Lonquex · 4.8 Undesirable effects · 1

HOS-216182 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequent undesirable effects are musculoskeletal pain and nausea. Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see section 4.4 and section 4.8). 6 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. Table 2: Adverse reactions System organ class Frequency Adverse reaction Blood and lymphatic system Common Thrombocytopenia* disorders Uncommon Leukocytosis*, Splenomegaly* Immune system disorders Uncommon Hypersensitivity reactions* Metabolism and nutrition Common Hypokalaemia* disorders Nervous system disorders Common Headache Vascular disorders Not known Capillary leak syndrome*, Aortitis* Respiratory, thoracic and Common Haemoptysis mediastinal disorders Uncommon Pulmonary adverse reactions*, Pulmonary Haemorrhage Gastrointestinal disorders Very common Nausea* Skin and subcutaneous tissue Common Skin reactions* disorders Uncommon Injection site reactions* Musculoskeletal and Very common Musculoskeletal pains* connective tissue disorders General diso

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HOS-216178 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 3

HOS-216177 · has-indication-information · PDF-Seite 2

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).

HOS-216180 · has-interaction-information · PDF-Seite 6

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. The safety and efficacy of Lonquex 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.

HOS-216181 · has-pregnancy-information · PDF-Seite 6

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 (see section 5.3). 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. Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility (see section 5.3).

HOS-216179 · has-warning-information · PDF-Seite 4

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. Lipegfilgrastim may also cause reversible thrombocytopenia (see section 4.8). 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. Leukocytosis may occur (see section 4.8). 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. 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 ha

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