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myqorzo aficamten tablets hcm 5mg

Description

 Indication & Scope

MYQORZO® Aficamten Tablets provides long-term treatment for adult patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM) to reduce cardiac outflow tract obstruction and relieve exercise-limiting symptoms.

  • Mechanism: Selective cardiac myosin ATPase inhibitor. It reversibly binds to cardiac β-myosin heavy chain, slows actin-myosin cross-bridge cycling, decreases left ventricular hypercontractility, reduces systolic anterior motion of mitral valve and relieves left ventricular outflow tract obstruction in HCM patients.
  • Drug class: Oral small-molecule cardiac myosin inhibitor / Cardioprotective anti-hypertrophic cardiomyopathy agent.
  • Clinical use: First-line long-term monotherapy for symptomatic obstructive HCM adults; improves exercise capacity, reduces chest pain, dyspnea and syncope risk, delays disease progression without surgical septal myectomy.
Specification
Generic Name Aficamten Tablets
Brand Name MYQORZO
Ingredient Aficamten
Dosage Form Tablets
Package 5mg*14 tablets*2 blisters/box
Conditions Treated Obstructive hypertrophic cardiomyopathy (HCM) in adult symptomatic patients
Taboos Severe hypersensitivity to aficamten or tablet excipients; patients with resting left ventricular ejection fraction (LVEF) <50%; pregnant and breastfeeding women; patients with uncorrected severe hypotension
Place of origin 2100 Syntex Court, Mississauga, Ontario, L5N 7K9, Canada
Prescription type Prescription-only
Storage Conditions Store sealed blister packs at controlled room temperature 15°C to 30°C, sealed away from high humidity and direct sunlight
Manufacturer Patheon Inc.
Registration Authority National Medical Products Administration (NMPA), China
Approval number HJ20250147
Approval Date Dec 16, 2025
Shelf Life 24 months

How to use ?

Recommended Dose: Initial titration dose: 10 mg oral once daily; adjust incrementally to maintenance doses of 15 mg, 20 mg or 30 mg daily based on echocardiogram outflow tract gradient and symptom severity.

 

Time: Fixed single oral dose taken once daily, can be consumed with or without meals at consistent daily timing.

 

Instructions for use: Swallow whole tablet with clean water without crushing or splitting; conduct baseline echocardiogram before treatment, repeat cardiac ultrasound every 4 weeks during dose titration; hold dose if symptomatic hypotension occurs.

 

Interaction: Strong CYP3A4 inhibitors elevate systemic aficamten exposure and hypotension risk; strong CYP3A4 inducers drastically lower therapeutic plasma concentration, reducing anti-obstruction efficacy. Concurrent beta-blockers or calcium channel blockers amplify hypotension risk.

 

Side effects:

1. Common adverse reactions: mild fatigue, dizziness, orthostatic hypotension, diarrhea, palpitations.

2. Severe grade ≥3 risks: symptomatic severe hypotension, bradycardia, reduced left ventricular ejection fraction.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What core cardiac protein target does Aficamten Tablets act on to treat obstructive HCM?

It selectively inhibits the ATPase activity of cardiac β-myosin heavy chain to weaken excessive myocardial contraction.

What mandatory cardiac test must clinicians perform before initiating Aficamten Tablets and during dose titration cycles?

Serial transthoracic echocardiograms to measure left ventricular outflow tract pressure gradients and LVEF.

Which two standard HCM medications amplify the hypotension risk when co-administered with Aficamten Tablets?

Beta-adrenergic blockers and non-dihydropyridine calcium channel blockers.

What key clinical symptom improvement serves as the primary therapeutic endpoint of Aficamten Tablets?

Reduction of exercise-induced dyspnea, chest pain and syncope by relieving left ventricular outflow tract mechanical obstruction.

MYQORZO® | Aficamten Tablets | HCM | DengYueRX

INN: Aficamten Tablets
Indications: Obstructive hypertrophic cardiomyopathy (HCM)
Dosage Form: Tablets
Strength: 5mg/tablet

Low MOQ

WHO-GMP

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Compliance and Regulatory Documents

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