Overview

This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Vyndamax® Capsules as the treatment of transthyretin amyloid cardiomyopathy during 10 years under the setting of routine practice in Korea.

Eligibility

*Inclusion Criteria:

        Patients must meet all of the following inclusion criteria to be eligible for inclusion in
        the study:
          -  1. Adult patients with the cardiomyopathy of wild type or hereditary
             transthyretin-mediated amyloidosis (ATTR-CM)
          -  2. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the
             cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
          -  3. Evidence of a personally signed and dated informed consent document indicating that
             the patient (or a legally acceptable representative) has been informed of all
             pertinent aspects of the study.
               -  Exclusion criteria
        Patients meeting any of the following criteria will not be included in the study according
        to the local product label:
          -  1. Patient with hypersensitivity or case history to tafamidis or to any of the
             excipients in the product
          -  2. This product contains sorbitol (E420). Patients with rare hereditary problems of
             fructose intolerance should not take this medicine.
          -  3. Patient who has a contraindication to Vyndamax® Capsules according to the approved
             local product label