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: 24/02/20

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Summary of Product Characteristics last updated on medicines.ie: 24/2/2020

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Vertex Pharmaceuticals (Ireland) Limited

Vertex Pharmaceuticals (Europe) Limited

Company Products

Medicine NameActive Ingredients
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 5 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 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 SmPC

Reasons for updating

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

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

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 SmPC

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

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

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 SmPC

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

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

Free text change information supplied by the pharmaceutical company

Wording updated to reflect new data

Updated on 4 October 2017 SmPC

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 4 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 June 2017 SmPC

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

  • 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 30 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 December 2016 SmPC

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 SmPC

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