Author: Kevin Shin, PharmD, BCPS + InpharmD™ AI
INTRODUCTION BY INPHARMD™ RESEARCHER
Zometa was withdrawn from the market in 2009. Per an official notice published by the FDA, the reason for withdrawal was not attributed to concerns over safety or efficacy; an exact reason has not been specified. In general, limited data exist comparing Zometa with Reclast, though both brands share similar pharmacokinetic properties. Notably, however, their elimination patterns exhibit some differences. For instance, Zometa's plasma concentration declines in a multiphasic manner, while Reclas...
According to an official notice published by the Food and Drug Administration in 2009, Zometa was withdrawn for sale in the United States. The reasons were not for safety or efficacy reasons, but an exact reason was not specified. An article from the Genetic Engineering & Biotechnology News dated from 2010 expands upon the reason, citing a phase III study that failed to show benefit when added to post-surgery chemotherapy and hormone therapy in breast cancer. These findings do not affect the current approved indications of zoledronic acid: treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors and treatment of hypercalcemia of malignancy. The FDA Orange Book confirms that all Zometa products are currently unavailable. [1-3]
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A search of the published medical literature revealed
3 studies investigating the researchable question:
Zoledronic acid has two formulations, Reclast and Zometa. Are there any pharmacokinetic differences between the two? Reclast recommends using total body weight for the creatinine clearance calculation. What weight should be used for Zometa creatinine clearance calculation? What weight did initial studies for FDA approval use for in the creatinine clearance calculation of Zometa renal adjustments?
Level of evidence
D - Case reports or unreliable data
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[1] Federal Register. Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Published April 14, 2009. Accessed November 13, 2024. https://www.federalregister.gov/documents/2009/04/14/E9-8524/determination-that-zometa-zoledronic-acid-for-injection-equivalent-to-4-milligrams-base-per-vial
[2] Genetic Engineering & Biotechnology News. Published December 10, 2010. Accessed November 13, 2024. https://www.genengnews.com/news/novartis-withdraws-u-s-...
Author: Open AI GPT
Zoledronic Acid Formulations: Reclast vs. Zometa
1. Pharmacokinetic Differences:
Both Reclast and Zometa contain the same active ingredient, zoledronic acid. While they are largely similar in their pharmacokinetic profiles due to the same active ingredient, they are used to treat different conditions and are dosed differently. There are no significant pharmacokinetic differences reported between the two formulations when accounting for these factors.
2. Creatinine Clearance Calculation for Zometa:
For Zometa, the manufacturer recommends using the Cockcroft-Gault formula to calculate creatinine clearance. Unlike Reclast, which specifies the use of total body weight, Zometa's prescribing information does not explicitly state which body weight (actual, ideal, or adjusted) should be used in the calculation. However, it is generally common in clinical practice to use the actual body weight unless otherwise specified.
3. Weight Used in Initial FDA Studies for Zometa:
In the initial studies supporting the FDA approval of Zometa, the specific details regarding the weight (actual, ideal, or adjusted) used in the creatinine clearance calculations for renal adjustments are not publicly detailed in the prescribing information or available summaries. Typically, unless specified, actual body weight is used in such pharmacokinetic and dosing studies.
For accurate dosing and adjustments, it is advised to consult with a healthcare provider or refer to any specific instructions detailed in clinical guidelines or study protocols related to the administration of zoledronic acid.