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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 VYNDAMAXVyndaLinkResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
6MWT and KCCQ-OSApproval of VYNDAMAX was based on ATTR-ACT, a phase 3, multicenter, international, randomized, double-blind, placebo-controlled study, which evaluated pooled VYNDAQEL® (tafamidis meglumine) doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary transthyretin cardiac amyloidosis*—a single VYNDAMAX 61-mg capsule is bioequivalent† to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1,2Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).ATTR-ACTAs early as 6 months, patients with ATTR cardiac amyloidosis experienced a difference vs placebo in health-related quality of life and functional capacity3In ATTR-ACT, patients with ATTR cardiac amyloidosis taking VYNDAQEL experienced a significant difference in health-related quality of life vs placebo based on the KCCQ-OS scale1,3

The KCCQ-OS score assesses patient health status using the following domains: total symptoms (symptom frequency, symptom burden), physical limitation, quality of life, and social limitation.1

In ATTR-ACT, VYNDAQEL helped patients with ATTR cardiac amyloidosis walk significantly farther vs placebo based on the 6MWT1,3

The 6MWT evaluates patients’ functional capacity by measuring their distance walked in 6 minutes.3

Key secondary endpoint overview: The treatment effect of tafamidis on functional capacity and health status was assessed by the 6-minute walk test (6MWT) and the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score, respectively. Both key secondary endpoints evaluated change from baseline to month 30.3

Next: 5-year data ContinueLoadingAs determined by the predefined 90% confidence interval criteria of 80% to 125% bioequivalence limits for tafamidis area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.26MWT=6-minute walk test; ATTR=transthyretin amyloidosis; ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire-Overall Summary; LS=least squares; SE=standard error.
References: Vyndaqel and Vyndamax [prescribing information]. New York, NY: Pfizer Inc; 2023.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.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.
About VYNDAMAXVYNDAMAX has been studied long-term
See the 5-year data
LoadingVYNDAQEL safety was similar to placebo See safety dataLoading

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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.