VYNDAQEL® OR VYNDAMAX™ Dosage and Administration

(tafamidis meglumine or tafamidis)

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily.

VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis [see Clinical Pharmacology (12.3)].

2.2 Administration Instructions

The capsules should be swallowed whole and not crushed or cut.

If a dose is missed, instruct patients to take the dose as soon as remembered or to skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.

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Dosage and Administration

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily.

VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis [see Clinical Pharmacology (12.3)].

2.2 Administration Instructions

The capsules should be swallowed whole and not crushed or cut.

If a dose is missed, instruct patients to take the dose as soon as remembered or to skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.

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