Contraindications for Entereg (Alvimopan)
Entereg (alvimopan) is absolutely contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking the medication. 1
Primary Contraindication
Alvimopan, a peripherally acting mu-opioid receptor antagonist (PAMORA), has one absolute contraindication:
- Prior opioid use: Patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately before starting alvimopan 1
This contraindication exists because patients with recent opioid exposure are more sensitive to mu-opioid receptor antagonists like alvimopan. In these patients, alvimopan can cause significant gastrointestinal adverse reactions including:
- Abdominal pain
- Nausea and vomiting
- Diarrhea
Situations Where Use Is Not Recommended
While not formal contraindications, the FDA label specifically recommends against using alvimopan in the following patient populations due to safety concerns:
Patients with severe hepatic impairment: Up to 10-fold higher plasma concentrations have been observed in these patients, increasing the risk of serious adverse reactions 1
Patients with end-stage renal disease: No studies have been conducted in this population 1
Patients with complete gastrointestinal obstruction: No studies have been conducted in patients with complete GI obstruction or in those undergoing surgery for correction of complete bowel obstruction 1
Patients with pancreatic or gastric anastomoses: Alvimopan has not been studied in these surgical populations 1
Important Restrictions and Warnings
REMS Program: Alvimopan is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program due to potential risk of myocardial infarction with long-term use 1
Short-term use only: Alvimopan is approved only for short-term use (maximum 15 doses) in hospitalized patients 1
Myocardial infarction risk: Long-term use of alvimopan has been associated with increased risk of myocardial infarction in patients treated for chronic non-cancer pain 1
Clinical Context
Alvimopan is FDA-approved specifically for the in-hospital management of postoperative ileus following bowel resection surgery 2. It is not approved for opioid-induced constipation in chronic non-cancer pain 2.
The American Society of Anesthesiologists recommends that alvimopan should be held preoperatively according to perioperative management guidelines 2.
Common Pitfalls to Avoid
Using in outpatient settings: Alvimopan must only be used in hospitalized patients enrolled in the REMS program
Prescribing for chronic opioid-induced constipation: For this indication, other FDA-approved options like methylnaltrexone, naloxegol, or naldemedine should be considered instead 2
Exceeding the 15-dose maximum: The REMS program strictly limits alvimopan to no more than 15 doses per patient
Dispensing after hospital discharge: Alvimopan must not be dispensed to patients after they have been discharged from the hospital 1