Classes
DAE Class; Rx
Common Brand Names; Vyndaqel
- Cardiovascular, Other
Description
Selective stabilizer of transthyretin (TTR) for cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults
Reduces cardiovascular mortality and cardiovascular-related hospitalizations
Potential to cause fetal harm; advise women of child-bearing potential to use contraception during therapy
Indications
Indicated for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization
Dosing Considerations
Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis
Warnings
Cautions
Drug interactions overview
Breast cancer-resistant protein (BCRP) inhibitor
BCRP substrates
- Monitor for signs of BCRP substrate-related toxicities and modify dosage of substrate if appropriate
- Tafamadis increases exposure and risk of toxicities of BCRP substrates
Pregnancy and Lactation
Pregnancy
Based on animal studies, fetal harm may occur when administered to a pregnant woman
Lactation
No data available on the presence of tafamidis in human milk, effect on the breastfed infant, or the effect on milk production
Maximum Dosage
Adults
80 mg once daily (Vyndaqel); 61 mg once daily (Vyndamax).
Geriatric
80 mg once daily (Vyndaqel); 61 mg once daily (Vyndamax).
Adolescents
Safety and efficacy have not been established.
Children
Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
How supplied
Tafamidis Meglumine
capsule
- 20mg