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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
VYNDAMAX has been studied long-term with ~5 years of data in transthyretin cardiac amyloidosis1*Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).Study Design: ATTR-ACT and Long-term Extension (post hoc, interim analysis)

Approval 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 ATTR 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. Upon completion of ATTR-ACT, patients could enroll in the ongoing long-term extension study.1-3

The long-term extension post hoc, interim analysis compared patients who were first treated with1:
  • VYNDAQEL 80 mg, continuing with VYNDAQEL 80 mg, then transitioned to VYNDAMAX (continuous VYNDAQEL/VYNDAMAX)
  • Placebo who were randomized (2:1) to VYNDAQEL 80 mg or 20 mg,|| then transitioned to VYNDAMAX (placebo to VYNDAQEL/VYNDAMAX)
  • The VYNDAQEL 20-mg arm in ATTR-ACT was not included in this analysis
 The data reported on the long-term efficacy and safety of tafamidis are from the long-term extension to the ATTR-ACT trial and are not included in the VYNDAQEL/VYNDAMAX prescribing information.Post hoc, interim analysisTime to all-cause mortality1¶
  • The updated analysis with long-term survival was non-prespecified. No formal hypothesis testing was performed given that the overall survival endpoint was met in ATTR-ACT study. This analysis of the long-term extension was not powered to make conclusions on all-cause mortality at 5 years
  • The preliminary 5-year survival rate in this interim analysis was 53% with continuous VYNDAQEL/VYNDAMAX treatment vs 32% in the placebo-to-VYNDAQEL/VYNDAMAX group1
  • No new safety concerns were observed in patients treated with VYNDAQEL or VYNDAMAX in this analysis. Incidence and types of adverse events were similar to, or lower than, that with pooled VYNDAQEL (80 mg and 20 mg) or placebo in ATTR-ACT1
  • The median follow-up was 58.5 months (continuous tafamidis group) and 57.1 months (placebo-to-tafamidis group)1

Adapted from Elliott P, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022:15:e008193.

Next: See how VYNDAMAX works in ATTR cardiac amyloidosis Continue LoadingAs 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.2The primary analysis was conducted using the Finkelstein-Schoenfeld method.1The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily.1Individual component of the primary analysis.1Heart transplant and implantation of a cardiac mechanical assist device were treated as death.1ATTR=transthyretin amyloidosis; ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; CV=cardiovascular; LTE=long-term extension; NNT=number needed to treat; qd=once daily.
References: Elliott P, Drachman BM, Gottlieb SS, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022;15:e008193.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.Data on file. Pfizer Inc., New York, NY.
About VYNDAMAXVYNDAMAX has been studied long-term See the 5-year dataLoadingVYNDAQEL 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.