ZOLEDRONIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

zoledronic acid (UNII: 6XC1PAD3KF) (zoledronic acid anhydrous - UNII:70HZ18PH24)

Available from:

Sagent Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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,

Product summary:

Zoledronic Acid Injection is supplied as follows: Storage Conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container and container closure are not made with natural rubber latex.

Authorization status:

New Drug Application

Summary of Product characteristics

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.10)
10/2020
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)
Limitations of Use: The safety and efficacy of Zoledronic Acid
Injection has not been established for use in
hyperparathyroidism or non-tumor-related hypercalcemia.
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)
4 mg as a single-dose intravenous infusion over no less than 15
minutes. (2.1)
4 mg as retreatment after a minimum of 7 days. (2.1)
Multiple myeloma and bone metastasis from solid tumors. (2.2)
4 mg as a single-dose intravenous infusion over no less than 15
minutes every 3 to 4 weeks for
patients with creatinine clearance of greater than 60 mL/min. (2.2)
This premixed ready-to-use bag is intended only for patients with
normal renal function (creatinine
clearance greater than 60 mL/min.) (2.2)
Coadminister oral calcium supplements of 500 mg and a multiple vitamin
containing 400 international
units of vitamin D daily. (2.2)
Administer through a separate infusion line and do not allow to come
in contact with any calcium or
divalent cation-containing solutions. (2.3)
DOSAGE FORMS AND STRENGTHS
Zoledronic Acid Injection: 4 mg in a 100 mL (0.04 mg per mL)
single-dose bag (3)
CONTRAINDICATIONS
Hypersensitivity to any component of Zoledronic Acid Injection (4)
WARNINGS AND