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VYNDAQEL® OR VYNDAMAX™ Highlights (tafamidis meglumine or tafamidis)

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.

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: 4/2023

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Resources

website
Vyndamax Website for Consumers and Patients
 
website
Vyndamax Website for Health Care Professionals
 
website
Your Heart's Message - Website for Consumers and Patients
 
website
ATTR-CM: Suspect & Detect: Website for US HCPs
 
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FDA Medwatch
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