Drug interactions are evaluated throughout the drug development continuum, based on information from pharmacokinetic (PK) models, clinical studies, and scientific publications. Drug interactions are of particular importance for Norvir® (ritonavir) and Kaletra® (lopinavir/ritonavir) as ritonavir is a CYP3A4 inhibitor and could affect exposures of CYP3A4 substrates. Drug manufacturers routinely evaluate new drug interactions. However, advancement can be made to efficiently and proactively assess new products for potential drug interactions. A web-based labeling tool from an evidence based medicine (EBM) technology platform was applied to this effort. The objective of the study is to demonstrate the application of a proprietary EBM technology platform in proactively identifying potential drug interactions between established AbbVie marketed products and newly approved products through a standardized process based on their prescribing information.
A technology based EBM platform was applied to identify newly approved products. PK-related information from the products’ prescribing information was summarized and reviewed to identify which drugs could potentially interact with ritonavir. AbbVie further evaluated PK, clinical, and postmarketing information pertinent to the interaction, using an algorithm to determine if a revision to the Norvir and Kaletra prescribing information were necessary.
Within a 5 month timeframe, nine new approved drugs were identified by the EBM platform as having potential interactions with Kaletra and/or Norvir. Based on an algorithm, three drugs were further evaluated to determine if labeling changes were necessary to appropriately communicate potential safety concerns. Based on the evaluation of these three drugs, no changes to the Kaletra and Norvir prescribing information were required.
This application enables AbbVie to utilize new technology and apply an algorithm to proactively assess and communicate findings through label revision when a potential drug interaction is identified based on the prescribing information of new products. Such an approach improves pharmacovigilance practices, augments routine surveillance, and ensures timely communication of risks to patients and healthcare providers.
J. Valdes, AbbVie, Inc: Employee and Shareholder , Salary
A. Parikh, AbbVie, Inc.: Employee and Shareholder , Salary
M. Voth, AbbVie, Inc.: Employee and Shareholder , Salary
S. Snyder, AbbVie, Inc.: Employee , Salary
M. Bhattacharya, AbbVie, Inc.: Employee and Shareholder , Salary
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