

Safety profile
Adverse reactions occurring in ≥1% of CIMZIA-treated patients and more frequently than in placebo groups in PSO clinical trials at Week 161*
*Pooled safety from CIMPASI-1, CIMPASI-2, and CIMPACT through Week 16.
†Upper respiratory tract infection cluster includes upper respiratory tract infection, pharyngitis bacterial, pharyngitis streptococcal, upper respiratory tract infection bacterial, viral upper respiratory tract infection, viral pharyngitis, viral sinusitis, and nasopharyngitis.
‡Headache includes headache and tension headache.
§Injection site reactions cluster includes injection site reaction, injection site erythema, injection site bruising, injection site discoloration, injection site pain, and injection site swelling.
||Herpes infections cluster includes oral herpes, herpes dermatitis, herpes zoster, and herpes simplex.
¶CIMZIA 200 mg Q2W patients received loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
Pooled incidence rates per 100 patient-years for adverse events of interest at Week 161,2
In clinical trials, the rates of reported elevated liver enzymes for CIMZIA were 2.3% for the 400 mg group and 4.3% for the 200 mg group compared to 2.5% for placebo.1
A change in PSO into a different PSO sub-type (including erythrodermic, pustular, and guttate) was observed in <1% of CIMZIA-treated subjects.1
There were no new safety signals with longer-term exposure.3,4#
See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma.
¶CIMZIA 200 mg Q2W patients received loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
#Serious infections include all serious AEs reported in the system organ class of infections and infestations.
AE=adverse event; CI=confidence interval; PSO=plaque psoriasis; Q2W=every 2 weeks.
CIMplicity® supports your patients every step of the way
Learn about same-day benefits verification, PA, and how commercially insured, eligible patients whose coverage is delayed or denied can start treatment right away, at no cost.*†
Find on-demand education at DermDiscovery
*Requires PA to be submitted.
†Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost for up to 24 months or until the patient’s coverage is approved, whichever comes first. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program or where otherwise prohibited by law. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. For initial enrollment into the Program the patient must be required by his/her commercial insurer to submit a prior authorization, or insurance coverage for the CIMZIA Prefilled Syringe must be unavailable. To maintain eligibility in the Program, the following are required: (1) a submitted prior authorization is denied or coverage remains unavailable for the patient; and (2) the prescriber must submit an appeal within 45 days of the first two denials and quarterly thereafter. UCB reserves the right to rescind, revoke, or amend this Program without notice.
PA=prior authorization.
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, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:
CONTRAINDICATIONS
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.
HEART FAILURE
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
DRUG INTERACTIONS
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please refer to full Prescribing Information.
US-CZ-2400612
References: 1. CIMZIA® [prescribing information]. Smyrna, GA: UCB, Inc. 2. Data on file. UCB, Inc., Smyrna, GA. 3. Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314.e6. 4. Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5.