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.
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 […]