Indications:
VYNDAMAX™ is indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.1
The recommended dosage of VYNDAMAX™ 61 mg (one 61-mg tafamidis capsule) orally once daily. 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. No clinically significant differences in the pharmacokinetics of tafamidis were observed following administration of a high fat, high calorie meal.1
Contraindications: None.1
In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with tafamidis was similar to placebo.1
Pregnancy: VYNDAMAX™ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.1
Lactation: 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. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Based on findings from animal studies which suggest the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with VYNDAMAX™.1
MOA: mechanism of action; MOD: mechanism of disease.
MOA: mechanism of action; MOD: mechanism of disease.
MOH Approval No. : HF0098OA171/082022
Invalidation Date : 11/08/2024
