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AboutAbout ATTR-CMUrgencySuspectDetectDiagnostic flowchartAbout ATTR-PNUrgencyAwarenessPartnershipStudy DesignStudy DesignAbout ATTR-PNUrgencyAwarenessPartnershipEfficacy & SafetyPivotal efficacyLong-term survivalSubgroup analysisKey secondary endpointsEarly efficacy measuresSafety profileATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileDosingATTR-CM dosingATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileMOD/MOARole of TTRATTR-CM MODATTR-CM MOAATTR-PNATTR-PN MODATTR-PN MOASupport & ResourcesMaterialsVideosATTR-PNATTR-PN MODATTR-PN MOA

Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
(ATTR-CM).1

▼ 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. Refer to section 4.8 of the SmPC for how to report adverse reactions.

One treatment that can give patients more time for life—oral VYNDAQEL1-4*VYNDAQEL† is indicated for:
  • Treatment of wild-type and hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)1
Discover the Urgency in ATTR-CM

Why early identification of ATTR-CM is critical to extend life

View the Results in ATTR-CMProven efficacy with 5 years of clinical data for ATTR-CM3‡ See Dosing for ATTR-CM A single VYNDAQEL 61 mg capsule corresponds to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1,4VYNDAQEL (tafamidis) 61 mg is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.1ATTR-ACT was a phase 3, multicenter, international, parallel-design, placebo-controlled, double-blind, randomized study in 441 patients with wild-type or hereditary ATTR-CM.2 In ATTR-ACT, patients with ATTR-CM were randomized (2:1:2) to VYNDAQEL 80 mg, VYNDAQEL 20 mg or placebo once daily (qd) for 30 months.2 Upon completion of ATTR-ACT, patients could enroll in the ongoing LTE study for up to 60 months. The LTE post hoc analysis assessed all-cause mortality in patients taking continuous VYNDAQEL compared to patients initially in the placebo arm who transitioned to VYNDAQEL.3ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; CV=cardiovascular; LTE=long-term extension.References:VYNDAQEL Summary of Product Characteristics.Maurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. doi:10.1056/NEJMoa1805689Elliott P, Drachman BM, Gottlieb SS, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022;15:e008193:1-8.Lockwood PA, Le VH, O'Gorman MT, et al. The bioequivalence of tafamidis 61 mg free acid capsules and tafamidis meglumine 4 × 20-mg capsules in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854. doi:10.1002/cpdd.789
VYNDAQEL Prescribing InformationLoading

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0175. December 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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