Name: Zoledronic acid-injection
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Indications and Usage for Zoledronic Acid Injection
Hypercalcemia of Malignancy
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)).
Multiple Myeloma and Bone Metastases of Solid Tumors
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.
Important Limitation of Use
The safety and efficacy of zoledronic acid in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. There was an increased incidence of Harderian gland adenomas in males and females in all treatment groups (at doses ≥0.002 times a human intravenous dose of 4 mg, based on a comparison of relative body surface areas). Rats were given oral doses of zoledronic acid of 0.1, 0.5, or 2.0 mg/kg/day. No increased incidence of tumors was observed (at doses ≤0.2 times the human intravenous dose of 4 mg, based on a comparison of relative body surface areas).
Zoledronic acid was not genotoxic in the Ames bacterial mutagenicity assay, in the Chinese hamster ovary cell assay, or in the Chinese hamster gene mutation assay, with or without metabolic activation. Zoledronic acid was not genotoxic in the in-vivo rat micronucleus assay.
Female rats were 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. Effects observed in the high-dose group (with systemic exposure of 1.2 times the human systemic exposure following an intravenous dose of 4 mg, based on AUC comparison) included inhibition of ovulation and a decrease in the number of pregnant rats. Effects observed in both the mid-dose group (with systemic exposure of 0.2 times the human systemic exposure following an intravenous dose of 4 mg, based on an AUC comparison) and high-dose group included an increase in preimplantation losses and a decrease in the number of implantations and live fetuses.
How Supplied/Storage and Handling
4 mg/100 mL single-dose premixed bag
Carton of 1 bag NDC 0409-4229-01
Store at temperatures not exceeding 30°C (86°F). Do not freeze.
Single Dose Only – Discard Unused Portion.
Patient Counseling Information
Laboratorios Grifols, SA
Hospira, Inc., Lake Forest, IL 60045 USA
Product of Spain
|ZOLEDRONIC ACID |
Zoledronic Acid Injection, solution
|Labeler - Hospira, Inc. (141588017)|
|Laboratorios Grifols, S.A.||463719725||MANUFACTURE(0409-4229), PACK(0409-4229)|
|Hospira Boulder, Inc.||141565163||ANALYSIS(0409-4229), API MANUFACTURE(0409-4229)|
|Laboratorios Grifols, S.A.||461842294||ANALYSIS(0409-4229)|