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pegfilgrastim

Neulasta · ATC code L03AA13

Key facts
Active substance
pegfilgrastim
Drug class
Immunostimulant
ATC code
L03AA13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Neulasta 6 mg solution for injection
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-28

Key facts

Pegfilgrastim (Neulasta) is a long-acting pegylated granulocyte colony-stimulating factor (G-CSF) that shortens neutropenia after chemotherapy.

What it is used for

  • Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes).

Dosing

  • One 6 mg dose (a single pre-filled syringe) per chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
  • Subcutaneous injection into the thigh, abdomen or upper arm.
  • No dose change in renal impairment, including end-stage renal disease.
  • No posology recommendation can be made for children; initiated and supervised by physicians experienced in oncology and/or haematology.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Pulmonary adverse reactions, especially interstitial pneumonia, up to ARDS; cough, fever or dyspnoea should be investigated.
  • Splenomegaly and splenic rupture (including fatal cases): consider rupture with left upper abdominal or shoulder tip pain.
  • Capillary leak syndrome, glomerulonephritis and aortitis have been reported.
  • Sickle cell crises in sickle cell trait or disease; caution.
  • Should not be used in myelodysplastic syndrome, chronic myelogenous leukaemia or secondary AML; monitor breast and lung cancer patients for signs of MDS/AML.

Side effects

  • Very common: bone pain, generally mild to moderate and controllable with standard analgesics.
  • Common: musculoskeletal pain.
  • Uncommon: hypersensitivity reactions including anaphylaxis, capillary leak syndrome, splenomegaly, splenic rupture, interstitial pneumonia and other pulmonary reactions.

Interactions

  • Give at least 24 hours after chemotherapy because rapidly dividing myeloid cells are sensitive to cytotoxic agents.
  • In animal models, co-administration with 5-fluorouracil or other antimetabolites potentiated myelosuppression.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women not using contraception.
  • During breast-feeding, a decision between stopping breast-feeding and abstaining from therapy is required.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

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)

  • Cavoley · biosimilarCuraTeQ Biologics s.r.o · EMEA/H/C/006937
  • Cegfila (previously Pegfilgrastim Mundipharma) · biosimilarMundipharma Corporation (Ireland) Limited · EMEA/H/C/005312
  • Dyrupeg · biosimilarCuraTeQ Biologics (Malta) Limited · EMEA/H/C/006407
  • Fulphila · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/004915
  • Grasustek · biosimilarJuta Pharma GmbH · EMEA/H/C/004556
  • NeulastaAmgen Europe B.V. · EMEA/H/C/000420
  • Nyvepria · biosimilarPfizer Europe MA EEIG · EMEA/H/C/005085
  • Pelgraz · biosimilarAccord Healthcare S.L.U. · EMEA/H/C/003961
  • Pelmeg · biosimilarMundipharma Corporation (Ireland) Limited · EMEA/H/C/004700
  • Stimufend · biosimilarFresenius Kabi Deutschland GmbH · EMEA/H/C/004780
  • Vivlipeg · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/006739
  • Ziextenzo · biosimilarSandoz GmbH · EMEA/H/C/004802

Source: European Medicines Agency (EMA), product information

Turkey

  • FilpegCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • NeulastimAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry
  • ZiextenzoSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Cegfila, Dyrupeg, Fulphila, Grasustek, Neulasta, Nyvepria, Pelgraz, Pelmeg, Stimufend, Vivlipeg
Liechtenstein
Cegfila, Dyrupeg, Fulphila, Grasustek, Nyvepria, Pelgraz, Pelmeg, Stimufend, Vivlipeg, Ziextenzo
Norway
Cegfila, Dyrupeg, Fulphila, Grasustek, Neulasta, Nyvepria, Pelgraz, Pelmeg, Stimufend, Vivlipeg, Ziextenzo

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

  1. European Medicines Agency. Neulasta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/neulasta-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L03AA.

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.