Kalydeco 25mg, 50mg and 75mg granules sachets

  • Name:

    Kalydeco 25mg, 50mg and 75mg granules sachets

  • Company:
    info
  • Active Ingredients:

    Ivacaftor

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/11/20

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Summary of Product Characteristics last updated on medicines.ie: 16/11/2020

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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 150 mg film-coated tablets Active Ingredients Ivacaftor
Medicine Name Kalydeco 25mg, 50mg and 75mg granules sachets 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 Active Ingredients Tezacaftor 100mg, Ivacaftor 150mg
1 - 0 of 6 items.Total: Infinity pages

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 16 November 2020

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Minor typographical changes throughout the SmPC and spelling correction.

4.1. Therapeutic indications

Updated indication to state that Kalydeco granules are indicated for the treatment of patients aged at least 4 months.

4.2          Posology and method of administration

Update to dosing recommendations table (Table 1) to add information for patients 4 months to less than 6 months, which is 25 mg granules taken orally every 12 hours with fait-containing food, for patients weighing at least 5kgs, with a total daily dose of 50 mg.

Update to subsection on concomitant use of CYP3A inhibitors to amend the dose recommendation for use with moderate and strong CYP3A inhibitors to patients aged 6 months and older.

Additional information added to state that treatment with ivacaftor is not recommended when co-administered with moderate or strong inhibitors of CYP3A in patients aged 4 months to less than 6 months of age.

Text added:Due to the variability in maturation of the cytochrome (CYP) enzymes involved in ivacaftor metabolism, treatment with ivacaftor is not recommended when co-administered with moderate or strong inhibitors of CYP3A in patients aged 4 months to less than 6 months, unless the benefits outweigh the risks. In such cases, the recommended dose is one packet of 25 mg granules twice weekly or less frequently (see sections 4.4 and 4.5). Dosing intervals should be modified according to clinical response and tolerability (see sections 4.4 and 5.2)

Update to the dose adjustment section for hepatically impaired to amend the dose recommendation for use with mild and moderate impairment to patients aged 6 months and older. Also the age of 6 months have been added to state there is no experience of the use of ivacaftor in patients with severe hepatic impairment (Child-Pugh class C).

Seville oranges removed from method of administration section and food or drink to be avoided during treatment.

​​​​​​​4.5 Interaction with other medicinal products and other forms of interaction

Removed Seville oranges as a food to be avoided during treatment with ivacaftor in the CYP3A inhibitors subsection.

4.8 Undesirable effects

Adverse events table header (Table 2) amended to patients 4 months and older.

Addition of the patient cohort information for patients between 4 months to less than 6 months of age who were studied as part of the paediatric population.

Amended the safety profile sentence in the paediatric population section to confirm the safety profile is generally consistent among paediatric patients aged 4 months and older.

Table 3 amended to add transaminase elevations data in patients 4 to less than 6 months of age.

​​​​​​​​​​​​​​5.1 Pharmacodynamic properties

Updated figures for mean absolute change from baseline in sweat chloride in study 8 and addition of the 4 months to less than 6 months age cohort data for study 8.

Table 7 and summary of data updated to include data for patients 4 months to less than 6 months. Patient numbers figure amended, in addition to the baseline and week 24 values showing the effect of ivacaftor on growth parameters.

​​​​​​​​​​​​​​5.2 Pharmacokinetic properties

Addition of mean ivacaftor exposure data for the 4 months to less than 6 months age group in Table 8.

 

 

Updated on 16 November 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Update to section 1. to update the therapeutic indication to state that Kalydeco granules are indicated for the treatment of babies and children and 4 months and older.

Update to section 2. warnings and precautions section (children) to state that it is not known if ivacaftor is safe and effective in children under 4 months of age.

Update to section 2. “Kalydeco with food and drink” to remove Seville oranges.

Section 3. How to take Kalydeco updated to include dose recommendation for children aged 4months to less than 6 months (Table 1).

Clarifications made on dose reduction and use of Kalydeco granules in children with moderate, severe liver problems. Addition of information for children with liver problems aged between 4 months and 6 months that use is not recommended, but your doctor will decide if it is appropriate for the child to use and what dose they should have.

Updated on 25 August 2020

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Minor edits throughout SmPC to amend  “Kalydeco” to “Ivacaftor”.

Update to Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

  • Revised excipient with known effect text to remove “as” to “lactose monohydrate”.

Update to Section 4.2 Posology and method of administration

  • Minor revision to “Missed dose” section to add clarifying text around existing language.

Update to Section 4.4 Special warnings and precautions for use

  • Interactions with medicinal products edited to clarify that exposure to ivacaftor is significantly decreased by concomitant use of CYP3A inducers.
  • Additionally for strong or moderate CYP3A inhibitors, exposure to ivacaftor is increased.
  • “Cataracts” header updated to “Paediatric population”.
  • “Potential for ivacaftor to interact with transporters” subsection moved location within this section.

 

Update to Section 4.8 Undesirable effects

  • Section updated to include additional data for transaminase elevations.
  • Addition of table for transaminase elevations in patients 6 months to < 12 years treated with ivacaftor as monotherapy.

 

Updates to section 5.2 Pharmacokinetic properties

  • Minor administrative edits.
  • Updates to the Biotransformation subsections.

Updated on 25 August 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Warnings and Precautions

  • Reformatting of “other medicines and Kalydeco” section to include medicines in alphabetical order, simplify descriptors and amend subheaders to “Antibiotic medicines” instead of antibacterial agents and Epilepsy medicines from “anticonvulsant medicines”.

Section 3. How to take Kalydeco

  • Addition of “Kalydeco” to dosing recommendation table for sachets.

Section 4. Possible side effects

  • Minor administrative edits.
  • Subsection “Possible signs of liver problems” included.

Updated on 24 June 2020

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 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

  • Updates to section 4.1 amd 4.2 associated with indication update for infants aged at least 6 months and over with an R117H mutation.
  • Updates to section 4.4 and 5.1 due to addition of data from Study 6 ( a study in patients with CF with an R117H mutation in the CTFR gene.

Updated on 24 June 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents

Free text change information supplied by the pharmaceutical company

Updates to PIL associated with indication update to include that Kalydeco granules can be used in the treatment of infants, toddlers and children who have an R117H CFTR mutation and weight 5kg to less than 25 kg with Cystic Fibrosis (CF).

Previous text:

  1. What Kalydeco is and what it is used for

 

Kalydeco contains the active ingredient ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell. Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF). Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.

 

Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

 

Updated text:

  1. What Kalydeco is and what it is used for

 

Kalydeco contains the active ingredient ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell. Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF). Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.

Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

 

Previous text:

  1. What you need to know before your child takes Kalydeco

Children

Do not give this medicine to children under 6 months of age with gating mutations as it is not known if ivacaftor is safe and effective in these children.

Updated text:

  1. What you need to know before your child takes Kalydeco

Children

Do not give this medicine to children under 6 months of age as it is not known if ivacaftor is safe and effective in these children.

 

 

Updated on 24 February 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

PIL updated to reflect license expansion to 6 months of age and new 25mg dose.

Dosing table updated to include lower weight group

Updated on 24 February 2020

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications

Free text change information supplied by the pharmaceutical company

Lisence expanded to include Kalydeco 25 mg granules in sachet.

Indicated age from 6 months and dosing table 1 updated to reflect this change.

Table 7 updated to include younger age group

 

Updated on 6 December 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 6 - marketing authorisation holder

Updated on 6 December 2018

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Note removal of black triangle

Section 4.1: age change from 2 years to 12 months and weight to 7 kilos.

Section 4.2 age change

Section 4.8: Tables updated to reflect age change and addition of the following wording:

During the 24‑week, open‑label, Phase 3 clinical study of ivacaftor in patients aged 12 months to less than 24 months (Study 8), the incidence of patients experiencing transaminase elevations (ALT or AST) >3, >5, and >8 x ULN was 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18), respectively. No patients had elevations in total bilirubin. No patients discontinued ivacaftor treatment due to transaminase elevations. The two patients with elevations of ALT or AST >8 x ULN interrupted treatment and subsequently resumed ivacaftor successfully (see section 4.4 for management of elevated transaminases). 

Section 5.1 new data on Study 8 added.

Section 5.2 Table updated to reflect age change

Section 7 MAH address changed

 

 

 

Updated on 8 November 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use

Updated on 7 November 2018

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Wording updated to reflect new data

Updated on 4 October 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 4 October 2017 SPC

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

Section 6.3: shelf life changed from 2 to 3 years

Updated on 2 June 2017 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

In section 3: minor editorial changes

In section 4.2: minor editorial changes

In section 4.4: Removal of the warning regarding limited data in patients with FEV1 <40%. Other minor editorial changes

In section 4.5: Removal of the drug-drug interaction information for CYP2C8 substrates. Other minor editorial changes

In section 4.6: minor editorial changes

In section 4.7: minor editorial changes

In section 4.8: minor editorial changes

In section 4.9: minor editorial changes

In section 5.1: minor editorial changes

In section 5.2: minor editorial changes

In section 6.5: minor editorial changes

In section 8: minor editorial changes

In section 9: minor editorial changes

 

Updated on 30 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 May 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 5 December 2016 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company



Section 2: minor editorial changes
Section 4.4: minor editorial changes
Section 4.5: minor editorial changes
Section 4.6: changes in relation to pre-clinical pregnancy, breast-feeding and fertility data
Section 5.1: minor editorial changes
Section 5.2: minor editorial changes
Section 5.3: changes to pre-clinical data on teratogenicity, carcinogenicity and findings of cataracts

Updated on 1 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 16 January 2016 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

None provided

Updated on 11 January 2016 PIL

Reasons for updating

  • New PIL for new product