Who is the LOTRONEX REMS Program intended for?

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The LOTRONEX Risk Evaluation and Mitigation Strategy (REMS) Program is specifically designed to address the safety concerns associated with the use of LOTRONEX (alosetron), which is approved for treating women suffering from severe diarrhea-predominant irritable bowel syndrome (IBS). The drug has been associated with serious gastrointestinal side effects, which is why a REMS program is necessary to ensure that it is prescribed and used safely.

This program necessitates that healthcare providers and patients participate in certain safety measures, including education regarding potential risks and a determination of whether the patient meets specific criteria for treatment. Female patients with severe diarrhea-predominant IBS are the target audience for this program because they represent the patient population that the drug is approved to help and is most susceptible to the risks associated with its use.

In contrast, the other answer choices either encompass patient populations that do not meet the specific criteria for LOTRONEX use or represent conditions that are not severe enough to warrant the REMS program. Thus, the focus on female patients with this specific type of IBS reflects both the medication's intended use and the risk mitigation strategies outlined in the REMS program.

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