Alvimopan

Alvimopan
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) Program.

Overview

Alvimopan is an opioid antagonist that is FDA approved for the {{{indicationType}}} of upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dyspepsia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

• For hospital use only. 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 until discharge for a maximum of 7 days. Patients should not receive more than 15 doses of ENTEREG.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Alvimopan in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alvimopan in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Alvimopan in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Alvimopan in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alvimopan in pediatric patients.

Contraindications

• ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

Warnings

WARNING See full prescribing information for complete Boxed Warning. POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) Program.

Precautions

• Potential Risk of Myocardial Infarction with Long-term Use

• There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.
• ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)].

• E.A.S.E. ENTEREG REMS Program

• ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG.
• Notable requirements of the E.A.S.E. Program include the following:
  • ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG.

• To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that:
  • hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use;
  • patients will not receive more than 15 doses of ENTEREG; and
  • ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

• Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

• Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients

• Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

• Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment

• Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population.

• End-Stage Renal Disease

• No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

• Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction

• No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

• Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses

• ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Alvimopan in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Alvimopan in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alvimopan in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Alvimopan during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Alvimopan with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Alvimopan with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Alvimopan with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Alvimopan with respect to specific gender populations.

Race

There is no FDA guidance on the use of Alvimopan with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Alvimopan in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Alvimopan in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Alvimopan in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Alvimopan in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Alvimopan in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Alvimopan in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Alvimopan in the drug label.

Pharmacology

There is limited information regarding Alvimopan Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Alvimopan in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Alvimopan in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Alvimopan in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Alvimopan in the drug label.

How Supplied

Storage

There is limited information regarding Alvimopan Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Alvimopan in the drug label.

Precautions with Alcohol

• Alcohol-Alvimopan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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