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filgrastim (Nivestim®)


Reference No. 666

Publication date:
31/03/2011


Appraisal information

filgrastim (Nivestim®) solution for injection/infusion


Company: Hospira UK Ltd
BNF category: Nutrition and blood
NMG meeting date: 13/01/2011
AWMSG meeting date: 16/02/2011
   
   
Submission Type: Full Submission
Status: Recommended
Advice No: 0111
Ministerial ratification: 29/03/2011

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Filgrastim (Nivestim®) is recommended as an option for use within NHS Wales for the treatment of neutropenia: - For the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. - For the mobilisation of peripheral blood progenitor cells (PBPC). - In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 × 10⁹/l and a history of severe or recurrent infections, long term administration of filgrastim (Nivestim®) is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. - For the treatment of persistent neutropenia (ANC less than or equal to 0.5 × 10⁹/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate. - Filgrastim (Nivestim®) is not suitable for shared care within NHS Wales for the above indication. - Filgrastim (Nivestim®) should be prescribed by brand name to avoid automatic substitution and therefore help with pharmacovigilance.
Final Appraisal Recommendation (FAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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