Provided to the general surgery nursing staff at St Paul's Hospital, Vancouver, British Columbia on August 20 and 22, 2013.

1. NURSING IN-SERVICE:
REMICADE®(INFLIXIMAB) IN
GI PATIENTS
10A/B Surgery Ward, St. Paul’s Hospital
August 20 & 22, 2013
Joan Ng, B. Sc. Pharm, Pharmacy Resident
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2. Outline
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1. Introduction
2. Pharmacology
3. Indications
4. Side Effects
5. Contraindications
6. Drug Interactions
7. Practical Considerations
8. Question & Answer

3. What is Remicade®?
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 Generic drug name: Infliximab
 Manufacturer: Janssen Inc.
 Formulation: 100 mg/vial powder
for solution (reconstituted by pharmacy), to
be administered as an IV infusion
 Drug Class: tumor necrosis factor alpha (TNF-
α) inhibitor
Reference: 2

4. Pharmacology
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 TNF-α = pro-inflammatory cytokine
 Infliximab = chimeric human-murine IgG MAb
 Infliximab binds to TNF-α
 Neutralizes TNF-α, blocks inflammation
 Apoptosis of T-lymphocytes and monocytes
 Down-regulation of other pro-inflammatory
cytokines
Reference: 2-5

5. Indications (focus: GI)
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 Chronic inflammatory diseases
 Crohn’s Disease (Moderate-Severe)
 Ulcerative Colitis (Moderate-Severe)
 For patients with inadequate response to
conventional therapies
 Induce and maintain remission
 Maintain fistula closure (in fistulizing Crohn’s)
 Induce and maintain mucosal healing (UC)
Reference: 2

6. Side Effects / Safety Concerns
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Resp Upper respiratory tract infection (32%)
GI Nausea (21%)
Abdominal pain (12%; Crohn’s 26%)
Misc Antinuclear antibodies (~50%)
Infection (36%)
Infusion reactions (20%; severe <1%)
Malignancies (<5%)
Reference: 5-9

7. Contraindications
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 Hypersensitivity to infliximab, any component
of the formulation
 Doses >5 mg/kg in patients with moderate or
severe heart failure (NYHA Class III/IV)
 Severe infections
 Sepsis, Abscesses
 Tuberculosis
 Opportunistic infections
Reference: 6

8. Drug Interactions
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 Other drugs that stimulate/suppress immune
system
 Vaccines
 Inactivated
 Live
Reference: 6

9. Practical: Screening/Preparation
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 TB Skin Test and follow-up CXR if (+)
 Hepatitis B virus evaluation
 Rule out infection/abscesses (C. diff, T, WBC)
 Arrange for 1-to-1 nursing
 Crohn's: Pharmacare Special Authority must
be applied before start ($3000 per dose!)
 Ulcerative Colitis: hospital provides first dose;
if respond to first dose, then we submit to SA
Reference: 10

10. Practical: Drug Administration
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 I.V.: 5 mg/kg at 0, 2, and 6 weeks, followed by
5 mg/kg every 8 weeks thereafter
 MD present for first 10 minutes of first dose
 Follow Initial Infliximab Infusion Orders (PPO)
Infuse at 20 mL/hr x15mins, 80 mL/hr
x15mins, 125 mL/hr until complete
 Compatibility: Stable in NS; do not infuse
with other agents
Reference: 6

11. Practical: Monitoring & SE Management
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 Vitals prior to start, q30 minutes during
infusion, and at least 1 hour post-infusion
 Monitor signs/symptoms of infusion reaction:
 headache, flushing, pruritis, rash, hives, respiratory
distress, swelling of lips or larynx, hypotension,
abdominal pain, hypoxemia, flu-like symptoms
 Follow PPO for management of acute reactions
 Mild infusion reactions: monitor for min 6h
 Anaphylactic reaction: monitor for min 24-48h

12. Questions?
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13. References
1. Government of Canada HC. Drug Product Database Online Query [Internet]. 2012 [cited 2012 Sep 17]. Available from:
http://webprod3.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng
2. Infliximab: AHFS Drug Information [Internet]. [cited 2013 Aug 14]. Available from: http://www.medicinescomplete.com
3. Järnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlén P, Grännö C, et al. Infliximab as Rescue Therapy in Severe to
Moderately Severe Ulcerative Colitis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2005 Jun;128(7):1805–11.
4. AccessMedicine | Tumor Necrosis Factor: The Other Primary Cytokine [Internet]. [cited 2013 Aug 14]. Available from:
http://www.accessmedicine.com.ezproxy.library.ubc.ca
5. Poggioli G, Laureti S, Campieri M, Pierangeli F, Gionchetti P, Ugolini F, et al. Infliximab in the treatment of Crohn’s disease.
Ther Clin Risk Manag. 2007 Jun;3(2):301–8.
6. AccessMedicine | InFLIXimab [Internet]. [cited 2013 Aug 15]. Available from:
http://www.accessmedicine.com.ezproxy.library.ubc.ca
7. Kapetanovic MC, Larsson L, Truedsson L, Sturfelt G, Saxne T, Geborek P. Predictors of infusion reactions during infliximab
treatment in patients with arthritis. Arthritis Res Ther. 2006 Jul 26;8(4):R131.
8. Anker SD, Haehling S von. Inflammatory mediators in chronic heart failure: an overview. Heart. 2004 Apr 1;90(4):464–70.
9. Chung ES, Packer M, Lo KH, Fasanmade AA, Willerson JT. Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of
Infliximab, a Chimeric Monoclonal Antibody to Tumor Necrosis Factor-α, in Patients With Moderate-to-Severe Heart Failure
Results of the Anti-TNF Therapy Against Congestive Heart failure (ATTACH) Trial. Circulation. 2003 Jul 1;107(25):3133–40.
10. Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, et al. Guidelines for the management of inflammatory bowel
disease in adults. Gut. 2011 May 1;60(5):571–607.
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