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Alunbrig

  • Name:

    Alunbrig

  • Company:
    info
  • Active Ingredients:

    Brigatinib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/21

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Summary of Product Characteristics last updated on medicines.ie: 18/2/2021
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.

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Alunbrig Active Ingredients Brigatinib
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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 18 February 2021 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Section 7: MAH Address Update

Updated on 18 February 2021 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 October 2020 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3 Shelf Life - Extension of shelf-life of finished product from 2 years to 3 years for 90 and 180 mg film-coated tablets

Updated on 21 August 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 20 April 2020 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

The following changes have been made to the SmPC: 

Section

Changes

4.1 Therapeutic indications

 

New frontline indication added:

Addition of the Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

4.2 Posology and method of administration

Table 2 Elevation of CPK adverse reaction amended

 

4.4 Special warnings and precautions for use

Creatine phosphokinase (CPK) elevation subsection amended

 

4.5 Interaction with other medicinal products and other forms of interaction
  • Removal of mibefradil from CYP3A inhibitors subsection
  • Amendment to wording in CYP3A substrates subsection

 

4.8 Undesirable effects

The following subsections have been updated:

  • Summary of the safety profile
  • Tabulated list of adverse reactions including Table 2
  • Pulmonay adverse reactions
  • Elderly
  • Hypertension
  • Bradycardia
  • Visual disturbance
  • Peripheral neuropathy
  • Creatine phosphokinase (CPK) elevation
  • Elevations of pancreatic enzymes
  • Elevation of hepatic enzymes
  • Hyperglycaemia
  • Reporting of suspected adverse reactions

5.1 Pharmacodynamic properties

Addition of ALTA 1L clinical trial data

 

5.2 Pharmacokinetic properties

The following subsections have been updated:

  • Distribution
  • Elimination

10. date of the revision of the text

1 April 2020

Updated on 20 April 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 26 March 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 January 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 January 2019 SPC

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

08.01.2019 = Two variations were approved on 18th December for Alunbrig -  to add a 28 tablet pack size for 30 mg strength and to add the starter pack