Aficamten Interactions

FDA Black Box Warning

WARNING: RISK OF HEART FAILURE MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40% [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction [see Dosage and Administration (2.2) ]. Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program [see Warnings and Precautions (5.2) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning. MYQORZO can cause heart failure due to systolic dysfunction. ( 5.1 ) Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during MYQORZO use. ( 2.1 ) Initiation in patients with left ventricular ejection fraction (LVEF) <55% is not recommended. ( 2.1 ) Decrease dose if LVEF <50% and ≥40%. Interrupt dosing if LVEF <40% or if worsening clinical status. ( 2.2 ) MYQORZO is available only through a restricted program called the MYQORZO REMS Program. ( 5.2 )