SIMPONI ARIA Rx
Generic Name and Formulations:
Golimumab 50mg/4mL; soln for IV infusion after dilution; preservative- and latex-free.
Janssen Biotech, Inc.
Indications for SIMPONI ARIA:
Moderately-to-severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA). Active ankylosing spondylitis (AS).
Infuse over 30 mins. 2mg/kg IV at Weeks 0 and 4, then every 8 weeks thereafter. RA: give with MTX. PsA, AS: may give with or without MTX or other non-biologic DMARDs. All: corticosteroids, NSAIDs, and/or analgesics may be continued during treatment.
<18yrs: not established.
Serious infections. Malignancy.
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, hematological abnormality (eg, cytopenias), lupus-like syndrome, or serious hypersensitivity reaction develops. Malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). CHF (monitor). Immunosuppression. Demyelinating disorders (eg, MS, Guillain-Barré syndrome); consider discontinuing if develop. Elderly. Infants (see Interactions). Pregnancy. Nursing mothers.
Concurrent abatacept, anakinra, live vaccines, therapeutic infectious agents, or other TNF blockers: not recommended. Infants exposed to golimumab in utero: do not give live vaccines for 6 months after mother’s last inj during pregnancy. Concomitant immunosuppressants (eg, corticosteroids, MTX) may increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and may need dose adjustments of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.
Upper RTI, elevated liver enzymes, viral infection, decreased neutrophil count, bronchitis, hypertension, rash; other serious infections, malignancies (eg, melanoma, lymphoma; monitor), blood dyscrasias, new or worsening CHF, antibody formation.