Safety Profile

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Most common adverse reactions (≥5% of CIMZIA-treated patients, or higher incidence vs placebo) in controlled Crohn's clinical studies¹

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Incidence of serious adverse events in CIMZIA clinical trials (per 100 patient-years)¹

In completed and ongoing clinical studies^1*: CIMZIA, n=5118

Tuberculosis: CIMZIA, 0.61 vs placebo, 0

In all clinical trials^1*: CIMZIA, n=4650; placebo, n=1319

Malignancies: CIMZIA, 0.5 (0.4, 0.7)^† vs placebo, 0.6 (0.1, 1.7)^†
A total of 3 cases of lymphoma were observed¹

^*Including other investigational uses.
^†Numbers in parentheses represent a 95% confidence interval.

Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.

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Indication
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.

*The CIMZIA Co-Pay Savings Card Program is valid for out-of-pocket expenses for CIMZIA for up to 17 uses. The CIMZIA Co-Pay Savings Card Program is not valid for prescriptions that are reimbursed, in whole or part, under Medicare (including Medicare Part D), Medicaid, similar federal or state funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), private insurance in the Commonwealth of Massachusetts, or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA and DoD) for reimbursement. The parties reserve the right to amend or end this program at any time without notice.

medication guide & prescribing information

important safety information regarding fungal infections

For more information 1-866-4-CIMZIA (1-866-424-6942)

References:

CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2011.
Lichtenstein GR, Thomsen OØ, Schreiber S, et al. Long-term remission with certolizumab pegol in Crohn's disease over 3.5 years: results from the PRECiSE 3 study. Poster presented at: American College of Gastroenterology Annual Meeting; October 23-28, 2009; San Diego, CA.

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