Tafamidis: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Thailand prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Hereditary transthyretin-mediated amyloidosis cardiomyopathy, Wild-type transthyretin-mediated amyloidosis cardiomyopathy

Adult: To decrease CV-related hospitalisation and mortality: As tafamidis 61 mg cap (equivalent to tafamidis meglumine 80 mg): 1 cap once daily. As tafamidis meglumine 20 mg cap: 4 caps once daily. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Hereditary transthyretin-mediated amyloidosis polyneuropathy

Adult: To slow down peripheral neurologic impairment in patients with stage 1 symptomatic polyneuropathy: As tafamidis meglumine 20 mg cap: 1 cap once daily. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Administration

May be taken with or without food. Swallow whole, do not crush/cut.

Special Precautions

Severe hepatic impairment. Pregnancy and lactation.

Adverse Reactions

Significant: Increased LFTs, decreased thyroxine.
Gastrointestinal disorders: Diarrhoea, upper abdominal pain, flatulence.
Infections and infestations: UTI, vaginal infection.
Skin and subcutaneous tissue disorders: Rash, pruritus.

Patient Counseling Information

Women of childbearing potential must use proven birth control methods during therapy and for 1 month after stopping the treatment.

Drug Interactions

May increase the exposure of breast cancer resistance protein (BCRP) substrates (e.g. imatinib, methotrexate, rosuvastatin).

Lab Interference

May reduce the serum concentrations of total thyroxine (T₄) without change in free T₄ or TSH.

Action

Description:
Mechanism of Action: Tafamidis is a transthyretin (TTR) stabiliser which selectively binds to TTR at the thyroxine binding sites resulting in the slowing down of TTR tetramer dissociation to monomers, the rate-limiting step in the pathogenesis of transthyretin amyloidosis.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 4 hours.
Distribution: Plasma protein binding: >99%, primarily to TTR.
Metabolism: Undergoes glucuronidation.
Excretion: Tafamidis meglumine: Via faeces (approx 59% as unchanged drug); urine (approx 22% as glucuronide metabolite). Elimination half-life: Approx 49 hours (tafamidis).

Chemical Structure

Storage

Store between 15-30°C.

MIMS Class

Other Cardiovascular Drugs

ATC Classification

N07XX08 - tafamidis ; Belongs to the class of other nervous system drugs.

References

Anon. Tafamidis. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/11/2023.

Anon. Tafamidis. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/11/2023.

Buckingham R (ed). Tafamidis. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/11/2023.

Joint Formulary Committee. Tafamidis. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/11/2023.

Vyndamax 61 mg Soft Capsules (Pfizer [Malysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/11/2023.

Vyndaqel 20 mg Soft Capsules (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/11/2023.

Vyndaqel 61 mg Soft Capsules (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/11/2023.

Vyndaqel and Vyndamax Capsule, Liquid Filled (Pfizer Laboratories Div Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/11/2023.

Disclaimer: This information is independently developed by MIMS based on Tafamidis from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com