Nivestim

Reduction in duration of neutropenia & incidence of febrile neutropenia in patients treated w/ established cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia & myelodysplastic syndromes) & in patients undergoing myeloablative therapy followed by bone marrow transplantation. Peripheral blood progenitor cells (PBPC) mobilisation. Long-term administration to increase neutrophil counts & reduce incidence & duration of infection-related events in adults or childn w/ severe congenital, cyclic or idiopathic neutropenia w/ ANC ≤0.5 x 10⁹/L & history of severe or recurrent infections. Persistent neutropenia (ANC ≤1 x 10⁹/L) in patients w/ advanced HIV infection to reduce risk of bacterial infections.

Established cytotoxic chemotherapy 5 mcg/kg/day as SC or IV infusion over 30 min. Administer 1st dose at least 24 hr after cytotoxic chemotherapy. Patient treated w/ myeloablative therapy followed by bone marrow transplantation Initially 10 mcg/kg/day as 30-min or 24-hr IV infusion or by continuous 24-hr SC infusion. Administer 1st dose at least 24 hr following cytotoxic chemotherapy & at least 24 hr after bone marrow infusion. Titrate dose against neutrophil response once neutrophil nadir has been passed. PBPC mobilisation during myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation Monotherapy: 10 mcg/kg/day as a 24-hr SC continuous infusion or SC inj for 5-7 consecutive days. Timing of leukapheresis: 1 or 2 leukapheresis on days 5 & 6, additional leukapheresis may be necessary. Maintain filgrastim dosing until last leukapheresis. PBPC mobilisation after myelosuppressive chemotherapy 5 mcg/kg/day SC inj from 1st day after completion of chemotherapy until expected neutrophil nadir is passed & neutrophil count has recovered to normal range. PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation 10 mcg/kg/day SC for 4-5 consecutive days. Severe chronic & congenital neutropenia Initially 12 mcg/kg/day SC as a single dose or in divided doses. Idiopathic or cyclic neutropenia Initially 5 mcg/kg/day SC as a single dose or in divided doses. Dose adjustment: Initial dose may be doubled or halved depending upon patient's response after 1-2 wk. Patient w/ HIV infection Reversal of neutropenia: Initially 1 mcg/kg/day SC w/ titration up to max of 4 mcg/kg/day until normal neutrophil count is reached & maintained (ANC >2 x 10⁹/L). Maintaining normal neutrophil counts: Initial dose adjustment to alternate day dosing w/ 300 mcg/day SC inj. Paed use in severe chronic neutropenia & cancer settings Same as those in adults receiving myelosuppresive cytotoxic chemotherapy.

Hypersensitivity.

Haematopoietic Agents / Supportive Care Therapy

L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.

POM