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Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.
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VYNDAQEL dose for ATTR-CM
Prescribe VYNDAQEL 61 mg once daily
Simple for patients to take at home
Can be taken with or without food1
Capsules should be swallowed whole – do not crush or cut capsules1
Requires no premedication or administration by a healthcare professional
Free acid formulation
VYNDAQEL (tafamidis meglumine)
Meglumine salt formulation
In a phase 1, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose bioequivalence study, fasted healthy individuals (n=30) received VYNDAQEL 61 mg once daily or VYNDAQEL 80 mg once daily.2†
The study compared the area under the concentration-time profiles from time 0 to time tau (AUCtau) and the maximum observed concentration (Cmax) at steady state.2
Approval of VYNDAQEL 61 mg was based on ATTR-ACT, which evaluated pooled 20-mg and 80-mg (4 × 20 mg) doses of VYNDAQEL. The relative bioavailability of 61 mg of VYNDAQEL (tafamidis) is similar to 80 mg of VYNDAQEL at steady state.2
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PP-UNP-IRL-0176. January 2023