Vyndamax Capsule, Soft
Tafamidis meglumine
61 mg
CATALENT PHARMA SOLUTIONS
| Pack size | 30's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1328.02 AED |
Indications
Vyndamax Capsule, Soft 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
Adverse Effects
Side effects of Tafamidis meglumine :
Mechanism of Action
Selectively binds to transthyretin tetramer to prevent transthyretin transport protein destabilization and amyloid formation that causes ATTR-CM
Note
Vyndamax 61 mg Capsule, Soft manufactured by CATALENT PHARMA SOLUTIONS. Its generic name is Tafamidis meglumine. Vyndamax is availble in Saudi Arabia.
Farmaco SA drug index information on Vyndamax Capsule, Soft is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.