Adult Dosing

Postoperative ileus

• Start: 12 mg PO 0.5 - 5 hrs before surgery followed by 12 mg PO bid beginning the day after surgery for 1wk or until discharge
• Max: 15 doses

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of post-operative ileus (accelerates the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis)

• Hypersensitivity to any of the ingredients of the product
• Therapeutic use of opioids for more than 7 consecutive days prior to alvimopan treatment

• Greater incidence of myocardial infarction was observed in patients treated with alvimopan in a 12-month clinical trial. However In short-term trials, no increased risk of myocardial infarction was observed
• Almivopan is is available only 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.) Program

Renal Dose Adjustment

• Mild to severe impairment: No dose adjustments
• End stage renal disease: Avoid use

Hepatic Dose Adjustment

• Child-Pugh Class A/B: No dose adjustments
• Child-Pugh Class C: Avoid use

• Use of drug is permitted only in registered hospitals meeting all requirements for the Entereg Access Support and Education (E.A.S.E.) program (US Black box warning). Ensure hospital staff is adequately trained for prescribing, dispensing, or administering the product
• Administer only for short-term (15 doses) use in hospitalized patients (US Black box warning)
• Do not administer to patients after being discharged from the hospital
• Higher incidence of MI was observed (12 month study) in patients who previously received opioids for chronic pain
• Patients treated with opioids are more susceptible to gastrointestinal related adverse effects of alvimopan
• Higher plasma levels of drug have occurred in patients with severe hepatic impairment
• Safety and efficacy have not been established in patients with severe hepatic impairment undergoing bowel resection
• Avoid use in patients undergoing surgery for correction of complete bowel obstruction
• Avoid use in patients receiving more than 3 doses of an opioid within the week prior to surgery
• Closely monitor patients with hepatic or renal function impairment for adverse reactions

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Recent exposure to opioids
• Japenese patients

Pregnancy Category:B

Breastfeeding: Safety unknown; manufacturer advises caution while administering to nursing woman.

• GI: Constipation, flatulence, dyspepsia
• GU: Urinary retention
• HEMA: Anemia
• METABOLIC: Hypokalemia
• MUSC: Back pain

• Opioid antagonist; binds to gastrointestinal tract mu-opioid receptors and selectively antagonizes peripheral opioid receptors thus inhibiting opioid effects on GI motility and secretion
• Bioavailability: 6%
• Metabolism: GI tract; converted by bacterial flora in the GI tract to an active metabolite
• Excretion: Feces and urine
• Half-life:
• Alvimopan: 10-17 hrs
• Metabolite: 10-18 hrs

US Trade Name(s)

• Entereg

US Availability

Entereg

• CAPS: 12 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Functional Bowel Disorder Agents

Peripheral Opioid Receptor Antagonists

Anesthesia

Functional Bowel Disorder Agents

Peripheral Opioid Receptor Antagonists

Drug Name: Entereg 12 MG Oral Capsule

Ingredient(s): Alvimopan

Imprint: ADL2698

Color(s): Blue

Shape: Capsule

Size (mm): 20.00

Score: 1

Inactive Ingredient(s): polyethylene glycol 3350

Drug Label Author:
Adolor Corporation

DEA Schedule:
Non-Scheduled