Description
What is Vyndamax (Tafamidis 61mg)?
Vyndamax (Tafamidis 61mg) Soft Gelatin Capsules is a transthyretin stabilizer indicated for the treatment of wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) in adults. It is an FDA-approved, once-daily oral medication specifically designed to slow the progression of cardiac-related symptoms in patients with this rare but fatal disease.
Other brand names for tafamidis include Vyndaqel (EU, UK, Canada), Vyndamax (USA), and Tafamidis Meglumine (Australia).
Mechanism of Action
Tafamidis selectively binds to transthyretin (TTR), a transport protein responsible for carrying thyroxine and retinol-binding protein. In patients with ATTR-CM, mutated or destabilized TTR proteins misfold and aggregate, forming amyloid fibrils that deposit in cardiac tissues. Tafamidis stabilizes TTR tetramers, preventing dissociation and subsequent amyloid formation. This action reduces the accumulation of amyloid deposits in the myocardium, thereby slowing disease progression and improving cardiac outcomes.
Source: American College of Cardiology
Clinical Efficacy and Trials
The efficacy of Tafamidis was established in the ATTR-ACT trial (Transthyretin Amyloidosis Cardiomyopathy Clinical Trial). This multicenter, randomized, double-blind, placebo-controlled study evaluated tafamidis meglumine in 441 patients over 30 months. Results showed a significant reduction in all-cause mortality and cardiovascular-related hospitalizations in patients receiving tafamidis compared to placebo.
The study concluded that tafamidis-treated patients had a 30% lower risk of death and a 32% reduction in cardiovascular-related hospitalizations.
Source: New England Journal of Medicine
On-Label and Off-Label Uses
On-label Use:
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Tafamidis is approved for the treatment of transthyretin amyloid cardiomyopathy (wild-type and hereditary).
Off-label Investigations (Emerging Areas):
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Tafamidis has been investigated for use in other TTR-related amyloidoses, such as familial amyloid polyneuropathy (FAP), although Vyndaqel is more commonly indicated for FAP in many jurisdictions.
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Some studies suggest potential neuroprotective effects in peripheral amyloid neuropathies, but more evidence is needed for clinical use approval.
Source: Mayo Clinic Proceedings
Dosage and Administration
Vyndamax is taken as one 61 mg capsule once daily, with or without food. This dosage is bioequivalent to 80 mg of tafamidis meglumine (administered as four 20 mg capsules of Vyndaqel). The simplified dosing of Vyndamax offers increased patient compliance with fewer capsules to manage daily.
Side Effects and Precautions
Common Side Effects:
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Urinary tract infections
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Diarrhea
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Muscle spasms
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Headache
Serious Adverse Effects:
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Liver function abnormalities (rare)
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Hypersensitivity reactions (rare)
Patients with liver impairment or those taking concurrent TTR-targeting therapies should consult their healthcare provider before initiating treatment.
Source: FDA Label for Vyndamax
Drug Interactions
Tafamidis has minimal interactions with CYP enzymes, reducing its likelihood of interfering with common medications. However, caution should be taken when co-administered with drugs that affect TTR binding or thyroid hormone transport.
Storage Information
Store Vyndamax at 20°C to 25°C (68°F to 77°F). Protect from moisture and keep in the original blister pack until use.
Availability and Brand Names
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USA: Vyndamax (Pfizer)
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Europe (EU): Vyndaqel
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UK: Vyndaqel
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Canada: Vyndaqel
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Australia: Tafamidis Meglumine
Tafamidis, Vyndaqel, and Vyndamax Price Information
The vyndamax price and tafamidis price vary depending on the market, insurance coverage, and provider. Tafamidis is known to be a high-cost orphan drug due to its targeted treatment and limited patient population. In the U.S., the wholesale acquisition cost of tafamidis can exceed $200,000 per year. International and generic pricing options may be available in select markets and pharmacies offering tafamidis online at reduced rates.
Source: Institute for Clinical and Economic Review (ICER)
Frequently Asked Questions (FAQ)
What is Vyndamax used for?
Vyndamax is used to treat transthyretin amyloid cardiomyopathy (ATTR-CM), both wild-type and hereditary forms, in adults.
Is Vyndamax the same as Vyndaqel?
Vyndamax (61mg) and Vyndaqel (80mg total, four 20mg capsules) contain the same active ingredient—tafamidis—but differ in formulation and dosing convenience.
What is the price of tafamidis (Vyndamax)?
The tafamidis price or vyndamax price can be high in the U.S., but varies globally. Patients may explore international options for affordability.
How does tafamidis work?
Tafamidis stabilizes the transthyretin protein, preventing its misfolding and subsequent deposition as amyloid in cardiac tissue.
Can I buy Tafamidis over the counter (OTC)?
No, Tafamidis is a prescription-only medication and is not available OTC.
Does Tafamidis cure ATTR-CM?
No, tafamidis does not cure ATTR-CM. It helps manage the condition by slowing disease progression and improving outcomes.
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