DACARBAZINE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DACARBAZINE (UNII: 7GR28W0FJI) (DACARBAZINE - UNII:7GR28W0FJI)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents. Dacarbazine is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

Product summary:

Dacarbazine for Injection, USP is supplied as follows: NDC 0143-9245-10  200 mg/vial of sterile dacarbazine in boxes of 10. Store in a refrigerator 2° to 8°C (36° to 46°F). To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DACARBAZINE- DACARBAZINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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DACARBAZINE FOR INJECTION, USP
RX ONLY
WARNING
It is recommended that dacarbazine be administered under the
supervision of a qualified physician
experienced in the use of cancer chemotherapeutic agents.
1.Hemopoietic depression is the most common toxicity with dacarbazine
(see WARNINGS).
2.Hepatic necrosis has been reported (see WARNINGS).
3.Studies have demonstrated this agent to have a carcinogenic and
teratogenic effect when
used in animals.
4.In treatment of each patient, the physician must weigh carefully the
possibility of achieving
therapeutic benefit against the risk of toxicity.
BOXED WARNING
WARNING
It is recommended that dacarbazine be administered under the
supervision of a qualified physician
experienced in the use of cancer chemotherapeutic agents.
1. Hemopoietic depression is the most common toxicity with dacarbazine
(see WARNINGS ).
2. Hepatic necrosis has been reported (see WARNINGS ).
3. Studies have demonstrated this agent to have a carcinogenic and
teratogenic effect when used
in animals.
4. In treatment of each patient, the physician must weigh carefully
the possibility of achieving
therapeutic benefit against the risk of toxicity.
DESCRIPTION
Dacarbazine for Injection, USP is a colorless to an ivory colored
solid which is light sensitive. Each
vial contains 200 mg of dacarbazine (the active ingredient), anhydrous
citric acid and mannitol.
Dacarbazine is reconstituted and administered intravenously (pH 3.0 to
4.0). Dacarbazine is an
anticancer agent. Chemically, dacarbazine is
5-(3,3-Dimethyl-1-triazeno)imidazole-4-carboxamide with
the following structural formula:
C H N O M.W. = 182.19
CLINICAL PHARMACOLOGY
After intravenous administration of dacarbazine, the volume of
distribution exceeds total body water
content suggesting localization in some body tissue, probably the
liver. Its disappearance from the
plasma is biphasic with initial half-life of 19 minutes and a terminal
half-li