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Approved Risk Evaluation and Mitigation Strategies (REMS)

Voydeya (danicopan)
NDA #218037
REMS last update: 03/29/2024



What is the purpose of the REMS?

The goal of the VOYDEYA REMS is to mitigate the risk of serious infections caused by encapsulated bacteria.
  1. Patients are vaccinated against infections caused by encapsulated bacteria (Neisseria meningitidis serogroups A, C, W, Y, and B; and Streptococcus pneumoniae) prior to starting therapy according to current Advisory Committee on Immunization Practices (ACIP) recommendations and receive antibacterial drug prophylaxis if needed.
  2. Patients are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.
  3. Prescribers are aware of early signs and symptoms of serious encapsulated bacterial infections and the need for immediate medical evaluation.

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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
03/29/2024 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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