Guidelines on Use of Haematopoietic Growth Factors in Adult Oncology and Haemato-oncology Patients

Transcription

1 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. Chemotherapy support 2. Severe neutropenic sepsis. 3. Peripheral blood stem cell harvest 4. 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

2 1. Chemotherapy support Dose: Biosimilar Filgrastim 5 micrograms / kg daily SC or IV Suggested dosage: Start at least 24 hours after completion of chemotherapy and stop at least 24 hours before the next course. GCSF should be discontinued after neutrophils > 1 x 10 9 /l unless otherwise indicated by the treating consultant or clinical trial protocol. In Haematology regimens GCSF is often stopped after 3 consecutive days of N > 1.0 x 10 9 /L or a single count of >10 x 10 9 /L. LCNDG review Feb 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 All regimens First cycle only FEC 100 FEC 100 T R-CODOX-M Small Cell Lung Adjuvant breast Adjuvant breast Burkitts Comment 2. 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 Ifosphamide / Doxorubicin ABVD CHOP 21 / RCHOP21 FMD Carboplatin / Etoposide BEP EP Gem- TIP TIP VIP MiniBeam Stanford V Sarcoma Germ Cell Germ Cell Comment

3 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. Stop the GCSF after neutrophils > 1 x 10 9 /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: Biosimilar filgrastim dose < micrograms > micrograms

4 OR at some providers Lenograstim is used: Lenograstim SC to commence on D+3 daily for 7 days: Lenograstim dose < x 263mcg > 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): Biosimilar filgrastim dose x 300micrograms x 480micrograms x 300micrograms x 300micrograms + 1 x 480micrograms > x 480micrograms Round doses to the nearest whole vial size the table below is available as a guide for Lenograstim (Granocyte): Lenograstim dose < x 263mcg x 263mcg + 1 x 105mcg x 263mcg x 263mcg + 1 x 105mcg x 263mcg x 263mcg + 1 x 105mcg > 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: Commence biosimilar filgrastim when neutrophil count is < 0.5 x 10 9 /L, and stop after 3 consecutive days of N > 1.0 x 10 9 /L or a single count of >10 x 10 9 /L. The first dose of filgrastim should not be administered within 24 hours of stem cell re-infusion

5 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.