Symkevi 100 mg/150 mg film coated tablets

  • Name:

    Symkevi 100 mg/150 mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Tezacaftor 100mg, Ivacaftor 150mg

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/02/19

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Summary of Product Characteristics last updated on medicines.ie: 21/4/2020
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 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
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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 21 April 2020 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

Change to section 6.3 - Shelf-life extension from 30 months to 4 years.

Updated on 15 April 2020 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

 

Change to section 4.5          Interaction with other medicinal products and other forms of interaction

New subsection for OATP1B1 substrates added as Symkevi in combination with ivacaftor has been studied with pitavastatin (OATP1B1 substrate):

Symkevi in combination with ivacaftor has been studied with pitavastatin, an OATP1B1 substrate, and was found to have no clinically relevant effect on the exposure of pitavastatin (1.24 fold increased exposure based on AUC).  No dose adjustment of OATP1B1 substrates is required when co-administered with Symkevi.

Previous wording deleted:

Symkevi may inhibit OATP1B1 and increase the exposures of medicinal products that are substrates of OATP1B1. When used concomitantly with OATP1B1 substrates, caution should be used.

 

Change to section 5.2     Pharmacokinetic properties

Clarification of CYP3A4 activity in patients carrying the CYP3A4*22 variant as follows:

The effect of the CYP3A4*22 heterozygous genotype on tezacaftor and ivacaftor exposure is consistent with the effect of co-administration of a weak CYP3A4 inhibitor, which is not clinically relevant. No dose-adjustment of tezacaftor and ivacaftor is considered necessary. No data are available for CYP3A4*22 homozygous genotype patients.

Previous wording deleted:

The effect of the potentially reduced activity of CYP3A4 in patients carrying the CYP3A4*22 variant on tezacaftor and ivacaftor exposures is not known.

Updated on 8 February 2019 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 8 February 2019 SmPC

Reasons for updating

  • 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

Change of address for MAH

Updated on 6 December 2018 SmPC

Reasons for updating

  • New SmPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

New Medicine

Updated on 6 December 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Free text change information supplied by the pharmaceutical company

New Medicine

Updated on 8 November 2018 PIL

Reasons for updating

  • New PIL for new product