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The recommended dosage is 61 mg (one 61-mg tafamidis capsule) orally once daily. The soft capsules should be swallowed whole and not crushed or cut. Vyndamax may be taken with or without food.
Vyndamax and Vyndaqel (tafamidis meglumine) are not substitutable on a per mg basis.
Vyndamax is not indicated for children and adolescents under 18 years of age. The safety and effectiveness of Vyndamax have not been established in pediatric patients.
No dosage adjustment is required for elderly patients (≥65 years). See prescribing information for full details.
Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Hypersensitivity to the active substance or to any of the excipients.
Women of childbearing potential should use appropriate contraception when taking tafamidis and continue to use appropriate contraception for 1-month after stopping treatment with tafamidis.
Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation.
Increase in liver function tests and decrease in thyroxine may occur.
This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. See prescribing information for full details.
Flatulence. See prescribing information for full details.
In a clinical study in healthy volunteers, 20 mg tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4. See prescribing information for full details.
Laboratory test abnormality Tafamidis may decrease serum concentrations of total thyroxine, without an accompanying change in free thyroxine (T4) or thyroid stimulating hormone (TSH). This observation in total thyroxine values may likely be the result of reduced thyroxine binding to or displacement from TTR due to the high binding affinity tafamidis has to the TTR thyroxine receptor. No corresponding clinical findings consistent with thyroid dysfunction have been observed.
Pregnancy and Lactation
Pregnancy: There are no data on the use of tafamidis in pregnant women. Tafamidis is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: Tafamidis should not be used during breast-feeding. See prescribing information for full details.
There is minimal clinical experience with overdose. During clinical trials, two patients diagnosed with ATTR-CM accidentally ingested a single tafamidis meglumine dose of 160 mg without the occurrence of any associated adverse events. The highest dose of tafamidis meglumine given to healthy volunteers in a clinical trial was 480 mg as a single dose. There was one reported treatment-related adverse event of mild hordeolum at this dose. Management in case of overdose, standard supportive measures should be instituted as required.
On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis is believed to have no or negligible influence on the ability to drive or use machines.
Store below 25ċ