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Alvimopan Dosage

Medically reviewed on June 5, 2017.

Applies to the following strengths: 12 mg

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 twice daily beginning the day after surgery for a maximum of 7 days or until discharge
Maximum dose: Not to exceed 15 doses

Comment:
-This drug is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior.
-Because of the risk of myocardial infarction with long-term use, this drug is only available to enrolled hospitals through a REMS program (ENTEREG Access Support and Education).

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 severe renal impairment: No adjustment recommended
ESRD: Not recommended

Liver Dose Adjustments

Mild-to-moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Not recommended

Dose Adjustments

Monitor for gastrointestinal adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or "metabolite" levels: this drug should be discontinued if adverse events occur

Monitor Japanese patients closely for gastrointestinal adverse effect and discontinue therapy if these occur

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Entereg(R). It includes an elements to assure safe use, and 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 alvimopan-treated patients compare to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials, not increased risk of MI was observed.
-Because of the risk of MI with long-term use, this drug is only available through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.[R]) Program.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended in patients with ESRD

Other Comments

Administration advice:
-This drug is for hospital use only and should be used for no more than 7 days
-To use this product, hospitals must register and meet all requirements for the Entereg(R) Access Support and Education (E.A.S.E.) program. Further information is available at www.ENTEREGREMS.com or 1-800-278-0340

General:
-Due to risk of serious adverse reactions, this drug is not recommended for use in patients with complete gastrointestinal obstruction, for patients having surgery for correction of complete bowel obstruction, or in patients having pancreatic or gastric anastomosis as it has not been studied.
-A potential risk of myocardial infarction (MI) may be associated with long-term use. MI was reported more frequently in a 12-month study among patients treated with opioids for chronic non-cancer pain with the majority occurring 1 to 4 months after therapy initiation. This imbalance has not been reported in other studies and a causal relationship has not been determined.

Monitoring:
-Monitor for gastrointestinal adverse reactions

Patient advice:
-Patients should understand this drug is for hospital use only.
-Patients should be instructed to report adverse gastrointestinal effects, e.g., diarrhea, gastrointestinal pain, and cramping.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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