Entereg (Alvimopan) - Oral

What Is Entereg?

Entereg (alvimopan) is a peripherally acting mu-opioid receptor antagonist that promotes faster gastrointestinal (GI) recovery after bowel resection surgery.

Following surgery, opioids are typically used to help manage surgical pain. However, they can temporarily slow or stop bowel function. This can lead to symptoms such as constipation and bloating.

As a mu-opioid receptor antagonist, alvimopan protects the bowel from these effects without reversing the opioid's pain-relieving properties so that you can recover more quickly from surgery.

Entereg is available as a prescription oral capsule. It is only prescribed for use in the hospital.

What Is Entereg Used For?

The Food and Drug Administration (FDA) approved Entereg to treat postoperative ileus in adults following the removal of part of the large or small intestine (partial large or small bowel resection surgery) with a surgical technique that connects two body structures (primary anastomosis).

Ileus is a condition in which the bowel does not work properly. It can slow or stop movement in the intestine, which can cause a blockage. Postoperative ileus occurs after a surgical procedure and is often worsened by opioid use.

As an opioid antagonist, Entereg stops opioids from affecting the intestines so that you are able to pass bowel movements. This aids your recovery from surgery.

How to Take Entereg

You will be given Entereg to take in the hospital only for short-term use—no more than 15 doses. Take the capsule with or without food.

Storage

Store Entereg capsules at room temperature (77 F).

Off-Label Uses

Healthcare providers may prescribe alvimopan for conditions not specifically indicated by the FDA (off-label uses).

For example, alvimopan can be used to treat bowel dysfunction in other circumstances, such as:

• Opioid-induced bowel dysfunction
• Postoperative ileus following abdominal removal of the uterus (hysterectomy)

What Are the Side Effects of Entereg?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effects in people undergoing bowel resection surgery taking Entereg were:

• Decrease in red blood cells (anemia)
• Indigestion
• Low level of potassium in the blood (hypokalemia)
• Back pain
• Inability to pass urine (urinary retention)

Severe Side Effects

Tell your healthcare provider immediately if you have serious side effects.

The above-listed side effects can become severe if left untreated. Be sure to tell your healthcare provider if you notice any new symptoms or changes in how you feel after taking Entereg.

Long-term use of Entereg can increase the risk of a heart attack. Therefore, this medication is only available for restricted short-term use under a Risk Evaluation and Mitigation Strategy (REMS) program.

Taking opioids within the last seven days of receiving Entereg can make you more prone to severe adverse reactions. Tell your healthcare team about recent opioid use, if applicable.

Dosage: How Much Entereg Should I Take?

Modifications

Entereg has not been studied enough in pregnancy to determine whether it is safe or not. If you are pregnant, talk to your healthcare provider to determine whether or not Entereg is a safe option for you. It is unknown if the medication passes into breast milk.

Missed Dose

This medication will be provided to you by a trained healthcare provider in the hospital, so missed doses are not likely to occur.

Overdose: What Happens If I Take Too Much Entereg?

Doses of this medication will be provided to you while in the hospital. Therefore, an overdose is unlikely.

There is no specific antidote for overdoses with Entereg. Treatment would likely be symptomatic and supportive. In clinical trials, single doses of up to 120 milligrams and multiple doses of up to 48 milligrams for seven days were given to otherwise healthy individuals and were well tolerated.

Precautions

What Are Reasons I Shouldn’t Take Entereg?

Do not take Entereg if you are allergic to alvimopan or other ingredients of Entereg.

You should also inform your healthcare provider if you have taken therapeutic doses of opioid pain medication for more than seven consecutive days immediately before taking Entereg.

This medication should not be prescribed for more than 15 doses.

What Other Medications Interact With Entereg?

No clinically significant drug-drug interactions have been identified with Entereg.

What Medications are Similar?

Other peripherally acting mu-opioid receptor antagonists used to treat opioid-induced constipation are:

• Relistor (methylnaltrexone): Oral and subcutaneous (under the skin) injections
• Movantik (naloxegol): Oral
• Naldemadine: Oral

These medications differ from Entereg in that they can be used outside the hospital for a longer time, whereas Entereg is only used short-term in the hospital.

How Can I Stay Healthy While Taking Entereg?

Follow your healthcare provider's instructions and take all medications as prescribed following your surgery to help ensure a smooth recovery.

After surgery, your bowel functioning may temporarily slow or stop, especially if you are taking opioid pain medication. Entereg can be used to help protect your bowels from this side effect. You will only take it while in the hospital.

Once discharged, you should continue to take care of yourself while recovering. Ask your healthcare provider about diet recommendations and when you can start to increase your physical activity. Remember to be patient and not push yourself too hard as you heal.