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ALVIMOPAN CAP,ORAL

Clinical Criteria Summary

Exclusion Criteria

  • Complete bowel obstruction or having surgery for correction of complete bowel obstruction
  • Patients scheduled for total colectomy, ileostomy, colostomy, pancreatic anastomosis or gastric anastomosis
  • Inflammatory bowel disease
  • Therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan
  • Intrathecal or epidural opioids or anesthetics are scheduled to be used during surgery
  • Recent treatment with alvimopan in current episode of care (No studies evaluated safety and efficacy of more than one treatment course)
  • Situations where pre-operative dose cannot be administered
  • Severe hepatic impairment (Child-Pugh C)
  • End-stage renal disease
  • Any non-FDA approved indication (Alvimopan Shared System REMS applies)

Inclusion Criteria

  • Undergoing surgery that includes partial bowel resection with primary anastomosis (including resection of intra-abdominal organs with large or small bowel resection / anastomoses, e.g. radical cystectomy)
  • Intravenous postoperative opioid pain management is planned
  • Particular consideration for patients at risk for prolonged post operative ileus (PPOI):
  • Prior occurrence of PPOI after any surgical procedure
  • Anticipation of extensive (over 2 hours) adhesiolysis associated with a small or large bowel resection
  • Significant en bloc resection of intraabdominal organs including large or small bowel

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