Treatment with IDACIO ® should not be initiated in patients with an active infection, including localized infections. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO ®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. with underlying conditions that may predispose them to infection. who resided in or traveled in regions where mycoses are endemic, 5. with a history of opportunistic infection, 4. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.Ĭarefully consider the risks and benefits of treatment with IDACIO ® prior to initiating therapy in patients: 1.

Consider empiric antifungal 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 IDACIO ® use. Test patients for latent TB before IDACIO ® 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 IDACIO ® if a patient develops a serious infection or sepsis. Patients treated with IDACIO ® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Claims submission and documentation are simplified with a permanent Q-code, facilitating and streamlining the billing and reimbursement process. Q-codes are permanent reimbursement codes granted to biosimilars and used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like IDACIO ® that are administered by a physician. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. IDACIO ® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira ® (adalimumab). To learn more about how Fresenius Kabi provides comprehensive patient support for IDACIO ® please click here. Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to IDACIO ® is effective for patients administered IDACIO on and after July 1, 2023. The Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for IDACIO ® (adalimumab-aacf). “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases.”Īn IDACIO ® branded biosimilar is available in more than 35 countries.* IDACIO ® (adalimumab-aacf) is indicated for reducing signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis in adults and plaque psoriasis. “We are thrilled to launch IDACIO, our first immunology biosimilar in the U.S.,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. IDACIO ® is available in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector). of its citrate-free adalimumab biosimilar IDACIO ® (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira ® (adalimumab). LAKE ZURICH, Ill.-( BUSINESS WIRE)-Fresenius Kabi announced today the immediate availability in the U.S.

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