Designate an authorized representative to complete the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
Have the authorized representative do the following:
A.Complete the CAMZYOS REMS training program, which includes reviewing the following materials:
B.Successfully complete the Pharmacy Authorized Representative Knowledge Assessment and submit it to the REMS
C.Enroll in the CAMZYOS REMS on behalf of the pharmacy by completing the Pharmacy Enrollment Form and submitting it to the REMS
D.Train all relevant staff involved in dispensing CAMZYOS using the Program Overview and the Education Program for Healthcare Providers and Pharmacies
Before dispensing each dose of CAMZYOS
A.Counsel the patient on drug-drug interactions and review all prescription and nonprescription medications and supplements with the patient. Complete and submit the Drug Interaction and Counseling Checklist for Pharmacies to the REMS
B.Document the prescribed dose
C.Obtain authorization to dispense each CAMZYOS prescription by contacting the CAMZYOS REMS online or calling the REMS Call Center at 833-628-7367833-628-7367 to verify that the:
D.Provide the patient with the Patient Brochure
Dispense no more than a 35-day supply of CAMZYOS.
For patients who delay treatment initiation up to 90 days from Patient Enrollment Form submission: Assess the patient’s treatment start date. Document and submit the new start date using the REMS website.
Report any adverse events of heart failure due to systolic dysfunction to Bristol Myers Squibb.
Any time the authorized representative changes, the new authorized representative must:
A.Successfully complete the Pharmacy Authorized Representative Knowledge Assessment
B.Complete and submit the Pharmacy Enrollment Form to the CAMZYOS REMS to re-certify the pharmacy to dispense
This website is best viewed
using the horizontal display
on your tablet device.
This website is best viewed
using the vertical display
on your mobile device.