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Golimumab

Generic Name
Golimumab
Brand Names
Simponi
Drug Type
Biotech
CAS Number
476181-74-5
Unique Ingredient Identifier
91X1KLU43E

Overview

Golimumab is a human IgG1қ monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. Golimumab binds and inhibits soluble and transmembrane human TNFα. Increased TNFα 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.

Background

Golimumab is a human IgG1қ monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. Golimumab binds and inhibits soluble and transmembrane human TNFα. Increased TNFα 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.

Indication

Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) in patients 2 years old and above with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS) or in combination with methotrexate, 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. It is also indicated (v) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

Associated Conditions

  • Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
  • Severe Ulcerative Colitis
  • Active Ankylosing spondylitis
  • Active Psoriatic arthritis
  • Moderate Ulcerative colitis
  • Moderate, active Rheumatoid arthritis
  • Severe, active Rheumatoid arthritis

FDA Approved Products

SIMPONI ARIA
Manufacturer:Janssen Biotech, Inc.
Route:INTRAVENOUS
Strength:50 mg in 4 mL
Approved: 2023/07/19
NDC:57894-350
Simponi
Manufacturer:Janssen Biotech, Inc.
Route:SUBCUTANEOUS
Strength:100 mg in 1 mL
Approved: 2023/11/21
NDC:57894-071
Simponi
Manufacturer:Janssen Biotech, Inc.
Route:SUBCUTANEOUS
Strength:50 mg in 0.5 mL
Approved: 2023/11/21
NDC:57894-070

Singapore Approved Products

SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED PEN 45MG/0.45ML
Manufacturer:Baxter Pharmaceutical Solutions LLC, Cilag AG
Form:INJECTION, SOLUTION
Strength:45mg/0.45ml
Online:Yes
Approved: 2021/03/09
Approval:SIN16118P
Simponi® Solution for Injection in Pre-filled Syringe 100 mg/1.0 ml
Manufacturer:Baxter Pharmaceutical Solutions LLC, Cilag AG
Form:INJECTION, SOLUTION
Strength:100mg/1.0ml
Online:Yes
Approved: 2015/02/23
Approval:SIN14735P
Simponi Solution for Injection in Pre-filled Syringe 50 mg/0.5 ml
Manufacturer:Baxter Pharmaceutical Solutions LLC, Cilag AG
Form:INJECTION, SOLUTION
Strength:50 mg/0.5ml
Online:Yes
Approved: 2012/02/15
Approval:SIN14105P
Simponi® I.V. Concentrate for Solution for Infusion 12.5mg/1 ml
Manufacturer:Cilag AG
Form:INFUSION, SOLUTION CONCENTRATE
Strength:12.5mg/1 ml in 4 ml vial
Online:Yes
Approved: 2015/02/23
Approval:SIN14734P

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