C o n s u m e r B rie f S u m m a r y fo r C im zia® (certolizumab pegol)
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.
Read the Medication Guide that comes with CIMZIA before you start using it, and before
each injection of CIMZIA. This brief summary does not take the place of talking with your
doctor about your medical condition or treatment.
What is the most important information I should know about CIMZIA?
CIMZIA is a medicine that affectsyour immune system. CIMZIA can lower the ability of
the immune system to fight infections. Serious infections have happened in patients taking
CIMZIA. These infections include 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 treatment
with CIMZIA.
Before starting CIMZIA, tell your doctor if you:
• think you have an infection. You should not start taking CIMZIA if you have any kind
• are being treated for an infection
• have signs of an infection, such as a fever, cough, flu-like spptoms
• have any open cuts or sores on your body
• get a lot of infections or have infections that keep coming back
• have diabetes
• have HIV
• have tuberculosis (TB), or have been in close contact with someone with TB
• were bom in, lived in, or traveled to countries where there is more risk for getting TB.
Ask your doctor if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River
valleys) where there is an increased risk for getting certain kinds of fungal infections
(histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or
become more severe if you take CIMZIA. If you do not know if you have lived in an area
where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B
• use the medicine Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or
Tysabri® (natalizumab)
After starting CIMZIA,
if you get an infection, any sign of an infection including a fever,
cough, flu-like spptoms, 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.
Certain types of Cancer
• There have been cases of unusual cancers in children and teenage patients using
TNF-blocking agents.
• For people taking TNF-blocker medicines, including CIMZIA, the chances of getting
lymphoma or other cancers may increase.
• People with RA, especially more serious RA, may have a higher chance of getting a
kind of cancer called lymphoma.
See the section “What are the possible side effects of CIMZIA?” for more
information.
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What is CIMZIA?
CIMZIA is a medicine called a Tumor Necrosis Factor (TNF) blocker. CIMZIA is used in
adult patients to:
• Lessen the signs and symptoms of moderately to severely active Crohn's disease (CD)
in adults who nave not been helped enough by usual treatments.
• Treat moderately to severely active rheumatoid arthritis (RA).
It is not known whether CIMZIA is safe and effective in children.
What should I tell my doctor before starting treatment with CIMZIA?
CIMZIA may not be right for you. Before starting CIMZIA, tell your doctor about all of your
medical conditions, including if you:
•
have an infection.
(See, “What is the most important information I should know
about CIMZIA?")
• have or have had any type of cancer
• have congestive heart failure
• 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 allergic to any of the ingredients in CIMZIA.
See the end of this Brief
Summary for a list of the ingredients in CIMZIA.
Tell your doctor if you are pregnant, planning to become pregnant, or
breastfeeding.
CIMZIA has not Been studied in pregnant or nursing women.
Tell your doctor about all the medicines you take including prescription and
nonprescription medicines, vitamins ana herbal supplements.
Your doctor will
tell you if it is okay to take your other medicines while taking CIMZIA. Especially, tell your
doctor if you take:
• Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab),Tysabri® (natalizumab).
taking CIMZIA with Kineret®,
• A TNF blocker: Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept),
Simponi® (golimumab).
You should not take CIMZIA, while you take one of these medicines.
How should I use CIMZIA?
• If your doctor prescribes the CIMZIA lyophilized pack for reconstitution, CIMZIA should
be injected by a healthcare provider.
• If your doctor prescribes the CIMZIA prefilled syringe, see the section
“Patient
Instructions for Use”
at the end of the Medication Guide for complete instructions
for use. Do not give yourself an injection of CIMZIA unless you have been shown by
your doctor or nurse.
Do not use more CIMZIA or inject more often than present
What are the possible side effects of CIMZIA?
CIMZIA can cause serious side effects including:
See
“What is the most important information I should know about CIMZIA?”
• Heart Failure
including new heart failure or worsening of heart failure you already
have. Symptoms include shortness of breath, swelling of your ankles or feet, or sudden
weight gain.
• Nervous System Problems
such as multiple sclerosis, seizures, or inflammation of
the nerves of the eyes. Spptoms include dizziness, numbness or tingling problems
with your vision, and weakness in your arms or legs.
• Allergic Reactions.
Signs of an allergic reaction include a skin rash, swelling of the
face, tongue, lips, or throat, 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. Tell your doctor if you have any of the
following symptoms:
• feel unwell
• tiredness (fatigue)
• poor appetite
• fever, skin rash, or joint pain
•
Blood Problems.
Your body may not make enough of the blood cells that help fight
infections or help stop bleeding. Symptoms include a fever that doesn’t go away,
bruising or bleeding very easily, or looking very pale.
• 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 in people taking CIMZIA are:
• upper respiratory infections (flu, cold)
• rash
• urinary tract infections (bladder infections)
Other side effects with CIMZIA include:
•
Psoriasis.
Some people using CIMZIA had new psoriasis or worsening of psoriasis
they already had. tell your doctor if you develop red scaly patches or raised bumps that
are filled with pus. Your doctor may decide to stop your treatment with CIMZIA.
•
Injection site reactions.
Redness, rash, swelling, itching or bruising can happen
in some people. These symptoms will usually go away within a few days. If you have
pain, redness, or swelling around the injection site that doesn’t go away witnin a few
days or gets worse, call your doctor right away.
Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the side effects with CIMZIA. Ask your doctor or pharmacist for
more information.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
General information about CIMZIA
Medicines are sometimes prescribed for purposes that are not mentioned in Medication
Guides. Do not use CIMZIA for a condition for which it was not prescribed. Do not give
CIMZIA to other people, even if they have the same condition. It may harm them.
This brief summary summarizes the most important information about CIMZIA. if you
would like more information, talk with your doctor. You can ask your doctor or pharmacist
for information about CIMZIA that is written for health professionals.
For more information go to www.CIMZIA.com or call 1-866-4CIMZIA (424-6942).
Always keep CIMZIA, injection supplies, puncture-proof container, and all
other medicines out of the reach of children.
What are the ingredients in CIMZIA?
CIMZIA lyophilized powder: Active ingredient: certolizumab pegol. Inactive ingredients:
sucrose, lactic acid, polysorbate. The pack contains Water for Injection, for reconstitution
of the lyophilized powder.
CIMZIA prefilled syringe: Active ingredient:
pegol. Inactive ingredients: sodium acetate, sodium chloride, and Water
CIMZIA has no preservatives.
certolizumab
and Water for Injection.
You have a high chance for serious infections when taking CIMI
Orencia®, Rituxan®, or Tysabri®.
Product developed and manufactured for:
UCB, Inc., 1950 Lake Park Drive, Smyrna, GA
30080
T "
Cimzia" is a registered trademark of the UCB Group of companies.
UCh ©
2009
UCB, Inc., Smyrna, GA
30080 A
ll rights reserved.
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Printed in the U.S.A.
U.S. License No 1736
CCD123-12105E
