Zoledronic Acid 5 mg/100mL
Zoledronic Acid · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Zoledronic Acid is a injection, solution containing zoledronic acid at 5 mg/100mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Zoledronic Acid
- Generic Name
- Zoledronic Acid
- NDC Code (Product)
63323-966- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 5 mg/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA204217
- Marketing Start
- 02/17/2017
Recall History
Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Sagent Pharmaceuticals Inc
Lack of Assurance of Sterility; leaking of premix bags
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility: Leaking vials
Breckenridge Pharmaceutical, Inc
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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. 1.1 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]). 1.2 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 t…
Dosage & Administration
2 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 to 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. 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 ) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.1 Hypercalcemia of Malignancy The maximum recommended dose of zoledronic acid injection in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes …
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to any component of zoledronic acid injection (4) 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) ].
Drug Interactions
7 DRUG INTERACTIONS Aminoglycosides: May have an additive effect to lower serum calcium for prolonged periods. ( 7.1 ) Loop Diuretics: Concomitant use with zoledronic acid injection may increase risk of hypocalcemia. ( 7.2 ) Nephrotoxic Drugs: Use with caution. ( 7.3 ) In vitro studies indicate that the plasma protein binding of zoledronic acid is low, with the unbound fraction ranging from 60% to 77%. In vitro studies also indicate that zoledronic acid does not inhibit microsomal CYP450 enzymes. In vivo studies showed that zoledronic acid is not metabolized, and is excreted into the urine as the intact drug. 7.1 Aminoglycosides and Calcitonin Caution is advised when bisphosphonates are administered with aminoglycosides or calcitonin, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in zoledronic acid injection clinical trials. 7.2 Loop Diuretics Caution should also be exercised when zoledronic acid injection is used in combination with loop diuretics due to an increased risk of hypocalcemia. 7.3 Nephrotoxic Drugs Caution is indicated when zoledronic acid injection is used with other potentially nep…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypercalcemia of Malignancy The safety of zoledronic acid injection was studied in 185 patients with hypercalcemia of malignancy (HCM) who received either zoledronic acid injection 4 mg given as a 5-minute intravenous infusion (n=86) or pamidronate 90 mg given as a 2-hour intravenous infusion (n=103). The population was aged 33 to 84 years, 60% male and 81% Caucasian, with breast, lung, head and neck, and renal cancer as the most common forms of malignancy. NOTE: pamidronate 90 mg was given as a 2-hour intravenous infusion. The relative safety of pamidronate 90 mg given as a 2-hour intra…
Frequently Asked Questions
What is Zoledronic Acid used for?
Zoledronic Acid contains Zoledronic Acid. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Zoledronic Acid a controlled substance?
Zoledronic Acid is not classified as a controlled substance by the DEA.
What is the generic name for Zoledronic Acid?
The generic name for Zoledronic Acid is Zoledronic Acid. There are 7 other brand versions of Zoledronic Acid.
What is the NDC code for Zoledronic Acid 5 mg/100mL?
The NDC (National Drug Code) for Zoledronic Acid 5 mg/100mL is 63323-966, listed by Fresenius Kabi USA, LLC.