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Adzine 200/500 Lyophilized Injection

Generic Name– Dacarbazine
Drug Class– Antineoplastic agent

Description- Dacarbazine is the most active alkylating used in the treatment of metastatic melanoma and has been used as the standard chemotherapy for this malignancy for 30 years. It acts by methylating nucleic acids, which results in DNA damage, cell cycle arrest and apoptosis (cell death).

Product Description

Adzine 200/500 (Dacarbazine for injection) is a single use glass vial containing lyophilized powder for intravenous use.

Indications and Usage

Dacarbazine is indicated for:
• Treatment of metastatic malignant melanoma
• Hodgkin’s disease in combination with other chemotherapeutic agents

Dosage and Administration

• Dosage Regimen for Malignant Melanoma
Cisplatin, Vincristine and Dacarbazine (CVD) Regimen
Cisplatin-20 mg/m2 IV on days 2-4
Vincristine-1.6 mg/m2 IV on days 1-5
Dacarbazine-800 mg/m2 IV on day 1
Repeat cycle every 21 days

• Dosage Regimen for Hodgkin’s Disease
Doxorubicin, Bleomycin, Vincristine and Dacarbazine (ABVD) Regimen
Doxorubicin-25 mg/m2 on days 1-15
Bleomycin-10 mg/m2 on days 1-15
Vincristine-6 mg/m2 IV on days 1-15
Dacarbazine-375 mg/m2 IV on days 1-15

Dosage Form and Strengths
• Supplied as a single use vial for intravenous infusion
• Available as 200mg and 500mg for injection

Clinical Efficacy

• Effective and well tolerated in treatment of patients with metastatic melanoma1
• Shows response rates of 20% and progression-free survival (PFS) of 1.5 to 1.6 months in metastatic melanoma patients7,8
• Produces response rates of 82.3% when used in combination with Doxorubicin, bleomycin, vinblastine for advanced stage classic Hodgkin lymphoma9

Adverse Reactions
• The most common adverse events that occurs after administration of dacarbazine are anorexia, nausea, vomiting, diarrhea, fever, myalgias, malaise, leucopenia, thrombocytopenia, anemia, hypotension, peripheral neuropathy, erythematous and urticarial rashes

• It is contraindicated in patients with a known hypersensitivity to dacarbazine and in patients who have previously had severe myelosuppression

Special Precautions

• Monitor white blood cells, red blood cells and platelet levels to determine the risk of bone marrow depression
• Discontinue the use of dacarbazine, in cases of severe hemopoietic toxicity
• Consider dose reductions in patients with renal and hepatic impairment
• Extravasations of dacarbazine during intravenous administration may result in tissue damage and severe pain
• Women with child bearing potential are advised to use effective contraception to avoid pregnancy
• Pregnant and nursing women should not receive treatment with dacarbazine, as it may be fatal

Dacarbazine 200/500mg Lyophilized Injection Brand Name ADZINE