LONQUEX SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML [SIN16019P]

Product Info

LONQUEX SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.6ML

[SIN16019P]

4.1 Therapeutic indications

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).

4.2 Posology and method of administration

Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.

Posology

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.

Special populations

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, but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with hepatic impairment
Currently available data are described in section 5.2, but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric population
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration

The solution is to be injected subcutaneously (SC). The injection 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.