This site is intended only for healthcare professionals resident in Egypt
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
Adverse events should be reported. Adverse events can be reported to [email protected]
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
The product information provided in this site is intended only for Healthcare Professionals of Egypt. The products discussed herein may have different product labeling in different countries.
Copyright © 2023 Pfizer biopharmaceutical LLC. All rights reserved.
These pages are not intended for patients or members of the general public. This portal contains healthcare promotional content.
If you select ""No"", you will be redirected to Pfizer.com, the global Pfoizer websitee.
I confirm that i am a healthcare professional resident in Egypt.