HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BORTEZOMIB FOR INJECTION safely and effectively. See full prescribing information for BORTEZOMIB FOR INJECTION.
BORTEZOMIB for injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
For injection: 1 mg or 2.5 mg of bortezomib as a lyophilized powder in a single-dose vial for reconstitution and withdrawal of the appropriate individual patient dose. (3)
WARNINGS AND PRECAUTIONS
Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Patients with diabetes may require close monitoring of blood glucose and adjustment of antidiabetic medication. (8.8)
See 17 for PATIENT COUNSELING INFORMATION.
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