Welcome to the CAMZYOS® REMS
(Risk Evaluation and Mitigation Strategy)
Healthcare Providers: Log into the REMS portal to complete certification in the program. Once certified, use the portal to manage REMS tasks and patients, and to enroll a REMS designee.
First time user? Register here
Pharmacies: The Pharmacy Authorized Representative may log into the REMS portal to complete certification. Once certified, use the portal to invite authorized staff members to manage REMS tasks and patients.
First time user? Register here
NOTE: This portal cannot be opened in Internet Explorer (IE) or the legacy version of Microsoft Edge available before 2020. The portal can be opened in the version of Microsoft Edge available in January 2020. You can also copy and paste the link into a different browser.
Healthcare Providers
Healthcare providers must be certified in the CAMZYOS REMS in order to prescribe CAMZYOS.
Patients
Patients must be enrolled in the CAMZYOS REMS in order to receive CAMZYOS.
Pharmacies
Pharmacies must be certified in the CAMZYOS REMS in order to dispense CAMZYOS.
A REMS is a strategy to manage known or potential serious risks associated with a drug. It is required by the US Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. Due to the risk of heart failure due to systolic dysfunction, CAMZYOS is only available through a restricted program called the CAMZYOS REMS.
The objectives of the CAMZYOS REMS are to:
- Monitor for detection of heart failure due to systolic dysfunction with periodic echocardiograms
- Screen for drug interactions prior to each dispense
INDICATION
CAMZYOS is indicated for the treatment of adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Please see full Prescribing Information.
Healthcare providers must report adverse events of heart failure due to systolic dysfunction associated with CAMZYOS at 833-628-7367.
