Safety

CIMZIA Is the Only Biologic With 3-Year Safety Data for People With nr-axSpA

See information about serious side effects and common side effects below.

The following side effects were most commonly seen within 1 year during the CIMZIA clinical trial in non-radiographic axial spondyloarthritis (nr-axSpA). These are not all the possible side effects that may happen with CIMZIA use. Always discuss the risks versus benefits of therapy with your doctor, and be sure to mention any side effects you experience.

Side effects occurring in ≥5% of people on CIMZIA in nr-axSpA studies

Bronchitis
CIMZIA (n†=159) 5.0%
Placebo (n†=158) 3.2%
Upper respiratory tract infection
CIMZIA (n=159) 18.9%
Placebo (n=158) 10.1%
Nasopharyngitis (common cold)
CIMZIA (n=159) 13.2%
Placebo (n=158) 8.2%
CPK‡ increased (muscle tissue damage)
CIMZIA (n=159) 5.0%
Placebo (n=158) 2.5%
Headache
CIMZIA (n=159) 6.9%
Placebo (n=158) 4.4%
Diarrhea
CIMZIA (n=159) 5.0%
Placebo (n=158) 6.3%
  CIMZIA
(n†=159)
Placebo
(n†=158)
Bronchitis 5.0% 3.2%
Upper respiratory tract infection 18.9% 10.1%
Nasopharyngitis (common cold) 13.2% 8.2%
CPK‡ increased (muscle tissue damage) 5.0% 2.5%
Headache 6.9% 4.4%
Diarrhea 5.0% 6.3%

*n=number of patients
‡CPK=Creatine Phosphokinase

Long-Term Safety With CIMZIA

After the first year of the trial, 243 patients were treated with CIMZIA for an additional 2 years. In that time, similar safety results were seen. The most frequent side effects included nasopharyngitis (common cold), upper respiratory tract infection, and bronchitis.

Risk of Serious Side Effects

CIMZIA is an anti-tumor necrosis factor (TNF) biologic, which 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.

Stop using CIMZIA, and tell your healthcare provider right away if you think you have an infection or have symptoms of an infection. Certain potentially fatal infections and cancers, including lymphoma, have occurred in people who received anti-TNF therapy.

For people who receive TNF blockers, including CIMZIA, the chances of getting certain types of cancers may increase. Some people who receive TNF blockers, including CIMZIA, have developed a rare type of cancer which may cause death, called hepatosplenic T-cell lymphoma. Some people who receive CIMZIA have developed certain types of skin cancer.

Other Serious Side Effects

  • Heart failure, including new or worsening heart failure
  • Allergic reactions
  • Hepatitis B virus reactivation in people who carry the virus
  • New or worsening nervous system problems
  • Blood problems
  • Immune reactions, including a lupus-like syndrome

What Should I Do if I Plan to Become Pregnant or Am Pregnant?

You and your doctor should decide if you should continue to take CIMZIA while you are pregnant. It is currently not known if CIMZIA will harm your unborn baby.

Pregnancy Registry: UCB has a registry for pregnant patients that monitors pregnancy outcomes in women who take CIMZIA. If you’d like to join this registry, call 1-877-311-8972 or click here.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 to reach the FDA

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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CIMZIA Is The First and Only Therapy of Its Kind for nr‑axSpA*

See how CIMZIA may work for you.

*CIMZIA is an anti-tumor necrosis factor (TNF) biologic.