Portrazza 800 mg concentrate for solution for infusion

  • Name:

    Portrazza 800 mg concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Necitumumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/12/16

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Summary of Product Characteristics last updated on medicines.ie: 12/12/2016
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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.

Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

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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 13 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 13 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 December 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 2, Qualitative and quantitative composition, sodium content is corrected to 76 mg

In Section 4.4, Special warnings and precautions for use, the following text is added -

 

Infections

In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first­‑line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.  A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first‑line therapy in patients with advanced non‑squamous NSCLC.

 

Special attention should be given to patients with clinical evidence of concomitant infectious conditions including early signs of active infections.  Treatment of any infection should be initiated according to local standards.

In Section 5, Pharmacodynamic properties, the following text is added -

In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.  The overall survival hazard ratio [HR] was 0.83 [0.55, 1.52].


In Section 10, The date of revision of the text is updated to 10 November 2016

Updated on 12 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 31 May 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 25 May 2016 PIL

Reasons for updating

  • New PIL for new product