Entereg alvimopan

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Entereg - alvimopan

• Manufacturer Adolor
• Marketed and Distributed by GSK
• FDA Approval Date 5/2008

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Entereg - alvimopan Clinical Application

• Indications To accelerate the time to upper and
  lower GI recovery following partial large or
  small bowel resection surgery with primary
  anastomosis
• Place in therapy Alvimopan is a novel therapy
  for the prevention of Post operative Ileus
  following bowel resection surgery

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Entereg - alvimopan Clinical Application

• Contraindications Recent opioid use
• Black Box Warnings
• Available only for short-term (15 doses) use in
  hospitalized patients.
• Hospitals must enroll in the Entereg Access
  Support and Education (E.A.S.E.) program in order
  to use this agent.

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Entereg - alvimopan Clinical Application

• Warnings
• CV risk
• Complete bowel obstruction
• Precautions
• Hepatic impairment
• Renal impairment
• Pregnancy Category B

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Entereg - alvimopanDrug Facts

• An opioid receptor antagonist which selectively
  and competitively blocks opioid binding at the mu
  receptor in the GI tract, antagonizing peripheral
  effects of opioids on GI motility and secretion.
  Alvimopan has restricted ability to cross the
  blood-brain barrier at therapeutic doses and thus
  does not affect opioid analgesic effects or
  induce opioid withdrawal symptoms.

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Entereg - alvimopanDrug Facts

• Pharmacokinetics
• A F6
• D Vd20-40 L, Protein binding of parent (80)
  and metabolite (94) to albumin
• M hydrolyzed by intestinal flora not an
  inhibitor, inducer or substrate of any P450
  enzymes
• E t1/210-18 hrs, 35 renal elimination, no
  hepatic elimination

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Entereg - alvimopan Drug Interactions

• Drug Interactions
• No clinically significant drug interactions
  identified

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Entereg - alvimopan Adverse Effects
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Entereg - alvimopan Monitoring Parameters

• Efficacy Monitoring
• Toleration of solid food, flatus, bowel movements
  should be monitored multiple times per day
• Toxicity Monitoring
• No toxicities have been observed in the approved
  dosing regimen

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Entereg - alvimopan Prescription Information

• Dosing
• 12 mg PO 30 minutes to 5 hours prior to surgery
• 12 mg PO BID for up to 7 days or until discharged
  from the hospital
• Cost
• 938 (62.50/dose)

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Entereg - alvimopan Summary

• Entereg?, alvimopan, is a novel therapy for the
  prevention of Post-Operative Ileus following
  bowel resection surgery. Alvimopan antagonizes mu
  opioid receptors in the gut without affecting
  analgesia or inducing withdrawal.
• Alvimopan is a preventive therapy which must be
  initiated prior to the surgery and has been shown
  to reduce hospital stay by up to one day.
• Alvimopan should be considered for inclusion on
  order sets in facilities with high volumes of
  bowel resection surgeries. However it is
  important to note that alvimopan is only
  available in hospitals enrolled in the E.A.S.E
  program.

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Entereg - alvimopan References

• www.entereg.com
• Entereg package insert. Adolor Corporation. May
  2008.
• Wolff BG. Alvimopan, a novel, peripherally acting
  mu opioid antagonist results of a multicenter,
  randomized, double-blind, placebo-controlled,
  phase III trial of major abdominal surgery and
  postoperative ileus. Ann Surg 2004240728735.