ZOLEDRONIC ACID injection, solution, concentrate

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Zoledronic Acid (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

Prieinama:

BluePoint Laboratories

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

4 mg/ 5mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion Zoledronic Acid Injection, 4 mg/5 mL NDC 68001-366-22 Vial of 4mg/5 mL NDC 68001-366-25 Carton of one vial Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Discard unused portion.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
BLUEPOINT LABORATORIES
----------
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) 12/2018
INDICATIONS AND USAGE
Zoledronic Acid Injection is a bisphosphonate indicated for the
treatment of:
•
•
Limitation 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)
•
•
Multiple myeloma and bone metastasis from solid tumors. (2.2)
•
•
•
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
Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior
to intravenous infusion (3)
CONTRAINDICATIONS
Hypersensitivity to any component of Zoledronic Acid Injection (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
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)
4 mg as a single-use intravenous infusion over no less than 15
minutes.
4 mg as retreatment after a minimum of 7 days.
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 international units of vitamin
D daily.
Patients b