With better control of severe D-IBS symptoms, your pateints may have less interference with social activities

Physician Enrollment

Welcome to the Prescribing Program for LOTRONEX (PPL)

To enroll, please read the Enrollment information below and click the "I AGREE" at the bottom of the page.

PRESCRIBING PROGRAM FOR LOTRONEX™:

The Prescribing Program for LOTRONEX™ was implemented to help reduce risks of serious gastrointestinal adverse events, some fatal, associated with this medicine. The program is intended to help physicians and their patients understand the benefits and risks of treatment with LOTRONEX in order to make fully informed decisions.

I wish to participate in the Prescribing Program for LOTRONEX™ (PPL) and acknowledge that I have read the complete Prescribing Information for LOTRONEX and understand and will follow the requirements of the PPL described below.

For safety reasons, LOTRONEX is approved only for women with severe, diarrhea- predominant irritable bowel syndrome (D-IBS) who have:
- Chronic IBS symptoms (generally lasting for 6 months or longer),
- had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
- not responded adequately to conventional therapy.
Diarrhea-predominant IBS 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 IBS
Physicians who enroll in the PPL should be able to diagnose and manage IBS, ischemic colitis, constipation, and complications of constipation, or refer patients to a specialist as needed.
Patients considering treatment with LOTRONEX must be educated on the benefits and risks of the drug, given a copy of the Medication Guide, instructed to read it, and encouraged to ask questions. The patient may be educated by the enrolled physician or a healthcare provider under a physician's direction.
After reviewing the Medication Guide prior to the initial prescription, the physician and the patient must both sign the Patient-Physician Agreement form. The original signed form must be placed in the patient's medical record, and a copy given to the patient.
Program stickers must be affixed to all prescriptions for LOTRONEX (i.e., the original and all subsequent prescriptions). Stickers will be provided as part of the Prescribing Program for LOTRONEX. Refills are permitted to be written on prescriptions.
All prescriptions for LOTRONEX must be written and not transmitted by telephone, facsimile, or computer.
Prescribers must report all serious adverse events with LOTRONEX to Prometheus at 1-888-423-5227 or to the Food and Drug Administration at 1-800-FDA-1088.

To enroll, select I AGREE. If you do not wish to enroll, select I DO NOT AGREE. To return to the Physician Home page, select RETURN.

Please consult the Complete Prescribing Information.