Generic drug: tafamidis meglumine and tafamidis
Brand name: Vyndaqel and Vyndamax
What is Vyndaqel and Vyndamax, and how does it work?
Vyndaqel and Vyndamax are prescription medicines used to treat adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.
It is not known if Vyndaqel and Vyndamax are safe and effective in children.
Before taking Vyndaqel or Vyndamax, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. Vyndaqel and Vyndamax may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Vyndaqel or Vyndamax. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.
- are breastfeeding or plan to breastfeed. It is not known if Vyndaqel or Vyndamax passes into your breast milk. You should not breastfeed during treatment with Vyndaqel or Vyndamax. Talk to your healthcare provider about the best way to feed your baby during treatment with Vyndaqel or Vyndamax.
What are the side effects of Vyndaqel and Vyndamax?
You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Vyndaqel and Vyndamax?
- 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.
- 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.
What drugs interact with Vyndaqel and Vyndamax?
- 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.
Is Vyndaqel and Vyndamax safe to use while pregnant or breastfeeding?
- 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