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AboutAbout ATTR-CMUrgencySuspectDetectDiagnostic flowchartAbout ATTR-PNUrgencyAwarenessPartnershipStudy DesignATTR-CM study designATTR-PN study designEfficacy & SafetyATTR-CMPivotal efficacyLong-term survivalSubgroup analysisKey secondary endpointsEarly efficacy measuresSafety profileATTR-PNPivotal efficacyLong-term efficacyMutations efficacyLong-term survivalSafety profileDosingATTR-CM dosing ATTR-CM LTE dosing analysisATTR-PN dosingMOD/MOAATTR-CMRole of TTRATTR-CM MODATTR-CM MOAATTR-PNATTR-PN MODATTR-PN MOASupport & ResourcesPrescribing informationEventsMaterialsVideos

VYNDAQEL® (tafamidis) 61 mg is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). VYNDAQEL® (tafamidis meglumine) 20 mg is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy (ATTR-PN) to delay peripheral neurologic impairment.

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​​​​​​​​​​​​​​​​​​​​​

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 placebo

  • 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 protocol
  • 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 observed
  • 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 is bioequivalent 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-PN pivotal efficacy 
References:VYNDAQEL [summary of product characteristics]. Bruxelles, Belgium: Pfizer Europe MA EEIG.Elliott 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 
Efficacy and Safety Profile ATTR-CM

240018 - January 2024

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