Pronunciation:

al-vi-MOE-pan

Brand Names:

• Entereg

Dosage Forms:

• Capsule

Warnings:

There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with Alvimopan, no increased risk of myocardial infarction was observed. Because of the potential risk of myocardial infarction with long-term use, alvimopan is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the Alvimopan REMS Program .

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Alvimopan is used to help restore normal bowel function in patients who have just had bowel resection surgery. This medicine works by blocking the effects of certain substances (e.g., hormones, opioids) on bowel movement and secretion, thus, helping prevent a condition called post-operative ileus.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of alvimopan in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of alvimopan in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Morphine
• Morphine Sulfate Liposome
• Naldemedine
• Naloxegol
• Oxycodone
• Oxymorphone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blocked bowels or
• Kidney disease, severe or
• Liver disease, severe—Not recommended for use in patients with these conditions.

Proper Use of This Medicine:

This medicine is used only as part of a special program called Entereg® Access Support and Education (E.A.S.E.) in hospitalized patients. It is intended for short-term use only.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For restoring normal bowel function after bowel surgery:
    • Adults—12 milligrams (mg) 30 minutes to 5 hours before the surgery, then 12 mg two times a day starting from the day after surgery up to a maximum of 7 days or until discharge.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to check for any problems or unwanted effects that may be caused by this medicine.

Taking this medicine for more than 15 doses may increase the risk for a heart attack. Patients should not receive more than 15 doses of this medicine.

Make sure your doctor knows if you have been using narcotic pain relievers (e.g., codeine, morphine, or Dolophine®) in the past 7 days before you start taking this medicine. Using this medicine together with narcotic pain relievers may increase the chance of unwanted effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Acid or sour stomach

belching

bloated

convulsions

decreased urine

difficulty having a bowel movement (stool)

dry mouth

excess air or gas in stomach or intestines

full feeling

heartburn

increased thirst

indigestion

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

numbness or tingling in hands, feet, or lips

pale skin

passing gas

shortness of breath

stomach discomfort, upset, or pain

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Decrease in frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

painful urination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.