Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers.Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population. In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S.In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.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.
If an infection develops, monitor carefully and initiate appropriate therapy.Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.Do not start CIMZIA during an active infection, including localized infections.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.
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).
0 kommentar(er)
