METHYLNALTREXONE INJ
Clinical Criteria Summary
Criteria for Methylnaltrexone Subcutaneous Injection
- Exclusion Criteria
- Known or suspected mechanical gastrointestinal obstruction or other condition that may compromise drug action or cause bowel dysfunction (e.g., acute abdomen, ostomy, active diverticulitis, ischemic bowel)
- Placement of peritoneal catheter for chemotherapy or dialysis
- End-stage renal impairment on dialysis
- Use solely for prevention of opioid-induced constipation or impaction
- Use for postoperative ileus
- Use for constipation that is not opioid-related
- Concomitant use of other opioid antagonists
- Inclusion Criteria: Opioid-Induced Constipation in Adults with Chronic Noncancer Pain (Applies to both injection and tablet formulations)
- Patient has been taking opioids for chronic noncancer pain (including chronic pain related to prior cancer or its treatment) for at least 4 weeks and does not require frequent opioid dose escalation
- A stimulant laxative (e.g., bisacodyl, sennosides; 1-month trial) is medically inadvisable, inadequate, or not tolerated
- MIRALAX-equivalent (twice daily) or other osmotic laxative (e.g., sorbitol, magnesium citrate; 1-month trial) is medically inadvisable, inadequate, or not tolerated
- Naloxegol at optimized, recommended oral dosage for renal function (at least a 1-week trial) is medically inadvisable, inadequate, or not tolerated
- Naldemedine at optimized, recommended oral dosage (at least a 1-week trial) is medically inadvisable, inadequate, or not tolerated
- Lubiprostone at optimized, recommended oral dosage for hepatic function (at least a 1-week trial) is medically inadvisable, inadequate, or not tolerated
- Inclusion Criteria: Opioid-Induced Constipation in Patients with Advanced Illness (Applies to both injection and tablet formulations)
- Prescriber is a VA/VA Community Care palliative care specialist or provider locally designated to prescribe methylnaltrexone
- Patient has advanced illness for which he/she is receiving palliative care in a monitored setting or at home with hospice care
- Patient has opioid-induced constipation and requires prompt laxative effects
- An oral and/or rectal stimulant laxative (e.g., bisacodyl, sennoside) in at least usual doses is medically inadvisable (e.g., dysphagia), inadequate, or not tolerated
- An oral osmotic laxative (such as lactulose or PEG 3350 in low doses) in at least usual doses is medically inadvisable (e.g., dysphagia), inadequate, or not tolerated
Criteria for Methylnaltrexone Tablets
- Shares all exclusion and inclusion criteria listed above for both chronic noncancer pain and advanced illness indications.
- Orally administered agents (naloxegol, lubiprostone, and methylnaltrexone tablets) may be preferred before daily methylnaltrexone injections.
Supplemental Clinical Considerations by Indication
- General Treatment Considerations
- Docusate is not required prior to use of methylnaltrexone for opioid-induced constipation.
- Bulk forming laxatives are relatively contraindicated in opioid-induced constipation.
- Sustained exposure to opioids prior to starting methylnaltrexone may increase the patient’s sensitivity to the effects of methylnaltrexone.
- Adverse events associated with methylnaltrexone therapy may include symptoms of opioid withdrawal (abdominal pain, nausea, diarrhea, hyperhidrosis, hot flush, tremor, chills).
- Treatment in Adults with Chronic Noncancer Pain
- Maintenance laxative therapy should be discontinued before starting methylnaltrexone; laxatives can be used as needed if there is a suboptimal response to methylnaltrexone after 3 days.
- Treatment in Patients with Advanced Illness
- Use of methylnaltrexone subcutaneous injections beyond 4 months has not been studied in the advanced-illness population.
- Opioid-induced constipation may be defined as fewer than three bowel movements in the preceding week or no bowel movement for 2 days.
- Chronic daily stimulant-based laxative regimens should be continued and optimized in addition to using methylnaltrexone as needed.
- Efficacy was shown when added on to usual two- to three-drug laxative therapy.