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Zoledronic Acid Injection is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone in men and women ( 1.5 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women Zoledronic Acid Injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Zoledronic Acid Injection reduces the incidence of fractures (hip, vertebral, and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Zoledronic Acid Injection reduces the incidence of new clinical fractures [see Clinical Studies ( 14.1 )] . 1.2 Prevention of Osteoporosis in Postmenopausal Women Zoledronic Acid Injection is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies ( 14.2 )] . 1.3 Osteoporosis in Men Zoledronic Acid Injection is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ( 14.3 )] . 1.4 Glucocorticoid-Induced Osteoporosis Zoledronic Acid Injection is …

Zoledronic acid injection is contraindicated in patients with the following conditions: Hypocalcemia [see Warnings and Precautions ( 5.2 )] Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions ( 5.3 )] . Known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions ( 6.2 )] . Hypocalcemia ( 4 ) Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment ( 4 , 5.3 ) Hypersensitivity to any component of zoledronic acid injection ( 4 , 6.2 )

Products Containing Same Active Ingredient : Patients receiving Zometa ® should not receive zoledronic acid injection ( 5.1 ) Hypocalcemia may worsen during treatment. Patients must be adequately supplemented with calcium and vitamin D ( 5.2 ) Renal Impairment : A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration. Monitor creatinine clearance before each dose ( 2.7 , 5.3 ) Osteonecrosis of the Jaw (ONJ) has been reported. All patients should have a routine oral exam by the prescriber prior to treatment ( 5.4 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered ( 5.5 ) Severe Bone, Joint, and Muscle Pain may occur. Withhold future doses of zoledronic acid injection if severe symptoms occur ( 5.6 ) 5.1 Drug Products With Same Active Ingredient Zoledronic acid injection contains the same active ingredient found in Zometa ® , used for oncology indications, and a patient being treated with Zometa ® should not be treated with zoledronic acid injection. 5.2 Hypocalcemia and Mineral Metabolism Preexisting hypocalcemia and disturbances of …

8.1 Pregnancy Risk Summary Available data on the use of zoledronic acid injection in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue zoledronic acid injection when pregnancy is recognized. In animal reproduction studies, daily subcutaneous administration of zoledronic acid to pregnant rats during organogenesis resulted in increases in fetal skeletal, visceral, and external malformations, decreases in postimplantation survival, and decreases in viable fetuses and fetal weight starting at doses equivalent to 2 times the recommended human 5 mg intravenous dose (based on AUC). Subcutaneous administration of zoledronic acid to …