DACARBAZINE- dacarbazine injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Fresenius Kabi USA, LLC

INN (International Nazwa):

DACARBAZINE

Skład:

DACARBAZINE 10 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 second-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.

Podsumowanie produktu:

DACARBAZINE FOR INJECTION, USP is available in the following forms: STORE IN A REFRIGERATOR 2°-8°C (36°-46°F). PROTECT FROM LIGHT. USE WITHIN 8 HOURS OF RECONSTITUTION. Vial stoppers do not contain natural rubber latex.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DACARBAZINE - DACARBAZINE INJECTION, POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
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DACARBAZINE FOR INJECTION, USP
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 white to pale yellow colored solid
which is light
sensitive. Each vial contains 100 mg of dacarbazine, or 200 mg of
dacarbazine (the
active ingredient), citric acid and mannitol. Dacarbazine for
Injection, USP is
reconstituted and administered intravenously (pH 3-4). Dacarbazine for
Injection, USP is
an anticancer agent. Chemically, dacarbazine is
5-(3,3-Dimethyl-1-triazeno) imidazole-4-
carboxamide with the following structural formula:
M.W. 182.19 C
H
N
O
CLINICAL PHARMACOLOGY
After intravenous administration of dacarbazine for injection, 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
6
10
6
1
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 for injection is extensively degraded. Besides
unchanged
dacarbazine, 5-aminoimidazole -4 carboxa