Medically reviewed by Drugs.com. Last updated on Jun 20, 2020.
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- Tafamidis Meglumine
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Vyndamax: 61 mg
Capsule, Oral, as meglumine:
Vyndaqel: 20 mg [contains brilliant blue fcf (fd&c blue #1)]
Brand Names: U.S.
- Transthyretin Stabilizer
Tafamidis is a transthyretin (TTR) stabilizer that selectively binds to TTR at the thyroxine binding sites and stabilizes the tetramer of the TTR transport protein, slowing dissociation into monomers which is the rate-limiting step in the amyloidogenic process. Tafamidis stabilizes both wild-type TTR tetramers and the tetramers of 14 TTR variants when tested clinically as well as 25 TTR variants tested ex vivo.
Tafamidis: Vdss: 18.5 L
Tafamidis: Not fully established; glucuronidation has been observed
Tafamidis meglumine: Feces: ~59% (unchanged); Urine: ~22% (glucuronide metabolite)
Tafamidis: Clearance: 0.236 L/hour
Time to Peak
Tafamidis: 4 hours
Tafamidis: ~49 hours
Tafamidis: >99%, primarily TTR
Special Populations: Hepatic Function Impairment
In moderate hepatic impairment (Child-Pugh class B), tafamidis systemic exposure decreased (~40%) and clearance increased (~68%) compared to healthy subjects. Since TTR levels are lower with moderate hepatic impairment, exposure of tafamidis relative to the amount of TTR is sufficient to maintain stabilization of the TTR tetramer in these patients.
Use: Labeled Indications
Amyloid cardiomyopathy: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Additional contraindications not in the US labeling: Hypersensitivity to tafamidis or any component of the formulation.
Amyloid cardiomyopathy: Oral:
Note: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Tafamidis (Vyndamax): 61 mg once daily.
Tafamidis meglumine (Vyndaqel): 80 mg once daily.
Refer to adult dosing.
Oral: Swallow capsules whole; do not crush or cut.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
BCRP/ABCG2 Substrates: Tafamidis may increase the serum concentration of BCRP/ABCG2 Substrates. Monitor therapy
There are no adverse reactions listed in the manufacturer's labeling.
• Appropriate use: Equivalency: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Based on adverse events observed in animal reproduction studies, the manufacturer recommends pregnancy planning and pregnancy prevention in females of reproductive potential.
Information related to tafamidis use in pregnancy is limited and based on doses of 20 mg/day.
What is this drug used for?
• It is used to treat a type of heart problem (cardiomyopathy).
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about tafamidis
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 3 Reviews
- Drug class: transthyretin stabilizers
Other brands: Vyndaqel