Alvimopan

Name: Alvimopan

Other uses for this medicine

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What other information should I know?

Ask your doctor or pharmacist if you have any questions about alvimopan.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Uses for Alvimopan

Postoperative Ileus

Acceleration of upper and lower GI recovery following partial large or small bowel resection with primary anastomosis.1 2 3 9 10 11 12 19

Efficacy for management of postoperative ileus in women undergoing total abdominal hysterectomy† under general anesthesia not established to date.1 8

Cautions for Alvimopan

Contraindications

  • Therapeutic doses of opiates for >7 consecutive days immediately prior to alvimopan administration.1 2

Warnings/Precautions

Restricted Distribution Program

Only for short-term (15 doses) use in hospitalized patients.1 2 For use only by hospitals enrolled in the EASE program.1 2 (See Restricted Distribution Program under Dosage and Administration.)

MI

May be associated with increased incidence of MI when used long term;1 2 3 4 7 not found with short-term (i.e., ≤7 days) use following bowel resection.1 3 4 Causal relationship not established.1 (See Boxed Warning and see Restricted Distribution Program under Dosage and Administration.)

Recent Opiate Use

Increased sensitivity to alvimopan possible with recent exposure to opiates; manifests principally as GI symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea).1 Use caution in patients who have received >3 doses of an opiate within 1 week prior to surgery.1 (See Contraindications under Cautions.)

Bowel Obstruction

Not recommended for use in patients undergoing surgical correction of complete bowel obstruction.1

Specific Populations

Pregnancy

Category B.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Use caution.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 15

Hepatic Impairment

Slight increase in plasma alvimopan concentrations possible in patients with mild to moderate hepatic impairment (Child-Pugh class A or B).1 Monitor for adverse effects (e.g., diarrhea, abdominal pain or cramping) that may indicate alvimopan or metabolite accumulation; discontinue if such effects occur.1 15 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Use not recommended in patients with severe hepatic impairment (Child-Pugh class C).1 8 15 Substantially increased plasma concentrations possible.1

Renal Impairment

Monitor for possible adverse effects in patients with renal impairment.1 15 Closely monitor those with severe renal impairment for adverse effects (e.g., diarrhea, abdominal pain or cramping) that may indicate elevated alvimopan or metabolite concentrations; discontinue if such effects occur.1 15 (See Renal Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Not studied in patients with end-stage renal disease.1 Use not recommended.1

Common Adverse Effects

Constipation,1 hypokalemia,1 11 flatulence,1 dyspepsia,1 anemia,1 back pain,1 urinary retention.1

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C).1

Precautions While Using alvimopan

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 alvimopan.

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

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 alvimopan. Using alvimopan together with narcotic pain relievers may increase the chance of unwanted effects.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take alvimopan or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alvimopan. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Index Terms

  • ADL-2698
  • LY246736

Dosing Hepatic Impairment

Mild-to-moderate impairment (Child-Pugh class A or B): No adjustment needed; use caution.

Severe impairment (Child-Pugh class C): Use not recommended.

ALERT U.S. Boxed Warning

Myocardial infarction:

There was a greater incidence of myocardial infarction (MI) 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 MI was observed.

Appropiate use:

Because of the potential risk of MI 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 ENTEREG Access Support and Education (E.A.S.E.) Program.

In Summary

More frequently reported side effects include: constipation. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to alvimopan: oral capsule

Hematologic

Hematologic side effects including anemia (5.2% to 5.4%).[Ref]

Genitourinary

Genitourinary side effects have included urinary retention (3.2% to 3.5%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included constipation (4% to 9.7%), flatulence (3.1% to 8.7%), and dyspepsia (5.9% to 7%).[Ref]

Metabolic

Metabolic side effects have included hypokalemia (6.9% to 9.5%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain (3.3% to 3.4%).[Ref]

Some side effects of alvimopan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild-to-moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Not recommended

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