HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use VYNDAQEL and VYNDAMAX safely and effectively. See full prescribing information for VYNDAQEL and VYNDAMAX. VYNDAQEL® (tafamidis meglumine) capsules, for oral administration Initial U.S. Approval: 2019 VYNDAMAX™ (tafamidis) capsules, for oral administration Initial U.S. Approval: 2019 INDICATIONS AND USAGEVYNDAQEL and VYNDAMAX are transthyretin stabilizers 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. (1) DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSCapsules: Tafamidis meglumine 20 mg and tafamidis 61 mg. (3) CONTRAINDICATIONSNone. (4) ADVERSE REACTIONSTo report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (5) USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2021 |
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VYNDAQEL® OR VYNDAMAX™ Highlights (tafamidis meglumine or tafamidis)
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