Dosing & Administration

For safety reasons, only physicians who enroll in the Prometheus Prescribing Program for LOTRONEX^TM should prescribe LOTRONEX. As a pharmacist, you have a very important role in the Prescribing Program for LOTRONEX^TM (PPL).

>> Dosing & Administration of LOTRONEX
>> Monitoring and Patient Involvement Are Important When Using LOTRONEX

Dosing & Administration of LOTRONEX
Starting dose:

To lower the risk of constipation, LOTRONEX should be started at a dosage of 0.5 mg twice a day. Patients well controlled on 0.5 mg twice a day may be maintained on this regimen
If, after 4 weeks, the 0.5-mg twice-daily dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day, the dose used in controlled clinical trials
LOTRONEX should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice per day

LOTRONEX is available in 0.5-mg and 1-mg tablets.

Counsel your patient about the risks and benefits of LOTRONEX in the patients for whom LOTRONEX is indicated, and discuss the impact of IBS symptoms on your patient's life.

Monitoring and Patient Involvement Are Important When Using LOTRONEX
Patients using LOTRONEX should follow up with their physicians 4 weeks after the initial dose to evaluate their treatment.

As outlined in the Medication Guide, patients should immediately discontinue LOTRONEX and contact their physicians if:

They become constipated
- Contact their physician if they develop constipation
- Patients should immediately contact their physicians again if their constipation does not resolve after discontinuation of LOTRONEX
- Resume LOTRONEX only if their constipation has resolved and after discussion with and the agreement of their physicians
They have symptoms of ischemic colitis such as new or worsening abdominal pain, bloody diarrhea, or blood in the stool

If signs or symptoms of ischemic colitis are reported, physicians should:

Discontinue LOTRONEX
Confirm the diagnosis of ischemic colitis by performing appropriate tests
Not restart LOTRONEX if ischemic colitis diagnosis was confirmed

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

IMPORTANT SAFETY INFORMATION: 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. Some patients have experienced serious complications of constipation or ischemic colitis without warning. In IBS clinical trials, approximately 10% of patients on LOTRONEX 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 or placebo. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving LOTRONEX 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 for longer than 6 months.

LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. 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.

LOTRONEX should not be initiated in IBS patients who are constipated. LOTRONEX is contraindicated in patients with a history of chronic or severe constipation or a history of sequelae from constipation; with a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; with a history of ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; with current or a history of Crohn's disease or ulcerative colitis; with severe hepatic impairment; with active diverticulitis or a history of diverticulitis; in patients who are unable to understand or comply with the Patient-Physician Agreement; and/or in patients with known hypersensitivity to any component of the product. Concomitant administration of alosetron with fluvoxamine is contraindicated.

Please consult the Complete Prescribing Information.