Simponi SC Injection

Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein). There was no evidence of the golimumab antibody binding to other TNF superfamily ligands; in particular, the golimumab antibody did not bind or neutralize human lymphotoxin. Golimumab did not lyse human monocytes expressing transmembrane TNF in the presence of complement or effector cells.

Elevated TNFα levels in the blood, synovium, and joints have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TNFα is an important mediator of the articular inflammation that is characteristic of these diseases. The exact mechanism by which golimumab treats ulcerative colitis is unknown. Golimumab modulated the in vitro biological effects mediated by TNF in several bioassays, including the expression of adhesion proteins responsible for leukocyte infiltration (E-selectin, ICAM-1 and VCAM-1) and the secretion of proinflammatory cytokines (IL-6, IL-8, G-CSF and GM-CSF).

Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: The Golimumab dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Golimumab should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Golimumab may be given with or without methotrexate or other nonbiologic Disease Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with Golimumab.

Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Golimumab induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.

• Abatacept: Increased risk of serious infection
• Anakinra: Increased risk of serious infection 
• Live vaccines/therapeutic infectious agents: Avoid use with Simponi

Most common adverse reactions (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions

There are no adequate and well-controlled trials of Golimumab in pregnant women. There is no information regarding the presence of Golimumab in human milk, the effects on
breastfed infants, or the effects on milk production.

Serious Infections: Do not start Simponi during an active infection. If an infection develops, monitor carefully, and stop Simponi if infection becomes serious

Invasive Fungal Infections: For patients who develop a systemic illness on Simponi, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic

Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Simponi and begin antiviral therapy

Malignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers

Congestive Heart Failure: Worsening, or new onset, may occur. Stop Simponi if new or worsening symptoms occur

Demyelinating Disorders: Exacerbation or new onset may occur

Lupus-like Syndrome: Discontinue Simponi if symptoms develop

Hypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur

Pediatric Use: Effectiveness of Simponi in pediatric patients less than 18 years of age has not been established.

Drugs used for Rheumatoid Arthritis

Simponi must be refrigerated at 2ºC to 8ºC and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake