Additions and/or
revisions underlined:
WARNING: SERIOUS
MENINGOCOCCAL INFECTIONS
ZILBRYSQ,
a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)].
Life- threatening and fatal meningococcal infections have occurred in patients
treated with complement inhibitors. These infections may become rapidly
life- threatening or fatal if not recognized and treated early.
Complete or update vaccination for meningococcal bacteria
(for serogroups A, C, W, Y,
and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks
of delaying therapy outweigh the risk of developing a serious infection. Comply
with the most current Advisory Committee on Immunization Practices (ACIP)
recommendations for vaccination against meningococcal bacteria in
patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the
management of the risk of serious infections caused by meningococcal bacteria.
Patients receiving ZILBRYSQ are at increased risk for invasive
disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and
symptoms of serious meningococcal infections and evaluate
immediately if infection is suspected.
Because of the
risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called
ZILBRYSQ REMS [see Warnings and
Precautions (5.2)].
5.1 Serious
Meningococcal Infections
Additions and/or
revisions underlined:
ZILBRYSQ, a complement inhibitor,
increases a patient’s susceptibility to serious, life- threatening, or fatal
infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have
occurred in both vaccinated and unvaccinated patients treated with complement
inhibitors. The initiation of ZILBRYSQ treatment is contraindicated in
patients with unresolved serious Neisseria
meningitidis infection.
Complete or update
meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ, according to current ACIP
recommendations for patients receiving a complement inhibitor. Revaccinate
patients in accordance with ACIP recommendations considering the duration of
ZILBRYSQ therapy. Note that ACIP recommends an administration schedule
in patients receiving
complement inhibitors that differs from the administration schedule in the
vaccine prescribing information.
If urgent ZILBRYSQ therapy is
indicated in a patient who is not up to date with meningococcal vaccines
according to ACIP recommendations, provide
the patient with antibacterial drug prophylaxis and
administer meningococcal vaccines as soon as possible. Various durations
and regimens of antibacterial drug prophylaxis have been considered, but the
optimal durations and drug regimens for prophylaxis and their efficacy have not
been studied in unvaccinated or vaccinated patients receiving complement inhibitors,
including ZILBRYSQ. The benefits and risks of treatment with ZILBRYSQ, as
well as the benefits and risks of antibacterial drug prophylaxis in
unvaccinated or vaccinated patients, must be considered against the known risks
for serious infections caused by Neisseria
meningitidis.
Vaccination does not eliminate
the risk of meningococcal infections, despite development of antibodies following vaccination.
Closely monitor patients for early
signs and symptoms of meningococcal infection and evaluate patients immediately
if infection is suspected. Inform patients of these signs and symptoms and
instruct patients to seek immediate medical care if these signs and symptoms occur.
Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal
if not recognized and treated early. Consider interruption of ZILBRYSQ
in patients who are undergoing treatment for serious meningococcal
infection, depending on the risks of interrupting treatment in the
disease being treated [see
Contraindications (4)].
ZILBRYSQ
is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions (5.2)].
5.2 ZILBRYSQ REMS
Additions and/or
revisions underlined:
ZILBRYSQ is available only
through a restricted program under a REMS called ZILBRYSQ REMS, because of the risk of serious meningococcal infections [seeWarnings and Precautions (5.1)].
Notable requirements of the ZILBRYSQ
REMS include the following:
Prescribers must enroll in the REMS.
Prescribers must counsel patients
about the risk of serious meningococcal infection.
Prescribers must provide the patients with the REMS educational materials.
Prescribers must assess patient
vaccination status for meningococcal vaccines (against serogroups A, C, W,
Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ZILBRYSQ.
Prescribers must
provide a prescription for antibacterial drug prophylaxis if treatment must be
started urgently and the patient is not up to date with meningococcal vaccines
according to current
ACIP recommendations at least two weeks prior to the first dose of
ZILBRYSQ.
Pharmacies that dispense ZILBRYSQ
must be certified
in the REMS and must verify prescribers are certified.
Patients must
receive counseling from the prescriber about the need to receive meningococcal vaccines
per ACIP recommendations, the need to take antibiotics as directed by the
prescriber, and the signs and symptoms of meningococcal infection.
Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following
treatment discontinuation with ZILBRYSQ.
Further information is available at www.ZILBRYSQREMS.com or 1-877-414-8353.
5.3 Other
Infections
Additions and/or
revisions underlined:
Serious infections with Neisseria
species (other than Neisseria
meningitidis), including
disseminated gonococcal infections, have been reported in patients treated with
complement inhibitors.
ZILBRYSQ blocks terminal complement
activation; therefore, patients may have increased susceptibility to
infections, especially with encapsulated bacteria, such as infections caused by
Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser
extent, Neisseria gonorrhoeae.
Administer vaccinations for the prevention of Streptococcus pneumoniae infection according to ACIP recommendations.
Patients receiving ZILBRYSQ are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.
Additions and/or revisions
underlined:
What is the most important information I should know about ZILBRYSQ?
ZILBRYSQ is a medicine
that affects part of your immune system.
ZILBRYSQ may lower the ability
of your immune system to fight infections.
Your healthcare
provider will give you a Patient Safety Card about the risk of serious
meningococcal infection. Carry it with you at all times during treatment and
for 2 months after your last ZILBRYSQ dose. Your risk of meningococcal infection may continue
for several weeks after your
last dose of ZILBRYSQ. It is important to show this card to any healthcare
provider who treats you. This will help them diagnose and treat you quickly.
ZILBRYSQ is only available
through a program
called the ZILBRYSQ
Risk Evaluation and Mitigation
Strategy (REMS). Before
you can receive ZILBRYSQ, your healthcare provider must:
enroll in the ZILBRYSQ
REMS program.
counsel you about the risk of meningococcal infections.
give you the Patient
Guide, including information about the signs and symptoms
of meningococcal infection.
give you a Patient Safety
Card about your risk of meningococcal infection, as discussed above.
make sure that you are vaccinated against serious infections caused by meningococcal bacteria and that
you receive antibiotics if you need to start ZILBRYSQ right away and
you are not up to date on your vaccines.
ZILBRYSQ may also
increase the risk of other types of serious infections caused by
encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria
gonorrhoeae.
Certain
people may be at risk of serious infections with gonorrhea. Talk
to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing.
Call your healthcare provider
right away if you have new signs or symptoms
of infection.
…
Who should not use ZILBRYSQ?
Do not use ZILBRYSQ
if you have a serious meningococcal infection when you are
starting ZILBRYSQ treatment.
…
Additions and/or
revisions underlined:
Advise the patients and/or
caregivers to read FDA-approved patient
labeling (Medication Guide and Instructions for Use).
Serious Meningococcal Infection
Advise patients of the risk of serious
meningococcal infection [see Warnings and
Precautions (5.1)]. Inform patients of the need to complete or update
meningococcal vaccinations at least 2 weeks prior to receiving the first
dose of ZILBRYSQ or receive antibacterial
drug prophylaxis if ZILBRYSQ treatment must be initiated
immediately and they have not
been previously vaccinated. Inform patients of the requirement to be
revaccinated according to current ACIP recommendations for meningococcal infection
while on ZILBRYSQ therapy.
Inform patients that vaccination may not prevent
serious meningococcal infection
and to seek immediate medical
attention if the following signs or symptoms occur:
fever and a rash
fever with high heart
rate
headache with nausea or vomiting
headache and a fever
headache with a stiff neck or stiff back
confusion
muscle aches
with flu-like symptoms
eyes sensitive
to light
Inform patients that they
will be given a Patient Safety Card for
ZILBRYSQ that they should carry with them at all times and for 2 months
following treatment with ZILBRYSQ. This card describes symptoms
which, if experienced, should prompt the patient to immediately seek medical
evaluation.
ZILBRYSQ REMS
ZILBRYSQ
is available only through a restricted program
called ZILBRYSQ REMS [see Warnings and Precautions (5.2)].
Inform the patient of the following notable requirements:
Patients must receive counseling about the risk of serious
meningococcal infections.
Patients must receive written
educational materials about
this risk.
Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following
treatment with ZILBRYSQ.
Patients must be instructed to complete or update meningococcal vaccines for serogroups
A, C, W, Y, and B per ACIP recommendations as directed by the
prescriber prior to treatment with ZILBRYSQ.
Patients must receive antibiotics as directed by the prescriber if they are not up to date with meningococcal
vaccines and have to start ZILBRYSQ right away.
Other Infections
Counsel patients of the increased
risk of infections, particularly those due to encapsulated bacteria, especially
Neisseria species. Advise patients of
the need for vaccination against meningococcal infections according to current medical
guidelines [see Warnings and
Precautions (5.3)]. Counsel patients about gonorrhea prevention and advise
regular testing for patients at risk. Advise
patients to report
any new signs and symptoms of infection.
…
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