alvimopan


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alvimopan

(al-vi-mo-pan) ,

Entereg

(trade name)

Classification

Therapeutic: gastric stimulant
Pharmacologic: opioid antagonists
Pregnancy Category: B

Indications

Speed time to upper/lower GI recovery following partial bowel resection surgery with primary anastamosis.

Action

Acts peripherally as μ-opioid receptor antagonist which speeds recovery of bowel function after to partial large or small bowel resection surgery with anastomosis surgery.

Therapeutic effects

Accelerated time to bowel recovery following primary anastamotic surgery.

Pharmacokinetics

Absorption: 6% absorbed following oral administration.
Distribution: Does not cross the blood-brain barrier.
Protein Binding: alvimopan—80% bound to albumin; metabolite—94% bound to albumin.
Metabolism and Excretion: Converted by bacterial flora in the GI tract to an active metabolite; elimination is mostly via biliary secretion, followed by conversion by bacterial flora. Elimination of unabsorbed drug and metabolites is via feces and urine.
Half-life: alvimopan—10–17 hr; metabolite—10–18 hr.

Time/action profile (blood leves)

ROUTEONSETPEAKDURATION
POunknown2 hr12 hr

Contraindications/Precautions

Contraindicated in: Therapeutic doses of opioid analgesics for more than 7 consecutive days before initiation of alvimopan; Severe hepatic impairment or end-stage renal disease.
Use Cautiously in: More than 3 doses of opioids within the wk prior to surgery (↑ sensitivity to effects and adverse reactions including abdominal pain, nausea, vomiting and diarrhea); Mild to moderate hepatic or renal impairment (↑ risk of adverse reactions); genetic implication Japanese patients (may have ↑ risk of adverse reactions); Geriatric: May have ↑ sensitivity to effects; Obstetric / Lactation: Use in pregnancy only if clearly needed; use cautiously during lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Cardiovascular

  • MI (life-threatening)

Gastrointestinal

  • constipation (most frequent)
  • dyspepsia (most frequent)
  • flatulence (most frequent)

Fluid and Electrolyte

  • hypokalemia

Genitourinary

  • urinary retention

Hematologic

  • anemia

Musculoskeletal

  • back pain

Interactions

Drug-Drug interaction

Previous (within 1 wk) opioid use ↑ risk of adverse reactions (avoid if therapeutic opioid doses used during prior wk, use cautiously if more than 3 doses have been used).

Route/Dosage

Oral (Adults) 12 mg for 30 min–5 hr prior to surgery, then 12 mg twice daily for up to 15 doses.

Availability

Capsules: 12 mg

Nursing implications

Nursing assessment

  • Assess bowel sounds and frequency, quantity, and consistency of stools periodically during therapy.
  • Lab Test Considerations: May cause anemia and hypokalemia.

Potential Nursing Diagnoses

Constipation (Indications)

Implementation

  • Must be administered only during hospitalization. Only available in hospitals enrolled in the Entereg Access Support and Education (E.A.S.E.) program.
  • Oral: Administer twice daily without regard to food for no more than 7 days.

Patient/Family Teaching

  • Explain purpose of alvimopan to patient.
  • Advise patient to notify health care professional if they have taken long term or intermittent opioid pain therapy, including any use of opioids in the wk prior to receiving alvimopan.

Evaluation/Desired Outcomes

  • Resolution of postoperative ileus following bowel resection.
References in periodicals archive ?
Our more contemporary patients received heparin 5000 units subcutaneously and oral alvimopan 12 mg preoperartively.
Alvimopan is the common drug used for treatment of post-operative ileus but patients might experience side effects, such as nausea and vomiting (5,6).
Key Words: Alvimopan, bladder cancer, cystectomy, enhanced recovery program (ERP), length of stay (LOS), Certified Wound Ostomy Continence Nurse (CWOCN).
These include methylnaltrexone, naloxegol, and alvimopan.
Alvimopan accelerates gastrointestinal recovery after radical cystectomy: A multicenter randomized placebo-controlled trial.
Food and Drug Administration to facilitate gastrointestinal recovery following abdominal surgery: alvimopan (Entereg[R]) and methylnaltrexone bromide (Relistor[R]) (Hiranyakas, Bashankaev, Seo, Khaikin, & Wexner, 2011; Yeh et al., 2009).
There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist.
Techner, "Patterns of gastrointestinal recovery after bowel resection and total abdominal hysterectomy: pooled results from the placebo arms of alvimopan phase III North American clinical trials," Journal of the American College of Surgeons, vol.
Alvimopan. Alvimopan is a peripherally acting popioid receptor antagonist (PAMORA) that does not cross the blood-brain barrier.
8 September 2011 - US biopharmaceutical firm Adolor Corporation (NASDAQ:ADLR) said on Tuesday it had finalised its reacquisition from UK-based GlaxoSmithKline (LON:GSK) of all rights to Adolor's US Food and Drug Administration (FDA)-approved ENTEREG (alvimopan).
Biopharmaceutical company Adolor Corporation (NasdaqGM:ADLR) reported on Tuesday an agreement to re-acquire all rights to its FDA-approved product ENTEREG (alvimopan).