Lenograstim

SPC section 4.2. Therapy should only be given in collaboration with an experienced oncology and/or haematology centre. THE 19.2 MIU (150 micrograms)/m2/day DOSE APPLIES TO: peripheral stem cell or bone marrow transplantation; established cytotoxic chemotherapy; and PBPC mobilisation after chemotherapy. PERIPHERAL STEM CELL OR BONE MARROW TRANSPLANTATION: administer daily as a 30-minute intravenous infusion diluted in isotonic saline solution or as a subcutaneous injection; the first dose should not be given within 24 hours of the bone marrow infusion. Continue until the expected nadir has passed and the neutrophil count returns to a stable level compatible with treatment discontinuation, with a maximum of 28 consecutive days if necessary; by day 14 after bone marrow transplantation 50% of patients are anticipated to achieve neutrophil recovery. ESTABLISHED CYTOTOXIC CHEMOTHERAPY: administer daily as a subcutaneous injection, with the first dose not less than 24 hours after cytotoxic chemotherapy; continue until the expected nadir has passed and the neutrophil count is stable, maximum 28 consecutive days. A transient increase in neutrophil count may occur within the first 2 days but treatment should not be stopped, since the subsequent nadir usually occurs earlier and recovers more quickly if treatment continues. PBPC MOBILISATION AFTER CHEMOTHERAPY: administer daily as a subcutaneous injection starting within 1 to 5 days after completion of chemotherapy according to the mobilising regimen, and maintain until the last leukapheresis; perform leukapheresis when the post-nadir leukocyte count is rising or after assessment of blood CD34+ cells. PBPC MOBILISATION WITH LENOGRASTIM ALONE: the recommended dose is 1.28 million IU (10 micrograms) per kg per day by subcutaneous injection for 4 to 6 days, with leukapheresis performed between day 5 and day 7; in healthy donors 10 micrograms/kg/day subcutaneously for 5-6 days allows a CD34+ collection of at least 3 x 10^6/kg body weight with a single leukapheresis in 83% of subjects and with 2 leukaphereses in 97%. PRESENTATIONS BY BODY SURFACE AREA: the 13 million IU/mL strength can be used in patients with body surface area up to 0.7 m2; the 34 million IU/mL strength can be used in patients with body surface area up to 1.8 m2. ELDERLY: clinical trials included a small number of patients up to the age of 70 years but special studies have not been performed, so specific dosage recommendations cannot be made. PAEDIATRIC: the SPC states that the dose in children older than 2 years and adolescents is the same as in adults when used to reduce the duration of neutropenia after myeloablative therapy followed by bone marrow transplantation or after cytotoxic chemotherapy; very limited data are available for mobilisation of peripheral blood progenitor cells at the adult dose; safety and efficacy in children aged less than 2 years have not been established. No separate numeric paediatric regimen is stated, so no structured paediatric dose is given here — verify against a children's formulary before prescribing, noting the SPC warning that in children with ALL an increased risk of secondary myeloid leukaemia or myelodysplastic syndrome has been reported with colony-stimulating factors. SOURCE NOTE: the US openFDA record retrieved in this bundle is an unrelated homeopathic pellet product and was not used; the dose above is from the UK SPC.