Patient: MJ
Age: 83
CrCl: 55 mL/min
Max Whitney, PharmD
Surgical Rotation Case Conference
August 8, 2014
Gender: F
Weight: 59 kg
Height: 5’
Allergies: Aspirin (stomach cramps)
Admit Date: 7/30/2014
Discharge Date: 8/4/2014
Reason for Admission:
 Abdominoperineal resection
History of Present Illness:
 MJ saw PCP 11/2013 for chronic anemia and thrombocytopenia where GI endoscopic evaluations were
recommended but not followed through by patient
 Patient presented to ED 7/13/2014 after large, bloody BM at home
 Colonoscopy performed on admission which revealed lower rectal cancer
 Family opted out of chemotherapy and radiation; therefore, surgical intervention is being performed to excise
the large tumor during this admission
Past Medical History:
 GERD
 Osteoarthritis
 Anemia/Chronic Thrombocytopenia
 Alzheimer’s Disease
Past Surgical History:
 TKA
 Sinus surgery
 Appendectomy
 Tonsillectomy
Pertinent Medications:
Drug
Alvimopan 12 mg x 1 pre-op, then twice daily beginning 7/31 AM
Hydromorphone 0.2-1mg IV every 2 hours as needed
Hydrocodone/APAP 5/525 mg 1-2 tabs PO every 4 hours as needed
Start Date
7/30
7/30
8/2
End Date
8/4
8/2
8/4
Indication
Prevention of post-op ileus
Severe post-operative pain
Moderate post-operative pain
Post-Operative Ileus Prevention Management
Subjective/Objective:
 Post-operative recovery was uneventful day-to-day
 MJ was started on thin oral liquids 7/30 post-op and was gradually advanced
 Stool output from the colostomy bag was first seen on post-operative day #3
 Pain scores ranged from 2-5/10 and was well-controlled with IV hydromorphone and oral hydrocone/APAP
Assessment/Plan:
 Patient has low level of dementia and was discharged to home with daughter
 MJ was able to discharge on post-operative day #6 in stable condition and intact colostomy site
 Patient resumed home medications and was given a script for oxycodone/APAP 5/325 mg
 Follow-up with surgeon as an outpatient one week from discharge date
Entereg® (alvimopan)
Dosing1,2
Indications1,2
Black Box Warning1,2
Contraindications1,2
Warnings/Precautions1,2
MOA1-6
Pharmacokinetics1,2
Adverse Drug Reactions1-6
Additional Information
Resources
Adult: 12 mg 30 minutes to 5 hours prior to surgery, followed by 12 mg twice daily
beginning the day after surgery for up to 7 days or until hospital discharge. MAX 15 doses.
Adjustments: No dose adjustments necessary
 Post-operative ileus
 Following partial large or small bowel resection surgery
An increased risk of myocardial infarction was seen in alvimopan-treated patients
compared with placebo when duration of therapy extended beyond 1 month.
Opioid use for more than 7 days immediately prior to taking alvimopan.
 Increase risk of MI (with 1-4 months of therapy)
 Complete GI obstruction
 Hepatic impairment: increased ADR risk d/t potentially increased concentrations
 ESRD: use not recommended
Mu-opioid receptor antagonist within the GI tract, thereby blocking the peripheral effects
of opioids.
Absorption
6% bioavailability; food decreases rate and extent of absorption.
Distribution
Vd= 30 L; 80% bound to albumin.
Metabolism
Metabolized to active metabolite in the intestinal wall by normal flora.
Excretion
Primarily via the bile and stool. 35% excreted by kidneys.
Half-life
10-17 hours
 Indigestion (1.5%)
 diarrhea, gastrointestinal pain, cramping, nausea
 Myocardial Infarction
One study found the mean total hospital cost was $12,865 for alvimopan
Cost
patients compared to $13,905 for controls (P=.033)7
Drug
Expect interactions with known p-glycoprotein inhibitors such as
Interactions
amiodarone, diltiazem, cyclosporine, itraconazole, and verapamil.
Future
 May alvimopan be discontinued after the first successful BM?
Considerations
 Will use be expanded to pediatrics, opioid-induced constipation?
1 Product Information: ENTEREG(R) oral capsules, alvimopan oral capsules. Cubist
Pharmaceuticals, Inc. (per manufacturer), Lexington, MA, 2013.
2. Micromedex Healthcare Series. DrugDex. Greenwood Village, CO: Truven Health
Analytics, 2014. http://www.micromedex.com/. Accessed August 5, 2014.
3. Tan E.K., Cornish J., Darzi A.W., et al: Meta-analysis: Alvimopan vs. placebo in the
treatment of post-operative ileus. Aliment Pharmacol Ther 2007; 25(1):47-57.
4. Wolff BG, Michelassi F, Gerkin TM, et al: 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 2004;
240(4):728-735.
5. Taguchi A, Sharma N, Saleem RM, et al: Selective postoperative inhibition of
gastrointestinal opioid receptors. N Engl J Med 2001; 345(13):935-940.
6. Vaughan-Saw PG, Fecher IC, Harris S, Knight JS. A meta-analysis of the effectiveness of
the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI
recovery in patients enrolled in a standardized accelerated recovery program after
abdominal surgery. Dis Colon Rectum 2012 May;55(5):611-620.
7. Poston S, Broder MS, Gibbons MM, et al. Impact of alvimopan on hospital costs after
bowel resection. P.T. 2011 April;36(4):209-220.
8. Akca O, Doufas AG, & Sessler DI: Use of selective opiate receptor inhibitors to prevent
postoperative ileus. Minerva Anestesiol 2002; 68(4):162-165.