Presentation and Status in Health Basket
0.6 ml X 6 mg
One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
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.
Patients with renal impairment: Currently available data are described in section 5.2 in prescribing information, but no recommendation on a posology can be made.
Patients with hepatic impairment: Currently available data are described in section 5.2 in prescribing information, but no recommendation on a posology
can be made.
Paediatric population: The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Method of administration: The solution is injected subcutaneously (SC). The injections should be given into the abdomen, upper arm or thigh.
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.
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).
Hypersensitivity to the active substance or to any of the excipients.
The safety and efficacy of Lipegfilgrastim have not been investigated in patients receiving high dose chemotherapy. Lipegfilgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. In order to improve the traceability, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
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.
Haematopoietic system: Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy. Lipegfilgrastim may also cause reversible thrombocytopenia.
Patients with myeloid leukaemia or myelodysplastic syndromes: Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
Splenic adverse reactions: Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives .Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound).
Pulmonary adverse reactions: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim . Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
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.
Patients with sickle cell anaemia: Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia.
Hypokalaemia: Hypokalaemia may occur. 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.
See prescribing information for full details.
Thrombocytopenia, leukocytosis, hypersensitivity reactions, hypokalaemia, headache, capillary leak syndrome, skin reactions, musculoskeletal pains, chest pain.
See prescribing information for full details.
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, Lipegfilgrastim 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.
The safety and efficacy of Lipegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.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.
Pregnancy and Lactation
Pregnancy: There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of this drug during pregnancy.
Lactation: It is unknown whether lipegfilgrastim/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with this drug.
There is no experience with overdose of lipegfilgrastim. In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Excipients: This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not use this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free’.
Storage: Store in a refrigerator (2 °C– 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. This drug may be removed from the refrigerator and stored below 25 °C for a maximum single period of up to 3 days. Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.