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See the DrugPatentWatch profile for cimzia
Is cimzia safe for long-term use? Cimzia contains certolizumab pegol, a tumor necrosis factor inhibitor given by injection every two to four weeks. Long-term safety data come from open-label extensions of rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease trials that followed patients for up to seven years. Serious infection rates stayed within the range seen in shorter studies, and no new safety signals appeared. [1] How does infection risk compare with other TNF inhibitors? Rates of serious infections, including tuberculosis and opportunistic infections, sit at roughly 5–7 events per 100 patient-years, similar to adalimumab and etanercept. Patients must be screened for latent tuberculosis and hepatitis B before starting treatment. Live vaccines are contraindicated during therapy. [2] What monitoring is needed while taking Cimzia? Physicians check blood counts and liver enzymes every three to six months. Patients should watch for persistent fever, cough, or unexplained weight loss and report these promptly. Because TNF inhibitors can raise lymphoma and skin-cancer risk, annual dermatologic exams are advised for anyone with prior sun exposure or family history of skin malignancy. [3] When does Cimzia’s patent expire and will biosimilars be available soon? U.S. composition-of-matter patent protection ends in 2024, with some formulation patents extending to 2028. DrugPatentWatch lists ongoing litigation and potential biosimilar filings, but none have launched yet. [4]
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