GHP April 2016

ghp April 2016 | 49 Research & Development of moderate to severe, active rheumatoid arthritis in adults, in combination with methotrexate, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate; severe, active and progressive rheuma- toid arthritis, in combination with methotrexate, in adults not previously treated with methotrexate; active and progressive psoriatic arthritis in adult patients, alone or in combination with methotrexate, when the response to previous DMARD therapy has been inadequate; severe, active ankylosing spondylitis in adults who have responded inadequately to conven- tional therapy; and for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroi- dal anti-inflammatory drugs (NSAIDs).9 Simponi is also the first and only subcutaneous anti-tumor necrosis factor (TNF)-alpha treatment administered as an every-four-week maintenance therapy for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptop- urine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Simponi is available either through the Simponi™ SmartJect autoinjector or a prefilled syringe as a subcutaneous administered injection.9 Janssen Biotech, Inc. discovered and developed Sim- poni and markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights for Simponi to Mitsub- ishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights for Simponi to Schering-Plough (Ireland) Com- pany, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Important Safety Information Simponi is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to Simponi or any of its excipients. Serious infections, including sepsis, pneumonia, tuberculosis, invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including Simponi. Some of these infections have been fatal. Simponi should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of Simponi in patients with a chronic infection or a history of recurrent infection. Patients should be monitored for signs and symptoms of infection before, during and for several months after treatment with Simponi. If a patient develops a new serious infection or sepsis, Simponi therapy should be discontinued and appropriate antimicrobial or antifungal therapy should be initiated until the infec- tion is controlled. Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate. For patients who have resided in or trav- elled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomy- cosis are endemic, the benefits and risks of Simponi treatment should be carefully considered before initiation of Simponi therapy. Patients must be evalu- ated for the risk of tuberculosis (TB), including latent tuberculosis, prior to initiation of Simponi. If active TB is diagnosed, Simponi must not be initiated. If latent TB is suspected or diagnosed, then the benefit/risk balance of Simponi treatment should be considered. Treatment of latent tuberculosis infection should be in- itiated prior to therapy with Simponi. Antituberculosis therapy prior to initiating Simponi should also be con- sidered in patients who have several or significant risk factors for tuberculosis infection and have a negative test for latent tuberculosis, or for patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Simponi should be monitored closely for signs and symptoms of active tuberculosis during and after treatment, including patients who tested negative for latent tuberculosis infections.9 The use of TNF blocking agents including Simponi has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. Some of these cases have been fatal. Chronic carriers of hepatitis B should be appropriately evaluated and monitored prior to the initiation of, during treatment with, and for several months following discontinuation of Simponi. In patients who develop HBV reactivation, SIMPONI should be discontinued.9 Lymphomas have been observed in patients treated with TNF blocking agents, including Simponi. The incidence of non-lymphoma malignancies was similar to controls, and lymphoma is seen more often than in the general population. The potential role of TNF-blocking therapy in the development of malignancies is not known. Based on an exploratory clinical trial in patients with COPD, caution should be exercised when using any TNF-blocking thera- py in COPD patients, as well as in patients with an increased risk for malignancy due to heavy smoking. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.9 Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initia- tion of therapy ≤ 18 years of age) in the post market- ing setting. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.9 It is not known if Simponi treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dys- plasia or colon carcinoma, or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.9 Melanoma has been reported in patients treated with TNF-blocking agents, including Simponi. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.9