Drug Detail:Alvimopan (Alvimopan [ al-vi-moe-pan ])
Drug Class: Peripheral opioid receptor antagonists
Usual Adult Dose for Gastrointestinal Surgery
FOR HOSPITAL USE ONLY:
Initial dose: 12 mg orally ONCE, administered 30 minutes to 5 hours prior to surgery
Maintenance dose: 12 mg orally 2 times a day, beginning the day after surgery
Maximum dose: Up to 15 doses
Duration of treatment: 7 days OR until discharge
Comment:
- This drug is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior.
Use: To accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Frequent monitoring recommended.
End-stage renal disease (ESRD): Not recommended.
Liver Dose Adjustments
Mild to moderate liver dysfunction: Frequent monitoring recommended. Treatment should be discontinued if adverse reactions occur.
Severe liver dysfunction: Not recommended.
Dose Adjustments
Japanese patients: Frequent gastrointestinal adverse event monitoring is recommended. Treatment should be discontinued if adverse reactions occur.
Precautions
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm
US BOXED WARNINGS:
POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY:
- There was a greater incidence of myocardial infarction (MI) in patients treated with this drug compared to those treated with placebo in a 12-month clinical trial, though a causal relationship has not established.
- In short-term trials with this drug, an increased risk of MI was not observed.
- This drug is only available through a restricted program for short-term use (15 doses) under a REMS due to the potential risk of MI with long-term use.
CONTRAINDICATIONS:
- Patients taking therapeutic opioid doses over 7 consecutive days prior to starting treatment
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take without regard to meals.
General:
- LIMITATION OF USE: For hospital use only.
Monitoring:
- GASTROINTESTINAL: Signs/symptoms of adverse events
Patient advice:
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Frequently asked questions
- Which drugs cause opioid-induced constipation?
