Annotation of FDA Label for tafamidis and TTR
PharmGKB ID
Summary
The FDA label for tafamidis (VYNDAQEL) and (VYNDAMAX) states is it indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
Annotation
Excerpts from the tafamidis (VYNDAQEL) and (VYNDAMAX) label:
VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
VYNDAQEL stabilized both the wild type TTR tetramer and the tetramers of 14 TTR variants tested clinically after once-daily dosing. Tafamidis also stabilized the TTR tetramer for 25 variants tested ex vivo.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the tafamidis drug label.
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Evidence for Clinical Annotations
This annotation has been used as evidence for the following clinical annotations.