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Vyndaqel Generic Name & Formulations
Legal Class
Rx
General Description
Tafamidis meglumine 20mg; soft gelatin caps.
Pharmacological Class
Transthyretin (TTR) stabilizer.
How Supplied
Caps—120
Manufacturer
Generic Availability
NO
Mechanism of Action
Tafamidis is a selective stabilizer of transthyretin (TTR). Tafamidis binds to TTR at the thyroxine binding sites, stabilizing the tetramer and slowing dissociation into monomers, the rate-limiting step in the amyloidogenic process.
Vyndaqel 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.
Vyndaqel Dosage and Administration
Adult
Swallow whole. 80mg once daily. Not substitutable with Vyndamax on a per mg basis.
Children
Not established.
Vyndaqel Contraindications
Not Applicable
Vyndaqel Boxed Warnings
Not Applicable
Vyndaqel Warnings/Precautions
Warnings/Precautions
Pregnancy. Advise females of reproductive potential to consider pregnancy planning and prevention. Nursing mothers: not recommended.
Vyndaqel Pharmacokinetics
Distribution
Steady state volume of distribution: 16 L.
Elimination
Fecal (59%); renal (22%). Apparent oral clearance of tafamidis meglumine: 0.228 L/h.
Vyndaqel Interactions
Interactions
May potentiate BCRP substrates (eg, methotrexate, rosuvastatin, imatinib); monitor and may need to adjust dose of substrate.
Vyndaqel Adverse Reactions
Not Applicable
Vyndaqel Clinical Trials
See Literature
Vyndaqel Note
Not Applicable
Vyndaqel Patient Counseling
See Literature
