Approved Risk Evaluation and Mitigation Strategies (REMS)

Empaveli (Pegcetacoplan)

NDA #215014

REMS last update: 05/14/2021

• View Empaveli's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the REMS is to mitigate the occurrence and morbidity associated with encapsulated bacteria infections (Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B) by educating healthcare providers and patients about:

1. the potential risk of infections caused by encapsulated bacteria with Empaveli
2. the need for vaccination and antibiotic prophylaxis, if required,
3. the early signs of invasive encapsulated bacteria infections, and
4. the need for immediate medical evaluation of signs and symptoms consistent with possible encapsulated bacteria infections

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

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
05/14/2021	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.