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Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

VYNDAQEL dosingOral VYNDAQEL 61 mg – a convenient, once-daily, single-dose capsule1
  • Amyloid light chain (AL) amyloidosis must be excluded before starting treatment with VYNDAQEL
  • Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy
VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.1

Contraindications, special warnings and precautions for use1

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Special populations

  • VYNDAQEL has not been studied in patients with severe hepatic impairment and caution is recommended

Special warnings

  • Women of childbearing potential should use appropriate contraception when taking VYNDAQEL and continue to use appropriate contraception for 1 month after stopping treatment with VYNDAQEL
  • VYNDAQEL should be discontinued in those who undergo organ transplantation
  • Increase in liver function tests and decrease in thyroxine may occur
  • Each VYNDAQEL capsule contains no more than 44 mg sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account as it may affect the bioavailability of other medicinal products for oral use administered concomitantly

Precautions for use

  • Pregnancy: There are no data on the use of VYNDAQEL in pregnant women. Studies in animals have shown developmental toxicity. VYNDAQEL is not recommended during pregnancy and in women of childbearing potential not using contraception
  • Lactation: Available data in animals have shown excretion of VYNDAQEL in milk. A risk to the newborns/infants cannot be excluded. VYNDAQEL should not be used during breast-feeding
Interactions with other medicinal products1

Interaction with other medicinal products and other forms of interaction

  • In vitro tafamidis inhibits the efflux transporter BCRP and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib). In a clinical study in healthy participants, the exposure of the BCRP substrate rosuvastatin increased approximately 2-fold following multiple doses of VYNDAQEL 61 mg daily dosing
  • Likewise tafamidis inhibits the uptake transporters OAT1 and OAT3 and may cause drug-drug interactions at clinically relevant concentrations with substrates of these
    transporters (e.g., non-steroidal anti-inflammatory drugs, bumetanide, furosemide,
    lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir,
    zidovudine, zalcitabine). Based on in vitro data, the maximal predicted changes in AUC of OAT1 and OAT3 substrates were determined to be less than 1.25 for the VYNDAQEL 61 mg dose, therefore, inhibition of OAT1 or OAT3 transporters by VYNDAQEL is not expected to result in clinically significant interactions
  • No interaction studies have been performed evaluating the effect of other medicinal products on VYNDAQEL

Laboratory test abnormality 

  • VYNDAQEL may decrease serum concentrations of total thyroxine, without an accompanying change in free thyroxine or thyroid stimulating hormone. No corresponding clinical findings consistent with thyroid dysfunction have been observed
Explore more We have a team ready to support you with any queries.Get in touchLoading

References:

VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.
PP-VYN-GBR-1128. November 2023

Learn about the efficacy of VYNDAQEL in patients with ATTR-CM

 ATTR-ACT results Loading

Learn more about the pathogenesis of ATTR-CM and how VYNDAQEL works

 About ATTR-CM and VYNDAQEL Loading

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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