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Grasustek is a brand name for Pegfilgrastim. 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 adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Verbatim from this product's EMA label. Tap a section to expand.
Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Special populations Paediatric population The safety and efficacy of pegfilgrastim in children has not yet been established. 2 but no dosing recommendations can be made. Patients with renal impairment 3 No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
Method of administration Grasustek is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm. 6.
8. Other warnings The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. 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. Excipients Sorbitol The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
e. it is essentially ‘sodium-free’. 5 Interaction with other medicinal products and other forms of interaction Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.
In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of pegfilgrastim with any chemotherapy has not been evaluated in patients. In animal models, concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials. 6 The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
There is no evidence that such an interaction would be harmful. , nitrosoureas. Specific interaction or metabolism studies have not been performed; however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
6 Fertility, pregnancy and lactation Pregnancy There are no or limited data on the use of pegfilgrastim in pregnant women. 3). Grasustek is not recommended during pregnancy and in women of childbearing potential not using contraception.
Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. 1). However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Granulocyte-colony stimulating factor (G- CSF) 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 pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high-dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.
Pulmonary adverse events Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. 8). The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome(ARDS).
8). Glomerulonephritis 4 Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim and pegfilgrastim.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Breast-feeding There is insufficient information on the excretion of pegfilgrastim / metabolites in breast milk. Therefore a risk for new-borns/infants cannot be ruled out. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Grasustek therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
3). 7 Effects on ability to drive and use machines Pegfilgrastim has no or a negligible influence on the ability to drive and use machines. 8 Undesirable effects Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common) [≥ 1/100 to < 1/10]).
Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics. Hypersensitivity-type reactions, including skin rash, urticaria, angioedema dyspnoea, erythema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
4). 4 and section “Description of selected adverse reactions” below. Splenomegaly, generally asymptomatic, is uncommon. 4). 7 Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
4). 4). Tabulated list 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 severity.
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) Very rare (< 1/10,000) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome1 Acute myeloid leukaemia1 Blood and lymphatic system disorders Thrombocytopenia1; Leukocytosis1 Sickle cell anaemia with crisis2; Splenomegaly2; Splenic rupture2 Immune system Disorders Hypersensitivity reactions; Anaphylaxis Metabolism and nutrition disorders Elevations in uric acid Nervous system Disorders Headache1 Vascular Disorders Capillary leak syndrome1 Aortitis Respiratory, thoracic and mediastinal disorders Acute Respiratory DistressSyndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis Pulmonary haemorrhage Gastrointestinal disorders Nausea1 Skin and subcutaneous tissue disorders Sweet’s syndrome (acute febrile neutrophilic dermatosis)1, 2; Cutaneous Vasculitis1,2 Stevens- Johnson syndrome Musculoskeletal and connective tissue disorders […]
Urinalysis monitoring is recommended. Capillary leak syndrome Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 8). 8). g. clinical examination, ultrasound).
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Thrombocytopenia and anaemia Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia. 8). Monitor breast and lung cancer patients for signs and symptoms of MDS/AML.
8). Therefore, doctors should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Leucocytosis White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leucocytosis have been reported.
Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product. Consistent with the clinical effects and the potential for leucocytosis, a WBC count should be performed at regular intervals during therapy.
If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity Hypersensitivity, including anaphylactic reactions, occurring during initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Pegfilgrastim should be permanently discontinued in patients with clinically significant hypersensitivity. Pegfilgrastim should not be 5 administered to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Stevens-Johnson syndrome Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must […]