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agila specialties private limited - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml

United States - English - NLM (National Library of Medicine)

amneal-agila, llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 0.8 mg in 1 ml

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl – patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see advers

United States - English - NLM (National Library of Medicine)

bpi labs, llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl =ca in mg/dl + 0.8 ( 4.0 g/dl – patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported

United States - English - NLM (National Library of Medicine)

athenex pharmaceutical division, llc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl – patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [ see adverse reactions ( 6.2) ] . risk summary based on findings from animal studies and its mechanism of action, zoledronic acid injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of zoledronic acid to pregnant rats during organogenesis resulted in fetal malformations and embryo-fetal lethality at maternal exposures that were ≥ 2.4 times the human clinical exposure based on auc (see data) . bisphosphonates, such as zoledronic acid injection, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. there may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in female rats given subcutaneous doses of zoledronic acid of 0.01, 0.03, or 0.1 mg/kg/day beginning 15 days before mating and continuing through gestation, the number of stillbirths was increased and survival of neonates was decreased in the mid- and high-dose groups (greater than or equal to 0.2 times the human systemic exposure following an intravenous dose of 4 mg, based on an auc comparison). adverse maternal effects were observed in all dose groups (with a systemic exposure of greater than or equal to 0.07 times the human systemic exposure following an intravenous dose of 4 mg, based on an auc comparison) and included dystocia and periparturient mortality in pregnant rats allowed to deliver. maternal mortality may have been related to drug-induced inhibition of skeletal calcium mobilization, resulting in periparturient hypocalcemia. this appears to be a bisphosphonate-class effect. in pregnant rats given a subcutaneous dose of zoledronic acid of 0.1, 0.2, or 0.4 mg/kg/day during gestation, adverse fetal effects were observed in the mid- and high-dose groups (with systemic exposures of 2.4 and 4.8 times, respectively, the human systemic exposure following an intravenous dose of 4 mg, based on an auc comparison). these adverse effects included increases in pre- and postimplantation losses, decreases in viable fetuses, and fetal skeletal, visceral, and external malformations. fetal skeletal effects observed in the high-dose group included unossified or incompletely ossified bones, thickened, curved, or shortened bones, wavy ribs, and shortened jaw. other adverse fetal effects observed in the high-dose group included reduced lens, rudimentary cerebellum, reduction or absence of liver lobes, reduction of lung lobes, vessel dilation, cleft palate, and edema. skeletal variations were also observed in the low-dose group at 0.1 mg/kg/day (with systemic exposure of 1.2 times the human systemic exposure following an intravenous dose of 4 mg, based on an auc comparison). signs of maternal toxicity were observed in the high-dose group and included reduced body weights and food consumption, indicating that maximal exposure levels were achieved in this study. in pregnant rabbits given subcutaneous doses of zoledronic acid of 0.01, 0.03, or 0.1 mg/kg/day during gestation (less than or equal to 0.5 times the human intravenous dose of 4 mg, based on a comparison of relative body surface areas), no adverse fetal effects were observed. maternal mortality and abortion occurred in all treatment groups (at doses greater than or equal to 0.05 times the human intravenous dose of 4 mg, based on a comparison of relative body surface areas). adverse maternal effects were associated with, and may have been caused by, drug-induced hypocalcemia. risk summary after administration of zoledronic acid injection, it is not known whether zoledronic acid is present in human milk, or whether it affects milk production or the breastfed child. zoledronic acid binds to bone long term and may be released over periods of weeks to years. because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during and after zoledronic acid injection treatment. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiation of zoledronic acid injection. contraception females zoledronic acid injection can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. zoledronic acid binds to bone long term and may be released over periods of weeks to years. advise females of reproductive potential to use effective contraception during and after zoledronic acid injection treatment. infertility females based on animal studies, zoledronic acid injection may impair fertility in females of reproductive potential [see nonclinical toxicology ( 13.1)]. zoledronic acid injection is not indicated for use in children. the safety and effectiveness of zoledronic acid was studied in a one-year, active-controlled trial of 152 pediatric subjects (74 receiving zoledronic acid). the enrolled population was subjects with severe osteogenesis imperfecta, aged 1 to 17 years, 55% male, 84% caucasian, with a mean lumbar spine bone mineral density (bmd) of 0.431 gm/cm 2 , which is 2.7 standard deviations below the mean for age-matched controls (bmd z-score of -2.7). at one year, increases in bmd were observed in the zoledronic acid treatment group. however, changes in bmd in individual patients with severe osteogenesis imperfecta did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain. the adverse events observed with zoledronic acid injection use in children did not raise any new safety findings beyond those previously seen in adults treated for hypercalcemia of malignancy or bone metastases. however, adverse reactions seen more commonly in pediatric patients included pyrexia (61%), arthralgia (26%), hypocalcemia (22%) and headache (22%). these reactions, excluding arthralgia, occurred most frequently within 3 days after the first infusion and became less common with repeat dosing. because of long-term retention in bone, zoledronic acid injection should only be used in children if the potential benefit outweighs the potential risk. plasma zoledronic acid concentration data was obtained from 10 patients with severe osteogenesis imperfecta (4 in the age group of 3 to 8 years and 6 in the age group of 9 to 17 years) infused with 0.05 mg/kg dose over 30 min. mean c max and auc (0-last) was 167 ng/ml and 220 ng•h/ml, respectively. the plasma concentration time profile of zoledronic acid in pediatric patients represent a multi-exponential decline, as observed in adult cancer patients at an approximately equivalent mg/kg dose. clinical studies of zoledronic acid injection in hypercalcemia of malignancy included 34 patients who were 65 years of age or older. no significant differences in response rate or adverse reactions were seen in geriatric patients receiving zoledronic acid injection as compared to younger patients. controlled clinical studies of zoledronic acid injection in the treatment of multiple myeloma and bone metastases of solid tumors in patients over age 65 revealed similar efficacy and safety in older and younger patients. because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3 mmol/l] using the formula: cca in mg/dl = ca in mg/dl + 0.8 (4 g/dl – patient albumin [1g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity reactions including cases of urticaria and angioedema, and cases of anaphylactic reaction/shock have been reported [see adverse reactions (6.2)] . risk summary based on findings from animal studies and its mechanism of action,

United States - English - NLM (National Library of Medicine)

dr. reddy's laboratories inc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin­-corrected calcium (cca) of greater than or equal to 12 mg/dl [3 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitation of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare casesof anaphylactic reaction/shock have been reported [see adverse re

United States - English - NLM (National Library of Medicine)

mylan institutional llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3 mmol/l] using the formula: cca in mg/dl = ca in mg/dl + 0.8 (4 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adverse r

United States - English - NLM (National Library of Medicine)

westminster pharmaceuticals, llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl = ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of 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. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adver