Alvimopan: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 8, 2024🚩 Report this page

Alvimopan

Peripheral Opioid Receptor Antagonists

US FDA

Drug class: Peripheral Opioid Receptor Antagonists
Availability: Prescription only
Routes: Oral
Markets covered: 1
Products on record: 1
FDA reports (12 mo): 1

A06AHPeripheral Opioid Receptor Antagonists

Overview

Alvimopan is an active pharmaceutical ingredient in the Peripheral Opioid Receptor Antagonists group (A06AH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	1	February 8, 2024

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised February 8, 2024[1]

1 INDICATIONS AND USAGE Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
( 1 )

How to take

Drug interactions

Known interactions involving Alvimopan. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]FDA DailyMed · 10e39d3b-8621-16… · revised February 8, 2024 [PDF]
[2]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised February 8, 2024[1]

5%): dyspepsia. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. gov/medwatch. 1 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 alvimopan 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 alvimopan 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).
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.

USOfficial regulatory label· Warnings and precautions· revised February 8, 2024[1]

5 mg twice daily compared with placebo in a 12-month study in patients treated with opioids for chronic non-cancer pain, although a causal relationship with long-term use has not been established. , abdominal pain, nausea and vomiting, and diarrhea).
3 ) Patients with Severe Hepatic Impairment : Increased risk of serious adverse reactions due to higher plasma concentrations; use is not recommended. 6 ) Patients with End-Stage Renal Disease : No studies have been conducted; use is not recommended.
7 ) 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; use is not recommended.
6 ) Patients with Pancreatic and Gastric Anastomoses : No studies have been conducted; use is not recommended. 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 alvimopan 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 alvimopan 12 mg twice daily for up to 7 days (the indicated dose and patient population; alvimopan 12 mg, n = 1,142; placebo, n = 1,120).
A causal relationship with alvimopan with long-term use has not been established. 2 )] . 1 )] .
Notable requirements of the Alvimopan REMS Program include the following:
Alvimopan capsules are 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 Alvimopan REMS Program may use alvimopan capsules. To enroll in the Alvimopan REMS Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer alvimopan capsules have been provided the educational materials on the need to limit use of alvimopan capsules to short-term, inpatient use; patients will not receive more than 15 doses of alvimopan capsules; and alvimopan capsules will not be dispensed to patients after they have been discharged from the hospital.
com or 1-800-278-0340. 3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of mu-opioid receptor antagonists, such as alvimopan.
, 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 alvimopan is administered to these patients, they should be monitored for gastrointestinal adverse reactions.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

USUnited States· FDA

Drug interactions

Drugs in the same class

Sources & citations