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Lonquex is a brand name for Lipegfilgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in 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.
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology. 6 ml solution in a single pre-filled syringe or vial) of Lonquex for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
60 ml) For children weighing 45 kg or more Lonquex can be used as vial or pre-filled syringe presentation. Special populations Elderly patients In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim.
Therefore, no adjustment of the dose is necessary for elderly patients. 2, but no recommendation on a posology can be made. 2, but no recommendation on a posology can be made. Paediatric patients (children less than 2 years) The safety and efficacy of Lonquex in children below 2 years of age have not been established.
No data are available. Method of administration The solution is to be injected subcutaneously (SC). The injection should be given into the abdomen, upper arm or thigh. Pre-filled syringe Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
The first injection should be performed under direct medical supervision. 6.
8. 8). Physicians should therefore exercise caution when administering Lonquex in patients with sickle cell anaemia, monitor appropriate clinical parameters and laboratory results and be attentive to the possible association of lipegfilgrastim with splenic enlargement and vaso-occlusive crisis.
8). For patients with increased risk on hypokalaemia due to underling disease or co-medications, it is recommended to monitor the serum potassium level carefully and to substitute potassium if necessary. Glomerulonephritis Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim.
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim. 8). 6 Excipients This medicinal product contains 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. 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, Lonquex should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Concomitant use of lipegfilgrastim with any chemotherapeutic medicinal product has not been evaluated in patients. In animal models, concomitant administration of G-CSF and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
g. nitrosoureas. 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. 6 Fertility, pregnancy and lactation Pregnancy There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women.
Traceability In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. General The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy.
Lonquex should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Allergic reactions and immunogenicity Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity.
No lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction. Most biological medicinal products elicit some level of anti-drug antibody response. This antibody response can, in some cases, lead to undesirable effects or loss of efficacy.
If a patient fails to respond to treatment, the patient should undergo further evaluation. If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered. Haematopoietic system Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy.
8). Regular monitoring of the platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products that are known to cause severe thrombocytopenia. 8).
No adverse events directly attributable to leukocytosis have been reported. Elevation in white blood cells (WBC) is consistent with the pharmacodynamic effects of lipegfilgrastim. A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis.
If WBC counts exceed 50 x 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
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3). As a precautionary measure, it is preferable to avoid the use of Lonquex during pregnancy. Breast-feeding It is unknown whether lipegfilgrastim/metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded.
Breast-feeding should be discontinued during treatment with Lonquex. Fertility No data are available. 3). 7 Effects on ability to drive and use machines Lonquex has no or negligible influence on the ability to drive and use machines. 8 Undesirable effects Summary of the safety profile The most frequent undesirable effects are musculoskeletal pain and nausea.
8). 7 Tabulated list of adverse reactions The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim. The adverse reactions listed below in table 2 are classified according to system organ class.
Frequency groupings are defined according to the following convention: 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, adverse reactions are presented in order of decreasing seriousness. 4). 4). Hypersensitivity reactions such as allergic skin reactions, urticaria, angioedema and serious allergic reactions may occur. 4).
4). 4). Nausea was very commonly observed in patients receiving chemotherapy. Skin reactions such as erythema and rash may occur. 8 Injection site reactions such as injection site induration and injection site pain may occur. The most frequent adverse reactions include musculoskeletal […]
This should be considered when interpreting bone-imaging results. Patients with myeloid leukaemia or myelodysplastic syndromes Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
The safety and efficacy of Lonquex have not been investigated in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia; it should therefore not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Myelodysplastic syndrome and acute myeloid leukaemia in breast and lung cancer patients 5 In an observational post-marketing study, myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) were associated with the use of pegfilgrastim, an alternative G-CSF, in combination with chemotherapy and/or radiotherapy in breast and lung cancer patients.
A similar association is not known between lipegfilgrastim and MDS/AML. Nevertheless, patients with breast cancer and patients with lung cancer should be monitored for signs and symptoms of MDS/AML. 8). g. clinical examination, ultrasound).
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. 8). Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. 8). In such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given.
Vascular adverse reactions Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 8). Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
g. C-reactive protein and white blood cell count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF. 8. 8). Physicians should therefore exercise caution when administering Lonquex in patients with sickle cell anaemia, monitor appropriate clinical parameters and laboratory results and be attentive to the possible association of lipegfilgrastim with splenic enlargement and vaso-occlusive crisis.
8). For patients with increased risk on hypokalaemia due to underling disease or co-medications, it is recommended to monitor the serum potassium level […]