Kaftrio 75 mg, 50 mg, 100 mg film coated tablets *
Pharmacy Only: Prescription

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 12 January 2022

File name

Kaftrio tablets_PIL IE_1641983840.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Individual PILs superseded by joint PIL

Free text change information supplied by the pharmaceutical company

Addition of new presentation for the 6 to less than 12 years age group to the PIL.

1.What Kaftrio is and what it is used for

  • Update to the indication statement for patients who are 6 years and older.

2. What you need to know before you take Kaftrio

  • Update to header “Children under..” and safety and efficacy statement, that it is not known if Kaftrio is safe and effective in children under the age of 6 years

3. How to take Kaftrio

  • Addition of statement that the doctor will determine the correct dose for the patient.
  • Addition of dose recommendation table with information for the 6yrs and older age group added. The table also includes dosing information related to weight.
  • Statement regarding Kaftrio usually being taken with ivacaftor has been moved so it is above the dose recommendation information/table.

 6. Contents of the pack and other information

  • Minor formatting/header updates related to the new strength of Kaftrio with inclusion of composition and what the Kaftrio 37.5 mg/25 mg/50 mg film‑coated tablets look like.
  • Clarification in the manufacturer’s address that Almac Craigavon is in Northern Ireland within the United Kingdom.

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_SmPC IE_1641983516.pdf

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Minor typographical changes throughout the SmPC and table numbers updated.

1.            NAME OF THE MEDICINAL PRODUCT

Addition of new strength for the 6 to <12yrs age group Kaftrio 37.5mg/25mg/50mg film-coated tablets

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of new strength with composition of Kaftrio given for ivacaftor 37.5mg, tezacaftor 25 mg and elexacaftor 50 mg.

Header added to differentiate both strengths.

3.         PHARMACEUTICAL FORM

Addition of description of tablets for 6 <12 yrs age group.

Header added to differentiate both strengths.

4.1       Therapeutic indications

Indication for Kaftrio in a combination regimen with ivacaftor updated to include patients who are 6 years and older.

4.2          Posology and method of administration

Dose recommendations table added. Information for the 6 to <12 years age group and weights ( <30kg and >30kg) have been included. The dosing information for patients 12 yrs and older is also included in the new table.

Statement below the table regarding the morning and evening dose has been updated to clarify that  both the morning and evening dose should be taken 12 hours apart with fat-containing food.

Statement regarding the safety and efficacy of Kaftrio in combination with ivacaftor has been updated from less than 12 yrs to less than 6 yrs given the indication update.

4.8          Undesirable effects

Clarification statement added above the adverse reactions table (Table 4) that with each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Addition of information related to study 445-106 ( 24-week open label study) in patients aged 6 to less than 12 years, stating that the safety data from this study was consistent with the pivotal study 445-102. In the paediatric populations subsection, data from the study for maximum transaminase (ALT or AST), transaminases elevations and total bilirubin have been clarified.

5.1      Pharmacodynamic properties

Pharmacodynamic effects subsection

Addition of sweat chloride data from study 445-106 for patients aged 6 to less than 12 years who are homozygous for F508del mutation or heterozygous for the F508del mutations and a minimal function mutation.

Clinical efficacy and safety

Addition of data from study 445-106 for the 6 to <12 years patient group including ppFEV1 and table Table 8 for secondary efficacy outcomes (including ppFEV1, CFQ-R Respiratory Domain score, BMI, Weight for age, Height for age, Number of pulmonary exacerbations and Lung Clearance Index).

5.2       Pharmacokinetic properties

Minor updates to Table 9 (Pharmacokinetic parameters). Addition of “SS” to clarify AUC parameter (area under curve) is at “steady state”.

Addition of definition of eGFR as estimated glomerular filtration rate.

Minor updates to age ranges in the paediatric population subsection, including addition of data to Table 10 related to mean elexacaftor (ELX), M23-ELX, tezacaftor(TEZ), M1-TEZ and ivacaftor ( IVA) exposures observed at steady state, by age group and dose administered.

8.         MARKETING AUTHORISATION NUMBER(S)

Addition of marketing authorisation number for new strength (6 to <12 years).

Updated on 12 December 2021

File name

Kaftrio SPC Tablets Ireland_1639333704.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 12 December 2021

File name

Kaftrio PIL Tablets Ireland_1639333578.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 01 December 2021

File name

Kaftrio PIL Ireland_1638378117.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Summary of changes 

  • Section 4 Possible side effects (Serious side effects-Possible signs of liver problems)

 

Updated on 01 December 2021

File name

Kaftrio SPC Ireland_1638377762.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors
  • Other

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

Free text change information supplied by the pharmaceutical company

Summary of changes 

  • Section 4.4 Special warnings and precautions for use (hepatic update)
  • Changes to the references
  • Section 4.8 Undesirable effects (Table 3 Adverse reactions and footnote)
  • Section 4.8 Description of selected adverse reactions (Transaminase elevations)
  • Correction to spelling and typing errors

Updated on 07 May 2021

File name

Ireland Kaftrio Tablets PIL_1620396554.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 07 May 2021

File name

Ireland Kaftrio Tablets SPC_1620396496.pdf

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

File name

Ireland Kaftrio Tablets PIL_1619663445.pdf

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

File name

Ireland Kaftrio Tablets SPC_1619663392.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 4.8 - 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

File name

Kaftrio PIL_Nov2020_IRL_1606475274.pdf

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

File name

Kaftrio SmPC_Aug2020_IRL_1598046032.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

Initial Marketing Authorisation: 21 August 2020

Updated on 21 August 2020

File name

Kaftrio PIL_Aug2020_IRL_1598045944.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Initial Marketing Authorisation: 21 August 2020