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About ATTR-CMAbout
ATTR-CM
Disease ImpactWhen to Rule Out ATTR-CMDiagnosing ATTR-CM
About VYNDAMAXAbout
VYNDAMAX
Mortality and Hospitalization6MWT/KCCQ-OS5-year DataHow VYNDAMAX WorksSafety Profile Study Design
DosingAccess & SupportAccess & SupportAccessing VYNDAMAXVyndaLinkResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
How VYNDAMAX WorksTafamidis is a disease-modifying therapy that inhibits cardiac amyloidosis by selectively stabilizing TTR1-5 Tafamidis specifically targets TTR and fortifies the TTR tetramer to help preserve its natural function5-9
  • The approved dose of tafamidis provides near-maximum stabilization10*† 
  • Stabilized TTR can continue to circulate naturally to perform critical biologic functions1-4
  • Biomarkers associated with heart failure (NT-proBNP and Troponin I) favored VYNDAQEL over placebo11
Next: Safety profile ContinueLoadingRelationship between TTR occupancy by tafamidis and TTR stabilization was evaluated analyzing data from ATTR-ACT using models of TTR concentrations in human plasma.6The degree the tetramer dissociation rate is decreased in human plasma following the approved dose of tafamidis.6ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; NT-proBNP=N-terminal pro-B-type natriuretic peptide; TTR=transthyretin.
References: Maurer MS, Hanna M, Grogan M, et al; THAOS Investigators. Genotype and phenotype of transthyretin cardiac amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016;68(2):161-172. Rubin J, Alvarez J, Teruya S, et al. Hip and knee arthroplasty are common among patients with transthyretin cardiac amyloidosis, occurring years before cardiac amyloidosis: can we identify affected patients earlier? Amyloid. 2017;24(4):224-228. Dorbala S, Ando Y, Bokhari S, et al. ASNC/AHA/ASE/EANM/HFSA/ISA/SCMR/SNMMI expert consensus recommendations for multimodality imaging in cardiac amyloidosis: part 1 of 2—evidence base and standardized methods of imaging. Circ Cardiovasc Imaging. 2021;14(7):e000029. Gillmore JD, Damy T, Fontana M, et al. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018;39(30):2799-2806. Data on file. Pfizer Inc., New York, NY. Sekijima Y. Transthyretin (ATTR) amyloidosis: clinical spectrum, molecular pathogenesis and disease-modifying treatments. J Neurol Neurosurg Psychiatry. 2015;86(9):1036-1043. Judge DP, Heitner SB, Falk RH, et al. Transthyretin stabilization by AG10 in symptomatic transthyretin amyloid cardiomyopathy. J Am Coll Cardiol. 2019;74(3):285-295. Coelho T, Merlini G, Bulawa CE, et al. Mechanism of action and clinical application of tafamidis in hereditary transthyretin amyloidosis. Neurol Ther. 2016;5(1):1-25. Monteiro C, Martins da Silva A, Ferreira N, et al. Cerebrospinal fluid and vitreous body exposure to orally administered tafamidis in hereditary ATTRV30M (p.TTRV50M) amyloidosis patients. Amyloid. 2018;25(2):120-128. Tess DA, Maurer TS, Li Z, et al. Relationship of binding-site occupancy, transthyretin stabilisation and disease modification in patients with tafamidis-treated transthyretin amyloid cardiomyopathy. Amyloid. 2023;30(2):208-219. Vyndaqel and Vyndamax [prescribing information]. New York, NY: Pfizer Inc; 2023.
About VYNDAMAXEfficacy and safety outcomes
Review the clinical data
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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.