Zoledronic Acid is a bisphosphonate sold in the U.S. under 3 brand and generic names, for bone neoplasms, hypercalcemia and multiple myeloma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Zometa (application NDA021386). Other zoledronic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hypercalcemia of malignancy ( 2.1 ) • 4 mg as a single-dose 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-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. • 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 ) 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 mmol/L]) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes . Patients who receive zoledronic acid injection should have serum creatinine assessed prior to each treatment. Dose adjustments of zoledronic acid injection are not necessary in treating patients for hypercalcemia of…
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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 was studied in 185 patients with hypercalcemia of malignancy (HCM) who received either zoledronic acid 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 intravenous infusion compared to the same dose given as a 24-hour intravenous infusion has not been adequately studied in controlled clinical trials. Renal Toxicity Administration of zoledronic acid 4 mg given as a 5-minute intravenous infusion has been…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Injectable | Generic | $0 | View → | |
| 2 | 64/100 | Prescription | Injectable | Generic |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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) ] . Hypersensitivity to any component of zoledronic acid injection ( 4 )
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. • Aminoglycosides : May have an additive effect to lower serum calcium for prolonged periods ( 7.1 ) • Loop Diuretics : Concomitant use with zoledronic acid may increase risk of hypocalcemia ( 7.2 ) • Nephrotoxic Drugs : Use with caution ( 7.3 ) 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 clinical trials. 7.2 Loop Diuretics Caution should also be exercised when zoledronic acid is used in combination with loop diuretics due to an increased risk of hypocalcemia. 7.3 Nephrotoxic Drugs Caution is indicated when zoledronic acid is used with other potentially nephrotoxic drugs. 7.4 Thalidomide No dose adjustment for zoledronic acid 4 mg is needed when coadministered with thalidomide. In a pharmacokinetic study of 24 patients with multiple myeloma, zoledronic acid 4 mg given as a 15-minute infusion was…
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| 3 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |