Alunbrig *
Pharmacy Only: Prescription

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 10 May 2022

File name

627a668b1c43f.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Minor correction of 2 errors in Table 4. Efficacy results in ALTA IL (ITT population)

Updated on 24 February 2022

File name

Alunbrig SmPC Ireland 17.02.2022_1645695934.pdf

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.1 updated with the ALTA-1L trial final efficacy data

Section 10 date of revision amended to 17 Feb 2022

Updated on 31 January 2022

File name

Alunbrig SmPC Ireland 27.01.2022_1643630884.pdf

Reasons for updating

  • 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 5.1 - Pharmacodynamic 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

Section 4.4 wording added for dose modifications of brigatinib if concomitant use of moderate CYP3A inducers cannot be avoided. Addition of sodium section.
Section 4.5 wording added for dose modifications of brigatinib if concomitant use of moderate CYP3A inducers cannot be avoided. Data also added into the CYP3A substrates section for midazolam.
Section 5.1 ATC code changed to L01ED04
Section 10 Date revised to 27 January 2022

Updated on 31 January 2022

File name

Alunbrig PIL Ireland Jan 2022_1643630817.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 2 Warnings and precautions - wording added for sodium.
Section 6 Marketing authorisation holder - Contact details amended for several countries including Ireland

Updated on 17 January 2022

File name

Alunbrig SmPC IRE 13.01.2022_1642431553.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4 Special warning and precautions for use: addition photosensitivity and photodermatosis wording

Section 4.8 Undesirable effects: Table 3 clarifying footnotes updated to include a footnote for photosensitivity reaction. New adverse reaction section added for photosensitivity and photodermatosis

Updated on 17 January 2022

File name

Alunbrig PIL Ireland Jan 2022_1642431367.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 February 2021

File name

Alunbrig SmPC IRE 15.09.2020_1613641338.pdf

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

File name

Alunbrig PIL IRE 11.12.2020_1613641280.pdf

Reasons for updating

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

Updated on 20 October 2020

File name

Alunbrig SmPC IRE 06.07.2020_1603204973.pdf

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

EDM Updated on 21 August 2020

File name

Alunbrig Patient Alert Card Ireland_1598023446.pdf

Reasons for updating

  • Add New Doc

Updated on 20 April 2020

File name

Alunbrig SmPC IRE 01.04.2020_1587393492.pdf

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

File name

Alunbrig PIL IRE 01.04.2020_1587393290.pdf

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

File name

Brigatinib PIL IRE 18.12.2018_1546957654.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 08 January 2019

File name

Brigatinib PIL IRE 18.12.2018_1546957654.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 January 2019

File name

Brigatinib SmPC IRE 18.12.2018_1546957607.pdf

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