filgrastim
Accofil, Filgrastim Hexal, Nivestim, Ratiograstim · ATC code L03AA02
Brand names: Neupogen, Filgrastim-Turgut, Fraven, Leucostim, Leukoplus, Nivestim, Tevagrastim, Zarzio
- Key facts
- Active substance
- filgrastim
- Drug class
- Immunostimulant
- ATC code
- L03AA02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled syringe · Accofil 48 MU/0.5 ml solution for injection/infusion in pre-filled syringe · Accofil 12 MU/0.2 mL solution for injection/infusion in pre-filled syringe · Accofil 70 MU/0.73 ml solution for injection/infusion in pre-filled syringe
- Information as of
- 2026-10-27
Key facts
Filgrastim is a granulocyte colony-stimulating factor (G-CSF; here Accofil). It is used to shorten neutropenia after chemotherapy, to mobilise blood stem cells and in chronic neutropenia.
What it is used for
- Reduction of neutropenia duration and febrile neutropenia with cytotoxic chemotherapy (except chronic myeloid leukaemia and myelodysplastic syndromes)
- Reduction of neutropenia duration after myeloablative therapy with bone marrow transplantation
- Mobilisation of peripheral blood progenitor cells (PBPCs)
- Severe congenital, cyclic or idiopathic neutropenia with severe or recurrent infections (children or adults)
- Persistent neutropenia in advanced HIV infection when other options are inappropriate
Dosing
- Cytotoxic chemotherapy: 0.5 MU (5 µg)/kg/day, first dose at least 24 hours after chemotherapy; daily until the expected nadir has passed and neutrophils recover
- Myeloablative therapy with bone marrow transplantation: start 1.0 MU (10 µg)/kg/day, then titrate to neutrophil response
- PBPC mobilisation alone: 1.0 MU (10 µg)/kg/day for 5-7 consecutive days
- Congenital neutropenia: start 1.2 MU (12 µg)/kg/day; idiopathic or cyclic neutropenia: 0.5 MU (5 µg)/kg/day
- HIV infection: start 0.1 MU (1 µg)/kg/day, titrating up to a maximum of 0.4 MU (4 µg)/kg/day; further regimens in the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Hypersensitivity including anaphylaxis; permanently discontinue after clinically significant reactions
- Pulmonary adverse effects (interstitial lung disease, ARDS); discontinue if signs develop
- Capillary leak syndrome, potentially life-threatening
- Splenomegaly and splenic rupture (some fatal); monitor spleen size
- Glomerulonephritis; urinalysis monitoring recommended
Side effects
- Most common: pyrexia, musculoskeletal pain (incl. bone, back, joint pain), anaemia, vomiting, nausea
- Serious: anaphylactic reaction, serious pulmonary events, capillary leak syndrome, splenic rupture, sickle cell crisis in sickle cell disease
- In severe chronic neutropenia: transformation to myelodysplastic syndrome or leukaemia; GvHD after allogeneic transplant
Interactions
- Not recommended from 24 hours before to 24 hours after myelosuppressive chemotherapy
- With 5-fluorouracil the severity of neutropenia may be exacerbated
- Lithium is likely to potentiate the effect of filgrastim
Pregnancy and breastfeeding
- Pregnancy: not recommended; transplacental passage reported, reproductive toxicity in animals
- Breast-feeding: excretion in human milk unknown; a benefit-risk decision is required
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Accofil · biosimilarAccord Healthcare S.L.U. · EMEA/H/C/003956
- Filgrastim Hexal · biosimilarHexal AG · EMEA/H/C/000918
- Nivestim · biosimilarPfizer Europe MA EEIG · EMEA/H/C/001142
- Ratiograstim · biosimilarRatiopharm GmbH · EMEA/H/C/000825
- Tevagrastim · biosimilarTeva GmbH · EMEA/H/C/000827
- Zarzio · biosimilarSandoz GmbH · EMEA/H/C/000917
- Zefylti · biosimilarCuraTeQ Biologics (Malta) Limited · EMEA/H/C/006400
Source: European Medicines Agency (EMA), product information
Germany
- NeupogenAmgen Europe B.V. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- Filgrastim-TurgutTURGUT İLAÇLARI A.Ş. · 5 register entries
- FravenARVEN İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- LeucostimDEM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
- LeukoplusHASBIOTECH İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- NivestimORNA İLAÇ TEKSTİL KİMYEVİ MAD. SAN. VE DIŞ TİC. LTD. ŞTİ. · 6 register entries
- TevagrastimTEVA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- ZarzioSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 13 more European countries
- Belgium
- Neupogen
- France
- Neupogen
- Iceland
- Accofil, Filgrastim Hexal, Nivestim, Ratiograstim, Tevagrastim, Zarzio, Zefylti
- Ireland
- Neupogen
- Italy
- Granulokine
- Liechtenstein
- Accofil, Filgrastim Hexal, Nivestim, Ratiograstim, Tevagrastim, Zarzio, Zefylti
- Luxembourg
- Neupogen
- Netherlands
- Neupogen
- Norway
- Accofil, Filgrastim Hexal, Neupogen, Nivestim, Ratiograstim, Tevagrastim, Zarzio, Zefylti
- Poland
- Neupogen
- Slovenia
- Neupogen
- Spain
- Neupogen
- Sweden
- Neupogen
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Accofil – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/accofil-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L03AA.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.