Arthritis/rheumatic disorders:

Indications for: SIMPONI ARIA

Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX) in adults. Active psoriatic arthritis (PsA) in patients ≥2yrs. Active ankylosing spondylitis (AS) in adults. Active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2yrs.

Adult Dosage:

Infuse over 30mins. RA, PsA, AS: 2mg/kg IV at Weeks 0 and 4, then every 8 weeks thereafter. RA: give with MTX.

Children Dosage:

<2yrs: not established. Infuse over 30mins. Base dose on body surface area. PsA, pJIA (2–17yrs): 80mg/m2 at Weeks 0 and 4, then every 8 weeks thereafter.

Boxed Warning:

Serious infections. Malignancy.

SIMPONI ARIA Warnings/Precautions:

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). Update immunizations based on current guidelines prior to initiating therapy. CHF (monitor). Immunosuppression. Demyelinating disorders (eg, MS, Guillain-Barré syndrome); consider discontinuing if develop. Elderly. Infants (see Interactions). Pregnancy. Nursing mothers.

SIMPONI ARIA Classification:

TNF-alpha blocker.

SIMPONI ARIA Interactions:

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.

Adverse Reactions:

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.

Generic Drug Availability:


How Supplied:

Single-use vial—1