Myqorzo Aficamten Tablets

1. Indications and Usage
Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM):
Aficamten is indicated for the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
2. Dosage and Administration
Recommended Dosage:
Starting Dose: 5 mg taken orally once daily.
Titration: Increase the dose in 5 mg increments (e.g., to 10 mg, 15 mg) every 2 to 8 weeks based on Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Outflow Tract Gradient (LVOT-G) to a maximum recommended dose of 20 mg once daily.
Administration Instructions:
Administer orally with or without food. Swallow tablets whole.
Missed Dose: If a dose is missed, take it as soon as possible on the same day, but do not take more than one dose on the same day.
Dose Adjustments:
If LVEF is <50% but ≥40%, reduce the dose by 5 mg.
If LVEF is <40% or if there is clinical worsening consistent with heart failure, interrupt treatment.
3. Mechanism of Action
Cardiac Myosin Inhibitor:
Aficamten is a cardiac myosin allosteric, reversible inhibitor.
Physiological Effect:
It binds directly to cardiac myosin, reducing the force generated by the myosin motor. This decreases cardiac contractility and reduces left ventricular outflow tract (LVOT) obstruction in patients with oHCM.
4. Safety and Warnings
Heart Failure:
Aficamten reduces cardiac contractility, which may lower LVEF and lead to heart failure.
Monitoring: Monitor LVEF and clinical status periodically via echocardiogram before and during treatment.
Contraindication: Do not initiate therapy in patients with LVEF <55%.
Hypertension:
Increases in blood pressure may occur. Monitor blood pressure regularly.
Drug Interactions:
Contraindicated: Do not use with Rifampin.
Caution: Use caution with strong CYP2C9 inhibitors (e.g., fluconazole) or CYP3A inducers, as they may alter aficamten exposure.
REMS Program:
Due to the risk of heart failure, Aficamten is available only through a restricted program called the Aficamten REMS Program.
5. Adverse Reactions
Most Common:
Hypertension (8%).
6. Drug Interactions
Strong CYP2C9 Inhibitors:
Co-administration with strong CYP2C9 inhibitors (e.g., fluconazole, voriconazole, fluvoxamine) may increase aficamten exposure.
CYP3A Inducers:
Co-administration with moderate to strong CYP3A inducers may decrease aficamten exposure and potentially lead to loss of efficacy.
Rifampin:
Contraindicated.
7. Pharmaceutical Information
Storage:
Store at room temperature. Avoid moisture and heat.