VYNDAMAX SOFT GELATIN CAPSULE 61MG
4.1 Therapeutic indications
VYNDAQEL/VYNDAMAX is indicated for the treatment of transthyretin amyloidosis in adult patients with wild-type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients of VYNDAQEL/VYNDAMAX (see Section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
4.2 Posology and method of administration
Posology
The recommended dose of VYNDAQEL/VYNDAMAX is 61 mg tafamidis orally once daily (see Section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or 80 mg tafamidis meglumine (administered as four 20 mg capsules) once daily.
VYNDAQEL/VYNDAMAX can be taken with or without food.
A single 61 mg tafamidis capsule is bioequivalent to 80 mg tafamidis meglumine (four 20 mg tafamidis meglumine capsules). The two formulations are not interchangeable on a per mg basis (see Sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Special populations
Paediatric
VYNDAQEL/VYNDAMAX should not be prescribed in the paediatric population as transthyretin amyloidosis is not a disease present in this population.
Elderly
No dosage adjustment is required for elderly patients (≥65 years) (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Renal or hepatic impairment
No dosage adjustment is required for patients with renal impairment, or mild or moderate hepatic impairment. VYNDAQEL/VYNDAMAX has not been studied in patients with severe hepatic impairment.
Method of administration
Oral use.
The capsule(s) should be swallowed whole and not crushed or cut. VYNDAQEL/VYNDAMAX may be taken with or without food.
If a dose is missed, the patient should take the dose as soon as remembered. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.
