• CHF and arrhythmias

Vyndamax Generic Name & Formulations

General Description

Tafamidis 61mg; soft gelatin caps.

Pharmacological Class

Transthyretin (TTR) stabilizer.

How Supplied


How Supplied

Reddish brown capsule printed with “VYN 61” in white.


Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).


Generic Availability


Vyndamax Indications


Treatment in adults with cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Vyndamax Dosage and Administration


Swallow whole. 61mg once daily. Not substitutable with Vyndaqel on a per mg basis.


Not established.

Other Modifications

Females of reproductive age: Use effective contraception.

Vyndamax Contraindications

Not Applicable

Vyndamax Boxed Warnings

Not Applicable

Vyndamax Warnings/Precautions


Pregnancy. Advise females of reproductive potential to consider pregnancy planning and prevention. Nursing mothers: not recommended.

Pregnancy Considerations

May cause fetal harm.

Report pregnancies to Pfizer at (800) 438-1985.

Nursing Mother Considerations

No available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production.

Based on findings from animal studies, breastfeeding is not recommended during treatment.

Pediatric Considerations

The safety and effectiveness of Vyndamax have not been established in pediatric patients.

Geriatric Considerations

No dosage adjustment is necessary for patients 65 years of age and older. 

Other Considerations for Specific Populations

Females of reproductive age: Use effective contraception.

Vyndamax Pharmacokinetics


Median tafamidis peak concentrations occurred within 4 hours following dosing.


Plasma protein binding of tafamidis is >99%.


Glucuronidation has been observed; however, metabolism of tafamidis has not been fully characterized.


Mean half-life of tafamidis is ~ 49 hours.

Approximately 59% of the dose was recovered in feces and approximately 22% of the dose was recovered in urine.

Vyndamax Interactions


May potentiate BCRP substrates (eg, methotrexate, rosuvastatin, imatinib); monitor and may need to adjust dose of substrate.

Vyndamax Adverse Reactions

Adverse Reactions



Vyndamax Clinical Trials

Clinical Trials

The efficacy of tafamidis was evaluated in a randomized, double-blind, placebo-controlled study that included 441 patients with wild-type or hereditary ATTR-CM (ClinicalTrials.gov Identifier: NCT01994889). Patients were randomly assigned to receive tafamidis 20mg (n=88), tafamidis 80mg (n=176), or placebo (n=177) once daily for 30 months in addition to standard of care (eg, diuretics).

The primary endpoint of the study was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations, which was defined as the number of times a patient was hospitalized for cardiovascular-related morbidity.

Results showed a significant reduction (P =.0006) in all-cause mortality and frequency of cardiovascular-related hospitalizations in the pooled tafamidis 20mg and 80mg groups vs placebo. An analysis of individual components showed a 30% relative reduction in the risk of death when compared with placebo (hazard ratio [HR] 0.70, 95% CI: 0.51, 0.96; P =.026). 

There were significantly fewer cardiovascular-related hospitalizations with tafamidis compared with placebo with a reduction in risk of 32% corresponding to a relative risk ratio of 0.68 (P <.0001). A significant treatment effect favoring tafamidis was first observed at month 6 and remained consistent through month 30 on both the 6-Minute

Walk Test (6MWT) and the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score.

Results of the primary analysis, 6MWT at month 30 and KCCQ-OS at month 30 were statistically significant for both the 80mg and 20mg doses of tafamidis vs placebo, with similar results for both doses.

The frequency of adverse events in patients treated with tafamidis was similar to that with placebo.

Vyndamax Note

Not Applicable

Vyndamax Patient Counseling

Patient Counseling

Vyndamax can cause fetal harm; report pregnancy immediately.

Breastfeeding is not recommended while on treatment.

Transthyretin Amyloidosis Outcome Survey (THAOS) registry: 

  • Designed to assess disease progression and the impact of interventions.
  • Participation is voluntary and involves long-term follow-up.

Cost Savings Program