Kaftrio 37.5 mg/25 mg/50 mg film coated tablets and 75 mg/50 mg/100 mg film coated tablets

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Updated on 16 April 2025

File name

Kaftrio Tablets_April2025.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to section 4 to add

HPRA Pharmacovigilance

Website: www.hpra.ie,

Change to section 6 to 04/2025

Updated on 10 April 2025

File name

emea-TABLETS-SmPC-en-IRL.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 02 April 2025

File name

emea - Tablets - SmPC - en- IRL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to 4.4    Special warnings and precautions for use - Rash events

Rash events typically occur during the first month of therapy. Most events were mild to moderate in severity and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment. Children have a higher incidence rate compared to adults. The incidence of rash events was also higher in females compared to males, particularly in females taking hormonal contraceptives (see section 4.8). A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with IVA/TEZ/ELX in combination with IVA and hormonal contraceptives should be considered. Following the resolution of rash, it should be considered if resuming IVA/TEZ/ELX in combination with IVA without hormonal contraceptives is appropriate. If rash does not recur, resumption of hormonal contraceptives can be considered (see section 4.8).

Update to 4.6    Fertility, pregnancy and lactation - Breast-feeding

Limited data show that ELX, TEZ, and IVA are excreted in human milk and have been quantified in plasma of breastfed newborns/infants of treated women. There is insufficient information on the effects of IVA/TEZ/ELX in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IVA/TEZ/ELX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 

Update to 4.8    Undesirable effects Table 4 Adverse reactions

Immune system disorders - Hypersensitivity - not known

Rash events

Studies in IVA/TEZ/ELX-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo‑treated patients. The paediatric population showed a higher incidence rate (see section Paediatric population for further details). The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in IVA/TEZ/ELX-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with IVA/TEZ/ELX, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive (see section 4.4).

Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment.

Rash

While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males. 

Updated on 02 April 2025

File name

emea - Tablets - SmPC - en- IRL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to 4.4    Special warnings and precautions for use - Rash events

Rash events typically occur during the first month of therapy. Most events were mild to moderate in severity and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment. Children have a higher incidence rate compared to adults. The incidence of rash events was also higher in females compared to males, particularly in females taking hormonal contraceptives (see section 4.8). A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with IVA/TEZ/ELX in combination with IVA and hormonal contraceptives should be considered. Following the resolution of rash, it should be considered if resuming IVA/TEZ/ELX in combination with IVA without hormonal contraceptives is appropriate. If rash does not recur, resumption of hormonal contraceptives can be considered (see section 4.8).

Update to 4.6    Fertility, pregnancy and lactation - Breast-feeding

Limited data show that ELX, TEZ, and IVA are excreted in human milk and have been quantified in plasma of breastfed newborns/infants of treated women. There is insufficient information on the effects of IVA/TEZ/ELX in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IVA/TEZ/ELX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 

Update to 4.8    Undesirable effects Table 4 Adverse reactions

Immune system disorders - Hypersensitivity - not known

Rash events

Studies in IVA/TEZ/ELX-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo‑treated patients. The paediatric population showed a higher incidence rate (see section Paediatric population for further details). The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in IVA/TEZ/ELX-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with IVA/TEZ/ELX, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive (see section 4.4).

Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment.

Rash

While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males. 

Updated on 02 April 2025

File name

emea - Tablets - SmPC - en- IRL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to 4.4    Special warnings and precautions for use - Rash events

Rash events typically occur during the first month of therapy. Most events were mild to moderate in severity and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment. Children have a higher incidence rate compared to adults. The incidence of rash events was also higher in females compared to males, particularly in females taking hormonal contraceptives (see section 4.8). A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with IVA/TEZ/ELX in combination with IVA and hormonal contraceptives should be considered. Following the resolution of rash, it should be considered if resuming IVA/TEZ/ELX in combination with IVA without hormonal contraceptives is appropriate. If rash does not recur, resumption of hormonal contraceptives can be considered (see section 4.8).


Update to 4.6    Fertility, pregnancy and lactation - Breast-feeding

Limited data show that ELX, TEZ, and IVA are excreted in human milk and have been quantified in plasma of breastfed newborns/infants of treated women. There is insufficient information on the effects of IVA/TEZ/ELX in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IVA/TEZ/ELX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 


Update to 4.8    Undesirable effects Table 4 Adverse reactions

Immune system disorders - Hypersensitivity - not known

Rash events

Studies in IVA/TEZ/ELX-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo‑treated patients. The paediatric population showed a higher incidence rate (see section Paediatric population for further details). The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in IVA/TEZ/ELX-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with IVA/TEZ/ELX, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive (see section 4.4).


Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment.

Rash

While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males. 

Updated on 02 April 2025

File name

emea - Tablets - SmPC - en- IRL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to 4.4    Special warnings and precautions for use - Rash events

Rash events typically occur during the first month of therapy. Most events were mild to moderate in severity and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment. Children have a higher incidence rate compared to adults. The incidence of rash events was also higher in females compared to males, particularly in females taking hormonal contraceptives (see section 4.8). A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with IVA/TEZ/ELX in combination with IVA and hormonal contraceptives should be considered. Following the resolution of rash, it should be considered if resuming IVA/TEZ/ELX in combination with IVA without hormonal contraceptives is appropriate. If rash does not recur, resumption of hormonal contraceptives can be considered (see section 4.8).


Update to 4.6    Fertility, pregnancy and lactation - Breast-feeding

Limited data show that ELX, TEZ, and IVA are excreted in human milk and have been quantified in plasma of breastfed newborns/infants of treated women. There is insufficient information on the effects of IVA/TEZ/ELX in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IVA/TEZ/ELX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 


Update to 4.8    Undesirable effects Table 4 Adverse reactions

Immune system disorders - Hypersensitivity - not known

Rash events

Studies in IVA/TEZ/ELX-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo‑treated patients. The paediatric population showed a higher incidence rate (see section Paediatric population for further details). The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in IVA/TEZ/ELX-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with IVA/TEZ/ELX, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive (see section 4.4).


Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment.

Rash

While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males. 

Updated on 02 April 2025

File name

emea - Tablets - SmPC - en- IRL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to 4.4    Special warnings and precautions for use - Rash events

Rash events typically occur during the first month of therapy. Most events were mild to moderate in severity and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment. Children have a higher incidence rate compared to adults. The incidence of rash events was also higher in females compared to males, particularly in females taking hormonal contraceptives (see section 4.8). A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with IVA/TEZ/ELX in combination with IVA and hormonal contraceptives should be considered. Following the resolution of rash, it should be considered if resuming IVA/TEZ/ELX in combination with IVA without hormonal contraceptives is appropriate. If rash does not recur, resumption of hormonal contraceptives can be considered (see section 4.8).


Update to 4.6    Fertility, pregnancy and lactation - Breast-feeding

Limited data show that ELX, TEZ, and IVA are excreted in human milk and have been quantified in plasma of breastfed newborns/infants of treated women. There is insufficient information on the effects of IVA/TEZ/ELX in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IVA/TEZ/ELX therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 


Update to 4.8    Undesirable effects Table 4 Adverse reactions

Immune system disorders - Hypersensitivity - not known

Rash events

Studies in IVA/TEZ/ELX-treated patients above 12 years of age showed an incidence of rash events (e.g., rash, rash pruritic) of 10.9% (study 445-102) compared to 6.5% in placebo‑treated patients. The paediatric population showed a higher incidence rate (see section Paediatric population for further details). The incidence of rash events by patient sex was 5.8% in males and 16.3% in females in IVA/TEZ/ELX-treated patients and 4.8% in males and 8.3% in females in placebo-treated patients. In patients treated with IVA/TEZ/ELX, the incidence of rash events was 20.5% in females taking hormonal contraceptive and 13.6% in females not taking hormonal contraceptive (see section 4.4).


Overall, rash events typically occur during the first month of therapy. Most events were mild to moderate in severity, and in rare cases, rash was associated with additional symptoms such as fever or facial swelling. In the majority of cases, administration of IVA/TEZ/ELX was continued and the rash resolved without treatment.

Rash

While studies in patients above 12 years of age showed an incidence rate of 10.9% (study 445-102), patients between 6 and 11 years of age had an incidence rate of 24.2% (study 445-106). During study 445-111 in patients aged 2 to less than 6 years, 15 (20.0%) subjects had at least 1 rash event, 4 (9.8%) females and 11 (32.4%) males. 

Updated on 02 April 2025

File name

emea - Tablets - PIL - en- IRL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to information about pregnancy or lactation

Free text change information supplied by the pharmaceutical company

Update to Breast-feeding: Ivacaftor, tezacaftor, and elexacaftor have been detected in breastfed babies. Your doctor will consider the benefit of breast-feeding for your baby and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.


Update to Possible side effects to add - Rash (more common in children, and in women compared to men) and Allergic reactions (hypersensitivity)

Updated on 02 April 2025

File name

emea - Tablets - PIL - en- IRL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to information about pregnancy or lactation

Free text change information supplied by the pharmaceutical company

Update to Breast-feeding: Ivacaftor, tezacaftor, and elexacaftor have been detected in breastfed babies. Your doctor will consider the benefit of breast-feeding for your baby and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.


Update to Possible side effects to add - Rash (more common in children, and in women compared to men) and Allergic reactions (hypersensitivity)

Updated on 21 November 2024

File name

Kaftrio Tablets PIL.pdf

Reasons for updating

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

Updated on 03 May 2024

File name

Kaftrio SPC Tablets Ireland 30Apr24.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)

Updated on 03 May 2024

File name

Kaftrio PIL Tablets Ireland 30Apr24.pdf

Reasons for updating

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

Updated on 14 March 2024

File name

Kaftrio EU Tablets Ireland SPC 16Feb2024.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 14 March 2024

File name

Kaftrio EU Tablets Ireland PIL 19Feb2024.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 04 December 2023

File name

Kaftrio EU Tablets Ireland SPC 22Nov23.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Updated on 04 December 2023

File name

Kaftrio EU Tablets Ireland PIL 22Nov23.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 July 2023

File name

Kaftrio SPC Tablets Ireland-July 2023.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)

Updated on 20 July 2023

File name

Kaftrio PIL Tablets Ireland-July 2023.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 25 January 2023

File name

Kaftrio SmPC_Jan2023_IRL.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container

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

Updated on 09 December 2022

File name

Kaftrio SmPC_Sep2022_IRL.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 09 December 2022

File name

Kaftrio SmPC_Aug2022_IRL.pdf

Reasons for updating

  • 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

  • In 4.8 under "Undesirable effects", added study 445-116 bullet
  • In 5.1, added new study 445-116 paragraph under "Pharmacodynamic effects", "Clinical efficacy and safety", and "Paediatric population"

Updated on 09 March 2022

File name

Kaftrio SPC - Ireland.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Update to change shelf-life for the Kaftrio 75 mg/50 mg/100 mg Tablets from 2 years to 3 years

Updated on 12 January 2022

File name

Kaftrio tablets_PIL IE.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_PIL IE.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_PIL IE.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Patient information leaflet including newly added strength Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets and Kaftrio 75 mg/50 mg/100mg film-coated tablets.

Updated on 12 January 2022

File name

Kaftrio tablets_6yr and 12 yrs_SmPC IE.pdf

Reasons for updating

  • New SPC for new product

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

Vertex Pharmaceuticals (Ireland) Limited

Vertex Pharmaceuticals (Ireland) Limited