial

UK Trade Name(s)

• Only generic available

UK Availability

dacarbazine (generic)

• PWDR for INJ: 100 mg/vial
• PWDR for INJ: 200 mg/vial
• PWDR for INJ: 500 mg/vial
• PWDR for INJ: 600 mg/vial
• PWDR for INJ: 1000 mg/vial

Australian Trade Name(s)

• Only generic available

Australian Availability

dacarbazine (generic)

• PWDR for INJ: 200 mg/vial

[Outline]

Hematology/Oncology

Antineoplastics

Alkylating Agents