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BUSULFAN INJECTION

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BUSULFAN INJECTION Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: MYELOSUPPRESSION

Busulfan Injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially...

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1 INDICATIONS AND USAGE

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous...

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2 DOSAGE AND ADMINISTRATION

2.1 Initial Dosing Information

  • Administer Busulfan Injection in combination with cyclophosphamide as a conditioning regimen prior to bone marrow...
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3 DOSAGE FORMS AND STRENGTHS

Injection: 60 mg/10 mL (6 mg/mL) as a clear, colorless, sterile, solution in a single-dose vial for intravenous use only.

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4 CONTRAINDICATIONS

Busulfan Injection is contraindicated in patients with a history of hypersensitivity to any of its components.

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5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

The most frequent serious consequence of treatment with Busulfan Injection at the recommended dose and schedule is...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Myelosuppression [see

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

7.1 Drugs that Decrease Busulfan Injection Clearance

Itraconazole decreases busulfan clearance by up to 25%. Metronidazole decreases the clearance...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Busulfan Injection can...

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10 OVERDOSAGE

There is no known antidote to Busulfan Injection other than hematopoietic progenitor cell transplantation. In the absence of hematopoietic progenitor cell transplantation, the recommended dosage for Busulfan...

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11 DESCRIPTION

Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CH3SO2O(CH...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Busulfan is a bifunctional alkylating agent in which two labile methanesulfonate groups are attached to opposite...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Busulfan is a mutagen and a clastogen. In in vitro ...

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14 CLINICAL STUDIES

Documentation of the safety and efficacy of busulfan as a component of a conditioning regimen prior to allogeneic hematopoietic progenitor cell reconstitution is derived from two sources:

i)...

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15 REFERENCES

1.OSHA Hazardous Drugs. OSHA. [Accessed on June 18, 2014 from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Busulfan Injection is packaged as a sterile solution in 10 mL single-dose clear glass vials.

Busulfan...

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17 PATIENT COUNSELING INFORMATION

Myelosuppression

Advise patients of the possibility of developing low blood cell counts and the need for...

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Manufactured by:
Gland Pharma Limited,
India

Manufactured for:
Hospira, Inc.
Lake Forest, IL...

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