Department of Clinical Haematology

Oxford BMT Programme

Plerixafor Use for Peripheral Blood Stem Cell Mobilisation

1. PURPOSE
The purpose of this protocol is to ensure standardised practice for the use of Plerixafor in
peripheral blood stem cell (PBSC) mobilisation. Plerixafor (Mozobil®) mobilises
haematopoietic stem cells from the bone marrow increasing their number in peripheral blood.
Unlike the standard treatment of G-CSF, Plerixafor is not a growth factor but works
alongside G-CSF to release cells more efficiently.

2. ELIGIBLE PATIENTS
Patients with any type of blood cancer and specific solid tumours, who are scheduled for
autologous HSCT in accordance with national guidance (British Society of Blood and
Marrow Transplantation Adult BSBMT Indications Table 2012, Paediatric BSBMT
Indications Table 2011) but:

2.1. Have failed a previous attempt at PBSC mobilisation – so-called “rescue” or “planned”
usage (see Protocol A) or
2.2. Patients who have a low peripheral blood CD34+ cell count on the day of expected
harvest and are not considered by the transplant consultant to have a reasonable chance of
collecting enough cells– so-called “pre-emptive” or “just-in-time” use (see protocol B)

The need for patients to receive “pre-emptive” Plerixafor is not predictable such that
resources cannot be allocated in advance. The ability to proceed is not guaranteed and will
be assessed on an individual case basis depending on availability of apheresis slots, stem cell
processing and ward care on the day. At least 2 further days of apheresis/processing slots
should be available before the patient receives Plerixafor. Where possible, patients with risk
factors known to adversely affect PBSC mobilisation (see appendix 1) will be identified in
advance and resource issues discussed at the weekly stem cell planning teleconference.

3. PRE-ASSESSMENT
See PBSCH protocol.
Consider whether the patient needs accommodation in Oxford. Options include the Churchill
flat for planned Plerixafor usage and bed and breakfast accommodation for just-in-time use.

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 Department of Clinical Haematology
Oxford BMT Programme

4. INDICATED SCHEDULING PROTOCOLS

4.1 PROTOCOL A – PLANNED OR “RESCUE” USE2

Day/Time Treatment:
Day 1 07:00 G-CSF at 1 MU/kg od s/c
Day 2 07:00 G-CSF at 1 MU /kg od s/c
Day 3 07:00 G-CSF at 1 MU /kg od s/c
Day 4 07:00 G-CSF at 1 MU /kg/d od s/c
17:00 or later Plerixafor 240 mcg/kg od s/c
Day 5 07:00 G-CSF at 1 MU /kg/d od s/c
08:30 Patient attends NHSBT apheresis unit:
If PB CD34 >/= 8 per ul (or HPC >0.045), proceed to harvest.
If PB CD34 < 8 per ul, discuss with consultant.*

17:00 or later ** Plerixafor 240 mcg/kg as od s/c injection

* Consider apheresis if CD34 is 7 per ul -see appendix 2 for background.
**If harvest yield is less than the target repeat Plerixafor + G-CSF doses after ensuring
there is apheresis and stem cell lab availability and after discussion with consultant.

4.2 PROTOCOL B - PRE-EMPTIVE OR “JUST-IN-TIME” USE4

Day/Time Treatment
Day 0 Expected day of apheresis after G-CSF with or without chemotherapy and
WCC greater than/equal to 1 x 109/l.

08:30 Patient attends NHSBT apheresis unit:

If PB CD34 >/= 15 per ul (or HPC >0.045), proceed to harvest as standard.
If PB CD 8-14 per ul proceed to harvest but consider plerixafor if yield
suboptimal.
If CD34 count is insufficient to harvest cells (< 8 per ul) or yield is
insufficient patient should receive a dose of plerixafor in evening*:
17:00 or Plerixafor 240 mcg/kg od s/c
later

afternoon/ G-CSF to continue (to be administered at same time as before Plerixafor

evening was started -usually evening). Check dose patient is receiving. If patient
only on 0.5 MU/kg for PBSC mobilisation (e.g. myeloma patient) dose
should be increased to 1 MU/kg for use with Plerixafor.
Day 1 Patient attends NHSBT apheresis unit:
08:30 If PB CD34 >/= 8 per ul, proceed to harvest.
If PB CD 8-14 per ul proceed to harvest but consider plerixafor if yield
suboptimal*.
If PB CD34 < 8 per ul, discuss with consultant.**
*If harvest yield is less than target repeat Plerixafor + G-CSF doses after ensuring there is
apheresis and stem cell lab availability (for at least 2 days after the first plerixafor dose)
and after discussion with consultant.
** Consider apheresis if CD34 is 7 per ul -see appendix 2 for background.

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Authorised by: Dr Andy Peniket
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 Department of Clinical Haematology
Oxford BMT Programme

Patients may receive a maximum of 3 plerixafor doses.

5. ACTIONS TO BE TAKEN BY TRANSFUSION SPR:

• If WCC > 60, discuss with consultant prior to proceeding with Plerixafor or G-CSF
administration.
• Patients should not be informed they are having plerixafor until the capacity to
accommodate this is confirmed with the referring team.
• If patient being considered for plerixafor, liaise with referring consultant or CNS. If
CD34 count < 8 per ul, do referring team have capacity to adminster plerixafor? If
CD34 8-14 per ul, would referring team have capacity to give plerixafor if yield is
low when this is known at about 4pm?
• For OUH patients inform patient’s CNS, Ward Pharmacist (bleep 4515) and DTU
co-ordinating nurse (bleep 5126)
• For OUH adult patients prescribe 3 doses of Plerixafor. Blueteq form required. If it
is not clear whether patient has consented to Plerixafor , re-take consent and give
patient a copy to take to DTU to be scanned onto EPR. For paediatrics, ask
Consultant of the Week to arrange prescription.
• For patients at other hospitals, discuss with their consultant or CNS
• Ask CNS to review whether patient needs help with accommodation or transport.

6. DOSE –

Creatinine clearance Plerixafor dose ( based on body weight)1

(ml/min)
>50 0.24 mg/kg (maximum 40mg/day) once daily given as
subcutaneous injection

20-50 0.16 mg/kg (maximum 27mg/day) once daily given as

subcutaneous injection

<20 Insufficient clinical evidence to recommend dose alterations *

The patient’s weight should be obtained within 1 week of the first dose. If the patient’s weight
is over 175% ideal body weight (IBW) the Plerixafor dose should be capped at the dose for
175% IBW.

IBW can be determined using the following equations:

Male (kg): 50 + 2.3 x ((height (cm) x 0.394) – 60)
Female (kg): 45.5 + 2.3 x ((height (cm) x 0.394) – 60)

*See section 7 for use of Plerixafor in dialysis-dependent patients.

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V.4.1 Plerixafor
Authorised by: Dr Andy Peniket
This is a controlled document and therefore must not be changed
 Department of Clinical Haematology
Oxford BMT Programme

6. ADMINISTRATION1

Plerixafor should be administered as a subcutaneous injection over the abdominal area. If

the volume to be given exceeds 1.2ml the dose may be split and given in 2 injections.

Patients should be monitored for one hour after drug administration

*Timings are crucial to the success of Plerixafor treatment; any variations to the
administration must be reported to the NHSBT apheresis unit.3

Contraindications:
• Hypersensitivity to active substance or any of the excipients.
• Patients with leukaemia (may mobilise leukaemic cells)

7. USE OF PLERIXAFOR IN RENAL IMPAIRMENT –PLANNED PROTOCOL5

Day -4 Day -3 Day -2 Day -1 Day 0 Day +1

(Plan for
Friday
start)
Morning G-CSF G-CSF G-CSF G-CSF G-CSF G-CSF
07:00 1 MU/Kg 1 MU /Kg 1 MU /Kg 1 MU /Kg 1 MU /Kg 1 MU /Kg *
Morning Apheresis* Apheresis*
after
G-CSF
HD anytime HD HD afternoon
Day anytime
Evening
17:00 or Plerixafor ?Plerixafor* ?Plerixafor*
later
HD – Haemodialysis; * dependent on CD34 count or yield

8. ADVERSE EFFECTS
Commonly occurring side effects:
• Vasovagal reactions (can occur up to 1 hour after admin. hence monitoring need)
• Gastrointestinal effects including diarrhoea (more than 1 in 10 patients), nausea, vomiting,
flatulence, dyspepsia, constipation.
• Reaction at injection site and allergic reactions
• Headache
• Arthralgia
• Dizziness
• Fatigue and insomnia

Potentially serious side effects:

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 Department of Clinical Haematology
Oxford BMT Programme

• Hyperleucocytosis
• Thrombocytopenia,
• Splenic enlargement with potential for rupture (Rare)
• Allergic reactions

9. AUDIT
Regular audit is required with data on the following2:
• % of total patients undergoing mobilisation requiring Plerixafor
• No. of doses of Plerixafor used per patient
• Total CD34+ cells mobilised following Plerixafor
• Number of collection days required to collect sufficient cells
• Time to engraftment

APPENDIX 1
Factors that may predict poor PBSC mobilisation include:
1. Heavy pre-treatment with any chemotherapy agents;
2. Previous treatment with any of fludarabine, alkylating agents, lenalidomide and possibly
thalidomide;
3. Previous radiotherapy to large bone marrow-containing areas;
4. History of low grade lymphoma;
5. Bone marrow involvement.

APPENDIX 2
Audit of Correlation between Pre-CD34 Counts and Stem Cell Yield
47 patients received plerixafor May 2012-Nov 2015, 45 in planned fashion.
In 64 of their apheresis episodes, pre-CD34 counts were available.
In 19 cases the pre-count was less than 8/ul. Only 3 of these episodes resulted in a yield
that may have been useful (0.85, 1 and 1.12 x 106 CD34/kg). In all 3 of these cases the pre-
CD34 count was 7. A pre-CD34 count of 6 or below was never associated with a useful
yield (defined as >= 0.7 x 106 CD34/kg). R Pawson, unpublished data Feb 2016

11. REFERENCES
1. https://www.medicines.org.uk/emc/product/790Mozobil: Summary of Product
Characteristics last updated on the eMC: 23/05/2019
2. Clinical Commissioning Policy: Plerixafor for stem cell mobilisation in adults
and children (Publication reference no: 200601P). NHS England.
https://www.england.nhs.uk/wp-
content/uploads/2020/09/1902_Plerixafor_Clinical_Commissioning_Policy.pdf
3. Cooper et al Late afternoon dosing of plerixafor for stem cell mobilisation:
Practical solution. Clinical Lymphoma, Myeloma & Leukemia, Vol. 11, No. 3,
267-72, 2011.
4. Nottingham University Hospitals Trust Bone Marrow Transplant Programme
Standard Operating Procedure: Protocol for Plerixafor PBSC Mobilisation, Prof
NH Russell July 2010.
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Oxford BMT Programme

5. Douglas K W et al Plerixafor for PBSC mobilisation in myeloma patients with

advanced renal failure: safety and efficacy data in a series of 21 patients from
Europe and the USA. Bone Marrow Transplantation advance online publication
28 February 2011; doi: 10.1038/bmt.2011.9
6. Baker J et al. Plerixafor: how can we achieve the best outcome for patients? The
role of the apheresis nurse. Oral presentation EBMT April 2015.
http://www.nature.com/bmt/journal/v50/n1s/pdf/bmt201531a.pdf
7. Cooper DL et al. Late afternoon dosing of plerixafor for stem cell mobilisation: a
practical solution. Clin Lymp Myeloma Leuk 2011 11: 267-272.

Audit: These processes are subject to the OxBMT audit programme

Author: Dr Rachel Pawson, Consultant Haematologist, updated

Circulation: NSSG website

Review
Name Revision Date Version Review
date
Dr Change to include rescue and pre-emptive April 1.1 May
Rachel use; G-CSF dosing in MIU/kg; change in 2012 2014
Pawson layout.
Julia Changed GCSF units from MIU to MU 15/08/14 1.2 August
Wong, Changed Pre-Emptive Day 0 GCSF doses. 2016
Pharmaci Stock management.
st
Sandy Removal of pre-assessment information. October 2.0 October
Hayes, Formatting. Change of location to DTU. 2014 2016
Quality
manager
Dr Change of earliest time for administration of April 2.1 October
Rachel plerixafor to 1700 in view of data on 147 2015 2016
Pawson patients in new references.
Dr Re-formatting to simplify tables. Inclusion Feb 2016 3.1 Feb
Rachel of HPC to assess mobilisation. Expansion of 2018
Pawson criteria for pre-emptive use to include
patients with CD34 <15 per ul as per NHSE
policy, Change to waiting for PB CD34
counts before harvest.
Dr Addition of children and young people with October 4.0 October
Rachel paediatric-type solid malignant tumours into 2020 2022
Pawson eligibility criteria as per updated NHSE
policy August 2016.

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V.4.1 Plerixafor
Authorised by: Dr Andy Peniket
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 Department of Clinical Haematology
Oxford BMT Programme

Dr Asif No significant changes. Oct 2023 4.1 Oct

Khan 2025

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V.4.1 Plerixafor
Authorised by: Dr Andy Peniket
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