Cimzia®

Important Safety Information you should know about CIMZIA® (certolizumab pegol)

What is the most important information I should know about CIMZIA?

CIMZIA may cause serious side effects, including:

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that can lower the ability of your immune system to fight infections. Some people who received CIMZIA have developed serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death.
Your healthcare provider should test you for TB before starting CIMZIA.
Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.

Before starting CIMZIA, tell your healthcare provider if you:

think you have an infection or have symptoms of an infection such as:
fever, sweat, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feeling very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, HIV-1, or a weak immune system. People with these conditions have a higher chance for infections.
have tuberculosis (TB), or have been in close contact with someone with TB
were born in, live, have lived, or traveled to certain countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis). These infections may develop or become more severe if you receive CIMZIA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis B
use the medicine Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab)

Stop using CIMZIA, and tell your healthcare provider right away if you have any of the symptoms of an infection listed above.

Cancer.
For people who receive TNF blockers, including CIMZIA, the chances of getting certain types of cancers may increase.
Some children, teenagers, and young adults who received TNF blockers, including CIMZIA, have developed lymphoma and other certain types of rare cancers, some of which have caused death. These cancers are not usually seen in this age group.
People with inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.
Some people who receive TNF blockers, including CIMZIA, have developed a rare type of cancer which may cause death, called hepatosplenic T-cell lymphoma. Most of these people were male teenagers and young adult males with Crohn’s disease or ulcerative colitis. Also, most of these people had been treated with both a TNF blocker and another medicine called IMURAN®