Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy (ATTR-PN).
The recommended dose of tafamidis meglumine is 20 mg orally once daily.
Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.
If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual.
No dosage adjustment is required for elderly patients (≥65 years) (see section 5.2).
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 meglumine has not been studied in patients with severe hepatic impairment and caution is recommended (see section 5.2).
There is no relevant use of tafamidis in the paediatric population.
Oral use.
The soft capsules should be swallowed whole and not crushed or cut. Vyndaqel may be taken with or without food.
There is minimal clinical experience with overdose. During clinical trials, two patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) accidentally ingested a single tafamidis meglumine dose of 160 mg without the occurrence of any associated adverse events. The highest dose of tafamidis meglumine given to healthy volunteers in a clinical trial was 480 mg as a single dose. There was one reported treatment-related adverse event of mild hordeolum at this dose.
In case of overdose, standard supportive measures should be instituted as required.
2 years.
Do not store above 25°C.
PVC/PA/alu/PVC-alu/PET/Paper perforated unit dose blisters.
Pack sizes: a pack of 30 × 1 soft capsules and a multipack containing 90 (3 packs of 30 × 1) soft capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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