Tafamidis meglumine

Indications

Tafamidis meglumine is used for: Transthyretin Amyloid Cardiomyopathy

Adult Dose

Transthyretin Amyloid Cardiomyopathy Indicated for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization 80 mg PO qDay

Child Dose

Renal Dose

Administration

May take with or without food

Contra Indications

Precautions

Pregnancy-Lactation

Pregnancy Based on animal studies, fetal harm may occur when administered to a pregnant woman Limited available human data with tafamidis meglumine use in pregnant women (at a dose of 20 mg/day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes Consider pregnancy planning and prevention for females of reproductive potential Animal data In animal reproductive studies, oral administration of tafamidis meglumine to pregnant rabbits during organogenesis resulted in adverse effects on development (embryofetal mortality, fetal body weight reduction, and fetal malformation) at a dosage providing ~9 times the human exposure (AUC) at the maximum recommended human dose (MRHD) of tafamidis meglumine 80 mg, and increased incidence of fetal skeletal variation at a dosage providing equivalent human exposure (AUC) at the MRHD Postnatal mortality, growth restriction, and impaired learning and memory were observed in offspring of pregnant rats administered tafamidis meglumine during gestation and lactation at a dosage ~2 times the MRHD based on body surface area Lactation No data available on the presence of tafamidis in human milk, effect on the breastfed infant, or the effect on milk production Tafamidis is present in rat milk; drug may likely be present in human milk Based on animal studies, which suggest the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment

Interactions

Breast cancer-resistant protein (BCRP) substrates Tafamidis inhibits BCRP in vitro and may increase exposure of BCRP substrates (eg, methotrexate, rosuvastatin, imatinib) if coadministered; dosage adjustment may be necessary

Side Effects

Side effects of Tafamidis meglumine :

Mode of Action

Selectively binds to transthyretin tetramer to prevent transthyretin transport protein destabilization and amyloid formation that causes ATTR-CM