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The goal of the FABHALTA 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; Streptococcus pneumoniae; and Haemophilus
influenzae type B) 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 FABHALTA.
Assess the patient's vaccination status for Neisseria meningitidis
serogroups A, C, W, Y, and B; Streptococcus pneumoniae; and
Haemophilus influenzae type B 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,
pneumococcal, and Haemophilus influenzae type B vaccines at least 2
weeks prior to initiation of treatment and who must start FABHALTA
urgently: Provide the patient with a prescription for antibacterial drug
prophylaxis.
Counsel the patient using the Patient Guide and Patient Safety Card.
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 2 weeks following the last dose of
FABHALTA.
| Patient Safety Card |
During treatment
Assess the patient for early signs and symptoms of serious bacterial
infection and evaluate immediately, if infection is suspected.
Revaccinate 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 Novartis Pharmaceuticals
Corporation.
Patients who are prescribed FABHALTA:
Before treatment initiation
Get vaccinated as directed by your prescriber against the following
encapsulated bacteria: Neisseria meningitidis serogroups A, C, W, Y,
and B; Streptococcus pneumoniae; and Haemophilus influenzae
type B.
Take antibiotics as directed by your prescriber if you have to start
FABHALTA right away.
Receive counseling from your prescriber using the Patient Guide and
Patient Safety Card.
| Patient Safety Card |
| Patient Guide |
Get additional vaccines as directed by your prescriber.
At all times during
treatment and for 2 weeks
after the last dose
Inform your prescriber or get emergency medical care right away if
any of the following occur: fever with or without shivers or 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 stiff neck or stiff back; confusion; body aches with flu-like symptoms;
clammy skin; eyes sensitive to light.
Outpatient pharmacies that dispense FABHALTA 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 Outpatient Pharmacy Enrollment Form to the
REMS.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing FABHALTA using the
Healthcare Provider Safety Brochure.
| Healthcare Provider Safety Brochure |
Establish processes and procedures to contact the prescriber to assess
the patient’s vaccination status for up to date meningococcal,
pneumococcal, and Haemophilus influenzae type B 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,
pneumococcal, and Haemophilus influenzae type B vaccines when
starting treatment: Establish processes and procedures to assess the
patient’s vaccination status for up to date meningococcal,
pneumococcal, and Haemophilus influenzae type B vaccines including
antibacterial drug prophylaxis, if needed, by contacting the prescriber
before dispensing prescriptions for 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,
pneumococcal, and Haemophilus influenzae type B vaccines according
to the current ACIP recommendations including antibacterial drug
prophylaxis, if needed, by contacting the prescriber 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,
pneumococcal, and Haemophilus influenzae type B vaccines when
starting treatment: Assess the patient’s vaccination status for up to date meningococcal, pneumococcal, and Haemophilus influenzae type
B vaccines including antibacterial drug prophylaxis, if needed, by
contacting the prescriber 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
Novartis Pharmaceuticals Corporation.
Not distribute, transfer, loan, or sell FABHALTA, 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 Novartis Pharmaceuticals
Corporation or a third party acting on behalf of Novartis
Pharmaceuticals Corporation to ensure that all processes and
procedures are in place and are being followed.
Inpatient pharmacies that dispense FABHALTA 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 FABHALTA 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 contact the prescriber to assess the patient’s vaccination status for
up to date meningococcal, pneumococcal, and Haemophilus influenzae
type B 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, pneumococcal, and Haemophilus
influenzae type B vaccines according to the current ACIP
recommendations, including antibacterial drug prophylaxis, by
contacting the prescriber 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
Novartis Pharmaceuticals Corporation.
Not distribute, transfer, loan, or sell FABHALTA, 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 Novartis Pharmaceuticals
Corporation or a third party acting on behalf of Novartis
Pharmaceuticals Corporation to ensure that all processes and
procedures are in place and are being followed.
Wholesalers-distributors that distribute FABHALTA 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 FABHALTA 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 Novartis Pharmaceuticals
Corporation or a third party acting on behalf of the applicant 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 Fabhalta 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
12/05/2023
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.