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bortezomib injection 3.5 MG VIAL (bortezomib for 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.
bortezomib injection 3.5 MG VIAL Quick Finder
Highlights
Indications and Usage
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1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Guidelines
Bortezomib for injection is for intravenous or subcutaneous use only. Do not administer bortezomib for...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: Each single-dose vial of bortezomib for injection contains 3.5 mg of bortezomib as a sterile lyophilized white to off-white powder for reconstitution and withdrawal of the...
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Contraindications
4 CONTRAINDICATIONS
Bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions [...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Peripheral Neuropathy
Bortezomib for injection treatment causes a peripheral neuropathy that is predominantly sensory; however, cases...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Bortezomib for Injection
Strong CYP3A4...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism...
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Overdosage
10 OVERDOSAGE
There is no known specific antidote for bortezomib for injection overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which...
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Description
11 DESCRIPTION
Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with bortezomib.
Bortezomib...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Multiple Myeloma
Randomized, Open-Label Clinical Study in Patients...
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References
15 REFERENCES
- "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual). OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html...
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How Supplied/Storage and Handling
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16 HOW SUPPLIED/STORAGE AND HANDLING
Bortezomib for Injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder.
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with bortezomib for injection:
Peripheral...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.