Vyndaqel (tafamidis)

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Vyndaqel (tafamidis) is a medication used for the treatment of transthyretin amyloidosis in adults with early-stage symptomatic polyneuropathy.

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What is Vyndaqel (tafamidis)?

Vyndaqel (tafamidis) is a medicine indicated for the treatment of transthyretin amyloidosis in patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment^[1]. Vyndaqel (tafamidis) is the first medication approved to stabilise the protein transthyretin (TTR) from misfolding and forming amyloids^[3].

It is available in capsule form each containing 20mg of tafamidis.

Who is Vyndaqel (tafamidis) for?

Vyndaqel (tafamidis) is indicated for adults with stage 1 transthyretin familial amyloid polyneuropathy (TTR-FAP).

Polyneuropathies, or peripheral neuropathies, result from damage to the peripheral nerves (nerves that go from the spinal cord to the arms, hands, legs, and feet^[2]), which often result in a sense of weakness, numbness and pain in the extremities^[1,4].

How does Vyndaqel (tafamidis) work?

Transthyretin amyloidosis is a rare disease characterised by the presence of a defective blood protein called transthyretin (TTR). This defective protein breaks easily, which results in the deposition of a fibrous substance (amyloid fibrils) within the body^[5]. The accumulation of amyloid fibrils causes damage to body structures, like tissues and organs, and prevents their normal function^[5]. When the nerves are affected the disease is called transthyretin familial amyloid polyneuropathy (TTR-FAP)^[10].

The active substance in Vyndaqel, tafamidis, is a transthyretin stabiliser. It attaches to transthyretin, the defective protein, and makes it stable. In this way, it prevents the protein from breaking up, and it may thus stop the formation of amyloid fibrils and slow down the progression of the neurological disorder^[5].

Where has Vyndaqel (tafamidis) been approved?

Vyndaqel (tafamidis) has been approved for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) by the:

EMA (EU), November 2011^[1]
FDA (USA), May 2019^[7]
Health Canada, January 2020^[11]
PMDA (Japan), September 2013^[12]
TGA (Australia), March 2020^[13]

It is also approved in Brazil, Argentina and Russia for this indication. Other countries, such as Australia, have granted it orphan drug designation. Orphan drug and fast track designations are processes designed to facilitate and expedite the development of a medicine to treat serious conditions and fill an unmet medical need^[8].

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team for assistance.

Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.

How is Vyndaqel (tafamidis) taken?

The standard dosage is:

20 mg orally once daily^[1].

Complete information about Vyndaqel (tafamidis) dosage and administration can be found in the official prescribing information listed in our references section^[1].

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Vyndaqel (tafamidis)?

Possible Side Effects

The most common adverse reactions listed in the prescribing information include^[1]:

diarrhoea
urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)
vaginal infection in women
stomach ache or abdominal pain.

Use in specific populations

It is advised to avoid pregnancy and breastfeeding during and for one month after treatment with Vyndaqel (tafamidis)^[1].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1].

References

Summary of Product Characteristics [EMA]: Vyndaqel (tafamidis)[PDF],

Pfizer Limited, November 2011

European public assessment report (EPAR) for Vyndaqel[PDF],

Pfizer Limited, November 2011

Pfizer Press Release, Pfizer’s Vyndaqel (tafamidis) first therapy approved in the European Union for the rare and fatal neurodefenerative disease transthyretin familial amyloid polyneuropathy (TTR-FAP),

www.pfizer.com, October 2018