Entereg reduces certain side effects of opioid medicine used to prevent pain after surgery. Some side effects of opioid medicine (stomach pain, bloating, constipation) can delay recovery after surgery on your stomach or intestines.

Entereg will not reduce the pain-relieving effects of the opioid.

Entereg is also used to help restore normal digestive functioning after surgery to remove a portion of your intestine.

Entereg is available only under a special program, and you will receive only 15 doses. You must be registered in the program and understand the risks and benefits of alvimopan.

You should not use Entereg if you have severe liver or kidney disease, or if you have used an opioid medicine for more than 7 days in a row just before your surgery.

Some people had heart attacks while taking Entereg long-term during clinical studies. It is not clear whether alvimopan is the actual cause of heart attack. This medicine should not be used for longer than 7 days after your surgery.

Tell your caregivers right away if you have pale skin, easy bruising or bleeding, painful or difficult urination, or confusion with uneven heart rate, leg discomfort, muscle weakness or limp feeling, and increased urination.

Entereg is given only in a hospital for a short period of time.

You will receive your first dose of Entereg before your surgery. You will then be given additional doses 2 times per day for up to 7 days.

This medicine should not be used for longer than 7 days after your surgery.

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

You should not use Entereg if you have severe liver or kidney disease.

Do not take Entereg if you have used opioid medicine for more than 7 days in a row just before your intestinal surgery. Opioid medicines include codeine, fentanyl, hydrocodone, meperidine, methadone, morphine, oxycodone, and many others.

To make sure Entereg is safe for you, tell your doctor if you have:

• liver or kidney disease;

• heart disease or prior heart attack;

• blockage in your digestive tract (stomach or intestines);

• a colostomy or ileostomy;

• a pancreas disorder; or

• if you have recently used any type of opioid medicine.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Entereg: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people had heart attacks while taking Entereg long-term. It is not clear whether alvimopan is the actual cause of a heart attack. Call your doctor at once if you have heart attack symptoms, such as:

• chest pain or pressure;

• pain spreading to your jaw or shoulder;

• anxiety, nausea, sweating.

Common Entereg side effect may include indigestion.

You may be more likely to have unpleasant effects on your stomach if you used any type of opioid medicine shortly before your surgery.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with alvimopan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

It is especially important to tell your doctor if you have used opioid medicine within the past 7 days. Opioid medicine is usually given to treat moderate to severe pain. Some prescription cough medications also contain opioids.