METHYLNALTREXONE TAB

Clinical Criteria Summary

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, etc.)
Placement of peritoneal catheter for chemotherapy or dialysis (not studied)
End-stage renal impairment on dialysis (not studied)
Use of methylnaltrexone solely for prevention of opioid-induced constipation or impaction (no supporting evidence)
Use of methylnaltrexone for postoperative ileus (preliminary results showed inefficacy)
Use of methylnaltrexone for constipation that is not opioid-related (not studied)
Concomitant use of other opioid antagonists (potential for increased risks of additive effects and opioid withdrawal)

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.

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.

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