Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Zinbryta (daclizumab)
BLA #761029
REMS last update: 11/01/2017



What is the purpose of the REMS?

To mitigate the risks of severe and fatal hepatic injury and serious immune mediated disorders associated with ZINBRYTA by:

  1. Ensuring that prescribers are educated on the following:
    1. the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
    2. the need to counsel patients about these risks and the need for appropriate baseline and monthly monitoring
  2. Ensuring that prescribers are educated on and adhere to:
    1. required baseline and monthly monitoring and evaluation of patients who receive ZINBRYTA
  3. Ensuring that patients are informed about:
    1. the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
    2. appropriate baseline and monthly monitoring
  4. Enrollment of all patients in a registry to further support long-term safety and safe use of ZINBRYTA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Zinbryta must

To become certified to prescribe To become certified to prescribe To become certified to prescribe
Before the first prescription
  • Counsel the patient on the risks of severe and fatal hepatic injury and serious immune mediated disorders and the need for baseline and monthly liver testing, using the Patient Guide.
    | Patient Guide |
  • Provide the patient with the Patient Guide and Patient Wallet Card.
    | Patient Guide | | Patient Wallet Card |
  • Assess the patient’s baseline hepatic status as described in the Prescribing Information.
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS program. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
    | Patient Enrollment Form |
Monthy during treatment
  • Assess the patient’s hepatic status as described in the Prescribing information.
Every 90 calendar days during treatment
At all times
  • Report any adverse events suggestive of hepatic injury and immune mediated disorders to the REMS program.
  • Report if an enrolled patient is no longer under your care or has discontinued therapy to the REMS program.
Every 90 calendar days after treatment discontinuation for six months Every 90 calendar days after treatment discontinuation for six months Every 90 calendar days after treatment discontinuation for six months

Patients who are prescribed Zinbryta

Before the first prescription
  • Review the Patient Guide.
    | Patient Guide |
  • Receive counseling from the prescriber on the risks of severe and fatal hepatic injury and serious immune mediated disorders and required baseline and monthly monitoring.
  • Enroll in the REMS by completing the Patient Enrollment Form with the prescriber.
    | Patient Enrollment Form |
  • Get a blood test.
Monthly during treatment
  • Get a blood test.
Monthly after discontinuing for six months
  • Get a blood test.

Pharmacies that dispense Zinbryta must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the Program Overview.
    | Program Overview |
  • Train all relevant staff involved in the dispensing of Zinbryta on the program requirements using the Program Overview.
    | Program Overview |
  • Establish processes and procedures to verify the pharmacy obtains authorization to dispense and dispenses no more than a one month supply to a patient.
  • Have the authorized representative enroll in the REMS by completing the Pharmacy Enrollment Form.
    | Pharmacy Enrollment Form |
Before dispensing
  • Obtain authorization to dispense by calling the REMS Program or accessing the REMS program website.
  • Dispense no more than a one months’ supply.
At all times
  • If the pharmacy designates a new authorized representative, re-enroll in the REMS program.
  • Report any adverse events suggestive of hepatic injury and immune mediated disorders to the REMS program.
  • Maintain records of training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Zinbryta must

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies
  • Train all relevant staff involved in distribution of Zinbryta on the program requirements.
At all times
  • Maintain records of distribution records of all shipments.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Zinbryta REMS, see the DailyMed link(s).
Material Name Material Name Link
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Letter_for_Healthcare_Providers.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Enrollment_Form.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Guide.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Status_Form.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Patient_Wallet_Card.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Knowledge_Assessment.pdf
Prescriber Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Prescriber_Training.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_Program_Overview.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Zinbryta_2017_11_01_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
11/01/2017

Modified to:

  1. Add a secured web-based tool to complete prescriber certification and enrollment and patient enrollment and monitoring online.
  2. Make editorial changes to the REMS document.
  3. Change the REMS materials to conform to the safety labeling changes pertaining to the risks of hepatic injury and immunemediated reactions that were approved on August 28, 2017.
03/10/2017 Revised to make an editorial change and correct a typographical error(s).
05/27/2016 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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