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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.

VYNDAQEL 80 mg/61 mg* has 5 years of clinical data and a demonstrated safety and tolerability profile compared to placebo1,2 

In the ATTR-ACT trial, the frequency of adverse events in patients treated with VYNDAQEL 80 mg* was generally similar and comparable to placebo1 

  • The safety data reflect exposure of 176 patients with ATTR-CM to VYNDAQEL 80 mg (administered as 4 × 20 mg) daily in a 30-month, placebo-controlled trial in patients diagnosed with ATTR-CM1 
  • The following adverse events were reported more often in patients treated with VYNDAQEL 80 mg compared to placebo: flatulence (8 patients [4.5%] vs 3 patients [1.7%]) and liver function test increased (6 patients [3.4%] vs 2 patients [1.1%]). A causal relationship has not been established1 
  • Study population included patients with wild-type or hereditary ATTR-CM; NYHA class I, II, and Ill; and a median age of 75 years at baseline in the treatment arm​​​​​​​1 ​​​​​​​​​​​​​​

In patients treated continuously with VYNDAQEL 80 mg to VYNDAQEL (tafamidis) 61 mg*, no new safety concerns were identified throughout the ATTR-ACT LTE study, and adverse events remained similar to placebo2

  • Patients who completed ATTR-ACT were eligible to enroll in the LTE study, with placebo-treated patients randomized to VYNDAQEL 80 mg or 20 mg (2:1); median follow-up of ~58 months across both studies2  
  • All patients were then transitioned to VYNDAQEL 61 mg* per the amended protocol2
  • VYNDAQEL may decrease serum concentrations of total thyroxine, without an accompanying change in free thyroxine (T4) or thyroid-stimulating hormone (TSH). No corresponding clinical findings consistent with thyroid dysfunction have been observed1 
  • Safety data for VYNDAQEL 61 mg was not evaluated in the double-blind, placebo-controlled, randomized phase 3 study1 
[Specific populations]
  • PREGNANCY
    ​​​​​​​​​​​​​​​​​​​​​​​​​​​​[There are no data on the use of VYNDAQEL in pregnant women. Studies in animals have shown developmental toxicity. VYNDAQEL is not recommended during pregnancy and in women of childbearing potential not using contraception1]
  • BREASTFEEDING
    [Available data in animals have shown excretion of tafamidis in milk. A risk to newborns/infants cannot be excluded. VYNDAQEL should not be used during breastfeeding1]
 ATTR-CM study design  LTE study design A single VYNDAQEL 61 mg capsule corresponds to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1,3 ATTR-ACT=Tafamidis in Transthyretin Cardlomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; LTE=long-term extension; NYHA=New York Heart Association. 
Explore More ATTR-CM dosing Learn More VYNDAQEL specifically targets TTR destabilization View VYNDAQEL Mechanism of Action
ATTR-CM identification and diagnosis Download Resources
NEXT: ATTR-CM pivotal efficacy
References:VYNDAQEL Summary of Product CharacteristicsElliott P, Drachman BM, Gottlieb SS, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022;153e008193:1-8. Lockwood PA, Le VH, O'Gorman MT, et al. The bioequivalence of tafamidis 61-mg free acid capsules and tafamidis meglumine 4 x 20-mg capsules in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854. doi:10.1002/cpdd.789 
VYNDAQEL Prescribing InformationLoading
Efficacy and Safety Profile

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0183. 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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