Alvimopan

What is Alvimopan?

• Alvimopan (Entereg) is an opioid antagonist used for the treatment of postoperative ileus.

Alvimopan

Alvimopan molecule ball

What are the uses of this medicine?

• Alvimopan (Entereg) is used in people to avoid postoperative ileus following partial large or small bowel resection with primary anastomosis.
• Alvimopan accelerates the gastrointestinal recovery period as defined by time to first bowel movement or flatus.

How does this medicine work?

• Alvimopan is a selective antagonist of the cloned human μ-opioid receptor.
• Postoperative ileus is the impairment of gastrointestinal motility after intra-abdominal surgery or other, non-abdominal surgeries. Postoperative ileus affects all segments of the gastrointestinal tract and may last from 5 to 6 days, or even longer.
• This may potentially delay gastrointestinal recovery and hospital discharge until its resolution.
• It is characterized by abdominal distention and bloating, nausea, vomiting, pain, accumulation of gas and fluids in the bowel, and delayed passage of flatus and defecation.
• Morphine and other μ-opioid receptor agonists are universally used for the treatment of acute postsurgical pain; however, they are known to have an inhibitory effect on gastrointestinal motility and may prolong the duration of postoperative ileus.
• Following oral administration, alvimopan antagonizes the peripheral effects of opioids on gastrointestinal motility and secretion by competitively binding to gastrointestinal tract μ-opioid receptors.
• Alvimopan achieves this selective gastrointestinal opioid antagonism without reversing the central analgesic effects of μ-opioid agonists.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking Entereg.

What drug interactions can this medicine cause?

• Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with Entereg.
• No dosage adjustments are necessary in patients taking acid blockers or antibiotics with Entereg.

Is this medicine FDA approved?

• It was approved for the treatment of postoperative ileus which it received in May 2008.

How should this medicine be used?

Recommended dosage:

• The recommended adult dosage of Entereg is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery until discharge for a maximum of 7 days.
• Patients should not receive more than 15 doses of Entereg.

Administration:

• Entereg can be taken with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 12 mg

This medicine is available in fallowing brand namesː

• Entereg

What side effects can this medication cause?

The most common side effects of this medicine include:

• dyspepsia

What special precautions should I follow?

• A higher number of myocardial infarctions was reported in patients treated with Entereg 0.5 mg twice daily compared with placebo in a 12-month study in patients treated with opioids for chronic non-cancer pain, although a causal relationship with long-term use has not been established.
• Patients recently exposed to opioids may be more sensitive to the effects of Entereg and experience gastrointestinal adverse reactions (e.g., abdominal pain, nausea and vomiting, and diarrhea).
• Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions). Therefore, the use of Entereg is not recommended in this population.
• No studies have been conducted in patients with end-stage renal disease. Entereg is not recommended for use in these patients.
• No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction; use is not recommended.
• Entereg has not been studied in patients having pancreatic or gastric anastomosis. Therefore, Entereg is not recommended for use in these patients.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data regarding use of Entereg in pregnant women are limited, and are insufficient to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• alvimopan

Inactive ingredients:

• POLYETHYLENE GLYCOL, UNSPECIFIED
• GELATIN, UNSPECIFIED

Who manufactures and distributes this medicine?

Manufactured for:

• Merck Sharp & Dohme Corp., a subsidiary of
• MERCK & CO., INC., Whitehouse Station, NJ, USA

Manufactured by:

• Pharmaceutical Manufacturing Research Services, Inc., Horsham, PA, USA

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

• Dailymed label info on Alvimopan
• FDA Alvimopan

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