Vyndamax Adverse Reactions

The data across clinical trials reflect exposure of 377 transthyretin amyloid cardiomyopathy (ATTR-CM) patients to either 20 mg or 80 mg (administered as four 20 mg capsules) of tafamidis meglumine daily for an average of 24.5 months (ranging from 1 day to 111 months).
Adverse events were assessed from ATTR-CM clinical trials with tafamidis meglumine including a 30-month placebo-controlled trial in patients diagnosed with ATTR-CM (see Pharmacology: Pharmacodynamics under Actions). The frequency of adverse events in patients treated with 20 mg or 80 mg tafamidis meglumine was similar and comparable to placebo.
A lower proportion of tafamidis meglumine-treated patients compared to placebo discontinued due to an adverse event in the 30-month placebo-controlled trial in patients diagnosed with ATTR-CM [40 (22.7%), 16 (18.2%), and 51 (28.8%) from the tafamidis meglumine 80 mg (administered as four 20 mg capsules), tafamidis meglumine 20 mg, and placebo groups, respectively].
An adverse reaction of diarrhoea was identified post-marketing in the ATTR-CM population and is listed as follows by MedDRA System Organ Class (SOC). (See Table 6.)

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