Zejula

niraparib

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

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

What is Zejula and what is it used for?

Zejula is a cancer medicine used in adult women with a type of advanced cancer of the ovary called ‘high grade serous epithelial ovarian cancer’, including cancer of the fallopian tubes (the tubes connecting the ovaries to the uterus) and cancer of the peritoneum (the membrane lining the abdomen).

Zejula is used on its own for the ‘maintenance’ treatment of patients who have relapsed disease (when the cancer comes back after previous treatment). The medicine is given after treatment with platinum-based medicines, when the tumour is diminishing in size or has completely disappeared.

Because the number of patients with ovarian cancer is low, the disease is considered ‘rare’, and Zejula was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 August 2010.

Zejula contains the active substance niraparib.

How is Zejula used?

Zejula is available as capsules (100 mg) to be taken by mouth. The dose is 3 capsules per day, taken together at the same time each day. Treatment should continue until the disease gets worse. Treatment may be interrupted and the dose may be reduced in patients who experience side effects.

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer medicines.

For further information, see the package leaflet.

How does Zejula work?

The active substance in Zejula, niraparib, blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. By blocking PARP enzymes, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

What benefits of Zejula have been shown in studies?

Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients. Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers. Patients had undergone treatment with two or more platinum-based therapies, with a lasting response (the cancer had not progressed for at least 6 months) before the last platinum-based therapy.

Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).

What are the risks associated with Zejula?

The most common side effects with Zejula (which may affect more than 1 in 10 people) are nausea (feeling sick), thrombocytopenia (low blood platelet counts), tiredness and weakness, anaemia (low red blood cell counts), constipation, vomiting, abdominal (belly) pain, neutropenia (low levels of neutrophils, a type of white blood cell), insomnia (difficulty sleeping), headache, lack of appetite, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dyspnoea (difficulty breathing), hypertension (high blood pressure), dyspepsia (heartburn), back pain, dizziness, cough, urinary tract infection (infection of the structures that carry urine), joint pain, palpitations and dysgeusia (taste disturbances). Serious side effects include thrombocytopenia and anaemia. For the full list of all side effects reported with Zejula, see the package leaflet.

Zejula must not be used in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

Why is Zejula approved?

Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again. Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies. This may allow the next cycle of platinum-based therapy to be delayed. Regarding safety, side effects are generally manageable with dose reductions.

The European Medicines Agency therefore decided that Zejula’s benefits are greater than 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 Zejula?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zejula have been included in the summary of product characteristics and the package leaflet.

Other information about Zejula

The European Commission granted a marketing authorisation valid throughout the European Union for Zejula on 16 November 2017.

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

Name Language First published Last updated
Zejula : EPAR - Summary for the public BG = bălgarski 2017-11-27  
Zejula : EPAR - Summary for the public ES = español 2017-11-27  
Zejula : EPAR - Summary for the public CS = čeština 2017-11-27  
Zejula : EPAR - Summary for the public DA = dansk 2017-11-27  
Zejula : EPAR - Summary for the public DE = Deutsch 2017-11-27  
Zejula : EPAR - Summary for the public ET = eesti keel 2017-11-27  
Zejula : EPAR - Summary for the public EL = elliniká 2017-11-27  
Zejula : EPAR - Summary for the public EN = English 2017-11-27  
Zejula : EPAR - Summary for the public FR = français 2017-11-27  
Zejula : EPAR - Summary for the public IT = italiano 2017-11-27  
Zejula : EPAR - Summary for the public LV = latviešu valoda 2017-11-27  
Zejula : EPAR - Summary for the public LT = lietuvių kalba 2017-11-27  
Zejula : EPAR - Summary for the public HU = magyar 2017-11-27  
Zejula : EPAR - Summary for the public MT = Malti 2017-11-27  
Zejula : EPAR - Summary for the public NL = Nederlands 2017-11-27  
Zejula : EPAR - Summary for the public PL = polski 2017-11-27  
Zejula : EPAR - Summary for the public PT = português 2017-11-27  
Zejula : EPAR - Summary for the public RO = română 2017-11-27  
Zejula : EPAR - Summary for the public SK = slovenčina 2017-11-27  
Zejula : EPAR - Summary for the public SL = slovenščina 2017-11-27  
Zejula : EPAR - Summary for the public FI = suomi 2017-11-27  
Zejula : EPAR - Summary for the public SV = svenska 2017-11-27  
Zejula : EPAR - Summary for the public HR = Hrvatski 2017-11-27  

This EPAR was last updated on 11/12/2017 .

Authorisation details

Product details

Product details for Zejula
NameZejula
Agency product numberEMEA/H/C/004249
Active substance

niraparib tosylate monohydrate

International non-proprietary name (INN) or common name

niraparib

Therapeutic area Fallopian Tube NeoplasmsOvarian NeoplasmsPeritoneal Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Zejula
Marketing-authorisation holder

Tesaro UK Limited

Revision1
Date of issue of marketing authorisation valid throughout the European Union16/11/2017

Contact address:

Tesaro UK Limited
55 Baker Street
London W1U 7EU
United Kingdom

Product information

Product information

14/09/2017  Zejula -EMEA/H/C/004249

Name Language First published Last updated
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  
Zejula : EPAR - Product Information HR = Hrvatski 2017-11-27  

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
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  
Zejula : EPAR - All Authorised presentations HR = Hrvatski 2017-11-27  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Zejula : EPAR - Public assessment report HR = Hrvatski 2017-11-27  
CHMP summary of positive opinion for Zejula HR = Hrvatski 2017-09-15  

Authorised

This medicine is approved for use in the European Union

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