Vyndaqel and Vyndamax (tafamidis meglumine and tafamidis)

There were no known side effects that happened during treatment with Vyndaqel or Vyndamax in people with cardiomyopathy of transthyretin-mediated amyloidosis.

You may report side effects to FDA at 1-800-FDA-1088.

• 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.

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.

BCRP Substrates

• Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) following Vyndaqel 80 mg or Vyndamax 61 mg.
• Dose adjustment may be needed for these substrates.

• Based on findings from animal studies, Vyndaqel and Vyndamax may cause fetal harm when administered to a pregnant woman. However, limited available human data with Vyndaqel use in pregnant women (at a dose of 20 mg per day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production.
• Breastfeeding is not recommended during treatment with Vyndaqel or Vyndamax.