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Filgrastim Hexal is a brand name for Filgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative…
Verbatim from this product's EMA label. Tap a section to expand.
Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities. The mobilisation and apheresis procedures should be performed in collaboration with an oncology- haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
5 MU/kg/day (5 mcg/kg/day). The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy. 4 mcg/kg/day) was used. Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days. Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 - 2 days after initiation of filgrastim therapy. However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended. 6). The subcutaneous route is preferred in most cases. There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
The clinical relevance of this finding to multiple dose administration is not clear. The choice of route should depend on the individual clinical circumstance. 0 MU/kg/day (10 mcg/kg/day). The first dose of filgrastim should be administered at least 24 hours following cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
0 × 109/L during the treatment period, the dose of filgrastim should be re-escalated according to the above steps ANC = absolute neutrophil count 4 Method of administration Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
8. Special precautions in patients undergoing PBPC mobilisation Mobilisation There are no prospectively randomised comparisons of the two recommended mobilisation methods (Filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult. It is therefore difficult to recommend an optimum method. The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
0 × 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree. Some cytotoxic agents exhibit particular toxicities to the haematopoietic progenitor pool and may adversely affect progenitor mobilisation. Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation. When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy. If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Assessment of progenitor cell yields In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation. The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and, recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Traceability In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the name and the batch number of the administered product should be clearly recorded. Special warnings and precautions across indications Hypersensitivity Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment has been reported in patients treated with filgrastim.
Permanently discontinue Filgrastim HEXAL in patients with clinically significant hypersensitivity. Do not administer Filgrastim HEXAL to patients with a history of hypersensitivity to filgrastim or pegfilgrastim. Pulmonary adverse effects Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration.
Patients with a recent history of lung infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs, such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS).
Filgrastim should be discontinued and appropriate treatment given in these cases. Glomerulonephritis Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Urinalysis monitoring is recommended. 7 Capillary leak syndrome Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported after granulocyte colony-stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
8). Splenomegaly and Splenic rupture Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim. Some cases of splenic rupture were fatal.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6). 0 MU/kg/day (10 mcg/kg/day) for 5 - 7 consecutive days. Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient. In other circumstances, additional leukaphereses may be necessary. Filgrastim dosing should be maintained until the last leukapheresis.
5 MU/kg/day (5 mcg/kg/day) from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. 0 × 109/L. For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
In other circumstances, additional leukaphereses are recommended.
Method of administration Filgrastim for PBPC mobilisation when used alone:
Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection. 6).
Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy:
Filgrastim should be given by subcutaneous injection. 0 MU/kg/day (10 mcg/kg/day) for 4 - 5 consecutive days. Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 × 106 CD34+ cells/kg recipient bodyweight.
Method of administration Filgrastim should be given by subcutaneous injection. 2 MU/kg/day (12 mcg/kg/day) as a single dose or in divided doses. 5 MU/kg/day (5 mcg/kg/day) as a single dose or in divided doses. 5 × 109/L. When the response has been obtained, the minimal effective dose to maintain this level should be established.
Long-term daily administration is required to maintain an adequate neutrophil count. After 1 - 2 weeks of therapy, the initial dose […]
Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship. 0 × 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery. Special precautions in normal donors undergoing PBPC mobilisation Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation with special attention to haematological values and infectious disease. The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Transient thrombocytopenia (platelets < 100 × 109/L) following filgrastim administration and leukapheresis was observed in 35% of subjects studied. Among these, two cases of platelets < 50 × 109/L were reported and attributed to the leukapheresis procedure.
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 × 109/L prior to leukapheresis; in general apheresis should not be performed if platelets < 75 × 109/L. Leukapheresis should not be performed in donors who are anticoagulated or who have known defects in haemostasis.
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal. Special precautions in recipients of allogeneic PBPCs mobilised with filgrastim Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Special precautions in SCN patients Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution. Blood cell counts Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts.
Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia, and myeloid leukaemia. Complete blood cell counts with differential and platelet counts, and an evaluation of bone marrow morphology and karyotype should be performed prior to treatment.
There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim. This observation has only been made in patients with congenital neutropenia. MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
A subset of approximately 12% of patients who had 11 normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation. It is currently unclear whether long-term treatment of patients with SCN will predispose patients to cytogenetic abnormalities, MDS or leukaemic transformation.
It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months). Other special precautions Causes of transient neutropenia, such as viral infections should be excluded.
Haematuria was common and proteinuria occurred in a small […]
g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal pain or shoulder tip pain. Dose reductions of filgrastim have been noted to slow or stop the progression of splenic enlargement in patients with severe chronic neutropenia, and in 3% of patients a splenectomy was required.
Malignant cell growth G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some non- myeloid cells in vitro. Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Filgrastim is not indicated for use in these conditions. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia. Acute myeloid leukaemia In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia (AML), filgrastim should be administered with caution.
The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established. Thrombocytopenia Thrombocytopenia has been reported in patients receiving filgrastim.
Platelet counts should be monitored closely, especially during the first few weeks of filgrastim therapy. Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 × 109/L).
3 MU/kg/day (3 mcg/kg/day). No undesirable effects directly attributable to this degree of leukocytosis have been reported. However, in view of the potential risks associated with severe leukocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
If leukocyte counts exceed 50 × 109/L after the expected nadir, filgrastim should be discontinued immediately. When administered for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 × 109/L.
8 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against filgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Special warning and precautions associated with co-morbidities Special precautions in sickle cell trait and sickle cell disease Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease. Osteoporosis Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Special precautions in cancer patients Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific […]