PRESCRIBING PROGRAM FOR LOTRONEX™
PHYSICIAN ENROLLMENT FORM
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 Prometheus 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. |
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Signature
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DEA Number
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Office Address:
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Upon enrollment, you will receive a prescribing kit for LOTRONEX with the complete Prescribing Information, Prescribing Program for LOTRONEX stickers, multiple copies of the Medication Guide and Patient-Physician Agreement for LOTRONEX, and instructions for ordering additional supplies of Program materials.
You only need to enroll once, and you are under no obligation to prescribe LOTRONEX.
If you have any questions, please call the Prescribing Program for LOTRONEX at 1-888-423-5227 or visit www.lotronex.com.
TO ENROLL, VISIT WWW.LOTRONEX.COM OR PHONE 1-888-423-5227 OR COMPLETE THIS FORM IN ITS ENTIRETY AND MAIL OR FAX TO THE FOLLOWING ADDRESS:
Prescribing Program for Lotronex
9410 Carroll Park Drive
San Diego, CA 92121
1-888-423-5227
Fax Number: 1-858-824-0896
Prometheus®
Therapeutics & Diagnostics
For the person in every patient
©2007 Prometheus Laboratories Inc. All rights reserved LX001A08
January 2008
WARNING
Infrequent but serious gastrointestinal adverse events have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.
- The Prescribing Program for LOTRONEX™ was implemented to help reduce risks of serious gastrointestinal adverse events. Only physicians who have enrolled in Prometheus' Prescribing Program for LOTRONEX, based on their understanding of the benefits and risks, should prescribe LOTRONEX (see PRECAUTIONS: Prescribing Program for LOTRONEX).
- LOTRONEX is indicated only for women with severe diarrhea-predominant IBS who have not responded adequately to conventional therapy (see INDICATIONS AND USAGE). Before receiving the initial prescription for LOTRONEX, the patient must read and sign the Patient-Physician Agreement for LOTRONEX (see PRECAUTIONS: Information for Patients).
- LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their physician. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their physician if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating physician.
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LOTRONEX SUMMARY
LOTRONEX®
(alosetron hydrochloride)
Tablets
The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3 receptor type.
Because of serious gastrointestinal adverse events, some fatal, reported with use of this drug, LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
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chronic IBS symptoms (generally lasting 6 months or longer),
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had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
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failed to respond to conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
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frequent and severe abdominal pain/discomfort
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frequent bowel urgency or fecal incontinence
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disability or restriction of daily activities due to IBS
Less than 5 percent of IBS is considered severe.
In men, the safety and effectiveness of LOTRONEX have not been established (see CLINICAL TRIALS).
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