Vyndamax - Drug Monograph

Introduction

Vyndamax (tafamidis meglumine) is a transthyretin stabilizer approved by the FDA for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. It represents a significant advancement in the management of this progressive and fatal disease.

Mechanism of Action

Vyndamax works by selectively stabilizing tetrameric transthyretin (TTR), inhibiting tetramer dissociation into monomers—the rate-limiting step in the amyloidogenesis process. By preventing TTR dissociation, tafamidis reduces the formation of amyloid fibrils that deposit in cardiac tissue, thereby slowing disease progression and preserving myocardial function.

Indications

• Treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults
• Includes both hereditary (hATTR) and wild-type (wtATTR) forms
• FDA-approved to reduce cardiovascular mortality and cardiovascular-related hospitalization

Dosage and Administration

• Renal impairment: No dosage adjustment necessary
• Hepatic impairment: Use with caution in severe impairment
• Elderly: No dosage adjustment required

Pharmacokinetics

Contraindications

• Hypersensitivity to tafamidis or any component of the formulation
• No other absolute contraindications identified

Warnings and Precautions

• Hepatic effects: Monitor liver function tests periodically
• Pregnancy: Use only if potential benefit justifies potential risk (Category C)
• Lactation: Decision should be made to discontinue nursing or discontinue drug
• Reproductive potential: Advise females of reproductive potential about potential risk
• Vitamin A deficiency: May occur; consider supplementation

Drug Interactions

• Strong inducers of UGT: May decrease tafamidis exposure
• Strong inhibitors of UGT: May increase tafamidis exposure
• Vitamin A: May decrease vitamin A levels; supplementation may be needed
• No clinically significant interactions with common cardiovascular medications

Adverse Effects

• Diarrhea
• Upper respiratory tract infection
• Urinary tract infection

• Abdominal pain
• Nausea
• Increased blood creatinine
• Headache
• Fatigue

• Hepatic enzyme elevations
• Vitamin A deficiency
• Cardiac arrhythmias (disease-related)

Monitoring Parameters

• Cardiac function: Regular echocardiograms, NT-proBNP, troponin levels
• Liver function: ALT, AST, bilirubin at baseline and periodically
• Renal function: Serum creatinine and BUN
• Vitamin A levels: Consider monitoring in long-term therapy
• Clinical status: Functional capacity, symptoms of heart failure
• Adherence assessment: Regular evaluation of medication compliance

Patient Education

• Take medication exactly as prescribed at the same time each day
• Do not stop taking Vyndamax without consulting your healthcare provider
• Report any new or worsening symptoms promptly
• Inform all healthcare providers about Vyndamax use
• Be aware of potential vitamin A deficiency symptoms (night blindness, dry eyes)
• Keep regular follow-up appointments for monitoring
• Store at room temperature in original container

References

1. FDA Prescribing Information: Vyndamax (tafamidis meglumine) 2. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016 3. National Comprehensive Cancer Network. Guidelines for Cardiac Amyloidosis. Version 1.2023 4. Hanna M, Damy T, Grogan M, et al. Efficacy and safety of tafamidis in patients with hereditary and wild-type transthyretin amyloid cardiomyopathy: results from the phase 3 ATTR-ACT trial. Eur Heart J. 2020;41(Supplement_2):ehaa946.3459 5. Product Monograph: Vyndamax. Pfizer Canada Inc. 6. American College of Cardiology Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis. J Am Coll Cardiol. 2020;75(22):2906-2923