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The goal of the VOYDEYA REMS is to mitigate the risk of serious infections caused by encapsulated
bacteria.
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.
Patients are aware of early signs and symptoms of serious encapsulated bacterial infections and
the need for immediate medical evaluation.
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.
Enroll by completing and submitting the Prescriber Enrollment Form to
the REMS.
| Prescriber Enrollment Form |
Before treatment initiation
Assess the patient for unresolved serious infections caused by
encapsulated bacteria.
For patients with an unresolved serious infection caused by
encapsulated bacteria: Not initiate VOYDEYA.
Assess the patient’s vaccination status for Neisseria meningitidis
serogroups A, C, W, Y, and B; and Streptococcus pneumoniae and
vaccinate as needed according to the current Advisory Committee on
Immunization Practices (ACIP) recommendations.
For patients who are not up to date with meningococcal and
pneumococcal vaccines at least 2 weeks prior to initiation of treatment
and who must start VOYDEYA urgently: Provide the patient with a
prescription for antibacterial drug prophylaxis.
Counsel the patient using the Patient Safety Card and Patient Guide.
Provide a copy of the materials to the patient.
| Patient Safety Card |
| Patient Guide |
Counsel the patient on the need to carry the Patient Safety Card at all
times during treatment and for 1 week following the last dose of
VOYDEYA.
| Patient Safety Card |
During treatment
Assess the patient for early signs and symptoms of serious bacterial
infection and evaluate immediately, if infection is suspected.
Vaccinate patients as needed according to the current ACIP
recommendations.
At all times
Report adverse events suggestive of serious bacterial infections,
including the patient’s clinical outcomes, to Alexion Pharmaceuticals,
Inc.
Patients who are prescribed VOYDEYA:
Before treatment initiation
Get vaccinated as directed by your prescriber against the following
encapsulated bacteria: Neisseria meningitidis serogroups A, C, W, Y
and B; and Streptococcus pneumoniae.
Take antibiotics as directed by your prescriber if you have to start
VOYDEYA right away.
Receive counseling from your prescriber using the Patient Safety Card
and Patient Guide.
| Patient Safety Card |
| Patient Guide |
Get additional vaccines as directed by your prescriber.
At all times during
treatment and for 1 week
after the last dose
Inform your prescriber or get emergency medical care right away if any
of the following occur: fever with or without chills; fever and a rash;
fever with chest pain and cough; fever with breathlessness/fast
breathing; fever with high heart rate; headache with nausea or
vomiting; headache and a fever; headache with a stiff neck or stiff
back; confusion; body 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 on
behalf of the pharmacy.
Have the Authorized Representative enroll in the REMS by completing
and submitting the Outpatient Pharmacy Enrollment Form to the REMS.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing VOYDEYA using the
Healthcare Provider Safety Brochure.
| Healthcare Provider Safety Brochure |
Establish processes and procedures to assess the patient’s vaccination
status for up to date meningococcal and pneumococcal vaccines
according to the current Advisory Committee on Immunization Practices
(ACIP) recommendations including antibacterial drug prophylaxis, if
needed, before treatment initiation and document the findings.
For patients who are not up to date with meningococcal and
pneumococcal vaccines when starting treatment: Establish processes
and procedures to assess the patient’s vaccination status for up to date meningococcal and pneumococcal vaccines including antibacterial drug
prophylaxis, if needed, before dispensing prescriptions up to 6 months
after the first dose and document the findings.
Before dispensing, first
dose
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
Assess the patient’s vaccination status for up to date meningococcal
and pneumococcal vaccines according to the current ACIP
recommendations including antibacterial drug prophylaxis, if needed,
and document the findings through the processes and procedures
established as a requirement of the REMS.
Before dispensing, for up
to 6 months after the first
dose
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
For patients who are not initially up to date with meningococcal and
pneumococcal vaccines when starting treatment: Assess the patient’s
vaccination status for up to date meningococcal and pneumococcal
vaccines including antibacterial drug prophylaxis, if needed, and
document the findings through the processes and procedures
established as a requirement of the REMS.
Before dispensing,
6 months after the first
dose and thereafter
Obtain authorization to dispense each prescription by contacting the
REMS to verify the prescriber is certified.
To maintain certification
to dispense
If the Authorized Representative changes, have a new Authorized
Representative enroll in the REMS by completing and submitting the
Outpatient Pharmacy Enrollment Form to the REMS.
| Outpatient Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of serious bacterial infections to
Alexion Pharmaceuticals, Inc.
Not distribute, transfer, loan, or sell VOYDEYA, except to other certified
pharmacies.
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 Alexion Pharmaceuticals, Inc. or a
third party acting on behalf of Alexion Pharmaceuticals, Inc., to ensure
that all processes and procedures are in place and are being followed.
Inpatient pharmacies that dispense VOYDEYA must:
To become certified to
dispense
Designate an Authorized Representative to carry out the certification
process and oversee implementation and compliance with the REMS on
behalf of the pharmacy.
Have the Authorized Representative enroll in the REMS by completing
and submitting the Inpatient Pharmacy Enrollment Form to the REMS.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing VOYDEYA using the
Healthcare Provider Safety Brochure.
| Healthcare Provider Safety Brochure |
Establish processes and procedures to verify if the patient is initiating
or continuing treatment.
For patients initiating treatment: Establish processes and procedures to
assess the patient’s vaccination status for up to date meningococcal
and pneumococcal vaccines according to the current Advisory Committee on Immunization Practices (ACIP) recommendations
including antibacterial drug prophylaxis, if needed, before treatment
initiation and document the findings.
Before dispensing, first
dose
Verify if the patient is initiating or continuing treatment through the
processes and procedures established as a requirement of the REMS.
For patients initiating treatment: Obtain authorization to dispense by
contacting the REMS to verify the prescriber is certified.
For patients initiating treatment: Assess the patient’s vaccination status
for up to date meningococcal and pneumococcal vaccines according to
the current ACIP recommendations including antibacterial drug
prophylaxis, if needed, and document the findings through the
processes and procedures established as a requirement of the REMS.
At discharge
Dispense no more than a 30 days’ supply.
To maintain certification
to dispense
If the Authorized Representative changes, have a new Authorized
Representative enroll in the REMS by completing and submitting the
Inpatient Pharmacy Enrollment Form to the REMS.
| Inpatient Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of serious bacterial infections to
Alexion Pharmaceuticals, Inc.
Not distribute, transfer, loan, or sell VOYDEYA, except to certified
pharmacies.
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 Alexion Pharmaceuticals, Inc. or a
third party acting on behalf of Alexion Pharmaceuticals, Inc. to 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 Voydeya 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
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.
