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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:
the potential risk of infections caused by encapsulated bacteria with Empaveli
the need for vaccination and antibiotic prophylaxis, if required,
the early signs of invasive encapsulated bacteria infections, and
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.
Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation at least 2 weeks before first dose
Assess the patient's vaccination status and immunize if needed according to the current Advisory Committee on Immunization Practices for the following: Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae type B.
Provide the patient with a prescription for a 2-week course of antibiotic prophylaxis if EMPAVELI must be started less than 2 weeks after the patient was immunized.
Counsel the patient using the Patient Safety Guide and Patient Wallet Card. Provide a copy of the materials to the patient.
| Patient Wallet Card |
| Patient Safety Guide |
At all times
Report cases of serious bacterial infection, including the patient's clinical outcomes, to Apellis Pharmaceuticals, Inc.
During treatment
Assess the patient for early signs and symptoms of serious bacterial infection and treat immediately, if infection is suspected.
Consider discontinuing EMPAVELI in patients who are being treated for a serious bacterial infection.
Revaccinate patients according to the current Advisory Committee on Immunization Practices Recommendations.
Patients who are prescribed EMPAVELI:
Before treatment initiation at least 2 weeks before first dose
Get Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae type B vaccines as directed by your doctor.
Take antibiotics as directed by your doctor for 2 weeks after you get your vaccine(s) if you have to start EMPAVELI right away.
Get Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B vaccines as directed by your doctor.
At all times
Inform the prescriber or get emergency medical care right away if any of the following occur: fever with or without shivers or the chills; fever and a rash; shortness of breath; extreme pain or discomfort; headache with nausea or vomiting; high heart rate; headache and a fever; headache with a stiff neck or stiff back; confusion; muscle aches with flu-like symptoms; clammy skin; eyes sensitive to light.
Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
Have the Authorized Representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing EMPAVELI using the Healthcare Provider Brochure.
| Healthcare Provider Brochure |
Establish processes and procedures to contact the prescriber to assess the patient’s vaccination history including antibiotic prophylaxis and document the findings.
Before dispensing
Obtain authorization to dispense each prescription by contacting the REMS Program to verify the prescriber is certified.
Assess the patient’s vaccination history including antibiotic prophylaxis by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS Program.
To maintain certification to dispense
If the Authorized Representative changes, have the new Authorized Representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS.
| Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of serious bacterial infections to Apellis Pharmaceuticals, Inc.
Not distribute, transfer, loan, or sell EMPAVELI, except to certified dispensers.
Maintain records of staff’s completion of REMS training.
Maintain records that all processes and procedures are in place and are being followed.
Comply with audits carried out by Apellis Pharmaceuticals, Inc. or a third party acting on behalf of the applicant, to ensure that all processes and procedures are in place and are being followed.
Wholesalers-distributors that distribute EMPAVELI must:
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
Train relevant staff involved in EMPAVELI distribution on the REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distributions.
Comply with audits carried out by Apellis Pharmaceuticals, Inc. or a third party acting on behalf of the applicantto ensure that all processes and procedures are in place and are being followed.
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Empaveli REMS, see the DailyMed link(s).
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.
