ZOMETA (zoledronic acid) Injection Label

These highlights do not include all the information needed to use ZOMETA safely and effectively. See full prescribing information for ZOMETA. ZOMETA (zoledronic acid) Injection Ready-to-Use Solution for Intravenous Infusion (For Single Use) Concentrate for Intravenous Infusion Initial U.S. Approval: 2001 ----------------------------RECENT MAJOR CHANGES-------------------------Warnings and Precautions, Hypocalcemia (5.10) 09/2013 ----------------------------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) • 4 mg as a single-use intravenous infusion over no less than 15 minutes. • 4 mg as retreatment after a minimum of 7 days. Multiple myeloma and bone metastasis from solid tumors. (2.2) • 4 mg as a single-use intravenous infusion over no less than 15 minutes every 3-4 weeks for patients with creatinine clearance of greater than 60 mL/min. • Reduce the dose for patients with renal impairment. • Coadminister oral calcium supplements of 500 mg and a multiple vitamin containing 400 international units of Vitamin D 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) 4 mg/5 mL 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 4 mg. 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, and/or muscle pain may occur. Discontinue Zometa if severe symptoms occur. (5.5) • Zometa can cause fetal harm. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant. (5.9, 8.1) • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture. (5.6) • Hypocalcemia: Correct before initiating Zometa. Adequately supplement patients with calcium and vitamin D (5.10) -------------------------------ADVERSE REACTIONS-----------------------------The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea (6.1)