Ninlaro

ixazomib

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

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

What is Ninlaro and what is it used for?

Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It is given together with two other medicines, lenalidomide and dexamethasone, to patients who have received at least one prior treatment.

Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Ninlaro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 September 2011.

Ninlaro contains the active substance ixazomib.

How is Ninlaro used?

Ninlaro can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.

Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food. The recommended dose is 4 mg taken once a week (on the same day of the week) for 3 consecutive weeks, followed by a week with no Ninlaro treatment. This 4-week treatment cycle should be continued until the disease gets worse or side effects become unacceptable. Treatment may need to be stopped temporarily or the dose reduced if the patient has certain side effects. The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.

For further information, see the package leaflet.

How does Ninlaro work?

The active substance in Ninlaro, ixazomib, is a proteasome inhibitor. This means that it blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed. When the proteins in the cancer cells are not broken down, including the proteins that control cell growth, the cancer cells are damaged and they eventually die.

What benefits of Ninlaro have been shown in studies?

Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not responded to or had come back after previous treatment. The study compared Ninlaro with placebo (a dummy treatment), both taken together with lenalidomide and dexamethasone. A first analysis of the data indicated that Ninlaro is effective at prolonging the time patients live without their disease getting worse (progression-free survival): patients treated with Ninlaro lived for an average of 21 months without their disease getting worse compared with 15 months in patients given placebo. However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.

What are the risks associated with Ninlaro?

The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and back pain. Similar side effects were seen when lenalidomide and dexamethasone were used without Ninlaro.

For the full list of all side effects and restrictions with Ninlaro, see the package leaflet.

Why is Ninlaro approved?

Data from the main study indicate that Ninlaro improves patients’ progression-free survival. However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine. In addition, Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ninlaro’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Ninlaro has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Ninlaro?

Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.

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

The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.

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

Other information about Ninlaro

The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21 November 2016.

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

The summary of the opinion of the Committee for Orphan Medicinal Products for Ninlaro is available.

Name Language First published Last updated
Ninlaro : EPAR - Summary for the public BG = bălgarski 2016-12-07  
Ninlaro : EPAR - Summary for the public ES = español 2016-12-07  
Ninlaro : EPAR - Summary for the public CS = čeština 2016-12-07  
Ninlaro : EPAR - Summary for the public DA = dansk 2016-12-07  
Ninlaro : EPAR - Summary for the public DE = Deutsch 2016-12-07  
Ninlaro : EPAR - Summary for the public ET = eesti keel 2016-12-07  
Ninlaro : EPAR - Summary for the public EL = elliniká 2016-12-07  
Ninlaro : EPAR - Summary for the public EN = English 2016-12-07  
Ninlaro : EPAR - Summary for the public FR = français 2016-12-07  
Ninlaro : EPAR - Summary for the public IT = italiano 2016-12-07  
Ninlaro : EPAR - Summary for the public LV = latviešu valoda 2016-12-07  
Ninlaro : EPAR - Summary for the public LT = lietuvių kalba 2016-12-07  
Ninlaro : EPAR - Summary for the public HU = magyar 2016-12-07  
Ninlaro : EPAR - Summary for the public MT = Malti 2016-12-07  
Ninlaro : EPAR - Summary for the public NL = Nederlands 2016-12-07  
Ninlaro : EPAR - Summary for the public PL = polski 2016-12-07  
Ninlaro : EPAR - Summary for the public PT = português 2016-12-07  
Ninlaro : EPAR - Summary for the public RO = română 2016-12-07  
Ninlaro : EPAR - Summary for the public SK = slovenčina 2016-12-07  
Ninlaro : EPAR - Summary for the public SL = slovenščina 2016-12-07  
Ninlaro : EPAR - Summary for the public FI = suomi 2016-12-07  
Ninlaro : EPAR - Summary for the public SV = svenska 2016-12-07  
Ninlaro : EPAR - Summary for the public HR = Hrvatski 2016-12-07  

This EPAR was last updated on 16/08/2017 .

Authorisation details

Product details

Product details for Ninlaro
NameNinlaro
Agency product numberEMEA/H/C/003844
Active substance

ixazomib citrate

International non-proprietary name (INN) or common name

ixazomib

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XX50
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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Ninlaro
Marketing-authorisation holder

Takeda Pharma A/S

Revision1
Date of issue of marketing authorisation valid throughout the European Union21/11/2016

Contact address:

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

Product information

06/07/2017  Ninlaro -EMEA/H/C/003844 -II/0002

Name Language First published Last updated
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16
Ninlaro : EPAR - Product Information HR = Hrvatski 2016-12-07 2017-08-16

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
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - All Authorised presentations HR = Hrvatski 2016-12-07  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ninlaro : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-08-16  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  
Ninlaro : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-07  

Initial marketing-authorisation documents

Name Language First published Last updated
Ninlaro : EPAR - Public assessment report HR = Hrvatski 2016-12-07  
CHMP summary of opinion for Ninlaro HR = Hrvatski 2016-09-16  
Questions and answers on refusal of the marketing authorisation for Ninlaro HR = Hrvatski 2016-05-27 2016-06-28