In patients treated continuously with VYNDAQEL 80 mg to VYNDAQEL (tafamidis) 61 mg*, no new safety concerns were identified throughout the ATTR-ACT LTE study, and adverse events remained similar to placebo²

• Patients who completed ATTR-ACT were eligible to enroll in the LTE study, with placebo-treated patients randomized to VYNDAQEL 80 mg or 20 mg (2:1); median follow-up of ~58 months across both studies²
• All patients were then transitioned to VYNDAQEL 61 mg* per the amended protocol²

Contra-indications: Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1 of SPC. Warnings and Precautions: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis and for one month after stopping treatment. Tafamidis should be added to the standard of care for the treatment of patients with transthyretin amyloidosis. Physicians should monitor patients and continue to assess the need for other therapy, including the need for organ transplantation, as part of this standard of care. As there are no data available regarding the use of tafamidis in organ transplantation, tafamidis should be discontinued in patients who undergo organ transplantation.
Increase in liver function tests and decrease in thyroxine may occur. This medicinal product contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Undesirable Effects: Safety data for tafamidis 61 mg are available from its open-label long-term extension study. Adverse reactions from cumulative clinical data in ATTR-CM participants: Common ( 1/100 to < 1/10) Diarrhoea, rash, pruritus.

Within the frequency group, adverse reactions are presented in order of decreasing seriousness. Adverse reactions listed in the table below are from cumulative clinical data in ATTR-CM participants.

• VYNDAQEL may decrease serum concentrations of total thyroxine, without an accompanying change in free thyroxine (T4) or thyroid-stimulating hormone (TSH). No corresponding clinical findings consistent with thyroid dysfunction have been observed¹
• Safety data for VYNDAQEL 61 mg was not evaluated in the double-blind, placebo-controlled, randomized phase 3 study¹

• 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 contraception¹]
• BREASTFEEDING
  [Available data in animals have shown excretion of tafamidis in milk. A risk to newborns/infants cannot be excluded. VYNDAQEL should not be used during breastfeeding¹]