Prescribers are now able to use the ZINBRYTA Program Portal to instantly enroll, train, certify, and manage their patients all online. If you are already a certified ZINBRYTA REMS Program prescriber, click Create Account. If you need to become certified, click Enroll Here.

Already Certified?

Create an online account to manage ZINBRYTA patients

Create Account

Begin Certification

Create an online account and become ZINBRYTA REMS Program certified

Enroll Here

To enroll in the ZINBRYTA REMS Program via fax or mail, click here for the required forms.

The requirements for treating with ZINBRYTA (daclizumab)

Please complete this 3-step process to prescribe ZINBRYTA.

Step 1. Become certified:

Complete the certification process before you prescribe ZINBRYTA

1. Register online to create a prescriber account and to access the ZINBRYTA Program Portal.

2. Review the following educational materials on ZINBRYTA to understand the risks of severe and fatal liver injury, including autoimmune hepatitis and liver failure, and serious immune-mediated disorders, and the ZINBRYTA REMS Program. Download the:

3. Complete the ZINBRYTA REMS Program Prescriber Knowledge Assessment and the ZINBRYTA REMS Program Prescriber Enrollment Form online, using the ZINBRYTA Program Portal, or via paper. You must answer all questions in the ZINBRYTA REMS Program Prescriber Knowledge Assessment correctly to become certified. Download the:

4. Submit the ZINBRYTA REMS Program Prescriber Knowledge Assessment and the ZINBRYTA REMS Program Prescriber Enrollment Form online, using the ZINBRYTA Program Portal. Alternatively, the completed forms may also be faxed to the ZINBRYTA REMS Program at 1-855-474-3067, or mailed to the ZINBRYTA REMS Program at 5000 Davis Drive, PO Box 13919, Research Triangle Park, NC 27709. You will be notified by the ZINBRYTA REMS Program within 2 business days upon receipt. When notified, you will receive either:

  • A confirmation of your certification in the ZINBRYTA REMS Program

OR

  • If necessary, instructions on how to retake the ZINBRYTA REMS Program Prescriber Knowledge Assessment

Once this one-time step has been completed, the ZINBRYTA REMS Program will contact you to finish certification.

Step 2. Before you start your patients on ZINBRYTA:

Enroll the patient in the ZINBRYTA REMS Program

1. Counsel your patient about the risks associated with ZINBRYTA and the need for baseline and monthly liver testing before the next dose and share the resources provided below. Download the:

2. Order and evaluate the baseline liver testing before each patient’s first dose of ZINBRYTA.

3. Complete the ZINBRYTA REMS Program Patient Enrollment Form and prescription with your patient online, using the ZINBRYTA Program Portal, or via paper and provide them with a copy of the finished form. Download the:

4. Submit the completed ZINBRYTA REMS Program Patient Enrollment Form online, using the ZINBRYTA Program Portal, and store a copy in the patient’s record. Completed forms can also be faxed to the ZINBRYTA REMS Program at 1-855-474-3067, or mailed to the ZINBRYTA REMS Program at 5000 Davis Drive, PO Box 13919, Research Triangle Park, NC 27709. Your patient can expect to be contacted by the ZINBRYTA REMS Program.

Step 3. Once a patient starts on ZINBRYTA:

Perform monthly monitoring and evaluation

1. Monitor your ZINBRYTA patients on an ongoing basis. Test transaminase levels and total bilirubin monthly and assess before the next dose of ZINBRYTA. Transaminase levels and total bilirubin should be followed monthly for 6 months after the last dose of ZINBRYTA. The patient will be contacted by the ZINBRYTA REMS Program each month to remind them to complete their liver testing.

If there are changes in the test results, adjust the monitoring and treatment with ZINBRYTA as follows:

*In clinical trials, permanent discontinuation of therapy was required if the patient had liver test abnormalities resulting in suspension of study treatment for at least 8 consecutive weeks.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.

2. Submit a completed ZINBRYTA REMS Program Patient Status Form online, using the ZINBRYTA Program Portal or send a completed form via fax or mail, every 90 days during treatment and every 90 days for 6 months after discontinuation of ZINBRYTA. Every 90 days, the ZINBRYTA REMS Program will send an individualized Patient Status Form to the certified prescriber for completion. Download the:

3. Report any adverse events suggestive of hepatic injury including autoimmune hepatitis, and other immune-mediated disorders to the ZINBRYTA REMS Program at 1-800-456-2255. You will be contacted for more information about these events.

4. Inform the ZINBRYTA REMS Program if the patient is no longer under your care or has discontinued ZINBRYTA. 

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If you have any questions about the ZINBRYTA REMS Program or need help enrolling, call 1-800-456-2255.

Indication

ZINBRYTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Please see Prescribing Information, including BOXED WARNING, for additional information.