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BUSULFAN INJECTION
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
BUSULFAN INJECTION Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
Busulfan Injection is contraindicated in patients with a history of hypersensitivity to any of its components.
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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Myelosuppression [see Warnings and Precautions (5.1)]...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Busulfan Injection can...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Busulfan is a mutagen and a clastogen. In in vitro ...
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Clinical Studies
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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References
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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How Supplied/Storage and Handling
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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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients of the possibility of developing low blood cell counts and the need for...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.