GRANOCYTE
LENOGRASTIM · by SANOFI-AVENTIS
Composition
Inj 263 mcg: Lenograstim 263 mcg (33.6 million units); powder in vials and water for injection in amp.
Indications & Dosage
Reduction in the duration of neutropenia following bone-marrow transplantation or peripheral stem cells transplantation for non-myeloid malignancy: BY SC INJ OR IV INF: Adult: 150 mcg/m2 daily until neutrophil count stable in acceptable range (max. 28 days), to be started the day after transplantation. Reduction in the duration of neutropenia following treatment with cytotoxic chemotherapy associated with a febrile neutropenia: BY SC INJ: Adult: 150 mcg/m2 daily until neutrophil countstable in acceptable range (max. 28 days), to be started on the day after completion of chemotherapy. Mobilization of peripheral blood progenitor cells for harvesting and subsequent INF: BY SC INJ: Adult: 10 mcg/kg daily for 4-6 days. Mobilisation of peripheral blood progenitor cells, used following adjunctive myelosuppressive chemotherapy: BY SC INJ: Adult:150 mcg/m2 daily until neutrophil count stable in acceptable range, to be started 1-5 days after completion of chemotherapy, (for treatment of leucopheresis, consult product literature).
Administration
For IV infusion, give intermittently over 30 min in Sodium chloride 0.9%; initially reconstitute with 1ml water for injection provided (do not shake vigorously) then dilute with up to 50ml infusion fluid for each vial of 263 mcg; give over 30 minutes.
Contraindications
Severe congenital neutropenia (Kostmanns syndrome) with abnormal cytogenetics.
Precautions
Tumours with myeloid characteristics (risk of tumour growth), pre-malignant myeloid conditions; reduced myeloid precursors; monitor leucocyte count (discontinue) treatment if leukocytosis); monitor platelet count and haemoglobin; regular morphological and cytogenetic bone marrow examinations recommended in severe congenital neutropenia (possible risk of myelodysplastic syndromes or leukaemia); monitor spleen size; osteoporotic bone disease (monitor bone density if given for more than 6 months); does not prevent other toxic effects of high-dose chemotherapy; pregnancy, breast-feeding.
Pregnancy
Risk cannot be ruled out.
Lactation
Caution advised or effect undetermined.
Side Effects
Mucositis, splenic rupture, toxic epidermal necrolysis, musculoskeletal pain, transient hypoten-sion, disturbances in liver enzymes and serum uric acid; thrombocytopenia; urinary abnormalities including dysuria; allergic reactions (more common after intravenous infusion), proteinuria, haematuria, and transient decrease in blood glucose; on long-term use cutaneous vasculitis, splenic enlargement, hepatomegaly, headache, diarrhoea, anaemia, epistaxis, alopecia, osteoporosis, and rash.