5.1 Hypercorticism and Adrenal Axis Suppression
Additions
and/or revisions underlined:
Systemic effects such as
hypercorticism and adrenal suppression may occur with use corticosteroids,
including UCERIS. Monitor patients for signs and symptoms of hypercorticism and
adrenal axis suppression during treatment with UCERIS.
Patients
with moderate to severe liver disease should be monitored for increased signs
and/or symptoms of hypercorticism. Discontinuing the use of UCERIS tablets
should be considered in these patients [see
Use in Specific Populations (8.6)].
Glucocorticosteroids,
including UCERIS, can reduce the response of the
hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where
patients are subject to surgery or other stress situations, supplementation
with a systemic glucocorticosteroid is recommended.
5.3 Immunosuppression and Increased Risk of
Infection
Subsection title revised
Newly added
information:
Corticosteroids,
including UCERIS, suppress the immune system and increase the risk of infection
with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic
pathogens. Corticosteroids can:
Reduce
resistance to new infections
Exacerbate
existing infections
Increase
the risk of disseminated infections
Increase
the risk of reactivation or exacerbation of latent infections
- Mask
some signs of infection
Corticosteroid-associated
infections can be mild but can be severe and at times fatal.
The rate of infectious complications increases with increasing corticosteroid
dosages.
Monitor
patients for the development of infection and consider discontinuation of
UCERIS if the patient develops an infection while on treatment.
Tuberculosis
If
UCERIS is used in patients with latent tuberculosis or tuberculin reactivity,
reactivation of tuberculosis may occur. Closely monitor such patients for
reactivation. During prolonged UCERIS therapy, patients with latent
tuberculosis or tuberculin reactivity should receive chemoprophylaxis.
Varicella
Zoster and Measles Viral Infections
Varicella
and measles can have a serious or even fatal course in non-immune patients
taking corticosteroids, including UCERIS. In corticosteroid-treated patients
who have not had these diseases or are non-immune, particular care should be
taken to avoid exposure to varicella and measles:
If
a UCERIS-treated patient is exposed to varicella, prophylaxis with varicella
zoster immune globulin may be indicated. If varicella develops, treatment with
antiviral agents may be considered.
If
a UCERIS-treated patient is exposed to measles, prophylaxis with immunoglobulin
may be indicated.
Hepatitis
B Virus Reactivation
Hepatitis B virus reactivation can occur in patients who are hepatitis
B carriers treated
with immunosuppressive dosages of corticosteroids, including
UCERIS. Reactivation can also occur
infrequently in corticosteroid-treated patients who appear to have resolved
hepatitis B infection.
Screen patients
for hepatitis B infection before
initiating immunosuppressive (e.g.,
prolonged) treatment with UCERIS. For patients who show evidence of
hepatitis B infection, recommend consultation with physicians with expertise in
managing hepatitis B regarding monitoring and consideration for hepatitis B
antiviral therapy.
Fungal Infections
Corticosteroids, including UCERIS, may
exacerbate systemic fungal infections; therefore, avoid UCERIS use in the
presence of such infections. For patients on chronic UCERIS therapy
who develop systemic fungal infections, UCERIS withdrawal or dosage reduction is recommended.
Amebiasis
Corticosteroids,
including UCERIS, may activate latent amebiasis. Therefore, it is recommended
that latent amebiasis or active amebiasis be ruled out before initiating UCERIS
in patients who have spent time in the tropics or patients with unexplained
diarrhea.
Strongyloides
Infestation
Avoid UCERIS in patients with known or
suspected Strongyloides (threadworm)
infection. Corticosteroids-induced immunosuppression may lead to Strongyloides superinfection and
dissemination with widespread larval migration, often accompanied by severe
enterocolitis and potentially fatal gram-negative septicemia.
Cerebral Malaria
Avoid corticosteroids, including UCERIS,
in patients with cerebral malaria. commended.
5.4
Kaposi’s Sarcoma
Newly
added subsection
Kaposi’s
sarcoma has been reported to occur in patients receiving corticosteroid
therapy, most often for chronic conditions. Discontinuation of corticosteroids
may result in clinical improvement of Kaposi’s sarcoma.
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
Immunosuppression
and Increased Risk of Infection
Advise
patients to avoid exposure to people with varicella (chicken pox) or
measles. Advise patients to inform their healthcare provider if they are
exposed to varicella or measles or develop a new or worsening infection.
[see Warnings and Precautions (5.3)]
Kaposi’s
Sarcoma
Advise
patients that Kaposi’s sarcoma has been reported in patients receiving
corticosteroids for chronic conditions and to inform their healthcare provider
if they experience signs or symptoms of Kaposi’s sarcoma [see Warnings and Precautions (5.4)].
PATIENT
INFORMATION
Additions and/or revisions underlined:
Before you take
UCERIS extended-release tablets
tell your healthcare provider about all of your medical conditions, including if you:
have
an infection, including fungal and threadworm (Strongyloides)
infections.
…
have malaria of the brain (cerebral malaria).
What
are the possible side effects of UCERIS extended-release tablets?
…
Decreased ability of your body to fight infections
(immunosuppression) and increased risk of infection.
Corticosteroid
medicines, including UCERIS, lower the ability of your immune system
to fight infections and increase the risk of infections caused by viruses,
bacteria, fungi, protozoan, or certain parasites. Corticosteroid medicines,
including UCERIS, can also:
make current infections worse
increase the risk of infections spreading
(disseminated)
increase the risk of making infections active again or
making infections worse that have not been active (latent)
hide (mask) some signs of infection
These
infections can be mild but can be severe and lead to death. Your healthcare
provider should check you closely for signs and symptoms of an infection while
taking UCERIS. Tell
you healthcare provider right away about any signs or symptoms of a
new or worsening infection while taking UCERIS, including flu-like
symptoms such as:
Tuberculosis: If you have inactive (latent)
tuberculosis, your tuberculosis may become active again while taking UCERIS.
Your healthcare provider should check you closely for signs and symptoms of
tuberculosis while taking UCERIS.
Chickenpox and measles: People taking corticosteroid
medicines, including UCERIS, who have not had chickenpox or measles, should
avoid contact with people who have these diseases. Tell your healthcare provider
right away if you come in contact with anyone who has chickenpox or measles.
Hepatitis B virus (HBV) reactivation: If you are a
carrier of HBV, the virus can become an active infection again while taking
UCERIS. Your healthcare provider will test you for HBV before you start taking
UCERIS.
Amebiasis: Inactive (latent) amebiasis may become an
active infection while taking UCERIS. Your healthcare provider should check you
for amebiasis before you start taking UCERIS in people who have spent time in
the tropics or have unexplained diarrhea.
•
Kaposi’s sarcoma. Kaposi’s sarcoma has happened in people who
received corticosteroid therapy, most often for treatment of long-lasting
(chronic) conditions.
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