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warnings and cautions
5 WARNINGS AND PRECAUTIONS 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 Femur Fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture ( 5.5 ) Severe Bone, Joint, and Muscle Pain may occur. Withhold future doses of Zoledronic Acid Injection if severe symptoms occur ( 5.7 ) 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 Pre-existing hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Zoledronic Acid Injection. Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended for these patients [see Contraindications ( 4 )]. Hypocalcemia following Zoledronic Acid Injection administration is a significant risk in Paget's disease. All patients should be instructed about the symptoms of hypocalcemia and the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration ( 2.8 ), Adverse Reactions ( 6.1 ), Patient Counseling Information ( 17 )]. All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration ( 2.8 ), Adverse Reactions ( 6.1 ), Patient Counseling Information ( 17 )]. 5.3 Renal Impairment A single dose of Zoledronic Acid Injection...
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adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity ( 6.1 ). Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea ( 6.2 ), and eye inflammation ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Osteoporosis in Postmenopausal Women The safety of Zoledronic Acid Injection in the treatment of postmenopausal osteoporosis was assessed in Study 1, a large, randomized, double-blind, placebo-controlled, multinational study of 7736 postmenopausal women aged 65 to 89 years with osteoporosis, diagnosed by bone mineral density or the presence of a prevalent vertebral fracture. The duration of the trial was three years with 3862 patients exposed to Zoledronic Acid Injection and 3852 patients exposed to placebo administered once annually as a single 5 mg dose in 100 mL solution infused over at least 15 minutes, for a total of three doses. All women received 1000 to 1500 mg of elemental calcium plus 400 to 1200 international units of vitamin D supplementation per day. The incidence of all-cause mortality was similar between groups: 3.4% in the Zoledronic Acid Injection group and 2.9% in the placebo group. The incidence of serious adverse events was 29.2% in the Zoledronic Acid Injection group and 30.1% in the placebo group. The percentage of patients who withdrew from the study due to adverse events was 5.4% and 4.8% for the Zoledronic Acid Injection and placebo groups, respectively. The safety of Zoledronic Acid Injection in the treatment of osteoporosis patients with a recent (within 90 days) low-trauma hip fracture was assessed in Study 2, a randomized, double-blind, placebo-controlled, multinational endpoint-driven study of 2127 men and women aged 50 to 95 years; 1065 patients were randomized to Zoledronic Acid Injection and 1062 patients were randomized to placebo. Zoledronic Acid Injection was administered once annually as a single 5 mg dose in 100 mL s...
adverse reactions table
Table 1. Adverse Reactions Occurring in greater than or equal to 2.0% of Patients with Osteoporosis and More Frequently than in Placebo-Treated Patients System Organ ClassStudy 1Study 25 mg IV Zoledronic Acid Injection once per year % (N = 3862)Placebo once per year % (N = 3852)5 mg IV Zoledronic Acid Injection once per year % (N = 1054)Placebo once per year % (N = 1057)Blood and the Lymphatic System Disorders Anemia 4.4 3.6 5.3 5.2 Metabolism and Nutrition Disorders Dehydration 0.6 0.6 2.5 2.3 Anorexia 2.0 1.1 1.0 1.0 Nervous System Disorders Headache 12.4 8.1 3.9 2.5 Dizziness 7.6 6.7 2.0 4.0 Ear and Labyrinth Disorders Vertigo 4.3 4.0 1.3 1.7 Cardiac Disorders Atrial Fibrillation 2.4 1.9 2.8 2.6 Vascular Disorders Hypertension 12.7 12.4 6.8 5.4 Gastrointestinal Disorders Nausea 8.5 5.2 4.5 4.5 Diarrhea 6.0 5.6 5.2 4.7 Vomiting 4.6 3.2 3.4 3.4 Abdominal Pain Upper 4.6 3.1 0.9 1.5 Dyspepsia 4.3 4.0 1.7 1.6 Musculoskeletal, Connective Tissue and Bone Disorders Arthralgia 23.8 20.4 17.9 18.3 Myalgia 11.7 3.7 4.9 2.7 Pain in Extremity 11.3 9.9 5.9 4.8 Shoulder Pain 6.9 5.6 0.0 0.0 Bone Pain 5.8 2.3 3.2 1.0 Neck Pain 4.4 3.8 1.4 1.1 Muscle Spasms 3.7 3.4 1.5 1.7 Osteoarthritis 9.1 9.7 5.7 4.5 Musculoskeletal Pain 0.4 0.3 3.1 1.2 General Disorders and Administrative Site Conditions Pyrexia 17.9 4.6 8.7 3.1 Influenza-like Illness 8.8 2.7 0.8 0.4 Fatigue