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About ATTR-CMAbout
ATTR-CMDisease ImpactWhen to Rule Out ATTR-CMDiagnosing ATTR-CMAbout VYNDAMAXAbout
VYNDAMAXMortality and Hospitalization6MWT/KCCQ-OS5-year DataHow VYNDAMAX WorksSafety Profile Study DesignDosingAccess & SupportAccess & SupportAccessing VYNDAMAXPaying for VYNDAMAXResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
How VYNDAMAX WorksTafamidis is a disease-modifying therapy that inhibits cardiac amyloidosis by selectively stabilizing TTR1*

Tafamidis specifically targets TTR and fortifies the TTR tetramer to help preserve its natural function2,3

  • Stabilized TTR can continue to circulate naturally to perform critical biologic functions3
  • Biomarkers associated with heart failure (NT-proBNP and Troponin I) favored VYNDAQEL over placebo2

*Relationship between TTR occupancy by tafamidis and TTR stabilization was evaluated analyzing data from ATTR-ACT using models of TTR concentrations in human plasma.3

Tafamidis delivers near-complete stabilization of TTR at the approved dosage3,4†‡

†The approved dosage studied was 80 mg of tafamidis meglumine once daily.3,4

‡In vitro stabilization, assessed via subunit exchange in plasma at dose-relevant concentrations (Nelson et al), demonstrated ≥96% stabilization. An estimated 92% tetramer stabilization was derived from an integrated model-based analysis combining in vitro binding affinities with data from ATTR-ACT (Tess et al).3,4

Next: Safety profile ContinueLoadingATTR-ACT=The Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; NT-proBNP=N-terminal pro B-type natriuretic peptide; TTR=transthyretin.
References: Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.VYNDAQEL and VYNDAMAX [prescribing information]. New York, NY: Pfizer Inc; 2023.Tess DA, Maurer TS, Li Z, Bulawa C, Fleming J, Moody AT. Relationship of binding-site occupancy, transthyretin stabilisation and disease modification in patients with tafamidis-treated transthyretin amyloid cardiomyopathy. Amyloid. 2023;30(2):208-219.Nelson LT, Paxman RJ, Xu J, Webb B, Powers ET, Kelly JW. Blinded potency comparison of transthyretin kinetic stabilisers by subunit exchange in human plasma. Amyloid. 2021;28(1):24-29.
About VYNDAMAXEfficacy and safety outcomes
Review the clinical data
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PP-VDM-USA-0908
INDICATION AND LIMITATIONS OF USE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.Please see Full Prescribing Information including Patient Information.
Important Safety InformationAdverse Reactions
In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

Specific Populations

Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.IndicationVYNDAQEL® (tafamidis meglumine) and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Please see Full Prescribing Information including Patient Information.