Neulasta

pegfilgrastim

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This is a summary of the European public assessment report (EPAR) for Neulasta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Neulasta.

What is Neulasta?

Neulasta is a solution for injection that contains the active substance pegfilgrastim. It is available in a prefilled syringe containing 6 mg pegfilgrastim.

What is Neulasta used for?

Neulasta is used in cancer patients to help with some of the side effects of their treatment. Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections. Neulasta is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).

Neulasta cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells). It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).

The medicine can only be obtained with a prescription.

How is Neulasta used?

Neulasta treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.

Neulasta is given as a single 6-mg injection under the skin around 24 hours after the end of each cycle of chemotherapy. Patients can inject themselves if they have been trained appropriately.

How does Neulasta work?

The active substance in Neulasta, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF), that has been ‘pegylated’ (attached to a chemical called polyethylene glycol). Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.

Filgrastim has been available in other medicines in the European Union (EU) for a number of years. Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.

The filgrastim in Neulasta is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim. The replacement acts in same way as naturally produced G-CSF.

How has Neulasta been studied?

Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy. In both studies, the effectiveness of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles. The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.

What benefit has Neulasta shown during the studies?

Neulasta was as effective as filgrastim in reducing the duration of severe neutropenia. In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when no stimulating factor is used.

What is the risk associated with Neulasta?

The most common side effects with Neulasta (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick). For the full list of all side effects reported with Neulasta, see the package leaflet.

Neulasta should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.

Why has Neulasta been approved?

The CHMP decided that Neulasta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Neulasta

The European Commission granted a marketing authorisation valid throughout the EU for Neulasta to Amgen Europe B.V. on 22 August 2002. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Neulasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Neulasta : EPAR - Summary for the public BG = bălgarski 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public ES = español 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public CS = čeština 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public DA = dansk 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public DE = Deutsch 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public ET = eesti keel 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public EL = elliniká 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public EN = English 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public FR = français 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public IT = italiano 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public LV = latviešu valoda 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public LT = lietuvių kalba 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public HU = magyar 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public MT = Malti 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public NL = Nederlands 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public PL = polski 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public PT = português 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public RO = română 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public SK = slovenčina 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public SL = slovenščina 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public FI = suomi 2009-06-19 2011-07-05
Neulasta : EPAR - Summary for the public SV = svenska 2009-06-19 2011-07-05

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Neulasta
NameNeulasta
Agency product numberEMEA/H/C/000420
Active substance

pegfilgrastim

International non-proprietary name (INN) or common name

pegfilgrastim

Therapeutic area NeutropeniaCancer
Anatomical therapeutic chemical (ATC) code L03AA13

Publication details

Publication details for Neulasta
Marketing-authorisation holder

Amgen Europe B.V.

Revision28
Date of issue of marketing authorisation valid throughout the European Union22/08/2002

Contact address:

Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

Product information

10/03/2017  Neulasta -EMEA/H/C/000420 - IAIN/0094

Name Language First published Last updated
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10
Neulasta : EPAR - Product Information SV = svenska 2009-11-09 2017-04-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22
Neulasta : EPAR - All Authorised presentations SV = svenska 2009-04-27 2013-07-22

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Neulasta : EPAR - Procedural steps taken before authorisation SV = svenska 2009-06-19  
Neulasta : EPAR - Scientific Discussion SV = svenska 2009-06-19  

Authorised

This medicine is approved for use in the European Union