I m p o r ta n t S a f e t y
I n fo r m a tio n A b o u t C IM Z IA ®
(certolizumab pegol)
What is the most important information I should
know about CIMZIA?
CIMZIA is a prescription medicine that affects your
immune system. CIMZIA can lower the ability of
the
immune
system
to
fight
infections.
Serious
infections
have
happened
in
patients
taking
CIMZIA, including tuberculosis (TB) and infections
caused
by
viruses,
fungi,
or
bacteria
that
have
spread throughout the body. Some patients have
died from these infections. Your doctor should test
you for TB before starting CIMZIA. Your doctor
should monitor you closely for signs and symptoms
of TB during your treatment with CIMZIA.
Certain Types of Cancer
There have been cases of unusual cancers in children and
teenage patients using TNF-blocking agents. CIMZIA is not
approved for use in pediatric patients. For people taking
TNF-blocker medicines, including CIMZIA, the chances for
getting lymphoma or other cancers may increase. People
with RA, especially more serious RA, may have a higher
chance for getting a kind of cancer called lymphoma.
Before starting CIMZIA, tell your doctor if you
• Think you have an infection. You should not start taking
CIMZIA if you have any kind of infection,
are being
treated for an infection or have signs of an infection such
as fever, cough or flu-like symptoms or if you get a lot of
infections or have infections that keep coming back.
• Have any open cuts or sores
• Have diabetes or HIV
• Have TB, or have been in close contact with someone
with TB
• Were born in, lived in, or traveled to countries where
there is more risk of getting TB. Ask your doctor if you
are not sure.
• Live or lived in certain parts of country (such as the Ohio
and Mississippi River valleys) where there is an increased
risk
for
getting
certain
kinds
of
fungal
infections
(histoplasmosis, coccidioidomycosis, blastomycosis). These
infections may develop or become severe if you take
CIMZIA. If you do not know if you have lived in these
types of areas, ask your doctor.
• Have or have had hepatitis B
• Have or have had any type of cancer
• Have congestive heart failure
CRD057-0510A
• Have seizures, any numbness or tingling, or a disease
that affects your nervous system such as multiple sclerosis
• Are scheduled to receive a vaccine. Do not receive a live
vaccine while taking CIMZIA
•Are
pregnant,
planning
to
become
pregnant,
or
breastfeeding. CIMZIA has not been studied in pregnant
or nursing women.
• Especially
tell
your
doctor
if
you
take:
Kineret®
(anakinra), Orencia® (abatacept), Rituxan® (rituximab),
Tysabri® (natalizumab), or another TNF blocker. You
have
a
higher
chance
for
serious
infections
when
taking CIMZIA with these medicines. You should not
take CIMZIA while you take one of these medicines.
After starting CIMZIA, if you get an infection, any sign
of an infection including a fever, cough, flu-like symptoms,
or have open cuts or sores on your body, call your doctor
right
away.
CIMZIA can
make
you
more
likely to
get
infections or make any infection that you may have worse.
What are the possible side effects of CIMZIA?
CIMZIA can cause serious side effects including:
Heart Failure including new heart failure or worsening
of heart
failure
you
already
have;
Nervous
System
Problems
such
as
Multiple
Sclerosis,
seizures,
or
inflammation
of
the
nerves
of
the
eyes;
Allergic
Reactions. Signs of an allergic reaction include a skin
rash,
swollen
face,
or trouble
breathing;
Hepatitis
B
virus reactivation in patients who carry the virus in
their blood. In some cases, patients have died as a result
of hepatitis B
virus being reactivated. Your doctor should
monitor you carefully during treatment with CIMZIA if you
carry the hepatitis B
virus in your blood; Blood Problems.
Your body may not make enough of the blood cells that
help
fight
infections
or
help
stop
bleeding;
Immune
reactions including a lupus-like syndrome. Symptoms
include shortness of breath, joint pain, or a rash on the
cheeks or arms that worsens with sun exposure.
Call your doctor right away if you develop any of
the above side effects or symptoms.
The
most
common
side
effects
of
CIMZIA are:
upper respiratory infections (flu, cold), rash, and urinary
tract infections (bladder infections).
Other
side
effects
have
happened
in
some
people
including
new
psoriasis or worsening
of psoriasis you
already have and injection site reactions.
You
are
encouraged
to
report
negative
side
effects to FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see Brief Summary on following pages.
