Prescriber Information

What is my role in the LOTRONEX REMS Program?

Healthcare professionals are expected to complete the LOTRONEX REMS Program Prescriber Training and return the LOTRONEX REMS Program Completion of Training Form (online or paper) in order to prescribe LOTRONEX or its authorized generic.

Step 1: Complete the LOTRONEX REMS Program Prescriber Training

You should become familiar with the risks of IC and CoC associated with LOTRONEX/alosetron hydrochloride and the requirements of the LOTRONEX REMS Program.
As a prescriber of LOTRONEX/alosetron hydrochloride, you should comply with the LOTRONEX REMS Program by reviewing a LOTRONEX REMS Program Prescriber Education Slide Deck. Then complete a Prescriber Completion of LOTRONEX REMS Program Training Form to document that you have trained on the benefits and risks of LOTRONEX/alosetron hydrochloride therapy.

Step 2: Educate Patients

Counsel patients on the risks associated with LOTRONEX/alosetron hydrochloride and provide the LOTRONEX REMS Program Patient Education Sheet.

Program Resources and Education Materials

The LOTRONEX REMS Program provides the resources and educational materials you and your patients need to understand your roles and responsibilities in the program.

There are two ways to obtain program materials:

  1. VIEW, PRINT, OR SAVE ON YOUR COMPUTER –You can view, print, or save the materials to your computer. Select items from the list below.
  2. BY PHONE – you can order materials by calling the LOTRONEX REMS Program Coordinating Center at 1-844-851-3395.

INDICATION: LOTRONEX/alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome who have: chronic irritable bowel syndrome symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant irritable bowel syndrome is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to irritable bowel syndrome. Because of infrequent but serious gastrointestinal adverse events associated with LOTRONEX/alosetron hydrochloride, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX/alosetron hydrochloride in men.

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This product may be covered by one or more US pending or issued patents.
LOTRONEX is a registered trademark of Prometheus Laboratories Inc., San Diego, CA