Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Lonquex is indicated in adults 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).
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
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.
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.
Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Currently available data are described in section 5.2, but no recommendation on a posology can be made.
The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2.
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.
For instructions on handling of the medicinal product before administration, see section 6.6.
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).
2 years.
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.
Lonquex 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.
Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]).
Each pre-filled syringe contains 0.6 ml of solution.
Pack sizes of 1 pre-filled syringe with or without safety device (which prevents needle stick injury and re-use).
Not all pack sizes may be marketed.
The solution should be visually inspected before use. Only clear, colourless solutions without particles should be used.
The solution should be allowed to reach a comfortable temperature (15°C-25°C) for injection.
Vigorous shaking should be avoided. Excessive shaking may aggregate lipegfilgrastim, rendering it biologically inactive.
Lonquex does not contain any preservative. In view of the possible risk of microbial contamination, Lonquex syringes are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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