Safety

Studied in Over 80 Clinical Trials Across
All Approved Indications*

*Includes trials in FDA-approved indications of RA, CD, PsA, AS, PSO, and nr-axSpA, as well as additional completed
and ongoing research.

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

The following side effects were most commonly seen during the CIMZIA clinical trials in psoriasis. 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 ≥1% of people on CIMZIA in psoriasis clinical studies†

Upper respiratory tract infection
CIMZIA 400 mg
every 2 weeks
(n‡=342)		 21.9%
CIMZIA 200 mg
every 2 weeks§
(n‡=350)		 19.4%
Placebo
(n‡=157)		 21.0%
Headache
CIMZIA 400 mg
every 2 weeks
(n=342)		 3.8%
CIMZIA 200 mg
every 2 weeks
(n=350)		 2.9%
Placebo
(n=157)		 2.5%
Injection site reactions
CIMZIA 400 mg
every 2 weeks
(n=342)		 3.2%
CIMZIA 200 mg
every 2 weeks
(n=350)		 1.7%
Placebo
(n=157)		 0.6%
Cough
CIMZIA 400 mg
every 2 weeks
(n=342)		 3.2%
CIMZIA 200 mg
every 2 weeks
(n=350)		 1.1%
Placebo
(n=157)		 1.9%
Herpes infections
CIMZIA 400 mg
every 2 weeks
(n=342)		 1.5%
CIMZIA 200 mg
every 2 weeks
(n=350)		 1.4%
Placebo
(n=157)		 1.3%
  CIMZIA 400 mg every 2 weeks
(n‡=342)		 CIMZIA
200 mg every 2 weeks§
(n‡=350)		 Placebo
(n‡=157)
Upper respiratory tract infection 21.9% 19.4% 21.0%
Headache 3.8% 2.9% 2.5%
Injection site reactions 3.2% 1.7% 0.6%
Cough 3.2% 1.1% 1.9%
Herpes infections 1.5% 1.4% 1.3%
  • <1% of people treated with CIMZIA experienced a change in their plaque psoriasis into a different sub-type of psoriasis (erythrodermic, pustular, or guttate)
  • Rates of reported elevated liver enzymes for CIMZIA were 2.3% for the 400-mg group and 4.3% for the 200-mg group vs. 2.5% for placebo
  • No new safety signals were observed with longer-term exposure

†Combined safety from three clinical studies through week 16.
‡n= number of patients.
§Subjects received 400 mg of CIMZIA at weeks 0, 2, and 4 followed by 200 mg every other week.

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 doctor should test you for TB before starting CIMZIA.

Stop using CIMZIA, and tell your doctor 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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