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. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.Ĭarefully 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.Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.Initiate treatment for latent TB prior to CIMZIA use. Test patients for latent TB before CIMZIA use and during therapy. Patients with TB have frequently presented with disseminated or extrapulmonary disease.
Active tuberculosis (TB), including reactivation of latent TB. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.ĭiscontinue CIMZIA if a patient develops a serious infection or sepsis. Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria. Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammationĬIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy. Treatment of adult patients with active ankylosing spondylitis (AS). Treatment of adult patients with active psoriatic arthritis (PsA). Treatment of adults with moderately to severely active rheumatoid arthritis (RA). Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. CIMZIA is not indicated for use in pediatric patients. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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). The parties reserve the right to amend or end this program at any time without notice. The maximum annual benefit amount is $15,000 per calendar year. Claims should not be submitted to any public payor (ie, Medicare, Medicaid, Medigap, TRICARE, VA, and DoD) for reimbursement. Product dispensed pursuant to program rules and federal and state laws. Not valid for prescriptions that are reimbursed, in whole or in 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), or where otherwise prohibited by law. 
*Eligibility: Available to individuals with commercial prescription insurance coverage for CIMZIA. The CIMplicity Nursing Program does not provide medical advice and does not replace the care of the healthcare provider. Some program eligibility and restrictions apply. The CIMplicity program may be amended or canceled at any time without notice. The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA.
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