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RELISTOR (methylnaltrexone bromide) is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
Opioid-induced constipation is a challenge in palliative care
More than 1.5 million Americans have an advanced illness.1 Many patients receive opioid analgesics to palliate moderate-to-severe pain, which can often lead to constipation.2 While laxatives may provide constipation relief for some patients, this treatment may be insufficient.
Target the underlying cause of OIC with RELISTOR
RELISTOR is the first opioid-induced constipation treatment that targets the underlying cause of OIC without impacting opioid-mediated analgesic effects on the central nervous system.2,3 RELISTOR delivers constipation relief for patients with advanced illness receiving palliative care by displacing opioid binding in tissues in the gastrointestinal tract.3
RELISTOR delivers rapid constipation relief
In 2 clinical studies, 62% and 48% of patients treated with RELISTOR had a bowel movement within 4 hours of the first injection.3 In each study, 50% of those who responded in 4 hours did so within 30 minutes.3
Dosage and administration for RELISTOR
RELISTOR is administered as a subcutaneous injection. Administer as needed but do not exceed 1 dose per 24-hour period.
Recommended Dose by Weight | Patient Weight in Pounds | Patient Weight in Kilograms | Injection Volume | Dose |
| 84 to less than 136 | 38 to less than 62 | 0.4 mL | 8 mg |
| 136 to 251 | 62 to 114 | 0.6 mL | 12 mg |
Patients whose weight falls outside of these ranges should be dosed at 0.15 mg/kg. The injection volume for these patients should be calculated using one of the following:
- Multiply the patient weight in pounds by 0.0034 and round the volume up to the nearest 0.1 mL
- Multiply the patient weight in kilograms by 0.0075 and round the volume up to the nearest 0.1 mL
In patients with severe renal impairment (creatinine clearance less than 30 mL/min) dose reductions of Relistor by one half is recommended.
Important Safety Information about RELISTOR
RELISTOR® is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
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. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
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%).
For complete Prescribing Information.
References: 1. National Hospice and Palliative Care Organization. NHPCO Facts and Figures: Hospice Care in America, 2010 ed.
http://www.nhpco.org/files/public/statistics_research/
hospice_facts_figures_oct-2010.pdf. Released September 2010. Accessed March 9, 2011.
2. Gutstein HB, Akil H. Opioid analgesics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman’s The Pharmacological
Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill; 2006:547-590.
3. RELISTOR [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2010.
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