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 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.
Other substances in the same group
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. 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.