Lonquex

lipegfilgrastim

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This is a summary of the European public assessment report (EPAR) for Lonquex. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Lonquex.

For practical information about using Lonquex, patients should read the package leaflet or contact their doctor or pharmacist.

What is Lonquex and what is it used for?

Lonquex is a medicine that contains the active substance lipegfilgrastim. It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.

Cytotoxic chemotherapy (medicines that kill fast-growing cells) commonly causes neutropenia because in addition to cancer cells it also kills other fast-growing cells such as neutrophils, leaving the patient at risk of infections.

Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) or myelodysplastic syndromes (a disease that can develop into a leukaemia).

How is Lonquex used?

Lonquex is available as a solution for injection in prefilled syringes. The injections should be given under the skin in the abdomen, upper arm or thigh. One 6-mg dose is given in each chemotherapy cycle around 24 hours after chemotherapy treatment.

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer and blood disorders. Well motivated patients may be able to self-administer the medicine once they have been properly trained, but the first injection should be done under the direct supervision of a doctor. For more information, see the package leaflet.

How does Lonquex work?

The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte-colony-stimulating factor (G‑CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow. Lipegfilgrastim acts in the same way as naturally produced G‑CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.

Lipegfilgrastim is similar to filgrastim, which has been available in the EU for a number of years. In Lonquex, the filgrastim has been ‘pegylated’ (attached to a chemical called polyethylene glycol). This decreases the rate at which filgrastim is removed from the body and allows the medicine to be given less often. The filgrastim in Lonquex is produced by a method known as ‘recombinant DNA technology’: it is made by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the filgrastim protein.

What benefits of Lonquex have been shown in studies?

Lonquex has been shown to be effective in reducing the duration of neutropenia and the number of febrile-neutropenia cases among patients undergoing chemotherapy. In a main study in 202 breast-cancer patients, Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was 0.7 days (around 17 hours) with Lonquex compared with 0.8 days (around 19 hours) with the other medicine. Lonquex also compared well with the other medicine in the number of febrile-neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.

In another main study in 376 patients with lung cancer, treatment with Lonquex was superior to placebo (a dummy treatment) in reducing the time it took to recover from neutropenia as well as the occurrence and duration of severe neutropenia.

What are the risks associated with Lonquex?

The most common side effects with Lonquex (which may affect more than 1 in 10 patients) are bone and muscle pain, which are generally mild to moderate in severity and can be treated with standard painkillers. For the full list of all side effects reported with Lonquex, see the package leaflet.

Why is Lonquex approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that the studies had shown that Lonquex is effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases. The side effects seen with the medicine were typical for this class of medicines and are considered manageable. The CHMP therefore concluded the benefits of Lonquex outweigh its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Lonquex?

A risk-management plan has been developed to ensure that Lonquex is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lonquex, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets the medicine will carry out a study to further investigate the effects of Lonquex on the patients’ cancer - the possibility of cancer worsening during treatment with G‑CSF medicines was a concern raised during the evaluation of the medicine though this was not established. The company will also provide data on the potential side effects in children under 18 years of age, including the immune reactions.

Other information about Lonquex

The European Commission granted a marketing authorisation valid throughout the European Union for Lonquex on 25 July 2013.

Name Language First published Last updated
Lonquex : EPAR - Summary for the public BG = bălgarski 02/09/2013  
Lonquex : EPAR - Summary for the public ES = español 02/09/2013  
Lonquex : EPAR - Summary for the public CS = čeština 02/09/2013  
Lonquex : EPAR - Summary for the public DA = dansk 02/09/2013  
Lonquex : EPAR - Summary for the public DE = Deutsch 02/09/2013  
Lonquex : EPAR - Summary for the public ET = eesti keel 02/09/2013  
Lonquex : EPAR - Summary for the public EL = elliniká 02/09/2013  
Lonquex : EPAR - Summary for the public EN = English 02/09/2013  
Lonquex : EPAR - Summary for the public FR = français 02/09/2013  
Lonquex : EPAR - Summary for the public IT = italiano 02/09/2013  
Lonquex : EPAR - Summary for the public LV = latviešu valoda 02/09/2013  
Lonquex : EPAR - Summary for the public LT = lietuvių kalba 02/09/2013  
Lonquex : EPAR - Summary for the public HU = magyar 02/09/2013  
Lonquex : EPAR - Summary for the public MT = Malti 02/09/2013  
Lonquex : EPAR - Summary for the public NL = Nederlands 02/09/2013  
Lonquex : EPAR - Summary for the public PL = polski 02/09/2013  
Lonquex : EPAR - Summary for the public PT = português 02/09/2013  
Lonquex : EPAR - Summary for the public RO = română 02/09/2013  
Lonquex : EPAR - Summary for the public SK = slovenčina 02/09/2013  
Lonquex : EPAR - Summary for the public SL = slovenščina 02/09/2013  
Lonquex : EPAR - Summary for the public FI = suomi 02/09/2013  
Lonquex : EPAR - Summary for the public SV = svenska 02/09/2013  
Lonquex : EPAR - Summary for the public HR = Hrvatski 02/09/2013  

This EPAR was last updated on 27/06/2016 .

Authorisation details

Product details

Product details for Lonquex
NameLonquex
Agency product numberEMEA/H/C/002556
Active substance

lipegfilgrastim

International non-proprietary name (INN) or common name

lipegfilgrastim

Therapeutic area Neutropenia
Anatomical therapeutic chemical (ATC) code L03AA14
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Lonquex
Marketing-authorisation holder

Sicor Biotech UAB

Revision9
Date of issue of marketing authorisation valid throughout the European Union25/07/2013

Contact address:

Sicor Biotech UAB
Molėtų pl. 5
LT-08409 Vilnius
Lithuania

Product information

Product information

26/05/2016  Lonquex -EMEA/H/C/002556 -II/0023

Name Language First published Last updated
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016
Lonquex : EPAR - Product Information HR = Hrvatski 02/09/2013 27/06/2016

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
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  
Lonquex : EPAR - All Authorised presentations HR = Hrvatski 02/09/2013  

Pharmacotherapeutic group

Immunostimulants, colony-stimulating factors

Therapeutic indication

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult 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

Name Language First published Last updated
Lonquex : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 16/05/2014 27/06/2016
Lonquex-H-C-2556-P46-0009 : EPAR - Assessment Report HR = Hrvatski 21/12/2015  
Lonquex-H-C-2556-P46 : EPAR - Assessment Report HR = Hrvatski 26/05/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Lonquex : EPAR - Public assessment report HR = Hrvatski 02/09/2013  
CHMP summary of positive opinion for Lonquex HR = Hrvatski 31/05/2013  

Authorised

This medicine is approved for use in the European Union