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Nivestim is a brand name for Filgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Filgrastim 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.
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 (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 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. 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 (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 Method of administration Filgrastim may be given as a 30 minute or 24 hour intravenous infusion or given by continuous 24 hour subcutaneous infusion.
a. Summary of the safety profile The most serious adverse reactions that may occur during filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
In clinical trials in cancer patients musculoskeletal pain was mild or moderate in 10%, and severe in 3% of patients. b. Tabulated summary of adverse reactions The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. MedDRA system organ class Adverse reactions 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) Infections and infestations Sepsis Bronchitis Upper respiratory tract infection Urinary tract infection Blood and lymphatic system disorders Thrombocytopenia Anaemiae Splenomegalya Haemoglobin decreasede Leucocytosisa Splenic rupturea Sickle cell anaemia with crisis Extramedullary haematopoiesis Immune system disorders Hypersensitivity Drug hypersensitivitya Graft versus host diseaseb Anaphylactic reaction 14 MedDRA system organ class Adverse reactions 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) Metabolism and nutrition disorders Decreased appetitee Blood lactate dehydrogenase increased Hyperuricaemia Blood uric acid increased Blood glucose decreased Pseudogouta (Chondrocalcinosis Pyrophosphate) Fluid volume disturbances Psychiatric disorders Insomnia Nervous system disorders Headachea Dizziness Hypoaesthesia Paraesthesia Vascular disorders Hypertension Hypotension Veno-occlusive diseased Capillary leak syndromea Aortitis Respiratory, thoracic and mediastinal disorders Haemoptysis Dyspnoea Cougha Oropharyngeal paina,e Epistaxis Acute respiratory distress syndromea Respiratory failurea Pulmonary oedemaa Pulmonary haemorrhage Interstitial lung diseasea Lung infiltrationa Hypoxia Gastrointestinal disorders Diarrhoeaa,e Vomitinga,e Nauseaa Oral pain Constipatione Hepatobiliary disorders Hepatomegaly Blood alkaline phosphatase increased Aspartate aminotransferase increased Gamma- glutamyl transferase increased 15 MedDRA system organ class Adverse reactions 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) Skin and subcutaneous tissue disorders Alopeciaa Rasha Erythema Rash maculo- papular Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis) Musculoskeletal and connective tissue disorders Musculoskeletal painc Muscle spasms Osteoporosis Bone density decreased Exacerbation of rheumatoid arthritis Renal and urinary disorders Dysuria Haematuria Proteinuria Glomerulonephritis Urine abnormality General disorders and administration site conditions Fatiguea Mucosal inflammationa Pyrexia Chest paina Paina Astheniaa Malaisee Oedema peripherale Injection site reaction Injury, poisoning and procedural complications Transfusion reactione a See section c (Description of selected adverse reactions).
Traceability In order to improve the traceability of biological medicinal products, 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 have been reported in patients treated with filgrastim.
Permanently discontinue filgrastim in patients with clinically significant hypersensitivity. Do not administer filgrastim 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 7 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. 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. 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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6). 0 MU (10 mcg)/kg/day for 5 to 7 consecutive days. Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient. In other circumstances, additional leukapheresis may be necessary. Filgrastim dosing should be maintained until the last leukapheresis.
5 MU (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 leukapheresis is 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 (10 mcg)/kg/day 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 × 106 CD34+ cells/kg recipient bodyweight.
Method of administration Filgrastim should be given by subcutaneous injection. 2 MU (12 mcg)/kg/day as a single dose or in divided doses. 5 MU (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 one to two weeks of therapy, the initial dose may be doubled or halved depending upon the […]
b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c). c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain.
d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilisation. e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy.
c. Description of selected adverse reactions Hypersensitivity Hypersensitivity-type reactions including anaphylaxis, rash, urticaria, angioedema, dyspnoea and hypotension occurring on initial or subsequent treatment have been reported in clinical studies and in post-marketing experience.
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). 16 Splenomegaly and splenic rupture Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim. 4). Capillary leak syndrome Cases of capillary leak syndrome have been reported with granulocyte-colony stimulating factor use.
4). Cutaneous vasculitis Cutaneous vasculitis has been reported in patients treated with filgrastim. The mechanism of vasculitis in patients receiving filgrastim is unknown. During long-term use cutaneous vasculitis has been reported in 2% of SCN patients.
Leucocytosis Leucocytosis (WBC > 50 × 109/L) was observed in 41% of normal donors and transient thrombocytopenia (platelets < 100 × 109/L) following […]
g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in donors and/or patients reporting left upper abdominal 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 Granulocyte colony-stimulating factor 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 leukaemia 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 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 leucocytosis have been reported. However, in view of the potential risks associated with severe leucocytosis, a white blood cell count should be performed at regular intervals during filgrastim therapy.
If leucocyte 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 leucocyte counts rise to > 70 × 109/L.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Rate 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.
Aortitis Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. g. C-reactive protein and white blood cell count). 8). Special warnings 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 […]