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

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, SOLUTION

**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_.