Alvimopan

Alvimopan 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.

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

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

Alvimopan is available only under a special program, Alvimopan REMS Program, and you will receive only 15 doses. Only hospitals registered in the program may use alvimopan.

Alvimopan may also be used for purposes not listed in this medication guide.

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

You may be given alvimopan with or without food.

You will be monitored at the hospital to make sure you do not have an allergic reaction or have severe side effects.

You will receive your first dose of alvimopan before your surgery. You will then be given additional doses 2 times per day until you leave the hospital.

alvimopan should not be used for longer than 7 days (maximum 15 doses) after your surgery.

You should not use alvimopan 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.

Alvimopan is for short-term use (no more than 7 days after your surgery, and a maximum of 15 doses) due to a potential risk of heart attack with long-term use. Alvimopan is only available through a special program, Alvimopan REMS Program. Hospitals must be registered, and you will not receive it after you leave the hospital.

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

Do not take alvimopan 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.

Tell your doctor if you have or have ever had:

• heart disease or prior heart attack;
• blockage in your digestive tract (stomach or intestines);
• a colostomy or ileostomy;
• a pancreas disorder;
• if you have recently used any type of opioid medicine; or
• liver or kidney disease.

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

Tell your doctor if you are breastfeeding before your surgery.

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

Some people had heart attacks while taking alvimopan 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 side effects of alvimopan may include:

• heartburn.

You may be more likely to have unpleasant effects including stomach pain, diarrhea, nausea, and vomiting 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.

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 surgeryMaximum dose: Up to 15 dosesDuration of treatment: 7 days OR until dischargeComment:-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

In a medical setting you are not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

Do not take opioid pain medicines right before surgery unless your doctor says it is okay.

Other drugs may affect 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.