DACARBAZINE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Parenteral Medicines, Inc.

INN (International Name):

DACARBAZINE

Composition:

DACARBAZINE 200 mg in 20 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Dacarbazine for injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

Product summary:

Sterile Dacarbazine for Injection, USP is available as follows: Store in a refrigerator 2° to 8°C (36° to 46°F). Use within 8 hours of reconstitution. Protect from light. Discard Unused Portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DACARBAZINE- DACARBAZINE INJECTION, POWDER, FOR SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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DACARBAZINE FOR INJECTION, USP
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.
1. Hemopoietic depression is the most common toxicity with dacarbazine
for injection. (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 white to an ivory colored solid
which is light sensitive. Each 20 mL
vial contains 200 mg of dacarbazine, USP (active ingredient). Each
vial also contains anhydrous citric
acid and mannitol. Dacarbazine for Injection, USP is reconstituted and
administered intravenously (pH
3.0 to 4.0). Dacarbazine for Injection, USP is an anticancer agent.
Chemically, Dacarbazine for Injection,
USP is 5-(3,3-Dimethyl-1-triazeno) imidazole-4-carboxamide
(dacarbazine) with the following
structural formula:
C H N O M.W. 182.19
CLINICAL PHARMACOLOGY
After intravenous administration of dacarbazine for injection, the
volume of distribution exceeds total
6
10
6
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-life of 5 hours.
In a
patient with renal and hepatic dysfunctions, the half-lives were
lengthened to 55 minutes and 7.2 hours.
The average cumulative excretion of unchanged dacarbazine in the urine
is 40% of the injected dose in
6 hours.
Dacarbazine is subject to renal tubular secretion rather than
glomerular filtration. At therapeutic
concentrations dacarbazine is not appreciably bound to human plasma
protein.
In man, dacarbazine is extensiv