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. Mobilisation of peripheral blood progenitor cells (PBPC). Long-term administration to increase neutrophil counts & reduce the incidence & duration of infection-related events in patients w/ severe congenital, cyclic or idiopathic neutropenia w/ an ANC of ≤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 the risk of bacterial infections.

Established cytotoxic chemotherapy 5 mcg/kg/day as SC or IV infusion over 30 min. Do not give 1st dose <24 hr following 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. Do not give 1st dose <24 hr following cytotoxic chemotherapy & w/in 24 hr of bone marrow infusion. Titrate dose against neutrophil response once neutrophil nadir has been passed. Mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation Monotherapy: 10 mcg/kg/day as a 24-hr SC continuous infusion or single daily SC inj for 5-7 consecutive days. Timing of leukapheresis: 1 or 2 leukaphereses on days 5 & 6, additional leukaphereses may be necessary. Maintain filgrastim dosing until last leukapheresis. PBPC mobilisation after myelosuppressive chemotherapy 5 mcg/kg/day given daily 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. Patient w/ 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 inj daily 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. Childn in severe neutropenia & cancer settings Same as those in adults receiving myelosuppresive cytotoxic chemotherapy.

Hypersensitivity.

Do not administer to patients w/ severe congenital neutropenia (Kostmann's syndrome) w/ abnormal cytogenetics. Myelodysplastic syndrome, chronic myelogenous leukaemia, secondary AML. Monitor bone density in patients w/ underlying osteoporotic bone diseases who undergo continuous therapy for >6 mth. Monitor patients who develop symptoms of capillary leak syndrome. Discontinue if leukocyte counts exceed 50 x 10⁹/L. During period of filgrastim administration, consider discontinuation or dosage reduction if leukocyte counts rise to >70 x 10⁹/L. High dose chemotherapy. Regular monitoring of platelet count, haematocrit, absolute neutrophil count, reduced myeloid progenitors. Chemotherapeutic drugs known to cause severe thrombocytopenia. Increased haematopoietic activity of bone marrow in response to growth factor therapy. Do not perform leukapheresis in donors who are anticoagulated or have known defects in haemostasis. Consider a diagnosis of splenic rupture. Discontinue treatment in case of suspected or confirmed pulmonary adverse reactions. Severe chronic neutropenia. Perform complete blood cell counts w/ differential & platelet counts, & an evaluation of bone marrow morphology & karyotype prior to treatment. Perform regular urinalysis. Thrombocytopenia & anemia. Sickle cell disease. Do not use in patients w/ fructose intolerance. May affect ability to drive or operate machinery. Pregnancy. Not recommended for use during lactation. Neonates.

Elevated alkaline phosphatase, LDH, uric acid; nausea, vomiting, elevated γ-glutamyl transferase; chest & musculoskeletal pain. Headache; cough, sore throat; constipation, anorexia, diarrhoea, mucositis; alopecia, skin rash; fatigue, generalised weakness.

Myelosuppressive cytotoxic chemotherapy given on the same day. Not recommended 24 hr before or after chemotherapy. Exacerbated severe neutropenia w/ 5-fluorouracil. Potentiated effect w/ lithium.

Haematopoietic Agents / Supportive Care Therapy

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

POM