Vyndamax Generic Name & Formulations
Legal Class
Rx
General Description
Tafamidis 61mg; soft gelatin caps.
Pharmacological Class
Transthyretin (TTR) stabilizer.
How Supplied
Caps—30
Manufacturer
Generic Availability
NO
Vyndamax Indications
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
Adult
Swallow whole. 61mg once daily. Not substitutable with Vyndaqel on a per mg basis.
Children
Not established.
Other Modifications
Females of reproductive age: Use effective contraception.
Vyndamax Contraindications
Not Applicable
Vyndamax Boxed Warnings
Not Applicable
Vyndamax Warnings/Precautions
Warnings/Precautions
Pregnancy. Advise females of reproductive potential to consider pregnancy planning and prevention. Nursing mothers: not recommended.
Vyndamax Pharmacokinetics
Absorption
Median tafamidis peak concentrations occurred within 4 hours following dosing.
Distribution
Plasma protein binding of tafamidis is >99%.
Elimination
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
Interactions
May potentiate BCRP substrates (eg, methotrexate, rosuvastatin, imatinib); monitor and may need to adjust dose of substrate.
Vyndamax Adverse Reactions
Vyndamax Clinical Trials
Vyndamax Note
Not Applicable