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About VYNDAQEL

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Study DesignEfficacySafety ProfileDosingSupporting Resources Supporting ResourcesAvailability in Scotland2021 ESC Heart Failure GuidelinesRisk Minimisation MaterialContact usMaterialsVideos

Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

Safety profile of VYNDAQEL​​​​​VYNDAQEL was generally well tolerated in the ATTR-ACT trial1

Safety data are based on 176 patients with ATTR-CM treated with 80 mg tafamidis meglumine
daily (4 x 20 mg) in a 30-month placebo-controlled trial2


Frequency of AEs was generally similar to placebo2

The following adverse events were reported more often in patients treated with tafamidis
meglumine 80 mg compared to placebo:2

  • Flatulence; 8 patients vs 3 patients (4.5% vs. 1.7%)
  • Liver function test increased; 6 patients vs 2 patients (3.4% vs. 1.1%)

A causal relationship has not been established.
 

From cumulative clinical data in ATTR-CM participants:2

Common AEs (occurring in ≥1% to <10% of patients) include diarrhoea, rash and pruritus

VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.2

View the ATTR-ACT study publication for study details and results

View the ATTR-ACT study publicationLoading
AE=adverse event; ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy.Explore more We have a team ready to support you with any queries.

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Reference:

Maurer MS, Schwartz JH, Gundapaneni B, et al. N Eng J Med. 2018;379:1007–1016.VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.
PP-VYN-GBR-1193. December 2023

View and download Vyndaqel Risk Minimisation Material

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View VYNDAQEL dosing information

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Learn about the efficacy of VYNDAQEL in patients with ATTR-CM

ATTR-ACT results Loading

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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