RELISTOR delivers a reliable response in patients with pain from advanced illness
Researchers looked at RELISTOR in 2 clinical studies in patients with constipation from opioid use who were receiving supportive care for their advanced illness.*
In studies, RELISTOR delivered a consistent, timely, reliable response
In both studies, half of the patients who responded to RELISTOR† experienced a bowel movement within 30 minutes.1,2 Overall, patient response was maintained for 3 to 4 months.3
Here's what researchers found in one study1:
- After the first dose: Nearly half of patients receiving RELISTOR experienced a bowel movement within 4 hours (compared to 16% of patients taking placebo, or an inactive medicine)
- After one or more doses: 79% of RELISTOR patients experienced a bowel movement within 4 hours (compared to 46% of patients taking placebo)
Side effects of RELISTOR
Researchers looked at the safety of RELISTOR in 2 clinical studies of patients with advanced illness who were receiving supportive care and managing pain with opioids.3
There were 165 patients receiving RELISTOR plus laxative therapy (RELISTOR group) and 123 patients receiving only laxative therapy (placebo group).3 The most common side effects were abdominal (stomach) pain, gas, nausea, dizziness, diarrhea, and sweating.
Stomach pain, also described by patients as "stomach cramping," was mostly mild to moderate.4 This side effect could be related to the experience of having a bowel movement. It decreased after the first dose.
- If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider3
- If you get stomach pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider3
These are not all of the possible side effects of RELISTOR. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
*For both studies, patients maintained their regular laxative regimen for at least 3 days before beginning the study and throughout the study. Efficacy reported is for the study drug (either RELISTOR or placebo) + laxative regimen.3
†Responders were RELISTOR patients experiencing a bowel movement within 4 hours of the first dose.1,2
Indication for 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.
Important Safety Information about RELISTOR
Do not take RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection if you have or may have a blockage in your intestines called a mechanical bowel obstruction. Symptoms of this blockage are vomiting, stomach pain, and swelling of your abdomen. Talk to your healthcare provider if you have any of these symptoms before taking RELISTOR.
Cases of holes or openings in your gastrointestinal (GI) tract have been reported in adult patients with opioid-induced constipation and advanced illness with certain conditions (i.e., cancer, peptic ulcer, Ogilvie's syndrome). These holes or openings have involved varying regions of the GI tract (e.g., stomach or intestines). Use RELISTOR with caution if you have a known or suspected wound or injury to the GI tract. If you get abdominal pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking RELISTOR and call your healthcare provider.
If you get diarrhea that is severe or does not stop while taking RELISTOR, stop taking RELISTOR and call your healthcare provider.
Use of RELISTOR beyond four months has not been studied.
Safety and efficacy of RELISTOR have not been established in children.
The most common side effects of RELISTOR in clinical studies include: abdominal (stomach) pain, gas, nausea, dizziness, diarrhea, and sweating.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
References: 1. Thomas J, Karver S, Cooney GA, et al. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008;358(22):2332-2343. 2. Slatkin N, Thomas J, Lipman AG, et al. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009;7(1):39-46. 3. RELISTOR® (methylnaltrexone bromide) Prescribing Information, Salix Pharmaceuticals, Inc; 2012. 4. Slatkin NE, Lynn R, Su C, Wang W, Israel RJ. Characterization of abdominal pain during methylnaltrexone treatment of opioid-induced constipation in advanced illness: a post hoc analysis of two clinical trials. J Pain Symptom Manage. 2011;42(5):754-760.