Vyndamax Tafamidis Soft Capsules

1. Indications and Usage
Transthyretin Amyloid Cardiomyopathy (ATTR-CM): Treatment of adult patients with transthyretin amyloid cardiomyopathy to reduce the risk of cardiovascular mortality and cardiovascular-related hospitalization.
Indicated for the treatment of adult wild-type or hereditary transthyretin amyloidosis cardiomyopathy (ATTR-CM).
2. Dosage and Administration
Recommended Dose: 61 mg once daily (One capsule).
Administration: Oral administration. The capsule should be swallowed whole and not crushed or cut.
Food Requirement: Can be taken with or without food.
Missed Dose: If a dose is missed, take it as soon as possible. Resume the normal schedule the next day. Do not take a double dose.
Note on Interchangeability: The 61 mg Tafamidis Soft Capsule is bioequivalent to the 80 mg Tafamidis Meglumine Soft Capsule (4 x 20 mg), but they are not interchangeable on a milligram-for-milligram basis.
3. Mechanism of Action
Tafamidis is a selective and high-affinity kinetic stabilizer of the transthyretin (TTR) tetramer.
It binds to the thyroxine-binding sites of the TTR tetramer, preventing its dissociation into monomers (the rate-limiting step in amyloid fibril formation).
By stabilizing the tetramer, it inhibits the misfolding and aggregation of TTR into amyloid fibrils.
4. Safety and Warnings
Embryo-Fetal Toxicity: May cause fetal harm based on animal data. Contraception is recommended for females of reproductive potential during treatment and for 1 month after the final dose.
Lactation: Breastfeeding is not recommended due to potential serious adverse reactions in infants.
Monitoring: Periodic monitoring of clinical symptoms and laboratory parameters is recommended.
5. Adverse Reactions
Based on clinical trial data (primarily using Tafamidis Meglumine which shares the same active moiety), the incidence of adverse reactions was similar to placebo.
Commonly reported adverse reactions include:
Gastrointestinal: Diarrhea, Nausea, Dyspepsia.
Infections: Urinary tract infection, Vulvovaginal infection.
Neurologic: Headache, Dizziness.
6. Drug Interactions
BCRP Substrates: Tafamidis may inhibit Breast Cancer Resistance Protein (BCRP). Use caution when co-administering with BCRP substrates (e.g., methotrexate, rosuvastatin, imatinib) as exposure to these drugs may increase, potentially requiring dose adjustment.
CYP450: Tafamidis does not significantly inhibit or induce major CYP450 enzymes (except for weak induction of CYP2B6 and CYP3A4 observed in vitro).
7. Pharmaceutical Information
Chemical Name: 2-(3,5-Dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid.
Molecular Formula: C14H7Cl2NO3.
Storage: Store at 25°C or less in a dry place.