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. USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 10/2023 |
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. USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 10/2023 |
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