Simponi IV

Simponi IV

golimumab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Golimumab
Indications/Uses
In combination w/ methotrexate for the treatment of moderate to severe active RA.
Dosage/Direction for Use
Adult 2 mg/kg as a 30-min IV infusion at wk 0 & 4, then every 8 wk thereafter.
Contraindications
Severe infections eg, sepsis, TB & opportunistic infections. Moderate or severe (NYHA class III/IV) CHF. Hypersensitivity.
Special Precautions
Do not initiate in patients w/ active infection, including clinically important localized infection. Use w/ caution in patients w/ chronic infection or history of recurrent infection. Evaluate for TB risk factors & test for latent infection prior to & during therapy. Monitor HBV carriers for signs of HBV reactivation. Opportunistic & invasive fungal infections, malignancies (eg, lymphoma, acute & chronic leukemia). Non-lymphoma malignancy, colon dysplasia/carcinoma, melanoma. Immunosuppression. Discontinue if new/worsening symptoms of CHF appear. Central or peripheral nervous system demyelinating disorders & significant cytopenias. Discontinue if patient develops symptoms of a lupus-like syndrome. Consider discontinuation in case of confirmed significant hematologic abnormalities. Concomitant w/ abatacept, anakinra, other biological therapeutics & live vaccines. Increased risk of infection when switching between biological therapeutics (biological DMARDs). Monitor for infections patients who require surgery while on therapy. May have a minor influence on the ability to drive & use machines. Pregnancy & lactation. Elderly. Childn <18 yr.
Adverse Reactions
Upper resp tract infection, nasopharyngitis. Serious infections, malignancies, inj site reactions, increased ALT & AST, formation of autoantibodies, immunogenicity. Ulcerative colitis, anaemia, appendicitis.
Drug Interactions
Increased risk of infection w/ anakinra, abatacept, rituximab, live vaccines & other biological therapeutics. Monitor effects/drug conc of CYP450 substrates w/ narrow therapeutic index eg, warfarin, cyclosporine or theophylline.
ATC Classification
L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Simponi IV infusion 50 mg/4 mL
Packing/Price
(single-use) 1's
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