"HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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 USAGE
VYNDAQEL 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 ADMINISTRATION
The recommended dosage is either:
VYNDAQEL 80 mg orally once daily, or
VYNDAMAX 61 mg orally once daily (2.1)
VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis. (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: Tafamidis meglumine 20 mg and tafamidis 61 mg. (3)
CONTRAINDICATIONS
None. (4)
ADVERSE REACTIONS
To 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 POPULATIONS
Pregnancy: Based on animal studies, may cause fetal harm. (8.1)
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019"