Restricted dispensing

Alvimopan

ENTEREG

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Pronunciation: al-vi-MOE-pan

Alvimopan ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Alvimopan ballicule

What it isPeripherally restricted mu antagonist; postoperative ileus after bowel resection.

Why this oneSpeeds return of bowel function without reversing systemic analgesia.

What limits itMyocardial infarction signal restricts it to inpatient use for a maximum of fifteen doses.

Alvimopan molecular structure (skeletal formula) — Molecular structure: Alvimopan

FDA-approved for

postoperative ileus (2008)

Principal riskMyocardial infarction signal; hospital use only, limited to 15 doses

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Legacy pregnancy categoryB

Defining liabilityRestricted short-course hospital use because of myocardial-infarction signal

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Potential risk of myocardial infarction with long-term use; for short-term hospital use only (max 15 doses) through the restricted Alvimopan REMS Program.

FDA dosing	Population	Start	Target	Max
Accelerate GI recovery after partial bowel resection with primary anastomosis	Adult (hospital)	12 mg 30 min–5 h before surgery	12 mg BID	15 doses / ≤7 days

Renal No adjustment for mild–severe impairment (monitor for GI reactions); not recommended in ESRD.

Hepatic No adjustment for mild–moderate impairment (monitor); not recommended in severe impairment.

Single 12 mg dose 30 min–5 h preop, then 12 mg BID until discharge; max 15 doses over ≤7 days.

Instructions

Hospital use only; do not exceed 15 doses.
Take with or without food.

Available strengths

cap 12 mg

Contraindications

Patients who have taken therapeutic doses of opioids for >7 consecutive days immediately prior

Cautions

MI risk with long-term use
GI reactions in opioid-tolerant patients
Not recommended in severe hepatic impairment, ESRD, complete GI obstruction, or pancreatic/gastric anastomoses

Adverse reactions

Dyspepsia

Pregnancy Limited human data; no fetal harm in animal reproduction studies.

Lactation No human data; alvimopan and metabolite detected in rat milk.

Cost

Alvimopan (ENTEREG)

Strength		#/mo	generic $/mo	CostPlus
12 mg	cap	60 BID		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Alvimopan is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

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Self-check

Does alvimopan reverse systemic analgesia?
No.
What inpatient maximum applies to alvimopan?
Fifteen doses.