Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
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).
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
The recommended dose is 6 mg (0.6 ml solution in a single pre-filled syringe or vial) of Lonquex for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
The recommended dose of Lonquex for paediatric patients is based on body weight according to the table below:
Table 1. Recommended dose in children 2 years of age and older:
| Body weight (kg) | Dose (for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy) |
| <10 | 0.6 mg (0.06 ml) |
| ≥10 to <20 | 1.5 mg (0.15 ml) |
| ≥20 to <30 | 2.5 mg (0.25 ml) |
| ≥30 to <45 | 4.0 mg (0.40 ml) |
| ≥45 | 6.0 mg (0.60 ml) |
For children weighing 45 kg or more Lonquex can be used as vial or pre-filled syringe presentation.
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 below 2 years of age have not been established. No data are available.
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.
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).
3 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 7 days. Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Pre-filled syringe:
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 and 4 pre-filled syringes with safety device (which prevents needle stick injury and re-use) or 1 pre-filled syringe without safety device.
Not all pack sizes may be marketed.
Vial:
Type I clear, borosilicate glass vial with a bromobutyl rubber stopper and an aluminium crimp seal with polypropylene flip-off cap.
Each vial contains 0.6 ml of solution.
Pack sizes of 1 or 6 vials.
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 or vials are for single use only. Any unused portions of each vial must be discarded properly. Do not save any unused portions for later administrations.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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