Vyndamax Dosage/Direction for Use

Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy.
When there is a suspicion in patients presenting with specific medical history or signs of heart failure or cardiomyopathy, etiologic diagnosis must be done by a physician knowledgeable in the management of amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL amyloidosis before starting tafamidis, using appropriate assessment tools such as: bone scintigraphy and blood/urine assessment, and/or histological assessment by biopsy, and transthyretin (TTR) genotyping to characterise as wild-type or hereditary.
Posology: The recommended dose is one capsule of Vyndamax 61 mg (tafamidis) orally once daily (see Pharmacology: Pharmacodynamics under Actions).
Vyndamax should be started as early as possible in the disease course when the clinical benefit on disease progression could be more evident. Conversely, when amyloid-related cardiac damage is more advanced, such as in NYHA Class III, the decision to start or maintain treatment should be taken at the discretion of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy (see Pharmacology: Pharmacodynamics under Actions). There are limited clinical data in patients with NYHA Class IV.
If vomiting occurs after dosing, and the intact Vyndamax capsule is identified, then an additional dose of Vyndamax 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.
Special populations: Elderly: No dosage adjustment is required for elderly patients (≥65 years) (see Pharmacology: Pharmacokinetics under Actions).
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 (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of tafamidis in the paediatric population.
Method of administration: Oral use.
The soft capsules should be swallowed whole and not crushed or cut. 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.