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InfoCard #: APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019 DukeMedicine Division of Cellular Therapy ^ AbULT ANb PEbIATRIC BLOOD AND MARROW TRANSPLANT PROGRAM DOCUMENT NUMBER: APBMT-COMM-017 DOCUMENT TITLE: Pneumocystis Jiroveci Pneumonia (PJP) Prophylaxis DOCUMENT NOTES: Document Information Revision: 05 Vault: APBMT-Common-rel Status: Release Document Type: Common Date Information Creation Date: 15 Feb 2019 Release Date: 01 Apr 2019 Effective Date: 01 Apr 2019 Expiration Date: Control Information Author: MOORE171 Owner: MOORE171 Previous Number: APBMT-COMM-017 Rev 04 Change Number: APBMT-CCR-141 CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am

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Page 1: DukeMedicinepub.emmes.com/study/duke/SOP/Clinical/APBMT-COMM-017... · 2019-04-02 · lnfoCard#:APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019 APBMT-COMM-017 PNEUMOCYSTIS JIROVECI

InfoCard #: APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019

DukeMedicineDivision of Cellular Therapy

^AbULT ANb PEbIATRIC BLOOD AND

MARROW TRANSPLANT PROGRAM

DOCUMENT NUMBER: APBMT-COMM-017

DOCUMENT TITLE:

Pneumocystis Jiroveci Pneumonia (PJP) Prophylaxis

DOCUMENT NOTES:

Document Information

Revision: 05 Vault: APBMT-Common-rel

Status: Release Document Type: Common

Date Information

Creation Date: 15 Feb 2019 Release Date: 01 Apr 2019

Effective Date: 01 Apr 2019 Expiration Date:

Control Information

Author: MOORE171 Owner: MOORE171

Previous Number: APBMT-COMM-017 Rev 04 Change Number: APBMT-CCR-141

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am

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lnfoCard#:APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019

APBMT-COMM-017PNEUMOCYSTIS JIROVECI PNEUMONIA (PJP) PROPHYLAXIS

1 PURPOSE

1. 1 To provide a consistent approach to the prevention ofpneumocystisjirovecipneumonia (PJP, formerly PCP; formerly pneumocystis carinii pneumonia) inautologous and allogeneic hematopoietic stem cell transplant recipients.

2 INTRODUCTION

2. 1 Level: Interdependent: Physicians, advanced practice providers, nurses, andpharmacists (*requires an order from physician or physician designee to beplaced in EPIC).

2. 2 Supportive Data: Recipients ofhematopoietic stem cell transplant (HSCT)recipients are at risk of developing opportunistic infections, including PJP. Therisk is dependent on the degree ofimmunosuppression experienced by the patientboth during prior therapy and after transplantation.

3 SCOPE AND RESPONSIBILITES

3. 1 The Adult and Pediatric Blood and Marrow Transplant (APBMT) medical teamwill provide medical management of the patient.

3. 2 The nursing staff formally trained and experienced in management of patientsreceiving cellular therapy will provide supportive care and administer anytreatment ordered by the medical team.

4 DEFINITIONS/ACRONYMS

4. 1 APBMT Adult and Pediatric Blood and Marrow Transplant

Graft versus Host Disease

Hematopoietic Stem Cell Transplant

Pneumocyctisi camii pneumonia

Pneumocystis jiroveci pneumonia

5

6

7

4.2

4.3

4.4

4.5

GvHD

HSCT

PCP

PJP

MATERIALS

5.1 N/A

EQUIPMENT

6.1 N/A

SAFETY

7.1 N/A

APBMT-COMM-017 Pneumocystis Jiroveci Pneumonia (PJP) ProphylaxisAPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am

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8.2

8.3

InfoCard #: APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019

8. 1. 5. 2 Pentamidine:

8. 1. 5. 2. 1 For patients >5 years of age:

. 300 mg inhaled monthly

8. 1. 5. 2.2 For patients 2-5 years of age:

. 150 mg inhaled monthly

8. 1. 5. 2. 3 For patients unable to comply with inhaledtherapy choose one of the following:

. Pentamidine:

> 4 mg/kg/dose IV monthly

. Atovaquone (dosing based on age):

> 1-3 months of age: 30 mg/kg/day withfood (up to 1500mg)> 4-24 months of age: 45 mg/kg/day oncedaily with food (up to 1500 mg)> 24 months to 13 years of age: 30mg/kg/day once daily with food (up to 1500mg)> ^13 years of age: 1 500 mg po daily withfood

Use before stem cell engraftment (neutrophils and platelets):

8.2. 1 Trimethoprim/sulfamethoxazole should be discontinued prior to stemcell infusion and resumed only after stem cell engraftment (Absoluteneutrophil count (ANC) greater than or equal to 1000).

8. 2. 2 Dapsone:

8. 2. 2. 1 Indicated for those allergic or intolerant totrimethoprim/sulfamethoxazole;

8. 2. 2.2 Caution should be used in sulfonamide-allergic individuals;

8. 2. 2. 3 Rarely causes hemolysis or methemoglobinemia.

8.2. 3 Inhaled pentamidine may be used in the time-period after cell infusionwhile waiting for engraftment.

8. 2. 3. 1 Consider use ofalbuterol before inhaled pentamidine.

Reportable Conditions

8. 3. 1 Intolerance or allergy to prophylactic regimen.

RELATED DOCUMENTS/FORMS

9. 1 N/A

APBMT-COMM-017 Pneumocystis Jiroveci Pneuinonia (PJP) ProphylaxisAPBMT, DUMCDurham. NC

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am

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InfoCard #: APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019

10 REFRENCES

10.1 Centers for Disease Control and Prevention. Guidelines for preventingopportunistic infections among hematopoietic stem cell transplant recipients:recommendations ofCDC, the Infectious Disease Society of America, and theAmerican Society of Blood and Marrow Transplantation. MMWR 2000;49(No. RR-10):25-6,106.

11 REVISION HISTORY

Revision No.

05Author

SallyMcCollum

Description of Change(s)- Acronyms defined throughout- Dosing for Atovaquone in pediatrics updated.- Removed reference to negative pressure room

requirements for pediatrics.- Combined second and third line therapies under

header of "Alternate Therapy" given any may bechosen based on patient status/clinical preference.

- Added pediatric dosing for Bactrim.

APBMT-COMM-017 Pneumocystis Jiroveci Pneumonia (PJP) ProphylaxisAPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am

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lnfoCard#:APBMT-COMM-017 Rev. 05 Effective Date: 01 Apr 2019

Signature Manifest

Document Number: APBMT-COMM-017

Title: Pneumocystis Jiroveci Pneumonia (PJP) Prophylaxis

Revision: 05

All dates and times are in Eastern Time.

APBMT-COMM-017 Pneumocystis Jiroveci Pneumonia (PJP) Prophylaxis

Author

Name/Signature ; TitleSally McCollum (MOORE171)

Management

I Date I Meaning/Reason

14 Mar 2019, 11:08:58 AM Approved

' Name/Signature

Nelson Chao (CHA00002)

Medical Director

Title Date | Meaning/Reason14Mar2019, 11:19:16AM Approved

; Name/Signature

Joanne Kurtzberg(KURTZ001)

Quality

Title ! Date ! Meaning/Reason

14 Mar 2019, 03:28:39 PM Approved

j Name/Signature

Bing Shen (BS76)

Document Release

Title Date

18 Mar 2019, 12:24:09 PM

j Meaning/Reason

Approved

Name/Signature

Betsy Jordan (BJ42)

Title Date18 Mar 2019, 01:41:23 PM

I Meaning/Reason

Approved

CONFIDENTIAL - Printed by: ACM93 on 01 Apr 2019 08:41:49 am