Given The New Designation Of The Medicinal Product For Human Use «Grastofil».

Original Language Title: Comunicato per la nuova indicazione del medicinale per uso umano«Grastofil».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=15A00035&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Specialty Grastofil.
Please be advised that the scientific technical Committee, at its meeting of November 10, 2014, expressed a favourable opinion on the new listings, without changing the price and negotiating conditions currently in force for the new indication below: Grastofil it is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) and to reduce the duration of neutropenia in patients receiving myeloablative chemotherapy followed by bone marrow transplantation and considered to be at high risk of prolonged severe neutropenia.
The safety and efficacy of Grastofil are similar in adults and children treated with cytotoxic chemotherapy.
Grastofil is indicated for the mobilization of peripheral blood progenitor cells (PBPC).
In patients, children or adults with severe congenital neutropenia, cyclic, or idiopathic counts absolute neutrophil count (ANC) of ≤ 0.5 × 109/l and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and reduce the incidence and duration of events related to infection.
Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 × 109/l) in patients with advanced HIV infection, to reduce the risk of bacterial infections when other options for management of neutropenia are inappropriate.