Kaftrio 75 mg, 50 mg, 100 mg film coated tablets

  • Name:

    Kaftrio 75 mg, 50 mg, 100 mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Ivacaftor, Tezacaftor, Elexacaftor

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/21

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Summary of Product Characteristics last updated on medicines.ie: 7/5/2021
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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Vertex Pharmaceuticals (Ireland) Limited

Vertex Pharmaceuticals (Europe) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Kaftrio 75 mg, 50 mg, 100 mg film coated tablets Active Ingredients Ivacaftor, Tezacaftor, Elexacaftor
Medicine Name Kalydeco 25mg, 50mg and 75mg granules sachets Active Ingredients Ivacaftor
Medicine Name Kalydeco 75 mg and 150 mg film-coated tablets Active Ingredients Ivacaftor
Medicine Name Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets Active Ingredients Ivacaftor, Lumacaftor
Medicine Name Symkevi 100 mg/150 mg film coated tablets and 50 mg/ 75 mg film coated tablets Active Ingredients Ivacaftor, Tezacaftor
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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 7 May 2021 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 7 May 2021 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 29 April 2021 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Free text change information supplied by the pharmaceutical company

Section 1: What Kaftrio is and what is it used for

Indication changed to: Kaftrio taken with ivacaftor is for patients aged 12 years and older who have CF, with at least one F508del mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene.”

Updated on 29 April 2021 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 4.8 - 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

4.1 Therapeutic Indications

Updated indication to “Kaftrio is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulatory (CFTR) gene.”

4.2 Posology and method of administration

Updated to match indication

Section 4.4 Special warnings and precautions for use: Elderly Population

Updated information to indicate studies did not include patients over 65 years old

Section 4.8: Undesirable effects: Summary of safety profile

Updated with study 445-104

Section 4.8: Undesirable effects: Paediatric population

Updated number of patients in safety data

5.1: Pharmacodynamic properties

Updated to include information on non-F508del CFTR variants

5.1: Pharmacodynamic properties- Effects on sweat chloride

Added Study 445-104 information and data

5.1: Pharmacodynamic properties- Clinical efficacy and safety

Added efficacy data for patients homozygous for F508del mutation or heterozygous for F508del mutation and a mutation with MF, a gating defect, or residual CFTR activity on the second allele

Study 445-104 added

Table 6: Primary and secondary efficacy analyses, full analysis set (study 445-104) added

Updated on 27 November 2020 PIL

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Update to include local representative details for MAH holder in the PIL.

Updated on 21 August 2020 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

Initial Marketing Authorisation: 21 August 2020

Updated on 21 August 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Initial Marketing Authorisation: 21 August 2020