Zuellig Pharma
Concise Prescribing Info
In combination w/ methotrexate (MTX) for moderate to severe active RA in adults when response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate; active, severe & progressive RA in adults not previously treated w/ MTX. Alone or in combination w/ MTX for active psoriatic arthritis (PsA) in adults when response to previous DMARD therapy has been inadequate. Active ankylosing spondylitis (AS) in adults when response to conventional therapy has been inadequate. Severe, active non-radiographic axial spondyloarthritis (nr-Axial SpA) in adults w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI evidence, who have inadequate response to or are intolerant to NSAIDs. Moderate to severe active ulcerative colitis in adults who had an inadequate response to conventional therapy eg, corticosteroids & 6-mercaptopurine or azathioprine, or who are intolerant to or have medical CI for such therapies.
Dosage/Direction for Use
IV RA, AS 2 mg/kg as 30-min infusion at wk 0 & 4, then every 8 wk thereafter. SC RA, PsA, AS & nr-Axial SpA 50 mg inj once mthly (same date each mth). Patient >100 kg w/ inadequate clinical response after 3 or 4 doses May increase dose to 100 mg once mthly. Ulcerative colitis Patient ≥80 kg Initially 200 mg, followed by 100 mg at wk 2, then 100 mg every 4 wk, <80 kg Initially 200 mg, followed by 100 mg at wk 2, then 50 mg at wk 6 & every 4 wk thereafter.
Hypersensitivity. Active TB or other severe & opportunistic infections. Moderate or severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue use if hypersensitivity reactions or new or worsening CHF symptoms occurs. Not to be given to patients w/ clinically important active infection. Chronic infection or history of recurrent infection & malignancy; lymphoma; leukemia; colon dysplasia/carcinoma; skin cancers, melanoma, Merkel cell carcinoma; heart failure; central or peripheral nervous system demyelinating disorders; current or past history of significant cytopenias. Formation of antinuclear Ab. Evaluate patient for TB risk factors & initiate treatment of latent TB prior to therapy. Evaluate & monitor HBV chronic carriers prior to, during & for several mth after discontinuation of treatment. Monitor for overlapping biological activity when being switched from one biologic to another. Avoid exposure to potential risk factors for infection. Concurrent use w/ anakinra, abatacept, other biologics. Avoid use w/ live vaccines. Latex sensitivity. Renal & hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Upper resp tract infection. Bacterial, lower resp tract, viral & superficial fungal infections, bronchitis, sinusitis, abscess; increased ALT & AST; leukopenia, anemia; autoantibody positive, non-serious allergic reaction; dizziness, paraesthesia; HTN; rash, alopecia; pyrexia, inj site erythema, urticaria, induration, pain, bruising, pruritus, irritation, paraesthesia.
Drug Interactions
Not recommended w/ concurrent use of anakinra, abatacept & other biological therapeutics. Not to be given concurrently w/ live vaccines. Higher steady-state trough conc w/ SC MTX.
ATC Classification
L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Simponi soln for inj 50 mg/ 0.5 mL
Simponi soln for inj 100 mg/mL
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