Alvimopan

ALVIMOPAN

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 144.0

Quick Summary

Alvimopan is an opioid antagonist used to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. It is administered orally, with a recommended dose of 12 mg 30 minutes to 5 hours prior to surgery, followed by 12 mg twice daily until discharge for a maximum of 7 days. The most common adverse reaction is dyspepsia. Alvimopan has a boxed warning for potential risk of myocardial infarction with long-term use and is only available through a restricted program for short-term use. It is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan.

Key Clinical Findings and Indications

Accelerates the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis
Selective antagonist of the cloned human μ-opioid receptor
Reduces the delay in small and large bowel transit induced by codeine

Important Safety Information

Warning

Potential risk of myocardial infarction with long-term use

Contraindications

Patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan

Adverse Reactions

Dyspepsia
Gastrointestinal-related adverse reactions in opioid-tolerant patients
Risk of serious adverse reactions in patients with severe hepatic impairment

Dosing Recommendations

General Guidance

No dosage adjustments are necessary in patients taking acid blockers or antibiotics

Surgeries that include partial bowel resection with primary anastomosis

Adult Dose

12 mg 30 minutes to 5 hours prior to surgery, followed by 12 mg twice daily until discharge for a maximum of 7 days

Pediatric Dose

Special Population Considerations

Pregnancy

Available data regarding use of alvimopan in pregnant women are limited and insufficient to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

Nursing Mothers

Safety and effectiveness in pediatric patients have not been established

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric patients and younger patients

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