| Document Date: 2010-08-10 12:14:47
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Company Centocor Ortho Biotech Inc. / Alteon Inc. / / Country United States / / Currency pence / / Event FDA Phase / / IndustryTerm dry natural rubber / leftover product / biologic products / / MedicalCondition Demyelinating disease / sometimes fatal infections / TB / severe fungal infection / COPD / Lymphoma / HBV / active infection / Ankylosing Spondylitis / severe persistent asthma / leukopenia / serious systemic illness / palmoplantar psoriasis / endemic / invasive fungal infection / rheumatoid arthritis / pneumocystosis / cellulitis / Demyelinating disorders / thrombocytopenia / Serious infections / Hepatitis B / tuberculosis infection / systemic illness / severely active rheumatoid arthritis / multiple sclerosis / mycoses / extrapulmonary disease / aspergillosis / Psoriasis / anaphylactic reactions / endemic tuberculosis / Ankylosing Spondylitis SIMPONI / blastomycosis / bacterial sepsis / MS / endemic mycoses / infections / injection site erythema / respiratory tract infection / Psoriatic Arthritis / central demyelination / lupus-like syndrome / severe systemic illness / fungal infections / sepsis / upper respiratory tract infection / pre existing psoriasis / leukemia / Autoimmune Disorders / nonmelanoma skin cancer / Congestive Heart Failure / pneumonia / acute liver failure / latent tuberculosis infection / HBV infection / peripheral demyelinating disorders / opportunistic infections / recurrent infection / disease / Active Ankylosing Spondylitis / active HBV infection / nasopharyngitis / peripheral nervous system demyelinating disorders / Guillain-Barré syndrome / Carcinogenesis / tuberculosis infections / neutropenia / aplastic anemia / acute and chronic leukemia / candidiasis / neutropenia / Active tuberculosis / chronic inflammatory diseases / histoplasmosis / active TB / localized disease / clinically important localized infections / lymphomas / MALIGNANCY Lymphoma / Psoriatic Arthritis SIMPONI / latent tuberculosis / opportunistic infection / latent infection / tumor necrosis factor / Heart failure / Reported infections / coccidioidomycosis / pustular psoriasis / onset psoriasis / highly active disease / infection / invasive fungal infections / peripheral demyelinating polyneuropathy / chronic hepatitis B / Active Psoriatic Arthritis / abscess / serious infection / disorders / tuberculosis / pancytopenia / / MedicalTreatment anti-fungal therapy / vaccination / antiviral therapy / anti-viral therapy / immunosuppression / antifungal therapy / Vaccinations / / Organization DOSAGE AND ADMINISTRATION Rheumatoid Arthritis / Anakinra Concurrent administration / DOSAGE AND ADMINISTRATION / FDA / / / Position general U.S. population / physician / General / / Product SC / cyclophosphamide / sulfasalazine / prednisone / SIMPONI / RA / / PublishedMedium the Medication Guide / / Technology antibodies / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SIMPONI® (golimumab) safely and effectively. See full prescribing information for SIMPONI. SIMPONI (golimumab) Inje