Before prescribing, healthcare providers must be certified and enrolled in the CAMZYOS REMS Program.1
*Certified healthcare providers may designate a member of their staff who is a licensed medical professional to be a Designee. The Designee can perform REMS activities in the CAMZYOS REMS. Certified healthcare providers are responsible for all information entered and activities performed in the CAMZYOS REMS by the Designee.
Initial and subsequent prescriptions for CAMZYOS must be written by the certified healthcare provider.Learn more about the REMS Program
Review the REMS Patient Brochure to counsel appropriate patients on the risk of heart failure due to systolic dysfunction, the risk of drug-drug interactions with CYP2C19 and CYP3A4 inhibitors and inducers, and the need to inform their healthcare providers of all the prescription and nonprescription medications they take.1 Provide the patient with the REMS Patient Brochure and allow them the opportunity to review and ask questions prior to the initiation of therapy.
Enroll patients in the CAMZYOS REMS program and educate them on the risk of heart failure due to systolic dysfunction and importance of regular cardiac monitoring during treatment.1
Complete and submit the REMS Patient Enrollment Form to enroll patients in the program.Download REMS Patient Brochure
This step is optional and not required for a prescription. If patients are interested, inform them about the MyCAMZYOS access and support program. Healthcare providers can help patients enroll and have them complete and sign the MyCAMZYOS Enrollment Form while in the office.Learn more about enrolling patients
CAMZYOS is available only from certified specialty pharmacies participating in the REMS Program. Provide patients with the telephone number and website for information on how to obtain the product.1 If a patient enrolls in MyCAMZYOS, their prescription will be submitted with the MyCAMZYOS Enrollment Form. If a patient does not want to enroll in MyCAMZYOS, complete and submit a prescription to a specialty pharmacy. If needed, complete and submit a letter of medical necessity and a prior authorization form.
When prescribing CAMZYOS, note that echocardiograms are required1:
Echocardiograms may also be needed after a change in the dose of CAMZYOS, a break in treatment, and/or after starting certain medicines that are known to affect CAMZYOS.1Find out more about dosing and the echocardiogram requirements
The Echocardiogram Scheduling Tool is available to help estimate the date ranges for a patient's echocardiograms, as required by the CAMZYOS REMS Program. Delayed or missed visits may lead to interruption or discontinuation of treatment. To use the tool, visit CAMZYOSechotool.com.
Dedicated Nurse Navigators are available to provide information and answer questions for patients on CAMZYOS. Nurse Navigators do not provide medical advice. For more information and additional patient resources, visit camzyos.com/patient-support.
In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%).
Effects on Systolic Function
In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.
Please see additional Important Safety Information below, including Boxed WARNING.
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