Indications for SIMPONI:

Moderately-to-severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).

Adult:

50mg SC once monthly. Rotate inj sites. Corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment.

Children:

<18yrs: not established.

Pharmacological Class:

TNF-alpha blocker.

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), or serious hypersensitivity reaction develops. Malignancies. Prior history of dysplasia or colon carcinoma; monitor. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Latex allergy. Elderly. Infants (see Interactions). Pregnancy (Cat.B). Nursing mothers: not recommended.

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:

Inj site reactions, infections (may be serious), upper respiratory tract infection, nasopharyngitis, hypertension; rare: malignancies (eg, melanoma, lymphoma; monitor), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis.

How Supplied:

Single-dose SmartJect autoinjector—1; Single-dose prefilled syringe—1