• Prescribing Information
  • Patient Information
  • Patient Site
  • Medical Information
  • Vyndamax logo

    Dosing

    VYNDAMAX for ATTR-CM—a convenient single-capsule, once-daily dose

    A single VYNDAMAX 61-mg capsule is bioequivalent* to VYNDAQEL® (tafamidis meglumine) 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis

    • Can be taken with or without food​​​​​​​
    • The capsule should be swallowed whole and not crushed or cut

        *As determined by the predefined 90% confidence interval criteria of 80%-125% bioequivalence limits for tafamidis area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.​​​​​​

        †Capsule shown is not actual size.

    Next: Primary analysis 

    Continue

    Reference:
    1. Tankisheva E. A phase 1, open-label, randomized, crossover, multiple dose, pivotal bioequivalence study to compare PF-06291826 4 × 20 mg tafamidis meglumine and 61 mg: tafamidis free acid soft gelatin capsules administered under fasted conditions to healthy volunteers. Full Clinical Study Report [protocol B3461056]. July 23, 2018.

    A selective stabilizer of TTR

    Explore the mechanism of action

    Explore

    Resources on dosing and more

    Explore resources


    VYNDAMAX® AND VYNDAQEL® are registered trademarks of Pfizer Inc.

    Adverse Reactions

    In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

    Specific Populations

    Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

    Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.

    VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
    ​​​​​​​
    Please see Full Prescribing Information including Patient Information.

      INDICATION AND LIMITATIONS OF USE

      VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
      ​​​​​​​
      Please see Full Prescribing Information including Patient Information.