Entereg (alvimopan) is an opioid receptor antagonist that works by preventing narcotic side effects without reducing the pain-relieving effects of the drug used to speed recovery of stomach and intestinal functions after a gastrointestinal surgery and to prevent side effects caused by narcotic medications.
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 for a maximum of 7 days or until discharge. It is for hospital use only.
What Drugs, Substances, or Supplements Interact with Entereg?
Entereg may interact with narcotics. Tell your doctor all medications and supplements you use.
Entereg During Pregnancy and Breastfeeding
Entereg is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Entereg (alvimopan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Entereg Consumer Information
Get emergency medical help if you have any of these 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 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.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Potential Risk of Myocardial Infarction with Long-Term Use [see WARNINGS AND PRECAUTIONS]
Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients [see WARNINGS AND PRECAUTIONS]
Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction [see WARNINGS AND PRECAUTIONS]
Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).
Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.
&Copy; Entereg Patient Information is supplied by Cerner Multum, Inc. and Entereg Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
