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The requirements for dispensing ZINBRYTA (daclizumab)

ZINBRYTA is not available to all pharmacies. If you have any questions about the ZINBRYTA REMS Program or how to obtain ZINBRYTA, call 1-800-456-2255.

Please complete this 2-step process to dispense ZINBRYTA.

Step 1. Become certified:

Complete the certification process before you are authorized to dispense ZINBRYTA

1. Designate an authorized representative for the pharmacy. He or she will need to review the ZINBRYTA REMS Program Overview and will oversee implementation and ensure compliance with the ZINBRYTA REMS Program requirements. Download the:

2. Have the authorized representative complete the ZINBRYTA REMS Program Pharmacy Enrollment Form. Download the:

3. Submit the completed form to the ZINBRYTA REMS Program. Completed forms should 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 contacted by the ZINBRYTA REMS Program to complete certification.

4. Have the authorized representative ensure that all relevant staff involved in the dispensing of ZINBRYTA are trained on the ZINBRYTA REMS Program requirements and that a record of training is maintained by the pharmacy.

Step 2. Dispense ZINBRYTA to authorized patients:

Ensure compliance with the ZINBRYTA REMS Program requirements

1. Before dispensing each dose, verify that the prescriber is certified and the patient is authorized to receive ZINBRYTA by calling the ZINBRYTA REMS Program at 1-800-456-2255. Do not dispense more than a one month supply per patient.

2. Ensure that the pharmacy complies with the procedures required by the ZINBRYTA REMS Program:

  • 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 may be contacted for more information about these events.
  • Maintain appropriate documentation that all processes and procedures are in place and are being followed so that it can be provided upon request to Biogen, the FDA, or a third party acting on behalf of Biogen or the FDA.
  • Comply with potential audits conducted by Biogen, FDA, or a third party acting on behalf of Biogen or the FDA to ensure that all processes and procedures are in place and are being followed.

3. Recertify in the ZINBRYTA REMS Program if a new authorized representative is designated by completing and submitting the ZINBRYTA REMS Program Pharmacy Enrollment Form.

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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.