Golimumab

DEA Class; Rx

Common Brand Names; Simponi, Simponi Aria

• Antipsoriatics, Systemic; 
• DMARDs, TNF Inhibitors; 
• Monoclonal Antibodies; 
• Inflammatory Bowel Disease Agents

Parenteral TNF blocker
Used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, and ulcerative colitis
Boxed warning highlights risk for serious infections and potential for malignancy

Indicated for the treatment of moderately to severely active rheumatoid arthritis in combination with methotrexate.

Indicated for moderately-to-severely active psoriatic arthritis alone or in combination with methotrexate

Indicated for active ankylosing spondylitis with or without methotrexate

Indicated in adults with moderate to severe active ulcerative colitis who demonstrate corticosteroid dependence or who have an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, achieving and sustaining clinical remission in induction responders

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Simponi

• Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (16%)

• Injection site reactions (eg, erythema, urticaria, induration, pain, bruising, pruritus, irritation, paresthesia) (6%)

• Viral infections (eg, influenza and herpes) (5%)

• Increased ALT (4%)

• Increased AST (3%)

• Dizziness (2%)

• Paresthesia (2%)

• Bronchitis (2%)

• Superficial fungal infections (2%)

• Sinusitis (2%)

• Constipation (1%)

Simponi Aria

• Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (12%)

• Viral infections (eg, influenza and herpes) (3%)

• Hypertension (2%)

• Rash (1%)

• Pyrexia (1%)

• Bronchitis (1%)

Treatment with TNF blockers, may result in the formation of antinuclear antibodies (ANA) and, rarely, in the development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, therapy should be discontinued

Care should be taken when switching from one biological product to another biological product since overlapping biological activity may further increase risk of infection

There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving golimumab; caution should be exercised when using TNF blockers in patients who have or have had significant cytopenias

Patients treated with SIMPONI may receive vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on response to live vaccination, or on secondary transmission of infection by live vaccines; use of live vaccines could result in clinical infections, including disseminated infections

Other uses of therapeutic infectious agents such as live attenuated bacteria (eg, BCG bladder instillation for treatment of cancer) could result in clinical infections, including disseminated infections; it is recommended that therapeutic infectious agents not be given concurrently with this drug

Therapy may not suppress the humoral immune response to the pneumococcal vaccine

In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) reported; some of these reactions occurred after first administration of therapy; if an anaphylactic or other serious allergic reaction occurs, therapy should be discontinued immediately and appropriate therapy instituted

There are no adequate and well-controlled trials in pregnant women; monoclonal antibodies are transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant

There is no information regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production

Golimumab 

SC solution (single-dose prefilled syringe/autoinjector)

• 50mg/0.5mL (Simponi)
• 100mg/1mL (Simponi)

IV solution (single-dose vial)

• 50mg/4mL (Simponi Aria)