Dorubin

Daunorubicin

Daunorubicin USP Injection

Composition: Each vial (4ml) contains Daunorubicin 20 mg as Daunorubicin Hydrochloride USP injection.

Indications: Dorubin (Daunorubicin) 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.

Dosage and Administration: Parenteral drug products should be inspected visually for particulate matter prior to administration. Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination: For patients under age 60, Dorubin (Daunorubicin) 45 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first
course and for 5 days for subsequent courses. For patients 60 years of age and above, Dorubin (Daunorubicin) 30 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This Dorubin (Daunorubicin) dosereduction is based on a single study and may not be appropriate if optimal supportive care is available. Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia: In Combination: Dorubin (Daunorubicin) 25 mg/m2 IV on day 1 every week, Vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Dorubin (Daunorubicin) dosage calculation should be based on weight (1 mg/kg) instead of body surface area. Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia: In Combination: Dorubin (Daunorubicin) 45 mg/m2/day IV on days 1, 2, and 3 and Vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32. Or, as directed by the registered physicians.

Use in pregnancy and lactation: Pregnancy Category D. Lactating Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Dorubin (Daunorubicin), mothers should be advised to discontinue nursing during Dorubin therapy.

Packing: Each box contains one vial of 20mg/4ml Daunorubicin USP for injection.

Prescribing Description

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