tafamidis meglumine: clinical use

Prescribing considerations

• Initiation should be supervised by a clinician experienced in transthyretin amyloid polyneuropathy.
• Use alongside appropriate standard care and continue assessing disease progression and the need for other therapy.
• Review concurrent BCRP substrates and monitor for their adverse effects.
• Discontinue if the patient undergoes liver transplantation because post-transplant use has not been studied.
• Consider the capsule’s sorbitol content when relevant to fructose or sorbitol exposure.

Contraindications and cautions

• Hypersensitivity to tafamidis meglumine or any capsule excipient.
• Not recommended during pregnancy or where required contraception is not being used.
• Do not use during breastfeeding.
• Limited evidence in severe renal impairment; severe hepatic impairment has not been studied and requires caution.

Monitoring

• Clinical progression of polyneuropathy and overall functional and nutritional status.
• Ongoing need for other disease-directed management, including transplantation assessment.
• Adverse effects from concomitant BCRP substrates.
• Interpret total thyroxine cautiously: tafamidis can lower total thyroxine without changing free thyroxine or thyroid-stimulating hormone.

Clinical pharmacology

Tafamidis selectively binds the thyroxine-binding sites of transthyretin and kinetically stabilises its tetramer. It is highly protein-bound, has a prolonged half-life and is thought to undergo glucuronidation followed mainly by biliary and faecal elimination.

Formulation and product differences

• Tafamidis meglumine and tafamidis formulations are not interchangeable on a milligram-for-milligram basis.
• The selected product is a soft capsule containing tafamidis as the meglumine salt and must be swallowed whole.
• The capsule contains sorbitol.

Capsule

Route: Oral

Strengths: 20 mg