- Capsules should be swallowed whole and not crushed or cut1
Bioequivalence
A study demonstrated the bioequivalence of VYNDAMAX™ 61 mg to 80 mg of tafamidis meglumine2
VYNDAMAX™ 61 mg is bioequivalent to 80 mg of tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per-mg basis.2
In a phase 1, open-label, randomised, 2-period, 2-sequence, crossover, multiple-dose bioequivalence study, fasted healthy individuals (n=30)
received VYNDAMAX™ (tafamidis) 61 mg once daily or tafamidis meglumine 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
[Bioequivalence was established by the 90% confidence interval falling within the 80%-125% bioequivalence limits for tafamidis area under curve (AUC) and peak plasma concentration (Cmax).2]
Approval of VYNDAMAX™ (tafamidis) 61 mg was based on ATTR-ACT, which evaluated the pooled 20 mg and 80 mg (4 × 20 mg) doses of tafamidismeglumine. The relative bioavailability of 61 mg of VYNDAMAX™ (tafamidis) is similar to 80 mg of tafamidismeglumine at steady state.2
*Capsule shown is not actual size.
†As determined by the predefined 90% confidence interval criteria of 80%-125% bioequivalence limits for tafamidis for area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.2
‡After a twice-daily loading dose on Days 1 and 2 to reduce the time to reach steady state, patients switched to a once-daily dose for Days 3 to 7.2
ATTR-CM: transthyretin amyloid cardiomyopathy; MOA: mechanism of action; MOD: mechanism of disease.
MOH Approval No. : HF0098OA171/082022
Invalidation Date : 11/08/2024
