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lnfoCard#: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018 PEbIATRIC BLOOD AND MARROW TRANSPLANT PROGRAM DOCUMENT NUMBER: PBMT-GEN-019 DOCUIVIENT TITLE: Administration of High Dose Chemotherapy - Cyclophosphamide (Cytoxan) DOCUMENT NOTES: Document Information Revision: 06 Vault: PBMT-General-rel Status: Release Document Type: General Date Information Creation Date: 31 Oct 2018 Release Date: 21 Nov 2018 Effective Date: 21 Nov 2018 Expiration Date: Control Author: Previous Information MOORE171 Number: PBMT-GEN-019 Rev 05 Owner: Change MOORE171 Number: PBMT-CCR-210 CONFIDENTIAL - Printed by: ACM93 on 21 Nov 2018 08:08:23 am

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lnfoCard#: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018

PEbIATRIC BLOOD AND MARROWTRANSPLANT PROGRAM

DOCUMENT NUMBER: PBMT-GEN-019

DOCUIVIENT TITLE:Administration of High Dose Chemotherapy - Cyclophosphamide (Cytoxan)

DOCUMENT NOTES:

Document Information

Revision: 06 Vault: PBMT-General-rel

Status: Release Document Type: General

Date Information

Creation Date: 31 Oct 2018 Release Date: 21 Nov 2018

Effective Date: 21 Nov 2018 Expiration Date:

Control

Author:

Previous

Information

MOORE171

Number: PBMT-GEN-019 Rev 05

Owner:

Change

MOORE171

Number: PBMT-CCR-210

CONFIDENTIAL - Printed by: ACM93 on 21 Nov 2018 08:08:23 am

lnfoCard#: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018

PBMT-GEN-019ADMINISTRATION OF HIGH DOSE CHEMOTHERAPY -

CYCLOPHOSPHAMIDE (CYTOXAN)

1. PURPOSE

1. 1. To outline the procedure required for the safe administration ofCyclophosphamide

1. 2. To describe the required elements of patient monitoring during and aftercyclophosphamide administration.

2. INTRODUCTION

2. 1. Cyclophosphamide is an alkylating antineoplastic agent which is chemicallyrelated to the nitrogen mustards. It is postulated that the mechanism of cellulartoxicity involves cross-linking of cell DNA.

2.2. The onset ofantineoplastic and immune and bone marrow suppressive effectsoccur within 7-21 days.

2. 3. Adverse effects include but are not limited to nausea, vomiting, hair loss,immunosuppression, secondary malignancies, cardiomyopathy, myocardialnecrosis, dizziness, inappropriate Antidiuretic Hormone (ADH) secretion,hyperkalemia, pancreatitis, pseudomembranous colitis, hemorrhagic cystitis,bladder cancer, sterility, hepatotoxicity, blurred vision, interstitial pneumonitis,pulmonary fibrosis, cellulitis with extravasation, and hypersensitivity withanaphylaxis.

3. SCOPE AND RESPONSIBILITIES

3. 1. Interdisciplinary: Requires an order from a chemotherapy certified physician inthe electronic medical records.

3.2. Registered Nurses (RNs) may administer cyclophosphamide after successfulcompletion of the medication administration test, the chemotherapy certificationtest and demonstration of clinical competency with their preceptors.

4. DEFINITIONS/ACRONYMS

4. 1. ADH Antidiuretic Hormone

4. 2. PPE Personal Protective Equipment

4.3. RN Registered Nurse

5. MATERIALS

5. 1. See the materials section ofPBMT-GEN-069 Administration of ChemotherapyInpatient Unit-5200

PBMT-GEN-019 Administration of High Dose Chemotherapy: Cyclophosphamide - CytoxanPBMT, DUMCDurham, NC Page 1 of 3

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InfoCardff: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018

6. EQUIPMENT

6. 1. See the equipment section ofPBMT-GEN-069 Administration of ChemotherapyInpatient Unit-5200

7. SAFETY

7. 1. Use appropriate Personal Protective Equipment (PPE) when handlingchemotherapy.

8. PROCEDURE

8. 1.

8.2.

See related SOP titled PBMT-GEN-069 Administration of ChemotherapyInpatient Unit-5200.

Patient Assessment

8.3. Check urine dips and specific gravity with every void.

8. 4. Encourage voiding every 2-3 hours.

8.5. Notify physician or designee for specific gravity greater than (>) 1.020 or bloodin the urine.

8.6. Monitor serum chemistries every 8 hours while administering Cyclophosphamidethis will continue until 24 hours after the completion ofCyclophosphamide.

8.7. Ten hours prior to the administration of Cyclophosphamide change maintenanceIV fluids to D5 3/4NS and increase rate to 2 times maintenance (3000niL/m2/day).This will continue until 24 hours after the completion of the last dose ofCyclophosphamide.

8. 8. Mesna therapy is initiated at the time of the first dose ofCyclophosphamide andcontinues until 24 hours after the last dose of Cyclophosphamide. Mesna isgenerally given as a 24 hour infusion and protects the bladder wall from irritatingCyclophosphamide metabolites.

8. 9. Administration

8. 10. See related SOP titled PBMT-GEN-069 Administration of ChemotherapyInpatient Unit-5200.

9. RELATED DOCUMENTS/FORMS

9. 1. PBMT-GEN-069 Administration of Chemotherapy Inpatient Unit-5200

10. REFERENCES

10. 1. Duke Online Clinical Pharmacology

PBMT-GEN-019 Administration of High Dose Chemotherapy: Cyclophosphamide - CytoxanPBMT, DUMCDurham, NC Page 2 of 3

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lnfoCard#: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018

11. REVISION HISTORY

Revision No.

06Author

SallyMcCollum

Description of Change(s). Additional statement added to introduction

section: To describe the required elementsof patient monitoring during and aftercyclophosphamide administration.

. Scope and responsibilities further defined toshow chemotherapy certification required:Requires an order from a chemotherapycertified physician in the electronic medicalrecords.

. Outdated SOP updated to correct titlethroughout: PBMT-GEN-069Administration of Chemotherapy InpatientUnit-5200

. Safety Section - statement added: Useappropriate Personal Protective Equipment(PPE) when handling chemotherapy.

. Acronyms defined throughout.

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InfoCardff: PBMT-GEN-019 Rev. 06 Effective Date: 21 Nov 2018

Signature Manifest

Document Number: PBMT-GEN-019 Revision: 06

Title: Administration of High Dose Chemotherapy - Cyclophosphamide (Cytoxan)All dates and times are in Eastern Time.

PBMT-GEN-019 Administration of High Dose Chemotherapy - Cyclophosphamide (Cytoxan)

Author

Name/Signature Title

Sally McCollum (MOORE171)

Medical Director

I Date Meaning/Reason

05Nov2018, 01:22:18PM Approved

Name/Signature Title

Joanne Kurtzberg(KURTZ001)

Quality

Date Meaning/Reason

05Nov2018, 01:28:10PM Approved

Name/Signature

Bing Shen (BS76)

Document Release

Title Date Meaning/Reason

07 Nov 2018, 10:10:07 AM Approved

Name/Signature Title Date Meaning/Reason

Betsy Jordan (BJ42) 09 Nov 2018, 11:08:25 AM Approved

CONFIDENTIAL - Printed by: ACM93 on 21 Nov 2018 08:08:23 am