Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Amneal-Agila, LLC
ZOLEDRONIC ACID
ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE AMNEAL-AGILA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLEDRONIC ACID INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID INJECTION. 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, addition of atypical subtrochanteric and diaphyseal femoral fractures (5.6) 03/2012 INDICATIONS AND USAGE Zoledronic acid injection 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 zoledronic acid injection 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 IU 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 per 5 mL single-use vial of concentrate (3) CONTRAINDICATIONS Hypersensitivity to any component of zoledronic acid injection (4) WARNINGS AND PRECAUTIONS Patien Read the complete document