What is the usage of Vyndamax (Tafamidis)?

From the Guidelines

Vyndamax (tafamidis) is used to treat adults with cardiomyopathy caused by transthyretin amyloidosis (ATTR-CM), with a standard dosage of 61 mg taken orally once daily, with or without food. The treatment is typically long-term, helping to slow the progression of the disease rather than cure it.

• The capsule should be swallowed whole and not crushed or cut.
• Vyndamax works by stabilizing the transthyretin protein, preventing it from breaking apart and forming harmful amyloid deposits in the heart.
• This helps maintain heart function and may improve survival, as shown in the ATTR-ACT clinical trial, where tafamidis had lower all-cause mortality (29.5% versus 42.9%) and lower cardiovascular-related hospitalization (0.48 versus 0.70 per year) after 30 months 1.
• Common side effects include respiratory tract infections, dizziness, and diarrhea.
• Regular follow-up appointments with a cardiologist are necessary to monitor heart function and treatment effectiveness.
• Patients should inform their healthcare provider about all medications they're taking, as certain drug interactions may occur.
• Vyndamax is expensive, so insurance coverage verification is important before starting treatment.
• The use of tafamidis is recommended for patients with ATTR-CA and NYHA functional class I-III symptoms, with the expected benefit being greater in patients with NYHA functional class I-II symptoms 1.
• However, the role of tafamidis in patients with NYHA functional class III symptoms is still an unmet need, and the use of varying doses of tafamidis when patients face financial toxicity from this therapy is also an important consideration 1.

From the FDA Drug Label

VYNDAQEL and VYNDAMAX are transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are prescription medicines used to treat adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.

The usage of Vyndamax (Tafamidis) is for the treatment of:

• Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults
• To reduce cardiovascular mortality and cardiovascular-related hospitalization 2, 2, 2

From the Research

Usage of Vyndamax (Tafamidis)

• Vyndamax (Tafamidis) is used to treat transthyretin amyloidosis with polyneuropathy (ATTR-PN), a rare and progressive hereditary disorder 3.
• Tafamidis is administered orally once daily, as a soft capsule, to delay peripheral neurological impairment in adults with stage 1 symptomatic polyneuropathy 3.
• The drug is also used to treat hereditary and wild-type ATTR cardiomyopathy in adults, with an approved dose of 80-mg, once-daily (4 × 20-mg capsules) in the United States, Japan, Canada, and Brazil 4.
• An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) is available for patient convenience, and has been shown to be bioequivalent to tafamidis meglumine 80-mg (4 × 20-mg capsules) 4.
• Tafamidis has been shown to slow deterioration of neurological function and maintain health-related quality of life in patients with early-stage ATTR-PN and the Val30Met mutation 3, 5, 6.
• The drug has also been shown to stabilize TTR in cerebrospinal fluid (CSF) to a clinically meaningful extent at CSF concentrations achieved by the normal tafamidis dosing regimen 7.

Dosage and Administration

• Tafamidis can be dosed at 20 or 80 mg QD, with the latter dose being bioequivalent to a 61 mg QD dose of tafamidis free acid (Vyndamax) 7.
• The tafamidis CSF concentration in ATTRv patients on 20 mg Vyndaqel is approximately 125 nM, and is expected to be around 500 nM at the higher dose of 80 mg QD 7.

Clinical Benefits

• Tafamidis has been shown to slow neurologic deterioration and preserve nutritional status, as well as quality of life in patients with early-stage Val30Met amyloidosis 5, 6.
• The drug has also been shown to reduce the progress of neuropathy, and maintain the nutritional status and quality of life of stage 1 Val30Met TTR-FAP patients 6.