NINLARO 2.3 mg, 3 mg, 4 mg hard capsules

  • Name:

    NINLARO 2.3 mg, 3 mg, 4 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Ixazomib Citrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/19

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Summary of Product Characteristics last updated on medicines.ie: 25/9/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 September 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 25 September 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC and labels – not affected

PIL –

  • section 6 – addition of Takeda Ireland Limited Grange Castle address.
  • Section 6 – date of revision

Updated on 28 September 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 September 2018 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Marketing authorisation renewal
  • Change of the word Ninlaro to Ixazomib throughout the SmPC document
  • Update to revision date of SmPC

Updated on 9 October 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

10. DATE OF THE REVISION OF THE TEXT

18 September 2017


Other formating changes also included

Updated on 9 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 October 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 9 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

4.8          Undesirable effects

 

Inclusion of pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).

 

AND

 

The frequency of the following adverse reactions has been reclassified:

Herpes zoster – common (≥ 1/100 to < 1/10)

Vomiting - uncommon (≥ 1/1,000 to < 1/100).

 

Updates to the paragraphs relating to thrombocytopenia, rash, peripheral neuropathy, eye disorders, other adverse reactions.

5.1       Pharmacodynamic properties

 

A randomized, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria. Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%). At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the NINLARO regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60). At the final analysis for OS at a median follow up of 19.8 months, OS was improved for patients treated in the ixazomib regimen compared with placebo the median OS was improved by 10 months (25.8 months in the NINLARO regimen and 15.8 months in the placebo regimen [p-value=0.0014, HR=0.42, 95% CI: 0.242, 0.726 ]).

 

10.      DATE OF REVISION OF THE TEXT

 

6 July 2017

 

Updated on 4 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2017 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided