BUSULFAN injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUSULFAN (UNII: G1LN9045DK) (BUSULFAN - UNII:G1LN9045DK)

Available from:

Actavis Pharma, Inc.

INN (International Name):

BUSULFAN

Composition:

BUSULFAN 6 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan is contraindicated in patients with a history of hypersensitivity to any of its components. Risk Summary Busulfan Injection can cause fetal harm when administered to a pregnant woman based on animal data. Busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. The solvent, DMA, may also cause fetal harm when administered to a pregnant woman. In rats, DMA doses of approximately 40% of the daily dose of DMA in the Busulfan Injection dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see Data ). There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown.

Product summary:

Busulfan Injection is packaged as a sterile solution in 10 mL single-dose clear glass vials each containing 60 mg of busulfan, USP at a concentration of 6 mg per mL for intravenous use and is available as follows: 1 Single-Dose vial in a carton - NDC 45963-640-57. 8 Single-Dose vials in a unit carton - NDC 45963-640-77. Unopened vials of Busulfan Injection must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .   Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSULFAN- BUSULFAN INJECTION, SOLUTION, CONCENTRATE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUSULFAN INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUSULFAN INJECTION.
BUSULFAN INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
WARNING: MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CAUSES SEVERE AND PROLONGED MYELOSUPPRESSION. (5.1)
HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION IS REQUIRED TO PREVENT
POTENTIALLY FATAL COMPLICATIONS
OF THE PROLONGED MYELOSUPPRESSION (5.1).
INDICATIONS AND USAGE
Busulfan is an alkylating drug indicated for:
Use in combination with cyclophosphamide as a conditioning regimen
prior to allogeneic hematopoietic progenitor cell
transplantation for chronic myelogenous leukemia (CML) (1)
DOSAGE AND ADMINISTRATION
Pre-medicate with anticonvulsants (e.g. benzodiazepines, phenytoin,
valproic acid or levetiracetam) and antiemetic (2.1,
5.2)
Dilute and administer as intravenous infusion. Do not administer as
intravenous push or bolus (2.1, 2.3)
Recommended adult dose: 0.8 mg per kg of ideal body weight or actual
body weight, whichever is lower, administered
intravenously via a central venous catheter as a two-hour infusion
every six hours for four consecutive days for a total
of 16 doses (2.1)
DOSAGE FORMS AND STRENGTHS
60 mg per 10 mL (6 mg per mL) single-dose vial (3)
CONTRAINDICATIONS
Busulfan is contraindicated in patients with a history of
hypersensitivity to any of its components (4)
WARNINGS AND PRECAUTIONS
Seizures: Initiate anticonvulsant prophylactic therapy prior to
treatment with Busulfan Injection. Monitor patients with
history of seizure disorder, head trauma or receiving epileptogenic
drugs (5.2)
Hepatic Veno-Occlusive Disease (HVOD): Increased risk of developing
HVOD at AUC greater than 1,500 µM•min.
Monitor serum transaminases, alkaline phosphatase and bilirubin daily
(5.3)
Embryo-fetal Toxicity: Can cause fetal har