InfoCardff: PBMT-GEN-030 Rev. 07 Effective Date: 01 Dec 2018

PEbIATRIC BLOOb ANb MARROWTRANSPLANT PROGRAM

DOCUMENT NUMBER: PBMT-GEN-030

DOCUMENT TITLE:Administration of Infliximab

DOCUMENT NOTES:

Document Information

Revision: 07 Vault: PBMT-General-rel

Status: Release Document Type: General

Date Information

Creation Date: 25 Oct 2018 Release Date: 01 Dec 2018

Effective Date: 01 Dec 2018 Expiration Date:

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MOORE171

Number: PBMT-GEN-030 Rev 06

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Change

MOORE171

Number: PBMT-CCR-203

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InfoCardff: PBMT-GEN-030 Rev. 07 Effective Date: 01 Dec 2018

PBMT-GEN-030ADMINISTRATION OF INFLIXIMAB

1 PURPOSE

1. 1 To outline the procedure required for indications for and administration ofinfliximab. Responsibilities of the nursing staff for administration and monitoringreactions to infliximab are described.

2 INTRODUCTION

2. 1 Infliximab is a monoclonal antibody used for the treatment of autoimmunediseases, pulmonary hemorrhage, and graft versus host disease (GVHD). It is thefirst marketed drug in the United States that specifically inhibits the activity oftumor necrosis factor-alpha (TNFalpha).

3 SCOPE AND RESPONSIBILITIES

3. 1 Interdisciplinary: Requires a physician or designee order to be placed into theelectronic medical record.

3.2 Registered Nurses (RNs) may administer infliximab after successful completionof medication administration test and demonstration of clinical competency withtheir preceptor.

4 DEFINITIONS/ACRONYMS

4. 1 GVHD Graft Versus Host Disease

4.2 PFO Patent Foramen Ovale

4. 3 RN Registered Nurse

5 MATERIALS

5. 1 Medication administration line

5. 2 Volumetric or syringe pump

6 EQUIPMENT

6. 1 Primed primary administration set

6. 2 Infliximab prepared by pharmacy for infusion

6. 3 Alcohol prep

6.4 Gloves (non-sterile)

6. 5 Secondary tubing iflnfliximab arrives in a bag

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InfoCardff: PBMT-GEN-030 Rev. 07 Effective Date: 01 Dec 2018

7 SAFETY

7. 1 N/A

8 PROCEDURE

.1

8.2

Patient Assessment

8. 1. 1 Assess intravenous access device for leakage, patency, and blood return.

8. 1. 2 Assess central venous access site for redness, swelling, drainage andpain.

8. 1.3

8. 1.4

Acute infusion-related reactions occur during or within 1-2 hours ofadministration. The most common reactions consist of nonspecificsymptoms such as fever, pain, dyspnea, hypotension, and hypertension.

Observe patient for adverse reactions that include:

8. 1.4. 1 Anaphylaxis

Arthralgia

Chills

Dyspnea

Hypertension

Hypotension

Nausea and vomiting

Diarrhea

Abdominal pain

Dyspepsia

Have emergency medications available at bedside.

Assess if patient requires Patent Foramen Ovale (PFO) filters.

Assess Vital Signs pre-infusion, 1 5 minutes into infusion, 1 hour intothe infusion and at the completion of the infusion.

Dosing and Administration:

8. 2. 1 Assess IV for patency.

8.2. 2 If visibly opaque particles, discoloration, or other abnormalities areobserved, the solution should not be used.

8.2.3 The infusion should begin within 3 hours of preparation.

8. 2. 4 The maximum concentration = 4 mg/mL diluted in normal saline.

8.2. 5 Infliximab prepared by pharmacy in a bag should be spiked withsecondary tubing and primed then attached to primary IV set after portis cleaned with an alcohol prep.

8. 1.4.2

8. 1.4.3

8. 1.4.4

8. 1.4.5

8. 1.4.6

8. 1.4.7

8. 1.4.8

8. 1.4.9

8. 1.4. 10

8. 1.5

8. 1.6

8. 1.7

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lnfoCard#: PBMT-GEN-030 Rev. 07 Effective Date: 01 Dec 2018

S. 2.6

{. 2.7

8.2.8

Infliximab prepared by pharmacy in a syringe should be attached toprimary syringe pump tubing.

Infuse per physician or designee orders.

8.2. 7. 1 The usual GVHD dose = 10 mg/kg given every week x 4doses.

8.2. 7. 1. 1 In patients with severe GVHD it may be givenmore frequently or for an extended period oftime.

8.2. 7. 1. 2 Some patients may require pre-medications forsubsequent doses if infusion related reactionoccurs with first dose.

8.2. 7.2 Infliximab is usually administered intravenously over aminimum of 2 hours unless otherwise specified in themedication order.

Once complete, flush the entire line with primary solution to ensureentire medication has been infused.

9 RELATED DOCUMENTS/FORMS

9. 1 NA

10 REFERENCES

10. 1 2003 Thompson Micromedex Role of Tumor Necrosis Factor-Alpha in Graft-Versus-Host Disease and Graft-Versus-Leukemia Responses.

10.2 R Komgold, JC Marini, ME de Baca, GF Murphy, and J Giles-Komar Biol BloodMarrow Transplant, May 2003; 9: 292-303.

10.3 Clinical Pharmacology, current edition.

11 REVISION HISTORY

Revision No.

07Author

S. McCollumDescription of Change(s)

Title updated to "PBMT-GEN-030 Administration ofInfliximab (formerly "Infliximab (Remicade)") to be inalignment with other medication infusion SOPs.

Acronyms defined throughout

Steps reordered to be in order of nursing workflow underdosing and administration section.

Section 8. 1. 7 added: Assess Vital Signs pre-infusion, 15minutes into infusion, 1 hour into the infusion and at thecompletion of the infusion.

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lnfoCard#: PBMT-GEN-030 Rev. 07 Effective Date: 01 Dec 2018

Signature Manifest

Document Number: PBMT-GEN-030

Title: Administration of Infliximab

Revision: 07

All dates and times are in Eastern Time.

PBMT-GEN-030 Administration of Infliximab

Author

me/Signature__Sally McCollum (MOORE171)

Medical Director

Title Meaning/Reason

19 Nov 2018, 10:48:54 AM Approved

Name/Signature Title Date Meaning/Reason

Joanne Kurtzberg(KURTZ001)

Quality

19 Nov 2018, 11:48:45 AM Approved

I Name/Signature

Bing Shen (BS76)

Document Release

Title I Date19 Nov 2018, 04:46:29 PM

Meaning/Reason

Approved

Betsy Jordan (BJ42)

Title Meaning/Reason

20 Nov 2018, 08:59:31 AM Approved

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