HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Zometa safely and effectively. See full prescribing information for Zometa.

Zometa® (zoledronicacid) Injection
Ready-to-Use Solution for Intravenous Infusion (For Single Use)
Concentrate for Intravenous Infusion
Initial U.S. Approval: 2001

 
RECENT MAJOR CHANGES
Dosage and administration, preparation of solution,4 mg/100 mL
Ready-to-Use Bottle (2.3) 06/2011

 
INDICATIONS AND USAGE
Zometa is a bisphosphonate indicated for the treatment of:

Hypercalcemia of malignancy (1.1)

Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy (1.2)
Important limitation of use: The safety and efficacy of Zometa has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia (1.3)

 
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)

4mg as a single-use intravenous infusion over no less than 15minutes

4mg as retreatment after a minimum of 7days
Multiple myeloma and bone metastasis from solid tumors (2.2)

4mg as a single-use intravenous infusion over no less than 15minutes every 3-4weeks for patients with creatinine clearance of greater than 60mL/min

Reduce the dose for patients with renal impairment

Coadminister oral calcium supplements of 500mg and a multiple vitamin containing 400IU of VitaminD daily.
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
4 mg/100 mL single-use ready-to-use bottle (3)

4mg/5mL single-use vial of concentrate (3)

 
CONTRAINDICATIONS
Hypersensitivity to any component of Zometa (4)

 
WARNINGS AND PRECAUTIONS
Patients being treated with Zometa should not be treated with Reclast® (5.1)

Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of Zometa and monitor electrolytes during treatment (5.2)

Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4mg. Treatment in patients with severe renal impairment is not recommended. Monitor serum creatinine before each dose (5.3)

Osteonecrosis of the jaw has been reported. Preventive dental exams should be performed before starting Zometa. Avoid invasive dental procedures (5.4)

Severe incapacitating bone, joint, muscle pain may occur. Discontinue Zometa if severe symptoms occur (5.6)

Zometa can cause fetal harm. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant (5.8, 8.1).

 
ADVERSE REACTIONS
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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
DRUG INTERACTIONS
Aminoglycosides: May have an additive effect to lower serum calcium for prolonged periods (7.1)

Loop diuretics: Con