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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
Study DesignTransthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT)—a pivotal clinical study in patients with transthyretin cardiac amyloidosis1*

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.1,2

Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).ATTR-ACT Study Design1Select inclusion criteria3
  • Patients between 18 and 90 years of age
  • Confirmation of ATTR cardiac amyloidosis, wild-type or hereditary
  • Echocardiography with an end-diastolic interventricular septal wall thickness >12 mm
  • History of heart failure with at least 1 prior hospitalization for heart failure, or clinical evidence of heart failure (without hospitalization)||
  • NT-proBNP level ≥600 pg/mL
  • 6MWT >100 m
Manifested in signs or symptoms of volume overload or elevated intracardiac pressures requiring treatment with a diuretic for improvement; an NT-proBNP level greater than or equal to 600 pg/mL; and a 6MWT distance exceeding 100 m.36MWT=6-minute walk test; NT-proBNP=N-terminal pro-B-type natriuretic peptide.Select exclusion criteria3
  • Heart failure unrelated to ATTR cardiac amyloidosis
  • NYHA class IV heart failure
  • Light-chain amyloidosis
  • History of liver or heart transplantation
  • Implanted cardiac mechanical assist device
    • Patients with a permanent pacemaker or implanted cardiac defibrillator were permitted in this study4
  • Previous VYNDAQEL treatment
  • eGFR <25 mL/min/1.73 m2
  • Liver transaminase levels >2x the upper limit of normal
  • mBMI <600
  • ​​Concurrent treatment with NSAIDs,# tauroursodeoxycholate, doxycycline, calcium channel blockers, or digitalis
Cardiac mechanical assist device (CMAD) term utilized to cover LVAD.3Select NSAIDs were permitted, eg, aspirin, ibuprofen, naproxen.3eGFR=estimated glomerular filtration rate; LVAD=left ventricular assist device; mBMI=modified body mass index; NSAID=nonsteroidal anti-inflammatory drug.The Finkelstein-Schoenfeld method3
  • A statistical method used to compare each patient to every other patient within each stratum in a pair-wise manner that proceeds in a hierarchical fashion using all-cause mortality first
  • The test statistic is based on the sum of scores and stratified by TTR genotype (wild-type and hereditary) and NYHA baseline classification resulting in a total of 4 strata**
  • Hierarchical comparison prioritizes all-cause mortality over CV-related hospitalizations
Frequency of CV-related hospitalizations is used to compare patients who cannot be differentiated based on all-cause mortality.1 Next: Dosing Continue Loading
As 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.The primary analysis was conducted using the Finkelstein-Schoenfeld method.ATTR=transthyretin amyloidosis; ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; CV=cardiovascular; NYHA=New York Heart Association; TTR=transthyretin.​​​​​​ 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. Data on file. Pfizer Inc., New York, NY.  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. [suppl appendix] https://www.nejm.org/doi/suppl/10.1056/NEJMoa1805689/suppl_file/nejmoa1805689_appendix.pdf. Accessed August 16, 2023.
A guide to getting your patients started on VYNDAMAX Learn more Loading Efficacy and safety outcomes Review the clinical data Loading

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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.