"Generic Name:
TAFAMIDIS MEGLUMINE VYNDAQEL- tafamidis meglumine capsule, liquid filled
VYNDAMAX- tafamidis capsule, liquid filled other related NDC Code(s): 0069-1975-12, 0069-1975-40, 0069-8730-01, 0069-8730-30
Description:
VYNDAQEL SPD, 20MG, CAPSULES, 4X30 EA
NDC:
00069-1975-40 0069-1975-40 0069197540 00069197540
UPC:
300691-975404 300691975404 3-00691-97540-4 Only Licensed Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item."
"HIGHLIGHTS OF PRESCRIBING INFORMATION: Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) ; FoldRx Pharmaceuticals; For the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, Approved May 2019. For additional information regarding Vyndaqel and Vyndamax or cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, please visit https://www.vyndaqel.com/
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"
