CinnoRA®

Description

CinnoRA^® (Adalimumab) is a recombinant monoclonal antibody that binds to human tumor necrosis factor alpha (TNF-alpha), thereby interfering with binding to TNFα receptor sites and subsequent cytokine-driven inflammatory processes.

Indications

• CinnoRA^® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
• CinnoRA^® is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
• CinnoRA^® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
• CinnoRA^® is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
• CinnoRA^® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. CinnoRA^® is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
• CinnoRA^® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6- mercaptopurine, or methotrexate.
• CinnoRA^® is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).
• CinnoRA^® is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
• CinnoRA^® is indicated for the treatment of moderate to severe hidradenitis suppurativa.
• CinnoRA^® is also indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

Important safety information

• Adalimumab may rarely cause hypersensitivity, anaphylaxis, anaphylactoid reactions, or angioedema.
• Rare cases of autoimmune disorders, including lupus-like syndrome, have been reported; monitor and discontinue if symptoms develop.
• Rare cases of new-onset or exacerbation of demyelinating disorders (eg, Multiple sclerosis) have been reported; consider discontinuing use in patients who develop peripheral or central nervous system demyelinating disorders during treatment.
• Worsening and new-onset heart failure (HF) has been reported. Use with caution in patients with HF or decreased left ventricular function.
• Rare cases of pancytopenia and aplastic anemia have been reported with TNF blockers. discontinue if significant hematologic abnormalities are confirmed. Use with caution in patients with a history of significant hematologic abnormalities.
• Rare reactivation of hepatitis B (HBV) has occurred in chronic carriers of the virus, evaluate for HBV prior to initiation in all patients. Monitor during and for several months following discontinuation of treatment in HBV carriers; interrupt therapy if reactivation occurs and treat appropriately with antiviral therapy; if resumption of therapy is deemed necessary, exercise caution and monitor patient closely.
• Patients receiving adalimumab are at increased risk for serious infections which may result in hospitalization and/or fatality; infections usually developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate, corticosteroids) and may present as disseminated (rather than local) disease.
• Lymphoma and other malignancies (some fatal) have been reported in children and adolescents receiving TNF-blocking agents, including adalimumab. Monitor signs/symptoms of malignancy, including periodic skin examination.
• Active tuberculosis, has been reported in patients receiving adalimumab. Evaluate patients prior to and during therapy. Treatment for latent tuberculosis should be initiated before use. Patients with initial negative tuberculin skin tests should receive continued monitoring for tuberculosis during and after treatment.