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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Outline 2

1. Introduction

2. Pharmacology

3. Indications

4. Side Effects

5. Contraindications

6. Drug Interactions

7. Practical Considerations

8. Question & Answer

What is Remicade®? 3

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

Pharmacology 4

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

Indications (focus: GI) 5

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

Side Effects / Safety Concerns 6

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

Contraindications 7

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

Drug Interactions 8

Other drugs that stimulate/suppress immune system

Vaccines

Inactivated

Live

Reference: 6

Practical: Screening/Preparation 9

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

Practical: Drug Administration 10

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

Practical: Monitoring & SE Management 11

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

Questions? 12

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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