Prescriber Certification:

Instructions:

  1. Review the ZILBRYSQ Prescribing Information, Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card.
  2. Submit this completed Prescriber Enrollment Form to the ZILBRYSQ REMS.

Prescriber Information:

Clinic / Practice Information:

Prescriber Attestations

By completing, signing, and submitting this form, I acknowledge and agree that:

  • I have read and understand the ZILBRYSQ Prescribing Information, Healthcare Provider Safety Brochure, Patient Guide, and Patient Safety Card.
  • Before treatment initiation, I must:
    • Assess the patient for unresolved meningococcal infection.
    • For patients with unresolved meningococcal infection: Not initiate ZILBRYSQ.
    • Assess the patient’s vaccination status for meningococcal serogroups A, C, W, and Y (MenACWY) and serogroup B (MenB) and vaccinate as needed according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor.
    • For patients who are not up to date with MenACWY and MenB vaccines at least two weeks prior to initiation of treatment and must start ZILBRYSQ urgently: Provide the patient with a prescription for antibacterial drug prophylaxis.
    • Counsel the patient using the Patient Safety Card and Patient Guide. Provide the patient with copies of these materials. Instruct the patient to carry the Patient Safety Card at all times and for 2 months after their last ZILBRYSQ dose.
  • During treatment, I must:
    • Assess the patient for early signs and symptoms of meningococcal infection and evaluate immediately, if infection is suspected.
    • For patients who are being treated for meningococcal infections: Withhold administration of ZILBRYSQ.
    • Revaccinate patients according to the current Advisory Committee on Immunization Practices (ACIP) recommendations on meningococcal vaccinations for patients receiving a complement inhibitor.
  • At all times, I must:
    • Report adverse events suggestive of meningococcal infection, including the patient’s clinical outcomes, to UCB, Inc. at 1-844-599-2273.
  • I understand that if I do not maintain compliance with the requirements of the ZILBRYSQ REMS, I will no longer be able to prescribe ZILBRYSQ.
  • I understand that ZILBRYSQ REMS and its agents or contractors may contact me to support the administration of the REMS.

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