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Fulphila 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 Patients with renal impairment No dose change is recommended in patients with renal impairment, including those with end stage renal disease. Paediatric population 3 The safety and efficacy of pegfilgrastim in children has not yet been established.
2 but no recommendation on a posology can be made. Method of administration Fulphila 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 This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg/mL. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say 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 agent 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. 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.
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. 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.
General 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 4 count may be preliminary signs of acute respiratory distress syndrome (ARDS).
8). 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of pegfilgrastim in pregnant women. 3). Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fulphila therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
3). 7 Effects on ability to drive and use machines Pegfilgrastim has no or 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 7 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). 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, adverse reactions 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) 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 8 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 Elevations in uric acid Nervous system disorders Headache1 Vascular disorders Capillary leak syndrome1 Aortitis Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome2 Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis […]
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 agents which are known to cause severe thrombocytopenia. 8). Monitor breast and lung cancer patients for signs and symptoms of MDS/AML. 8). Therefore, physicians 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.
Leukocytosis 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 leukocytosis 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. 5 Consistent with the clinical effects and the potential for leukocytosis, 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 on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim 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 […]