- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of tafamidis.
Treatment of wild-type or hereditary ATTR-CM
Treatment of wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.
Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.
The recommended dose is 61mg of tafamidis once daily.
Additional Dosage Information
If vomiting occurs after dosing and the capsule is identified and intact, then an additional dose should be administered. If no capsule is identified, then no additional dose is necessary. Resume with next day dosing as usual.
Children under 18 years
Solid organ transplant recipients
Hereditary fructose intolerance
Precautions and Warnings
Females of childbearing potential
New York Heart Association class IV failure
Renal impairment - creatinine clearance below or equal to 30ml/minute
Severe hepatic impairment
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
May affect results of some laboratory tests
Discontinue if patient undergoes organ transplant
Female: Contraception required during and for 1 month after treatment
Patients should be monitored continually to assess the need for other therapy, including the need for organ transplantation.
Before treatment begins with 61mg dose, ensure patients presenting with specific medical history or signs of heart failure or cardiomyopathy have an aetiologic diagnosis to confirm transthyretin amyloidosis with cardiomyopathy and exclude AL amyloidosis. Diagnosis should be performed via bone scintigraphy and blood/urine assessment and/or by biopsy, and transthyretin genotyping to characterise as wild type or hereditary.
Treatment should be initiated as soon as possible in the disease course. However if amyloid related cardiac damage is advanced such as New York Heart Association Class III, treatment initiation or continuation is taken at the discretion of the physician.
Pregnancy and Lactation
Tafamidis is contraindicated during pregnancy.
The manufacturers do not recommend using tafamidis during pregnancy and in women of childbearing potential not using contraception. Animal studies have shown developmental toxicity. Human data is limited and as such a potential risk cannot be ruled out.
Tafamidis is contraindicated during breastfeeding.
The manufacturers do not recommend breastfeeding whilst taking tafamidis. Animal studies indicate tafamidis is expressed in the breast milk, but the quantity is unknown.
Altered liver function tests
Effects on Laboratory Tests
An increase in liver function tests and a decrease in total thyroxine with no accompanying change to free thyroxine (T4) or thyroid stimulating hormone (TSH) may occur during tafamidis treatment.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2020
Summary of Product Characteristics: Vyndaqel 61mg soft capsules. Pfizer Ltd. Revised February 2020.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.