Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 03 October 2017

Indication(s)

Accofil is indicated 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 Accofil are similar in adults and children receiving cytotoxic chemotherapy.

Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).

In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109 /L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 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.

Full Prescribing information

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Category Value
Agency product number EMEA/H/C/003956
Orphan designation No
Date First Approved 18-09-2014
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Accord Healthcare Ltd
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions