US Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed March 23, 2012.
US Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed March 23, 2012.
US Food and Drug Administration. NDA 21-107. Lotronex^® (alosetron hydrochloride) tablets. Risk Evaluation and Mitigation Strategy. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM227960.pdf. Accessed March 23, 2012.
Prometheus Laboratories Inc. Lotronex^® (alosetron HCl) tablets: understanding the benefits and risks. Prescribing Program for Lotronex^™Pharmacist Education Slide Deck. Available at: http://www.lotronexppl.com/PDF/REMS_PPL%20Pharmacist%20Education%20Slide%20Deck.pdf. Accessed March 23, 2012.
Prometheus Laboratories Inc. Lotronex^® (alosetron hydrochloride) tablets. Highlights of prescribing information. Available at: http://www.lotronex.com/hcp/_docs/Lotronex_PI.pdf. Accessed March 23, 2012.
Chang L, Chey WD, Harris L, et al. Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. Am J Gastroenterol. 2006;101:1069-1079.
Krause R, Ameen V, Gordon SH, et al. A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS. Am J Gastroenterol. 2007;102:1709-1719.
Gallo-Torres H, Brinker A, Avigan M. Alosetron: ischemic colitis and serious complications of constipation. Am J Gastroenterol. 2006;101:1080-1083.
Prometheus. Welcome to the Prescribing Program for Lotronex™ (PPL). Available at: http://www.lotronexppl.com/. Accessed March 23, 2012.
Prometheus. For pharmacists: your role in the Prescribing Program for Lotronex. Available at: http://www.lotronexppl.com/Pharmacists/Role/. Accessed March 23, 2012.
Daily Med. Lotronex (alosetron hydrochloride) tablet [Prometheus Laboratories Inc]. Available at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=23733&CFID=26362846&CFTOKEN=a447992b853f4f17-8AE1BEC0-90B4-11B6-8277A4F5E077BCF4&jsessionid=8430fc1a5f56000d6a1169c406f76141bc65. Accessed March 23, 2012.
U.S. Food and Drug Administration. Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Subcommittee background package. April 23, 2002. Available at: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3848B1_02_FDA%20Lotronex.pdf. Accessed March 18, 2012.

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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Author

Carl N. Kraus, MD

Vice President of Medical Affairs, Medscape, LLC

Disclosures

Disclosure: Carl N. Kraus, MD, has disclosed no relevant financial relationships.

Dr Kraus does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Kraus does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Sarah Williams, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

CE

What Does Every Pharmacist Need to Know About REMS for Alosetron?

Authors: Carl N. Kraus, MD
CE Released: 4/10/2012
THIS ACTIVITY HAS EXPIRED
Valid for credit through: 4/10/2013

Start Activity

Target Audience and Goal Statement

This activity is intended for pharmacists.

The goal of this activity is to educate pharmacists on the REMS required for Lotronex®(alosetron).

Upon completion of this activity, participants will be able to:

Describe why a risk evaluation and mitigation strategy (REMS) is required for alosetron
Summarize the requirements of the REMS for alosetron that relate to the responsibilities of pharmacists

Disclosures

Author

Carl N. Kraus, MD

Vice President of Medical Affairs, Medscape, LLC

Disclosures

Disclosure: Carl N. Kraus, MD, has disclosed no relevant financial relationships.

Dr Kraus does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr Kraus does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Sarah Williams, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Accreditation Statements

For Pharmacists

Medscape, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Medscape, LLC designates this continuing education activity for 0.5 contact hour(s) (0.05 CEUs) (Universal Activity Number 0461-0000-12-050-H05-P).

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Under the US Food and Drug Administration (FDA) Amendments Act of 2007, the FDA has the authority to require a manufacturer to implement a risk evaluation and mitigation strategy (REMS) for any drug or biologic agent.^[1] The primary goal of a REMS requirement is to ensure that the benefits of the drug or biologic agent outweigh the risks. The complexity and the specific components of a REMS program vary. In many cases a medication guide is the only requirement, but some programs have additional components, such as elements to assure safe use, which may involve special training or certification or a restricted distribution process.^[2]

The FDA has determined that a REMS is necessary for a number of prescription drugs, one of which is alosetron hydrochloride. Alosetron is marketed as Lotronex^® (alosetron hydrochloride) tablets by Prometheus Laboratories Inc. This review will summarize the REMS requirements for this product, with a particular focus on what pharmacists need to know and, in fact, what they are responsible for, according to the REMS program for Lotronex that was approved by the FDA in September 2010.^[3]The primary source of the information provided below is the Prescribing Program for Lotronex Pharmacist Education Slide Deck.^[4]

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The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Author

Carl N. Kraus, MD

Editor

Sarah Williams, PhD

CME Reviewer(s)

Nafeez Zawahir, MD

CE

What Does Every Pharmacist Need to Know About REMS for Alosetron?

Target Audience and Goal Statement

Disclosures

Author

Carl N. Kraus, MD

Editor

Sarah Williams, PhD

CME Reviewer(s)

Nafeez Zawahir, MD

Accreditation Statements

For Pharmacists

Instructions for Participation and Credit

What Does Every Pharmacist Need to Know About REMS for Alosetron?