4.1 Dosing Considerations
VYNDAMAX (tafamidis) capsules and VYNDAQEL (tafamidis meglumine) capsules are different formulations with the active moiety tafamidis. To avoid dosing errors, it is important that prescriptions of tafamidis/tafamidis meglumine specify the salt form and the prescribed dose. VYNDAMAX and VYNDAQEL are not interchangeable on a per mg basis (see 10.3 Pharmacokinetics, Section 14.3 Comparative Bioavailability Studies and the Product Monograph for VYNDAQEL).
4.2 Recommended Dose and Dosage Adjustment
The recommended dose of VYNDAMAX (tafamidis) is 61 mg tafamidis (administered as one 61‑mg tafamidis capsule) orally once daily.
The recommended dose of VYNDAQEL (tafamidis meglumine) is 80 mg administered as 4 x 20 mg tafamidis meglumine capsules (equivalent to 48.8 mg tafamidis) orally once daily.
The dose may be reduced to one capsule of 20 mg VYNDAQEL (tafamidis meglumine) (equivalent to 12.2 mg of tafamidis) if not tolerated (see 14 Clinical Trials section and also Product Monograph for VYNDAQEL).
VYNDAMAX should not be used during pregnancy (see 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women).
Women of childbearing potential should use appropriate contraception when taking VYNDAMAX and continue to use contraception for one month after stopping treatment.
Pediatrics (<18 years of age)
VYNDAMAX is not indicated in the pediatric population.
Geriatrics (≥65 years of age)
No dosage adjustment is required for elderly patients (≥65 years). Of the total number of patients receiving tafamidis meglumine in the ATTR-CM clinical study (n=441), 90.5% were 65 and over, with a median age of 75 years.
Renal or hepatic impairment
VYNDAMAX has not been studied in patients with severe hepatic impairment and use is not recommended in these patients. No dosage adjustment is required for patients with mild or moderate hepatic impairment. Data are limited in patients with severe renal impairment. No dosage adjustment is required for patients with renal impairment.
The capsule(s) should be swallowed whole and not crushed or cut. VYNDAMAX may be taken with or without food.
4.5 Missed Dose
If a dose is missed, the patient should take the dose as soon as remembered. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.