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Biograstim

Active Substance: filgrastim
Common Name: filgrastim
ATC Code: L03AA02
Marketing Authorisation Holder: AbZ-Pharma GmbH
Active Substance: filgrastim
Status: Withdrawn
Authorisation Date: 2008-09-15
Therapeutic Area: Neutropenia Hematopoietic Stem Cell Transplantation Cancer
Pharmacotherapeutic Group: Colony-stimulating factors

Therapeutic Indication

Biograstim 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 filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

Biograstim is indicated 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 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Biograstim 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.

The marketing authorisation for Biograstim has been withdrawn at the request of the marketing-authorisation holder.

Further information

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