Vyndaqel was generally well tolerated in the ATTR-ACT trial²

Safety data are based on 176 patients with ATTR-CM with 80 mg tafamidis meglumine daily (4 x 20 mg) in a 30-month placebo-controlled trial¹

A causal relationship has not been established.

From cumulative clinical data in ATTR-CM participants.¹

Common AEs (occurring > 1% to <10% of patients) including diarrhoea, rash and pruritus

VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine.
Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.¹

References:
1. VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.

2. Maurer MS, Schwartz JH, Gundapaneni B, et al. N Eng J Med. 2018;379:1007–1016.

3. Nice. [TA984]. Tafamadis for treating transthyretin amyloidosis with cardiomyopathy. Available at: Overview | Tafamidis for treating transthyretin amyloidosis with cardiomyopathy | Guidance | NICE [Last accessed Jan 2026].

4. BNF. Tafamidis. Available at: https://bnf.nice.org.uk/drugs/tafamidis/ [Last accessed Jan 2026].

VYNDAQEL - a convenient, once-daily, single-dose oral capsule¹

• Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy
• Amyloid light chain (AL) amyloidosis must be excluded before starting treatment with VYNDAQEL

VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. 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

• Hepatic and renal impairment: No dosage adjustment is required for patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis has not been studied in patients with severe hepatic impairment and caution is recommended

Special warnings and precautions for use

• Women of childbearing potential should use appropriate contraception when taking tafamidis and continue to use appropriate contraception for 1 month after stopping treatment with tafamidis
• Tafamidis should be discontinued in those who undergo organ transplantation
• Increase in liver function tests and decrease in thyroxine may occur
• Each tafamidis 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

Pregnancy and Lactation

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