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GRANOCYTE is a brand name for Lenograstim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GRANOCYTE is indicated in adults, adolescents and children aged older than 2 years for: The reduction of the duration of neutropenia in patients (with non myeloid malignancy) undergoing myeloablative therapy followed by bone marrow transplantation (BMT) and considered to be at increased risk of prolonged severe…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration GRANOCYTE can be administered by sub-cutaneous injection or by intravenous infusion. 6. Posology Therapy should only be given in collaboration with an experienced oncology and/or haematology centre. 64 MIU (5 μg) per kg per day for: Peripheral Stem Cells or bone marrow transplantation, established cytotoxic chemotherapy PBPC mobilisation after chemotherapy.
7 m2. 8 m2. 28 MIU (10 μg) per kg per day. 2 MIU (150 μg) per m2 per day as a 30-minute intravenous infusion diluted in isotonic saline solution or as a subcutaneous injection. The first dose should not be administered within 24 hours of the bone marrow infusion.
Dosing should continue until the expected nadir has passed and the neutrophil count returns to a stable level compatible with treatment discontinuation, with, if necessary, a maximum of 28 consecutive days of treatment. It is anticipated that by day 14 following bone marrow transplantation, 50% of patients will achieve neutrophil recovery.
2 MIU (150 μg) () per m2 per day as a subcutaneous injection. 5). Daily administration of GRANOCYTE should continue until the expected nadir has passed and the neutrophil count returns to a stable level compatible with treatment discontinuation, with, if necessary, a maximum of 28 consecutive days of treatment.
A transient increase in neutrophil count may occur within the first 2 days of treatment, however GRANOCYTE treatment should not be stopped, since the subsequent nadir usually occurs earlier and recovers more quickly if treatment continues.
2 MIU (150 μg) per m2 per day as a subcutaneous injection starting within 1 to 5 days after completion of chemotherapy, according to the chemotherapy regimen administered for mobilisation. GRANOCYTE should be maintained until the last leukapheresis.
Leukapheresis should be performed when the post nadir leukocyte count is rising or after assessment of CD34+ cells in blood with a validated method. 0 x 106 CD34+ cells per kg). 28 MIU (10 μg) per kg per day as a subcutaneous injection for 4 to 6 days.
Leukapheresis should be performed between day 5 and 7. 0 x 106 CD34+ cells per kg). In healthy donors, a 10μg/kg daily dose administered subcutaneously for 5-6 days allows a CD34+ cells collection ≥ 3 x 106 /kg body weight with a single leukapheresis in 83% of subjects and with 2 leukapheresis in 97%.
8.
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. 4). Possible interactions with other haematopoietic growth factors and cytokines have yet to be investigated in clinical trials.
6 Fertility, pregnancy and lactation Pregnancy There are no adequate data from the use of lenograstim in pregnant women. 3). The potential risk for humans is unknown. GRANOCYTE should not be used during pregnancy unless clearly necessary.
Breast-feeding It is unknown whether lenograstim is excreted in human milk. The excretion of lenograstim in milk has not been studied in animals. Breast-feeding should be discontinued during therapy with GRANOCYTE. 7. Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
8 Undesirable effects The safety profile in children, adolescents, and adults is comparable. 4). In Peripheral Stem Cells or Bone Marrow Transplantation and Chemotherapy-Induced Neutropenia In clinical trials, the most frequently reported adverse events (15%) were the same in patients treated with either GRANOCYTE or placebo.
These adverse events were those usually encountered with conditioning regimens and those observed in cancer patients treated with chemotherapy. The most commonly reported adverse events were infection/inflammatory disorder of the buccal cavity, sepsis and infection, fever, diarrhoea, abdominal pain, vomiting, nausea, rash, alopecia, and headache.
In PBPC mobilisation in healthy donors The most frequently reported undesirable effects were transient and mild to moderate: pain, bone pain, back pain, asthenia, fever, headache and nausea, increased ALAT, ASAT, blood alkaline phosphatise and LDH.
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. The safety and efficacy of GRANOCYTE administration in patients with myelodysplasia or secondary AML or chronic myelogenous leukaemia have not been established.
Therefore, it should not be used in these indications. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia. Clinical trials have not established whether GRANOCYTE influences the progression of myelodysplastic syndrome to acute myeloid leukaemia.
Caution should be exercised in using it in any pre-malignant myeloid condition. As some tumours with non-specific characteristics can exceptionally express a G-CSF receptor, caution should be exerted in the event of unexpected tumour regrowth concomitantly observed with rHuG- CSF therapy In children with ALL An increased risk for secondary myeloid leukaemia or myelodysplastic syndrome associated with CSFs has been reported in children with ALL.
804 adult patients with solid tumors or lymphomas, a risk, however, without negative impact on long term outcome in the adults investigated. Therefore, GRANOCYTE 13 million IU/mL and GRANOCYTE 34 million IU/ml should be used in children, in particular with favorable long term prognosis, only after careful weighting of short term benefits versus long term risks.
64 million units/kg/day) following bone marrow transplantation. 64 million units/kg/day). No adverse events directly attributable to this degree of leukocytosis have been reported. In view of the potential risks associated with severe leukocytosis, a white blood cell count should, however, be performed at regular intervals during GRANOCYTE therapy.
If leukocyte counts exceed 50 x 109/L after the expected nadir, GRANOCYTE should be discontinued immediately. During PBPC mobilisation, GRANOCYTE should be discontinued if the leukocyte counts rise to > 70 x 109/L. 1%) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSFs administration.
1. GRANOCYTE should not be used to increase the dose intensity of cytotoxic chemotherapy beyond established doses and dosage regimens since the drug could reduce myelo-toxicity but not overall toxicity of cytotoxic drugs. It should not be administered concurrently with cytotoxic chemotherapy.
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Elderly Clinical trials with GRANOCYTE have included a small number of patients up to the age of 70 years but special studies have not been performed in the elderly and therefore specific dosage recommendations cannot be made. Children The dose in children older than 2 years and adolescent is the same as in adults when used to reduce the duration of neutropenia after myeloablative therapy followed by BMT or after cytotoxic chemotherapy.
Very limited data are available for mobilisation of peripheral blood progenitor cells at the adult dose. Paediatric population The safety and efficacy of GRANOCYTE in children aged less than 2 years have not been established. 7 m². 8 m².
Apheresis-related thrombocytopenia and leukocytosis were observed in 42% and 24% respectively in study subjects. Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported. Allergic reactions including anaphylaxis have been reported very rarely after the first subcutaneous administration of lenograstim.
4). Frequency of adverse reactions issued from clinical trials and post-marketing surveillance data. Very common (≥ 10%); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1/10000 to ≤ 1/1000); very rare (≤ 1/10000); not known (cannot be estimated from the available data).
Medra System Organ Class Very common Common Uncommon Rare Very rare Not known Investigations Elevated LDH C-reactive protein increased Blood and lymphatic system disorders Leucocytosis Thrombocytopenia Enlarged spleen size Splenic rupture (5) Nervous system disorders Headache Asthenia Vascular Disorders Capillary leak syndrome6 Aortitis Venous thromboembolism Arterial thromboembolism Respiratory, thoracic and mediastinal disorders Haemoptysi s (8) Pulmonary edema Interstitial pneumonia (3) Pulmonary infiltrates Pulmonary fibrosis Pulmonary haemorrhage (8) Gastrointestina l disorders Abdominal pain Skin and subcutaneous tissue disorders Cutaneous vasculitis Sweet’s syndrome (4) Erythema nodosum Pyoderma gangrenosum Lyell’s syndrome Musculoskelet al and connective tissue disorders Musculoskeletal pain (7) Pain (1) Renal and urinary disorders Glomerulonephritis General disorders and administration site condition Injection site reaction Immune system disorders Allergic reaction Anaphylactic shock Hepatobiliary disorders Elevated ASAT/ALAT (2) Elevated Alkaline- phosphatase 1 / The risk of occurrence of pain is increased in subjects with high peak WBC values, especially when WBC ≥ 50 x 109 /L 2 / Transient increase of ASAT and/or ALAT was observed.
In most cases, liver function abnormalities improved after lenograstim discontinuation. 3 / Some of the respiratory reported cases have resulted in respiratory failure or acute respiratory distress syndrome (ARDS) which may be fatal.
4 / Sweet’s syndrome, erythema nodosum and pyoderma gangrenosum were mainly described in patients with hematological malignancies, a condition known to be associated with neutrophilic dermatosis, but also in non- malignant related neutropenia.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. […]
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary symptoms or 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).
GRANOCYTE should be immediately discontinued and appropriate treatment given. In donors and patients, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, dyspnoea and hypoxia) have been reported in post marketing experience.
In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with Granocyte should be considered and appropriate medical care given. Venous and arterial thromboembolic events Cases of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) have been reported in donors treated with lenograstim.
8). In Peripheral Stem Cells or Bone Marrow Transplantation Special attention should be paid to platelet recovery since in double-blind placebo-controlled trials the mean platelet count was lower in patients treated with GRANOCYTE as compared with placebo.
The effect of GRANOCYTE on the incidence and severity of acute and chronic graft-versus-host disease has not been accurately determined. 5). The safety of the use of GRANOCYTE with antineoplastic agents characterized by cumulative or predominant platelet lineage myelotoxicity (nitrosurea, mitomycin) has not been established.
Administration of GRANOCYTE might enhance the toxicity of these agents, particularly to the platelets. Risks Associated with Increased Doses of Chemotherapy The safety and efficacy of GRANOCYTE have yet to be established in the context of intensified chemotherapy.
It should not be used to decrease, beyond the established limits, intervals between chemotherapy courses and/or to increase the doses of chemotherapy. Non-myeloid toxicities were limiting factors in a phase II chemotherapy intensification trial with GRANOCYTE.
Special precautions in Peripheral Blood Progenitor Cells mobilisation. Choice of the mobilisation method Clinical trials carried out among the same patient population have shown that PBPC mobilisation, as assessed within the same laboratory, was higher when GRANOCYTE was used after chemotherapy than when used alone.
Nevertheless the choice between the two mobilisation methods should be considered in relation to the overall objectives of treatment for an individual patient. Prior exposure to radiotherapy and/or cytotoxic agents Patients, who have undergone extensive prior myelosuppressive therapy and/or radiotherapy, may not show sufficient PBPC mobilisation to achieve the acceptable minimum yield (≥ 2 x106 CD34+ /kg) and therefore adequate haematological reconstitution.
A PBPC transplantation program should be defined early in the treatment course of the patient and particular attention should be paid to the number of […]