C o n s u m e r B r i e f S u m m a r y f o r C im z ia ®
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 affects your 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 of infection.
•
are being treated for an infection.
•
have signs of an infection, such as a fever, cough, flu-like symptoms
•
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 born 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 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.
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.
What is CIMZIA?
CIMZIA is a medicine called a Tumor Necrosis Factor (TNF) blocker.
CIMZIA is used in adult patients to:
•
Lessen the signs of symptoms of moderately to severely active
Crohn's disease (CD) in adults who have not been helped enough by
usual treatments.
c i m z i a
(certolizumab pegol)
• 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 and 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). You have a high chance for
serious infections when taking CIMZIA with Kineret®, Orencia®,
Rituxan®, or Tysabri®.
• 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.
•
CIMZIA is given by an injection under the skin, into your abdomen or
thigh area. Your doctor will tell you how much CIMZIA to inject and
how often to inject CIMZIA, based on your condition to be treated.
Do not use more CIMZIA or inject more often than prescribed.
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. Symptoms 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
