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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. (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: 6/2021

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Resources

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Vyndamax Website for Consumers and Patients
 
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Vyndamax Website for Health Care Professionals
 
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Your Heart's Message - Website for Consumers and Patients
 
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ATTR-CM: Suspect & Detect: Website for US HCPs
 
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Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

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If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.