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Biograstim is a brand name for Filgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Biograstim is indicated for the 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 for the reduction in the duration of…
Verbatim from this product's EMA label. Tap a section to expand.
Medicinal product no longer authorised 3 Special requirements Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (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 MIU (5 μg)/kg/day. The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy. 6 for instructions on dilution). 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. 4 μg/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 leukaemias, 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 to 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. 0 MIU (10 μg)/kg/day given by continuous 24 hour subcutaneous infusion. 6 for instructions on dilution). The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
Summary of the safety profile During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim. The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
8. The following undesirable effects and their frequencies have been observed under treatment with filgrastim based on published information.
The assessment of undesirable effects is based on the following frequency data:
Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000 Not known: cannot be estimated from the available data Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
In cancer patients In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10 %, and severe musculoskeletal pain in 3 % of patients.
Musculoskeletal pain is usually controlled with standard analgesics. Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria. In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Undesirable effects reported with equal frequency in patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50 %, 35 %, 25 %, and 10 % of patients respectively, at recommended doses.
Special warnings Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens (see below). Filgrastim should not be administered to patients with severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics (see below).
Special precautions in patients with acute myeloid leukaemia Malignant cell growth Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established. Therefore, filgrastim is not indicated forMedicinal product no longer authorised 6 use in these conditions.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia. In view of limited safety and efficacy data in patients with secondary 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. Other special precautions 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.
Rare pulmonary undesirable effects, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary 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 Adult Respiratory Distress Syndrome (ARDS).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 MIU (10 μg)/kg/day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days. 6 for instructions on dilution). 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 MIU (5 μg)/kg/day given daily by subcutaneous injection 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 x 109/L. For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient. In other circumstances, additional leukaphereses are recommended. 0 MIU (10 μg)/kg/day subcutaneously for 4 to 5 consecutive days.
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight. 2 MIU (12 μg)/kg/day subcutaneously as a single dose or in divided doses. 5 MIU (5 μg)/kg/day subcutaneously as a single dose or in divided doses.
5 x 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 one to two weeks of therapy, the initial dose may be […]
Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally. 1). Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
The causal association with filgrastim has not been established. Very rare events of cutaneous vasculitis have been reported in patients treated with filgrastim. Medicinal product no longer authorised 12 The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established. Exacerbation of rheumatoid arthritis has been observed in individual cases.
Pseudogout has been reported in patients with cancer treated with filgrastim. 4).
Allergic Reactions:
Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment, have been reported in patients receiving filgrastim. Overall, reports were more common after IV administration.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction. 4). 8 In peripheral blood progenitor cell mobilisation in normal donors The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain.
Medicinal product no longer authorised 13 Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in […]
Filgrastim should be discontinued and appropriate treatment given in these cases. Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
8). 3 MIU/kg/day (3 μg/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 x 109/L after the expected nadir, filgrastim should be discontinued immediately. However, during the period of administration of filgrastim for PBPC mobilisation, filgrastim should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
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 Summary of Product Characteristics of the specific chemotherapy agents used).
Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy. g. full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia. Regular monitoring of platelet count and haematocrit is recommended.
Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Other special precautions The effects of filgrastim in patients with substantially reduced myeloid progenitors have not been studied. Filgrastim acts primarily on neutrophil precursors to exert its effect in elevating neutrophilMedicinal product no longer authorised 7 counts.
Therefore, in patients with reduced precursors, neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour). 1). Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
This should be considered when interpreting bone-imaging results. Special precautions in patients undergoing peripheral blood progenitor cell 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 x 106 CD34+ cells/kg) or acceleration of platelet […]