4.1 Dosing Considerations
- VYNDAQEL (tafamidis meglumine) capsules and VYNDAMAX (tafamidis) capsules are different formulations with the active moiety tafamidis. To avoid dosing errors, it is important that prescriptions should specify VYNDAQEL (tafamidis meglumine) or VYNDAMAX (tafamidis) and the prescribed dose. VYNDAQEL and VYNDAMAX are not interchangeable on a per mg basis (see 10.3 Pharmacokinetics, 14.3 Comparative Bioavailability Studies of the Product Monograph for VYNDAMAX). The recommended dose of VYNDAMAX (tafamidis) is 61 mg tafamidis (administered as one 61 mg tafamidis capsule) orally once daily.
4.2 Recommended Dose and Dosage Adjustment
The recommended dose is VYNDAQEL (tafamidis meglumine) 80 mg administered as four 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 if not tolerated (see 14 CLINICAL TRIALS).
Pregnant Women: VYNDAQEL 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 VYNDAQEL and continue to use contraception for 1‑month after stopping treatment.
Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age): No dosage adjustment is required for elderly patients (≥65 years).
Renal or hepatic impairment: VYNDAQEL 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 capsules should be swallowed whole and not crushed or cut. VYNDAQEL 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.