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Basic Drug Info
Drug Name:Daunorubicin Hydrochloride
Manufacturer:Bedford Laboratories
Other Info:Manufactured by:                                                                          Manufactured for:Ben Venue Laboratories, Inc.                                                       Bedford Laboratories™Bedford, OH 44146                                                                     Bedford, OH 44146July 1999                                                                                       DNOP-AQ-01



Clinical Trials:


Indications and Usage
Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Acute lymphocytic leukemia -- acute leukemia in which lymphoblasts and their progenitor cells predominate; the most common childhood cancer and accounts for 20 percent of adult acute leukemia; common ALL antigen (CALLA) expressed in most cases.

Precursor Cell Lymphoblastic Leukemia Lymphoma -- A neoplasm characterized by abnormalities of the lymphoid cell precursors leading to excessive lymphoblasts in the marrow and other organs. It is the most common cancer in children and accounts for the vast majority of all childhood leukemias.

Contraindications
Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Daunorubicin hydrochloride is a potent bone marrow suppressant.

Suppression will occur in all patients given a therapeutic dose of this drug.

Therapy with daunorubicin hydrochloride should not be started in patients with pre-existing drug-induced bone marrow suppression unless the benefit from such treatment warrants the risk.

Persistent, severe myelosuppression may result in superinfection or hemorrhage.
Branded Drugs
The following US Branded drugs contain Daunorubicin Hydrochloride


CERUBIDINE -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

CERUBIDINE -- SANOFI AVENTIS US LLC

CERUBIDINE -- WYETH AYERST RESEARCH


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