Approved April 24, 2009

GOLIMUMAB
(FDA Category 1S)

SIMPONI(TM) (Centocor Ortho Biotech, Inc.) is a human monoclonal antibody which blocks tumor necrosis factor alfa activity.

DOSING INFORMATION: The recommended dose of golimumab is 50 milligrams subcutaneously once a month.

PHARMACOKINETICS: Following subQ administration the median time to reach maximum concentration was 2 to 6 days; steady state serum concentrations are reached in 12 weeks. The estimated absolute bioavailability is approximately 53%, mean volume of distribution ranged from 58 to 126 mL/kg, mean systemic clearance was estimated to be 4.9 to 6.7 mL/day/kg. The median terminal half-life was approximately 2 weeks.

CAUTIONS: Golimumab may increase the risk of serious infections due to opportunistic pathogens including invasive fungal infections. New-onset tuberculosis, reactivation of latent disease, and dissemination may occur. Hepatitis B reactivation, new-onset or worsening of preexisting congestive heart failure and demyelinating disease including multiple sclerosis may occur. Evaluate risk-benefit of continued golimumab therapy in patients with preexisting or new-onset malignancy. Concomitant use of abatacept, anakinra, and live vaccines is not recommended. Serious adverse events include infection, hepatic reactions and elevated liver enzymes.

FDA APPROVED INDICATIONS: Golimumab is indicated in adults for the treatment of moderately to severely active rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis with or without methotrexate, and active ankylosing spondylitis.