
(goh lim’ yoo mab)
Simponi, Simponi Aria
PREGNANCY CATEGORY B
Drug Classes
Antiarthritic
Disease modifying antirheumatic (DMAR)
Monoclonal antibody
Tumor necrosis factor inhibitor
Therapeutic Actions
Tumor necrosis factor antibody that binds to tumor necrosis factor, blocking an important mediator in the inflammatory response seen in chronic inflammatory diseases, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Indications
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Treatment of moderately to severely active rheumatoid arthritis in adults in combination with methotrexate
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Treatment of active psoriatic arthritis in adults, as monotherapy or in combination with methotrexate
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Treatment of ankylosing spondylitis in adults
Contraindications and Cautions
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Contraindicated with hypersensitivity to components of drug, active infection, active tuberculosis, lactation.
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Use cautiously with heart failure, history of exposure to fungal infections, hepatitis B, TB, bacterial infections, malignancies, demyelinating disorders such as multiple sclerosis, pregnancy.
Available Forms
Single-use prefilled syringe—50 mg/0.5 mL; single-use autoinjector—50 mg/0.5 mL; injection—50 mg/4 mL single-use vial
Dosages
Adults
50 mg by subcutaneous injection once/mo. Or 2 mg/kg IV over 30 min at wk 0 and 4; then every 8 wk.
Pediatric patients
Safety and efficacy not established.
Pharmacokinetics
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