BUSULFAN injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Busulfan (UNII: G1LN9045DK) (Busulfan - UNII:G1LN9045DK)

Beschikbaar vanaf:

Apotex Corp.

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 injection is contraindicated in patients with a history of hypersensitivity to any of its components. Risk Summary Busulfan 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 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, t

Product samenvatting:

Busulfan injection is packaged as a sterile clean colorless solution in 10 mL single-dose clear tubular USP type-I glass vial, NDC 60505-6177-0. Busulfan injection is distributed as a unit carton of eight vials NDC 60505-6177-8. Unopened vials of busulfan injection must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Discard unused portion. 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 is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BUSULFAN- BUSULFAN INJECTION
APOTEX CORP.
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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._
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INDICATIONS AND USAGE
Busulfan Injection is an alkylating drug indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 60 mg/10 mL (6 mg/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
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ADVERSE REACTIONS
Most common adverse reactions (incidence greater than 60%) were:
myelosuppression, nausea,
stomatitis, vomiting, anorexia, diarrhea, insomnia, fever,
hypomagnesemia, abdominal pain, anxiety,
headache, hyperglycemia and hypokalemia (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-706-5575 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Drugs that Decrease Busulfan Clearance: Metronidazole, itraconazole,
iron chelating agents,
CAUSES SEVERE AND PROLONGED MYELOSUPPRESSION. (5.1)
HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION IS REQUIRED TO PREVENT
POTENTIALLY
FATAL COMPLICATIONS OF THE PROLONGED MYELOSUPPRESSION. (5.1)
Use in combination with cyclophosphamide as a conditioning regimen
prior to allogeneic
hematopoietic progenitor cell transplantation for chronic myelogenous
leukemia (CML) (1)
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