Lotronex

Warnings
Precautions

WARNINGS

(See BOXED WARNING and DOSAGE AND ADMINISTRATION.)

Some patients have experienced serious complications of constipation or ischemic colitis without warning.

Constipation: Serious complications of constipation including obstruction, ileus, impaction, toxic megacolon, and secondary bowel ischemia have been reported with use of LOTRONEX (alosetron hydrochloride) during clinical trials. In addition, rare cases of perforation and death have been reported from postmarketing clinical practice. In some cases, complications of constipation required intestinal surgery, including colectomy. In IBS clinical trials, approximately 10% of patients on LOTRONEX (alosetron hydrochloride) withdrew prematurely because of constipation. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either LOTRONEX (alosetron hydrochloride) or placebo. Patients who are elderly, debilitated, or taking additional medications that decrease gastrointestinal motility may be at greater risk for complications of constipation.

LOTRONEX (alosetron hydrochloride) should be discontinued immediately in patients who develop constipation (see BOXED WARNING).

Ischemic Colitis: Ischemic colitis has been reported in patients receiving LOTRONEX (alosetron hydrochloride) in clinical trials as well as during marketed use of the drug. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving LOTRONEX (alosetron hydrochloride) was 0.2% (2 per 1,000 patients, 95% confidence interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months. Ischemic colitis was not reported in women receiving placebo. The patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking LOTRONEX (alosetron hydrochloride) for longer than 6 months.

LOTRONEX (alosetron hydrochloride) should be discontinued immediately in patients with signs of ischemic colitis such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Because ischemic colitis can be life-threatening, patients with signs or symptoms of ischemic colitis should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with LOTRONEX (alosetron hydrochloride) should not be resumed in patients who develop ischemic colitis.

PRECAUTIONS

Prescribing Program for LOTRONEX (alosetron hydrochloride) : To prescribe LOTRONEX (alosetron hydrochloride) , the physician must be enrolled in the Prescribing Program for LOTRONEX (alosetron hydrochloride) . To enroll, physicians must understand the benefits and risks of treatment with LOTRONEX (alosetron hydrochloride) for severe diarrhea-predominant IBS, including the information in the Prescribing Information, Medication Guide, and Patient-Physician Agreement for LOTRONEX (alosetron hydrochloride) . Physicians need to be able to:

  • Diagnose and manage IBS, ischemic colitis, constipation and complications of constipation, or refer patients to specialists as needed.
  • Educate patients on the benefits and risks of treatment with LOTRONEX, provide them with the Medication Guide, instruct them to read it, and encourage them to ask questions when first considering LOTRONEX (alosetron hydrochloride) . Patients may be educated by the enrolled physician or a healthcare provider under a
  • Prior to the initial prescription of LOTRONEX (alosetron hydrochloride) , obtain the patient's sign it, place the original signed form in the patient's
  • Affix program stickers to all prescriptions for LOTRONEX (alosetron hydrochloride) (i.e., the original and all subsequent prescriptions). Stickers will be provided as part of the Prometheus Prescribing Program for LOTRONEX (alosetron hydrochloride) . No telephone, facsimile, or computerized prescriptions are permitted with this program. Refills are permitted to be written on prescriptions.
  • Report all serious adverse events with LOTRONEX (alosetron hydrochloride) to Prometheus at 1-888-423-5227 or to the Food and Drug Administration's MedWatch Program at 1-800-FDA-To enroll in the Prescribing Program for LOTRONEX (alosetron hydrochloride) call 1-888-423-5227 or visit www.lotronex (alosetron hydrochloride) .com to complete the Physician Enrollment Form.

Information for Patients: Patients should be fully counseled on and understand the risks and benefits of LOTRONEX (alosetron hydrochloride) before an initial prescription is written. The patient may be educated by the enrolled physician or a healthcare provider under a physician's direction.

PHYSICIANS MUST:

  • Counsel patients for whom LOTRONEX (alosetron hydrochloride) is appropriate about the benefits and risks of LOTRONEX (alosetron hydrochloride) and discuss the impact of IBS symptoms on the patient's life.
  • Give the patient a copy of the Medication Guide, which outlines the benefits and risks of LOTRONEX (alosetron hydrochloride) , and instruct the patient to read it carefully. Answer all questions the patient may have about LOTRONEX. The complete text of the Medication Guide is printed at the end of this document.
  • Review the Patient-Physician Agreement for LOTRONEX (alosetron hydrochloride) with the patient, answer all questions, and give a copy of the signed agreement to the patient.
  • Provide each patient with appropriate instructions for taking LOTRONEX (alosetron hydrochloride) .

Copies of the Patient-Physician Agreement for LOTRONEX and additional copies of the Medication Guide are available by contacting Prometheus at 1-888-423-5227 or visiting www. lotronex (alosetron hydrochloride) .com.

PATIENTS WHO ARE PRESCRIBED LOTRONEX (alosetron hydrochloride) SHOULD BE INSTRUCTED TO:

  • Read the Medication Guide before starting LOTRONEX (alosetron hydrochloride) and each time they refill their prescription.
  • Not start taking LOTRONEX (alosetron hydrochloride) if they are constipated.
  • Immediately discontinue LOTRONEX (alosetron hydrochloride) and contact their physician if they become constipated, or have symptoms of ischemic colitis such as new or worsening abdominal pain, bloody diarrhea, or blood in the stool. Contact their physician again if their constipation does not resolve after discontinuation of LOTRONEX (alosetron hydrochloride) . Resume LOTRONEX (alosetron hydrochloride) only if their constipation has resolved and after discussion with and the agreement of their treating physician.
  • Stop taking LOTRONEX (alosetron hydrochloride) and contact their physician if LOTRONEX (alosetron hydrochloride) does not adequately control IBS symptoms after 4 weeks of taking 1 mg twice a day.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In 2-year oral studies, alosetron was not carcinogenic in mice at doses up to 30 mg/kg/day or in rats at doses up to 40 mg/kg/day. These doses are, respectively, about 60 to 160 times the recommended human dose of alosetron of 2 mg/day (1 mg twice daily) based on body surface area. Alosetron was not genotoxic in the Ames tests, the mouse lymphoma cell (L5178Y/TK± ) forward gene mutation test, the human lymphocyte chromosome aberration test, the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, or the in vivo rat micronucleus test for mutagenicity. Alosetron at oral doses up to 40 mg/kg/day (about 160 times the recommended daily human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male or female rats.

Pregnancy:Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 40 mg/kg/day (about 160 times the recommended human dose based on body surface area) and rabbits at oral doses up to 30 mg/kg/day (about 240 times the recommended daily human dose based on body surface area). These studies have revealed no evidence of impaired fertility or harm to the fetus due to alosetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, LOTRONEX (alosetron hydrochloride) should be used during pregnancy only if clearly needed.

Nursing Mothers: Alosetron and/or metabolites of alosetron are excreted in the breast milk of lactating rats. It is not known whether alosetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LOTRONEX (alosetron hydrochloride) is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation (see WARNINGS).

Last reviewed on RxList: 5/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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