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RELISTOR rapidly relieved OIC in 2 randomized, double-blind, placebo-controlled clinical studies

PROVEN RESPONSE: 62% and 48% of patients treated with RELISTOR had a bowel movement within 4 hours of the first injection.1

RAPID RESPONSE: Approximately 30% of patients reported a bowel movement within 30 minutes of a dose of RELISTOR in both studies.1

• In both studies, patients had advanced illness (a primary diagnosis of incurable cancer or other advanced illnesses, such as end-stage cardiovascular disease or end-stage COPD) with a life expectancy of less than 6 months and received care to control their symptoms. Prior to screening, patients had been receiving palliative opioid therapy (median daily baseline oral morphine equivalent dose = 172 mg).¹
• Patients maintained their regular laxative regimen in addition to RELISTOR or placebo throughout the studies. Rescue laxatives were prohibited from 4 hours before to 4 hours after taking an injection of medication.¹

STUDY 1: All patients had OIC (no bowel movement within 2 days) on stable laxatives for at least 3 days prior to treatment in a single-dose study.^1,3

STUDY 2: All patients had OIC (either <3 bowel movements in the preceding week or no bowel movement within 2 days) on stable laxatives for at least 3 days prior to receiving either RELISTOR or placebo every other day for 2 weeks.^1,3

STUDY 2: A double-blind, placebo-controlled study of RELISTOR given every other day for 2 weeks

• 52% of patients responded to at least 2 of 4 doses of RELISTOR given every other day for the first week vs 9% for placebo.¹

• Response was consistent from dose 1 through 7 over the course of the 2-week double-blind period.¹

Open-label experience

• In both studies, patients who completed the double-blind periods could enroll in open-label extensions in which RELISTOR was given as needed, but no more frequently than 1 dose in a 24-hour period, for up to 3 or 4 months.^1,3,4
  • During the open-label treatment, patients maintained their regular laxative regimens.¹
  • A total of 136, 21, and 82 patients received at least 1 open-label dose in the extension phases of the 2 studies (Study 1 [Open Label], Study 1 Extension, and Study 2 Extension, respectively).¹

Important Safety Information for RELISTOR

• RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction
• If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician
• Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients. Use RELISTOR with caution in patients with known or suspected lesions of the GI tract
• Use of RELISTOR has not been studied in patients with peritoneal catheters
• The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhidrosis (6.7% vs 6.5%)
• Safety and efficacy of RELISTOR have not been established in pediatric patients

Please see the full Prescribing Information.

Next: Safety & Tolerability »