Alvimopan

Alvimopan is a prescription medication used to accelerate gastrointestinal recovery after a Bowel resection surgery.

• Alvimopan is available under the following different brand names: Entereg

Adult dosage

Capsule

• 12mg

GI Recovery Post Bowel Resection

Adult dosage

• 12 mg orally administered 30 minutes to 5 hours preoperative, then 12 mg orally every 12 hours beginning 1 day after surgery until discharge for a maximum of 7 days; patients should not receive above 15 doses

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Alvimopan include:

• stomach pain or upset,
• indigestion,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• gas,
• bloating, 
• back pain

Serious side effects of Alvimopan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• anxiety,
• nausea, and
• sweating

Rare side effects of Alvimopan include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Alvimopan has severe interactions with at least 34 other drugs.
• Alvimopan has serious interactions with the following drugs
  • naldemedine
  • naloxegol
• Alvimopan has moderate interactions with the following drugs
  • dichlorphenamide
  • eliglustat
  • glecaprevir/pibrentasvir
  • ivacaftor
  • ponatinib
  • quinidine
• Alvimopan has minor interactions with at least 35 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Taken more than 7 days of therapeutic opioids before taking alvimopan
• Above 15 doses
• Non-hospitalized patients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Alvimopan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Alvimopan?”

Cautions

• High-fat meal reduces absorption
• Higher risk for Myocardial Infraction was observed in studies with long-term use (.g, chronic noncancer pain); not observed with postsurgical short-term use
• Not recommended in severe hepatic impairment (10-fold higher serum levels), ESRD, bowel obstruction corrective surgery; patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions); up to 10-fold higher plasma concentrations of drug observed in such patients compared to patients with normal hepatic function; therapy not recommended
• Not studied in patients having pancreatic or gastric anastomosis; therefore, not recommended for use in these patients
• Patients recently exposed to opioids are expected to be more sensitive to the effects of mu-opioid receptor antagonists, symptoms may include abdominal pain, nausea, vomiting, and diarrhea (see Contraindications); if administered to these patients, they should be monitored for gastrointestinal adverse reactions
• No studies were conducted in patients with end-stage renal disease; therapy is not recommended in these patients
• No studies were conducted in patients with complete gastrointestinal obstruction or patients who have surgery for correction of complete bowel obstruction; not recommended in these patients
• available through a restricted access program

Pregnancy & Lactation

• Available data regarding use in pregnant women are limited and are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of the drug in human milk, effects on the breastfed infant, or milk production; the drug and its ‘metabolite’ are detected in the milk of lactating rats following intravenous administration; it is unknown if alvimopan is present in rat milk following oral administration
  • Consider developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from the drug or an underlying maternal condition