BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

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 <55>

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)

Camzyos

Patient Counseling Information

Camzyos

Package Inserts

Camzyos

Updated August 2022