SIMPONI Rx

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SIMPONI

Arthritis/rheumatic disorders
Colorectal disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Golimumab 50mg/0.5mL, 100mg/mL; soln for SC inj; preservative-free.

Select therapeutic use:

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.

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). Prior history of dysplasia or colon carcinoma; monitor. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Latex allergy. Elderly. Infants (see Interactions). Pregnancy. Nursing mothers.

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.

Pharmacological Class:

TNF-alpha blocker.

Adverse Reactions:

Upper respiratory tract infection, nasopharyngitis, inj site reactions, viral infections; other serious infections, malignancies (eg, melanoma, lymphoma; monitor), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis.

Generic Availability:

NO

How Supplied:

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

SIMPONI 0.5ml of 50mg/0.5ml syringes (Qty:1)

appx. price $4243.00

Indications for SIMPONI:

In moderately-to-severely active ulcerative colitis (UC) adult patients who have demonstrated corticosteroid dependence or have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine or 6-MP 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.

Adult:

Initially 200mg by SC inj at Week 0, followed by 100mg at Week 2, and then 100mg every 4 weeks. Rotate inj sites.

Children:

<18yrs: not established.

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). Prior history of dysplasia or colon carcinoma; monitor. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Latex allergy. Elderly. Infants (see Interactions). Pregnancy. Nursing mothers.

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.

Pharmacological Class:

TNF-alpha blocker.

Adverse Reactions:

Upper respiratory tract infection, nasopharyngitis, inj site reactions, viral infections; other serious infections, malignancies (eg, melanoma, lymphoma; monitor), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis.

Generic Availability:

NO

How Supplied:

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

SIMPONI 0.5ml of 50mg/0.5ml syringes (Qty:1)

appx. price $4243.00