BUSULFEX- busulfan injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Otsuka America Pharmaceutical, Inc.

INN (الاسم الدولي):

Busulfan

تركيب:

Busulfan 6 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

BUSULFEX is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. BUSULFEX is contraindicated in patients with a history of hypersensitivity to any of its components. Risk Summary BUSULFEX 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 BUSULFEX 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. However, the background risk

ملخص المنتج:

BUSULFEX is packaged as a sterile solution in 10 mL single-dose clear glass vials, NDC 59148-047-90. BUSULFEX is distributed as a unit carton of eight vials NDC 59148-047-91. Unopened vials of BUSULFEX must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Discard unused portion. BUSULFEX 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. BUSULFEX 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. BUSULFEX is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .

الوضع إذن:

New Drug Application

خصائص المنتج

BUSULFEX- BUSULFAN INJECTION
OTSUKA AMERICA PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUSULFEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUSULFEX.
BUSULFEX (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
BUSULFEX 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
Injection: 60 mg/10 mL (6 mg/mL) single-dose vial (3)
CONTRAINDICATIONS
BUSULFEX 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 BUSULFEX. 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 harm. Advise of potential ri