Simponi50 mg/0.5 ml

Simponi 50 mg/0.5 ml is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate Active psoriatic arthritis (PsA) alone, or in combination with methotrexate Active ankylosing spondylitis (AS) ... Read moreSimponi 50 mg/0.5 ml is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate Active psoriatic arthritis (PsA) alone, or in combination with methotrexate Active ankylosing spondylitis (AS) Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, achieving and sustaining clinical remission in induction responders

Drugs used for Rheumatoid Arthritis

Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml antibody binding to other TNF superfamily ligands; in particular, the Simponi 50 mg/0.5 ml antibody did not bind or neutralize human lymphotoxin. Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml treats ulcerative colitis is unknown. Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Simponi 50 mg/0.5 ml should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml.Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Simponi 50 mg/0.5 ml 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.

Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: The Simponi 50 mg/0.5 ml dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Simponi 50 mg/0.5 ml should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml.Dosage in Moderately to Severely Active Ulcerative Colitis: The recommended Simponi 50 mg/0.5 ml 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 50 mg/0.5 ml

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

There are no adequate and well-controlled trials of Simponi 50 mg/0.5 ml in pregnant women. There is no information regarding the presence of Simponi 50 mg/0.5 ml in human milk, the effects onbreastfed infants, or the effects on milk production.

Serious Infections: Do not start Simponi 50 mg/0.5 ml during an active infection. If an infection develops, monitor carefully, and stop Simponi 50 mg/0.5 ml if infection becomes seriousInvasive Fungal Infections: For patients who develop a systemic illness on Simponi 50 mg/0.5 ml, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemicHepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Simponi 50 mg/0.5 ml and begin antiviral therapyMalignancies: Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockersCongestive Heart Failure: Worsening, or new onset, may occur. Stop Simponi 50 mg/0.5 ml if new or worsening symptoms occurDemyelinating Disorders: Exacerbation or new onset may occurLupus-like Syndrome: Discontinue Simponi 50 mg/0.5 ml if symptoms developHypersensitivity Reactions: Serious systemic hypersensitivity reactions including anaphylaxis may occur

Simponi 50 mg/0.5 ml 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

Pediatric Use: Effectiveness of Simponi 50 mg/0.5 ml in pediatric patients less than 18 years of age has not been established.

Drugs used for Rheumatoid Arthritis

Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml antibody binding to other TNF superfamily ligands; in particular, the Simponi 50 mg/0.5 ml antibody did not bind or neutralize human lymphotoxin. Simponi 50 mg/0.5 ml 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 Simponi 50 mg/0.5 ml treats ulcerative colitis is unknown. Simponi 50 mg/0.5 ml 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).

There are no adequate and well-controlled trials of Simponi 50 mg/0.5 ml in pregnant women. There is no information regarding the presence of Simponi 50 mg/0.5 ml in human milk, the effects onbreastfed infants, or the effects on milk production.

Pediatric Use: Effectiveness of Simponi 50 mg/0.5 ml in pediatric patients less than 18 years of age has not been established.