Guidelines on Use of Haematopoietic Growth Factors in Adult Oncology and Haemato-oncology
Patients
The recombinant human granulocyte-colony stimulating factor (GCSF) of choice is Biosimilar filgrastim (Zarzio).
Biosimilar Filgrastim (Zarzio) is available as:
30 million IU (equivalent to 300 micrograms) per 0.5ml
48 million IU (equivalent to 480 micrograms) per 0.5ml
Doses should be rounded up or down to the most appropriate vial size, 300micrograms and 480 micrograms
Administration: As a subcutaneous (SC) injection or 30 minute intravenous infusion (IV) diluted in 50ml of
5% glucose (suitable for doses of 300micrograms or more)
For some indications Lenograstim (Granocyte) is used at some providers across London Cancer as described below.
It is available as:
13.4 million IU (equivalent to 105 micrograms) per ml
33.6 million IU (equivalent to 263 micrograms) per ml
Using Pegfilgrastim (Neulasta) – see Appendix A
Growth factors are not be routinely used in patients receiving palliative chemotherapy
Haematopoietic growth factors outside the context of a clinical trial may be prescribed for the following:
1.
2.
3.
4.
Chemotherapy support
Severe neutropenic sepsis.
Peripheral blood stem cell harvest
Post peripheral blood stem cell and bone marrow transplants.
It is not licensed for use in those patients with chronic myeloid leukaemia (CML) and myelodysplastic syndromes (MDS).
MHRA Alert- Filgrastim and Pegfilgrastim- September 2013
Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing
chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation
CLS has also been reported in recipients of pegfilgrastim undergoing chemotherapy.
Episodes varied in severity and frequency. CLS is characterised by: hypotension and oedema;
hypoalbuminaemia; and haemoconcentration, and may be fatal unless promptly diagnosed and managed.
Prescribers should monitor patients and healthy donors for signs and symptoms of CLS, and should give standard
symptomatic treatment immediately if symptoms occur.
Prescribers should advise patients to seek medical attention immediately if they experience symptoms of CLS
Based on the Barts Health Guideline
Reviewed for London Cancer by: Simon Jenkinson
Version 1. 12th February 2014
Review Date: 12.02.2016
1. Chemotherapy support
Dose: Biosimilar Filgrastim 5 micrograms / kg daily SC or IV
Suggested dosage:
Which dosing schedule is used depends upon provider:
< 80kg
Biosimilar Filgrastim 300micrograms daily
≥ 80kg
Biosimilar Filgrastim 480micrograms daily
<85kg
Biosimilar Filgrastim 300micrograms daily
≥85kg
Biosimilar Filgrastim 480micrograms daily
Start at least 24 hours after completion of chemotherapy and stop at least 24 hours before the next course. GCSF should
9
be discontinued after neutrophils > 1 x 10 /l unless otherwise indicated by the treating consultant or clinical trial
9
protocol. In Haematology regimens GCSF is often stopped after 3 consecutive days of N > 1.0 x 10 /L or a single count of
9
>10 x 10 /L.
LCNDG review Feb 2010
1. GCSF should be considered in patients who are receiving chemotherapy regimens with a febrile neutropenia rate
of >20%. Examples of commonly used regimens with documented febrile neutropenia rates >20% are:
Regimens used
R-ICE
Lymphoma
All regimens – First cycle only
Small Cell Lung
FEC 100
Adjuvant breast
FEC 100 T
Adjuvant breast
R-CODOX-M
Burkitts Lymphoma
2.
Comment
GCSF support should be considered in patients who are receiving chemotherapy regimens with a febrile
neutropenia rate of 10-20% (table 2) and have at least one patient related risk factors for febrile
neutropenia.(table 3).
Table 2
Regimens used
Comment
Ifosphamide / Doxorubicin
Sarcoma
ABVD
Lymphoma
CHOP 21 / RCHOP21
FMD
Carboplatin / Etoposide
BEP
EP
Gem- TIP
TIP
VIP
MiniBeam
Stanford V
Lymphoma
Lymphoma
Germ cell
Germ cell
Germ Cell
Germ Cell
Germ cell
Germ cell
Lymphoma
Lymphoma
Based on the Barts Health Guideline
Reviewed for London Cancer by: Simon Jenkinson
Version 1. 12th February 2014
Review Date: 12.02.2016
Table 3
Patient related risk factors:
Pre-existing neutropenia due to disease infiltration of bone marrow or other aetiology
Age > 65 years
Advanced disease stage
Poor performance status
Previous episodes of febrile neutropenia whilst receiving earlier chemotherapy of a similar or less dose intensity
Extensive prior chemotherapy
Previous irradiation to large volume of bone marrow
Poor nutritional status
Active infections or increased risk of infections (e.g. presence of open wounds)
Serious co-morbidities
2. Severe neutropenic sepsis
GCSF is not routinely indicated unless the likely duration of neutropenia exceeds five days or co-morbidities make it
desirable to shorten the duration of neutropenia.
Which dosing schedule is used depends upon provider:
< 80kg
Biosimilar Filgrastim 300micrograms daily
≥ 80kg
Biosimilar Filgrastim 480micrograms daily
<85kg
Biosimilar Filgrastim 300micrograms daily
≥85kg
Biosimilar Filgrastim 480micrograms daily
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Stop the GCSF after neutrophils > 1 x 10 /l.
3. Peripheral blood stem cell harvest
Autologous Priming in solid germ cell tumour patients:
GCSF Priming with Biosimilar filgrastim: 13micrograms/kg for 3 days (4 days for heavily pre-treated)
Paclitaxel and GCSF priming: Biosimilar filgrastim from day 3 for 8days –
< 60kg 300 micrograms SC
> 60kg 480 micrograms SC
Haemato-oncology transplant protocols:
Cyclophosphamide/GCSF priming or Cytarabine/GCSF priming
Biosimilar Filgrastim SC to commence on D+3 daily for 7 days:
Weight
(kg)
< 80
> 80
Based on the Barts Health Guideline
Reviewed for London Cancer by: Simon Jenkinson
Version 1. 12th February 2014
Review Date: 12.02.2016
Biosimilar filgrastim
dose (micrograms)
300micrograms
480micrograms
OR at some providers Lenograstim is used:
Lenograstim SC to commence on D+3 daily for 7 days:
Weight
(kg)
< 85
> 85
Lenograstim dose
(micrograms)
263
368
Vials used
1 x 263mcg
1 x 263mcg + 1 x 105mcg
Single agent GCSF priming – biosimilar filgrastim or lenograstim 10micrograms/kg daily for 4 days
Round doses to the nearest whole vial size – see the tables available below as a guide:
Healthy donor GCSF priming – biosimilar filgrastim or lenograstim 10micrograms/kg daily for 4 days
Round doses to the nearest whole vial size – the table below is available as a guide for Biosimilar filgrastim (Zarzio):
Weight
(kg)
30-39
40-54
55-68
69-87
Biosimilar filgrastim dose
(micrograms)
300
480
600
780
>88
960
Vials used
1 x 300micrograms
1 x 480micrograms
2 x 300micrograms
1 x 300micrograms + 1 x
480micrograms
2 x 480micrograms
Round doses to the nearest whole vial size – the table below is available as a guide for Lenograstim (Granocyte):
Weight
(kg)
<30
30-39
40-54
55-64
65-79
80-84
>85
Lenograstim dose
(micrograms)
263
368
526
631
789
894
1052
Vials used
1 x 263mcg
1 x 263mcg + 1 x 105mcg
2 x 263mcg
2 x 263mcg + 1 x 105mcg
3 x 263mcg
3 x 263mcg + 1 x 105mcg
4 x 263mcg
4. Post peripheral blood stem cell and bone marrow transplants
GCSFs are currently NOT indicated routinely post allogeneic transplant.
For autologous transplant regimens:
9
9
Commence biosimilar filgrastim when neutrophil count is < 0.5 x 10 /L, and stop after 3 consecutive days of N > 1.0 x 10 /L or a single
9
count of >10 x 10 /L.
The first dose of filgrastim should not be administered within 24 hours of stem cell re-infusion
Which dosing schedule is used depends upon provider:
< 80kg
Biosimilar Filgrastim 300micrograms daily
≥ 80kg
Biosimilar Filgrastim 480micrograms daily
<85kg
Biosimilar Filgrastim 300micrograms daily
≥85kg
Biosimilar Filgrastim 480micrograms daily
Based on the Barts Health Guideline
Reviewed for London Cancer by: Simon Jenkinson
Version 1. 12th February 2014
Review Date: 12.02.2016
Appendix A
Guidance on the use of Pegfilgrastim (Neulasta) in Adult Oncology and Haemato-oncology Patients
Pegfilgrastim (Neulasta) is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in
patients treated with cytotoxic chemotherapy for malignancy.
It is not licensed for use in those patients with chronic myeloid leukaemia (CML) and myelodysplastic syndromes
(MDS).
Pegfilgrastim is prescribed on the authorisation by a Consultant.
Note- initiation of growth factors in solid tumour patients is always a consultant decision
One 6 mg dose (a single pre-filled syringe) of Pegfilgrastim is administered as a subcutaneous injection approximately
24 hours following cytotoxic chemotherapy.
Eligibility for Pegfilgrastim - Patients who are unable to self-administer standard GCSF and would otherwise be
suitable for discharge.
In terms of cost, a single dose of Peg-filgrastim is equivalent to:
o
o
30 days treatment with Biosimilar filgrastim 300 micrograms per day
18 days treatment with Biosimilar filgrastim 480 micrograms per day
Please note, Pegfilgrastim is not licensed for use to mobilise stem cells for harvest or for use post stem cell reinfusion and hence should not be used for these indications.
Based on the Barts Health Guideline
Reviewed for London Cancer by: Simon Jenkinson
Version 1. 12th February 2014
Review Date: 12.02.2016