Mavacamten
Risk of heart failure
- CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunctions.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF
PATIENT CARE PLAN
Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:
- Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors
- Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Package Inserts
Updated December 2022