Golimumab Recombinant Human Monoclonal Antibody

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Product Description

Endotoxin level < 0.01EU/µg by LAL method Use a manual defrost freezer and avoid repeated freeze thaw cycles. Store at 2 to 8 °C for one week. Store at -20 to -80 °C for twelve months from the date of receipt. Golimumab is a human IgG1kappa monoclonal antibody derived from immunizing genetically engineered mice with human TNFalpha. Golimumab binds and inhibits soluble and transmembrane human TNFalpha. Increased TNFalpha is associated with chronic inflammation. Thus golimumab is indicated for use in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. In the U. S. and Canada, golimumab is marketed under the brand name Simponi®. The FDA label includes a black box warning of serious infections and malignancy. Additionally in children and adolescents taking golimumab, there have been lymphoma and other malignancies observed.