Dr. Conar Fitton, Board Certified Gastroenterology Specialist in New Orleans, LA, paid consultant of Salix Pharmaceuticals
About 9-12 million Americans suffer from chronic pain annually, and most are prescribed opioid medications to treat and control their symptoms1. While opioids can help relieve and manage chronic pain, they can also cause many side effects, including constipation2. Opioid-induced constipation (OIC) is one of the most common side effects of taking opioid pain medications to treat chronic pain, affecting about 40-80% of patients on long-term opioid therapy3,4,5,6. OIC is a different form of constipation that may not always respond to over the counter (OTC) laxatives7. OIC is caused by opioids binding to mu-opioid receptors in the gastrointestinal (GI) tract, significantly slowing GI motility8.
As a board-certified gastroenterologist, I sometimes find that conversations about gut health, including during screening prior to a colonoscopy, can incidentally help me identify OIC in adult patients taking opioids for chronic pain conditions. Since colorectal cancer screening, including a colonoscopy, is recommended in the U.S. for all adults ages 45-75 for both men and women, pre-procedure screenings present an opportunity to discuss gut health and may lead to identifying cases of OIC9. To initiate treatment for my patients’ OIC symptoms before the procedure, my preference is to prescribe RELISTOR® (methylnaltrexone bromide)10.
RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation10. RELISTOR works differently than OTC laxatives as it is specifically designed to target the constipating effects by preventing opioids from attaching to the mu-opioid receptors in the gut, without impacting opioid pain relief in the central nervous system10. In the form of a subcutaneous injection or oral tablet, RELISTOR is used to treat OIC in adults with chronic non-cancer pain, advanced illness, or pain caused by active cancer, who require opioid dosage escalation for palliative care10. RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation10. I’ve been prescribing RELISTOR for almost 10 years and have seen an improvement in my patients’ OIC symptoms.
RELISTOR injection may help increase the number of bowel movements patients have each week, and some patients report experiencing a bowel movement within four hours of treatment10. Regardless of the situation, I work to educate my patients about OIC and the various treatment options available to provide relief from their OIC symptoms.
Opioid-induced constipation is an issue most people feel uncomfortable discussing, even with a healthcare provider. I urge patients and healthcare providers to have this conversation, whether it is prior to a colonoscopy or not. Scheduling a quick appointment for screening to examine irregularities with bowel movements can lead to an OIC diagnosis and perhaps RELISTOR may have a place in their treatment options.
For more information, please visit https://www.relistor.com/.
INDICATIONS
RELISTOR® is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
IMPORTANT SAFETY INFORMATION
- RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
- Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
- Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
- Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
- The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
- A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
- A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
- In the clinical studies, the most common adverse reactions were:
- OIC in adult patients with chronic non-cancer pain
- RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
- RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).
- OIC in adult patients with chronic non-cancer pain
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- OIC in adult patients with advanced illness
- RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%), flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).
- OIC in adult patients with advanced illness
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To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.
Relistor is a trademark of Salix Pharmaceuticals or its affiliates.
© 2023 Salix Pharmaceuticals or its affiliates.
REL.0014.USA.23
References:
- Crockett SD, Greer KB, Heidelbaugh JJ, et al. Gastroenterology. 2019;156(1), 218–226.
- Benyamin R, Trescot AM, Datta S, et al. Pain physician. 2008;11(2 Suppl), S105–S120.
- Argoff CE, Brennan MJ, Camilleri M, et al. Pain Med. 2015;16: 2324-2337
- Bell TJ, Panchal SJ, Miaskowski C, et al. Pain Med. 2009;10(1): 35-42
- Hjalte F, Berggren AC, Bergendahl H, et al. J Pain Symptom Manage. 2010;40(5):696-703.
- Kalso E, Edwards JE, Moore AR, et al. Pain. 2004;112(3):372-380
- Webster LR. Pain Med. 2015;16: S16-S21
- Pergolizzi JV, Raffa RB, Pappagallo M, et al. Patient Preference and Adherence. 2017;11: 107-119
- Davidson, KW. JAMA. 2021;325(19): 1965-1977
- Relistor [prescribing information]. Salix Pharmaceuticals; 2020