BNF for Children 2011-2012

BNFC 2011–2012 9.1.6 Drugs used in neutropenia 455Pregnancy There have been reports of toxicityin animal studies and manufacturers advise not touse granulocyte-colony stimulating factors duringpregnancy unless the potential benefit outweighs therisk.Breast-feeding There is no evidence for the use ofgranulocyte-colony stimulating factors during breastfeedingand manufacturers advise avoiding use.Side-effects Side-effects of granulocyte-colony stimulatingfactors include gastro-intestinal disturbances,anorexia, headache, asthenia, fever, musculoskeletalpain, bone pain, rash, alopecia, injection-site reactions,thrombocytopenia, and leucocytosis. Less commonlychest pain can occur. Pulmonary side-effects, particularlyinterstitial pneumonia (see Cautions above), cutaneousvasculitis, and acute febrile neutrophilic dermatosishave rarely been reported.FILGRASTIM(Recombinant human granulocyte-colony stimulatingfactor, G-CSF)Cautions see notes above; also regular morphologicaland cytogenetic bone-marrow examinations recommendedin severe congenital neutropenia (possiblerisk of myelodysplastic syndromes or leukaemia);secondary acute myeloid leukaemia; osteoporoticbone disease (monitor bone density if given for morethan 6 months); interactions: Appendix 1 (filgrastim)Contra-indications severe congenital neutropenia(Kostman’s syndrome) with abnormal cytogeneticsPregnancy see notes aboveBreast-feeding see notes aboveSide-effects see notes above; also mucositis, splenicenlargement, hepatomegaly, transient hypotension,epistaxis, urinary abnormalities (including dysuria,proteinuria, and haematuria), osteoporosis, exacerbationof rheumatoid arthritis, anaemia, transientdecrease in blood glucose, pseudogout, and raiseduric acid; very rarely splenic ruptureLicensed use not licensed for treatment of glycogenstorage disease or neonatal neutropeniaIndication and doseCytotoxic-induced neutropenia. Preferably by subcutaneous injection or byintravenous infusion (over 30 minutes)Child 1 month–18 years 5 micrograms/kg dailystarted not less than 24 hours after cytotoxicchemotherapy, continued until neutrophil count innormal range, usually for up to 14 days (up to 38days in acute myeloid leukaemia)Myeloablative therapy followed by bone-marrowtransplantation. By intravenous infusion over 30 minutes orover 24 hours or by subcutaneous infusion over24 hoursChild 1 month–18 years 10 micrograms/kg daily,started not less than 24 hours following cytotoxicchemotherapy (and within 24 hours of bone-marrowinfusion), then adjusted according to absoluteneutrophil count (consult product literature andlocal protocol)Mobilisation of peripheral blood progenitorcells for autologous infusion, used alone. By subcutaneous injection or by subcutaneousinfusion over 24 hoursChild 1 month–18 years 10 micrograms/kg dailyfor 5–7 daysMobilisation of peripheral blood progenitorcells for autologous infusion following adjunctivemyelosuppressive chemotherapy (toimprove yield). By subcutaneous injectionChild 1 month–18 years 5 micrograms/kg daily,started the day after completion of chemotherapyand continued until neutrophil count in normalrange; for timing of leucopheresis consult productliteratureMobilisation of peripheral blood progenitorcells in normal donors for allogeneic infusion. By subcutaneous injectionChild over 16 years 10 micrograms/kg daily for4–5 days; for timing of leucopheresis consult productliteratureSevere chronic neutropenia. By subcutaneous injectionChild 1 month–18 years in severe congenitalneutropenia, initially 12 micrograms/kg daily insingle or divided doses (initially 5 micrograms/kgdaily in idiopathic or cyclic neutropenia), adjustedaccording to response (consult product literatureand local protocol)Persistent neutropenia in HIV infection. By subcutaneous injectionChild 1 month–18 years initially 1 microgram/kgdaily, increased as necessary until absolute neutrophilcount in normal range (usual max. 4 micrograms/kgdaily), then adjusted to maintainabsolute neutrophil count in normal range (consultproduct literature)Neonatal neutropenia. By subcutaneous injectionNeonate 10 micrograms/kg daily, discontinue ifwhite cell count exceeds 50 10 9 /litreGlycogen storage disease type 1b. By subcutaneous injection5 micrograms/kg daily, adjusted as necessaryAdministration For subcutaneous or intravenousinfusion, dilute with Glucose 5% to a concentration ofnot less than 15 micrograms/mL; to dilute to a concentrationof 2–15 micrograms/mL, add albuminsolution (human albumin solution) to produce a finalalbumin solution of 2 mg/mL; not compatible withSodium Chloride solutionsNeupogen c (Amgen) AInjection, filgrastim 30 million units (300 micrograms)/mL;net price 1-mL vial = £58.56Injection (Singleject c ), filgrastim 60 million units(600 micrograms)/mL, net price 0.5-mL prefilledsyringe = £58.56; 96 million units (960 micrograms)/mL, 0.5-mL prefilled syringe = £93.409 Nutrition and blood