aficamten
Risk of Heart Failure
Aficamten reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure. Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional monitoring considerations.
Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the aficamten dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should prompt an evaluation of cardiac function.
Initiation of MYQORZO in patients with LVEF <55% is not recommended
Monitoring data
To report SUSPECTED ADVERSE REACTIONS, contact Cytokinetics at 1-833-633-2986 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
REMS
MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.
Notable requirements of the MYQORZO REMS Program include the following:
- Prescribers must be certified by enrolling in the MYQORZO REMS Program.
- Patients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirements.
- Pharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZO.
- Wholesalers and distributors must only distribute to certified pharmacies.
Further information is available at www.MYQORZOREMS.com or by telephone at 1-844-285-7367.