This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog Out
ProductsOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

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
Safety Profile
In ATTR-ACT, VYNDAQEL® (tafamidis meglumine) was well tolerated, with a safety profile similar to placebo1
  • The frequency of adverse events (AEs) in clinical trials in patients treated with VYNDAQEL was similar to placebo
  • VYNDAQEL showed similar rates of discontinuation due to AEs compared with placebo
  Discontinuation, n (%)
VYNDAQEL 80 mg (n=176) 12 (7%)
VYNDAQEL 20 mg (n=88) 5 (6%)
Placebo (n=177) 11 (6%)
Specific populations
  • Pregnancy1

    Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman
  • Lactation1

    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      
 Next: Learn more about the clinical study, ATTR-ACT ContinueLoadingAEs=adverse events; ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial.
Reference: Vyndaqel and Vyndamax [prescribing information]. New York, NY: Pfizer Inc; 2023.
About VYNDAMAXA once-daily, oral treatment for wild-type or hereditary ATTR cardiac amyloidosis View VYNDAMAX dosingLoading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2024 Pfizer Inc. All rights reserved.

PP-VDM-USA-2023
You are now leaving Pfizer You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.

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.