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Adverse event reporting can be found at the bottom of the page
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Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information.
Following completion of ATTR-ACT, patients were eligible to enrol in an open-label LTE study where they were able to switch from placebo to tafamidis, or continue treatment with tafamidis, for up to 60 months1
All-cause mortality was assessed in patients taking continuous tafamidis meglumine 80 mg to tafamidis free acid 61 mg vs. those initiated on placebo before transitioning to tafamidis meglumine 80 mg/20 mg and then to tafamidis 61 mg/day in the LTE1
The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily. VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Tafamidis meglumine 20 mg is not licensed in ATTR-CM.2
Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193
There was a significant 41% risk reduction in all-cause mortality in patients receiving continuous tafamidis treatment compared with those first receiving placebo (p<0.001)1
A total of 82 placebo-treated patients continued in LTE, 54 of whom were randomised to receive tafamidis meglumine 80 mg/day and 28 of them were randomised to receive tafamidis meglumine 20 mg/day3
The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily. VYNDAQEL 61 MG (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Tafamidis meglumine 20 mg is not licensed in ATTR-CM.1
Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193
Tafamadis was generally well tolerated in the LTE.
Frequency of AEs was generally similar or lower, in patients treated with tafamidis meglumine 80 mg/day who transitioned to tafamidis free acid 61 mg/day in the LTE vs. patients from the pooled tafamidis (tafamidis meglumine 80 mg/daily and tafamidis meglumine 20 mg/daily) or placebo arms in ATTR-ACT3,1
No new safety concerns emerged in patients treated with tafamidis meglumine 80 mg/day or tafamidis free acid 61 mg/day in the LTE1
References:
Remind yourself of the key ATTR-ACT results
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