Opinion
Video
Role of Mavacamten in Treating oHCM
Author(s):
James L. Januzzi, MD, comments on mavacamten as the first approved cardiac myosin inhibitor for oHCM, balancing the increased risk of heart failure with the medication, and the role of the REMS program.
This is a video synopsis of a discussion involving James L. Januzzi, MD, detailing the use of mavacamten (cardiac myosin inhibitor) in obstructive hypertrophic cardiomyopathy (HCM) and the associated Risk Evaluation and Mitigation Strategy (REMS) program. Mavacamten is the first approved drug for adults with symptomatic NYHA class 2-3 obstructive HCM, aiming to improve functional capacity and symptoms. Despite favorable efficacy and safety data from clinical trials, the FDA mandated inclusion in the REMS program due to philosophical concerns regarding the potential for an excessive drop in ejection fraction.
The REMS program requires prescribers and patients to follow specific steps to ensure safe administration and monitoring of mavacamten. Prescribers must enroll in the program and educate patients about its requirements, emphasizing that it's not a one-and-done therapy. Patients undergo baseline echocardiograms before initiating treatment and at four-week intervals until reaching a maximally tolerated dose. Regular echocardiograms continue every 12 weeks or with any changes in drug regimen or use of cytochrome P450 inhibitors.
Close therapeutic alliance with patients is crucial, necessitating their active engagement in the REMS program. Patient selection prioritizes those with obstructive HCM, and shared decision-making sessions underscore the program's ongoing nature. Involving a pharmacist in discussions helps mitigate risks and enhance education for patients and clinicians alike.
Monitoring for drug-drug interactions, especially with cytochrome P450 inhibitors, is essential to manage potential complications. The REMS program emphasizes collaborative decision-making and close follow-up to optimize patient outcomes while minimizing risks associated with mavacamten therapy in obstructive HCM.
Video synopsis is AI-generated and reviewed by HCPLive® editorial staff.
