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Relistor (Methylnaltrexone Bromide Subcutaneous) - Summary

 
 



RELISTOR SUMMARY

Carcinogenesis, Mutagenesis, Impairment of Fertility

RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, a peripherally-acting mu-opioid receptor antagonist, is a sterile, clear and colorless to pale yellow aqueous solution.

RELISTOR is indicated for the treatment of opioid-induced constipation 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.


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NEWS HIGHLIGHTS

Media Articles Related to Relistor (Methylnaltrexone Subcutaneous)

Constipation
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2014.07.15]
Title: Constipation
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/15/2014 12:00:00 AM

Published data demonstrate naloxegol improved opioid-induced constipation in chronic pain patients
Source: Pain / Anesthetics News From Medical News Today [2014.06.23]
AstraZeneca has announced that the New England Journal of Medicine (NEJM) has published results of two pivotal Phase III studies - KODIAC-4 and KODIAC-5 of naloxegol, an investigational treatment...

Laxatives for Constipation
Source: MedicineNet Anal Fissure Specialty [2014.04.22]
Title: Laxatives for Constipation
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 4/22/2014 12:00:00 AM

Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Source: MedicineNet Irritable Bowel Syndrome Specialty [2013.05.09]
Title: Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Category: Slideshows
Created: 5/9/2013 12:00:00 AM
Last Editorial Review: 5/9/2013 12:00:00 AM

Linzess (Linaclotide) For IBS With Constipation Or Chronic Idiopathic Constipation Now Available, USA
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.12.27]
Linzess (linaclotide), a medication for irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation is now available in American pharmacies, Ironwood Pharmaceuticals Inc.

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Published Studies Related to Relistor (Methylnaltrexone Subcutaneous)

Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. [2012]
patients with acute OIC after orthopedic procedures... CONCLUSIONS: Methylnaltrexone was generally well tolerated and was active in

Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. [2011.05]
PURPOSE: Postoperative ileus contributes to surgical morbidity and is associated with prolonged hospitalization and increased health care costs. The efficacy and safety of the peripherally acting mu-opioid receptor antagonist methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy was evaluated... CONCLUSIONS: Although the efficacy of methylnaltrexone in reducing the duration of postoperative ileus was not demonstrated in these studies, intravenous methylnaltrexone at doses of 12 mg and 24 mg was safe, in general, and well tolerated in postcolectomy patients. The utility of intravenous methylnaltrexone in treating postoperative ileus remains unproven.

Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. [2011.05]
Methylnaltrexone is effective for opioid-induced constipation (OIC) in advanced illness patients. This 4-week, double-blind, randomized, placebo-controlled study investigated the effect of subcutaneous methylnaltrexone on OIC in patients receiving opioids for chronic, nonmalignant pain...

Effect of subcutaneous methylnaltrexone on patient-reported constipation symptoms. [2011.01]
BACKGROUND: Methylnaltrexone, a selective peripheral acting mu-opioid receptor antagonist, alleviates the constipating effects of opioids without affecting centrally mediated analgesia. OBJECTIVES: To assess the effect of subcutaneous (SC) methylnaltrexone injection on patient-reported constipation symptoms and pain scores... CONCLUSION: The results of our study indicate significant improvement in constipation symptoms with methylnaltrexone QD or QOD dosing compared to placebo without a significant effect on pain scores. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Characterization of abdominal pain during methylnaltrexone treatment of opioid-induced constipation in advanced illness: a post hoc analysis of two clinical trials. [2011]
studies... CONCLUSION: Abdominal pain AEs in methylnaltrexone-treated patients in clinical

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Clinical Trials Related to Relistor (Methylnaltrexone Subcutaneous)

Methylnaltrexone for Opioid-induced Constipation in Cancer Patients [Recruiting]

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit [Recruiting]
The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department? [Recruiting]
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.

Methylnaltrexone Use for Opioid-induced Postoperative Constipation [Not yet recruiting]
The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients [Recruiting]
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group. Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug. The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.

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Reports of Suspected Relistor (Methylnaltrexone Subcutaneous) Side Effects

Vomiting (3)Nausea (3)Mental Status Changes (2)Metabolic Acidosis (2)Hypotension (2)NO Therapeutic Response (2)Agitation (1)Confusional State (1)Haematocrit Decreased (1)Abdominal Distension (1)more >>


Page last updated: 2014-07-15

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