HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZOLEDRONIC ACID INJECTION safely and effectively. See full prescribing information for ZOLEDRONIC ACID INJECTION.
ZOLEDRONIC ACID INJECTION, for intravenous infusion
Initial U.S. Approval: 2001
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy. (2.1)
Multiple myeloma and bone metastasis from solid tumors. (2.2)
Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion. (3)
Hypersensitivity to any component of zoledronic acid injection. (4)
WARNINGS AND PRECAUTIONS
The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc., at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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