Zurampic

lesinurad

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This is a summary of the European public assessment report (EPAR) for Zurampic. 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 Zurampic.

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

What is Zurampic and what is it used for?

Zurampic is a medicine used in adults with gout to reduce high levels of uric acid in the blood. It is used in combination with a xanthine oxidase inhibitor, another type of gout medicine, when the xanthine oxidase inhibitor on its own is not able to control uric acid levels sufficiently.

Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.

Zurampic contains the active substance lesinurad.

How is Zurampic used?

Zurampic is available as 200-mg tablets. The recommended dose is 200 mg once daily, taken in the morning at the same time as a xanthine oxidase inhibitor medicine such as allopurinol or febuxostat.

Patients should drink plenty of fluids throughout the day. If treatment with the xanthine oxidase inhibitor is interrupted, then treatment with Zurampic must also be interrupted at the same time.

The medicine can only be obtained with a prescription.

How does Zurampic work?

The active substance in Zurampic, lesinurad, helps to remove uric acid from the body. It does this by blocking a protein called ‘uric acid transporter-1’ (URAT1) in the kidneys. URAT1 normally allows some uric acid to return to the blood after the kidneys have filtered it out. By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.

Zurampic is used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat. Xanthine oxidase inhibitors reduce the production of uric acid in the body. Thus, adding Zurampic to treatment with a xanthine oxidase inhibitor lowers uric acid levels further. This prevents the build-up of uric acid in joints where it can cause pain, swelling and joint damage.

What benefits of Zurampic have been shown in studies?

Zurampic was studied in two main studies involving over 1,200 adults with gout who were previously treated with allopurinol. Their blood level of uric acid was not sufficiently controlled with allopurinol alone and was above 60 mg/litre at the start of the study. These studies compared the effect of adding Zurampic or placebo (a dummy treatment) to patients’ allopurinol treatment. The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 60 mg/litre after 6 months of treatment. Adding Zurampic 200 mg once daily was effective in 55% (222 of 405) patients. This compared with 26% (104 of 407) in patients who took placebo in addition to allopurinol.

A third main study involved 324 adults who had at least one measurable tophus (large deposit of uric acid in or around a joint or under the skin) and with high blood levels of uric acid (over 80 mg/litre without gout medicines or above 60 mg/litre despite treatment with allopurinol or febuxostat). Patients were first treated with febuxostat alone for three weeks and then with febuxostat plus either Zurampic or placebo. The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 50 mg/litre after 6 months of treatment. Overall, Zurampic 200 mg once daily was effective in 57% (60 of 106) patients. This compared with 47% (51 of 109) patients given placebo. Looking just at patients whose blood uric acid level did not fall sufficiently on treatment with febuxostat alone, the level dropped to less than 50 mg/litre in 44% (26 of 59) patients taking Zurampic compared to 24% (12 of 51) patients taking placebo.

What are the risks associated with Zurampic?

The most common side effects with Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastro-oesophageal reflux disease) stomach acid coming back to the mouth, and blood tests showing increased blood creatinine levels (a marker of kidney function). The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100. For the full list of all side effects reported with Zurampic, see the package leaflet.

Patients must not take Zurampic if they suffer from tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or a rare hereditary disease called Lesch-Nyhan syndrome, both of which raise uric acid levels in the blood. Patients with very poor kidney function or who have had a kidney transplant must also not take Zurampic. For the full list of restrictions, see the package leaflet.

Why is Zurampic approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zurampic’s benefits are greater than its risks and recommended that it be approved for use in the EU. Combined with a xanthine oxidase inhibitor, Zurampic reduced blood levels of uric acid in patients with gout whose high uric acid levels were not sufficiently controlled by a xanthine oxidase inhibitor. Over time, visible deposits of uric acid disappeared in increasing number of patients continuing Zurampic and febuxostat treatment, and fewer patients had recurrence of gout attacks. Risks such as kidney damage or heart problems are addressed in the product information.

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

The patient’s kidney function will be monitored regularly during treatment with Zurampic and the doctor will advise the patient to take sufficient fluid during the day and always take Zurampic with either allopurinol or febuxostat, which helps to prevent kidney damage from Zurampic.

A risk management plan has been developed to ensure that Zurampic 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 Zurampic, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that markets Zurampic will carry out a study on the risk of heart, circulation or kidney disorders in patients treated with Zurampic, particularly in those who have previously suffered from such disorders. This is because these disorders have occurred during treatment with Zurampic.

Further information can be found in the summary of the risk management plan.

Other information about Zurampic

The European Commission granted a marketing authorisation valid throughout the European Union for Zurampic on 18 February 2016.

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

Name Language First published Last updated
Zurampic : EPAR - Summary for the public BG = bălgarski 2016-03-09  
Zurampic : EPAR - Summary for the public ES = español 2016-03-09  
Zurampic : EPAR - Summary for the public CS = čeština 2016-03-09  
Zurampic : EPAR - Summary for the public DA = dansk 2016-03-09  
Zurampic : EPAR - Summary for the public DE = Deutsch 2016-03-09  
Zurampic : EPAR - Summary for the public ET = eesti keel 2016-03-09  
Zurampic : EPAR - Summary for the public EL = elliniká 2016-03-09  
Zurampic : EPAR - Summary for the public EN = English 2016-03-09  
Zurampic : EPAR - Summary for the public FR = français 2016-03-09  
Zurampic : EPAR - Summary for the public IT = italiano 2016-03-09  
Zurampic : EPAR - Summary for the public LV = latviešu valoda 2016-03-09  
Zurampic : EPAR - Summary for the public LT = lietuvių kalba 2016-03-09  
Zurampic : EPAR - Summary for the public HU = magyar 2016-03-09  
Zurampic : EPAR - Summary for the public MT = Malti 2016-03-09  
Zurampic : EPAR - Summary for the public NL = Nederlands 2016-03-09  
Zurampic : EPAR - Summary for the public PL = polski 2016-03-09  
Zurampic : EPAR - Summary for the public PT = português 2016-03-09  
Zurampic : EPAR - Summary for the public RO = română 2016-03-09  
Zurampic : EPAR - Summary for the public SK = slovenčina 2016-03-09  
Zurampic : EPAR - Summary for the public SL = slovenščina 2016-03-09  
Zurampic : EPAR - Summary for the public FI = suomi 2016-03-09  
Zurampic : EPAR - Summary for the public SV = svenska 2016-03-09  
Zurampic : EPAR - Summary for the public HR = Hrvatski 2016-03-09  
Name Language First published Last updated
Zurampic : EPAR - Risk-management-plan summary (English only) 2016-03-09  

This EPAR was last updated on 02/05/2017 .

Authorisation details

Product details

Product details for Zurampic
NameZurampic
Agency product numberEMEA/H/C/003932
Active substance

lesinurad

International non-proprietary name (INN) or common name

lesinurad

Therapeutic area Hyperuricemia
Anatomical therapeutic chemical (ATC) code M04AB05
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 Zurampic
Marketing-authorisation holder

Grünenthal GmbH

Revision2
Date of issue of marketing authorisation valid throughout the European Union18/02/2016

Contact address:

Grünenthal GmbH
Zieglerstr. 6
D-52078Aachen
Germany

Product information

Product information

09/03/2017  Zurampic -EMEA/H/C/003932 -IAIN/0005/G

Name Language First published Last updated
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02
Zurampic : EPAR - Product Information EN = English 2016-03-09 2017-05-02

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
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  
Zurampic : EPAR - All Authorised presentations EN = English 2016-03-09  

Pharmacotherapeutic group

Antigout preparations

Therapeutic indication

Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zurampic : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-09-02 2017-05-02

Initial marketing-authorisation documents

Name Language First published Last updated
Zurampic : EPAR - Public assessment report EN = English 2016-03-09  
CHMP summary of opinion for Zurampic EN = English 2015-12-18  

Authorised

This medicine is approved for use in the European Union

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