Simponi

Golimumab

SC: RA, psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographical axial spondyloarthritis (nr-Axial SpA), ulcerative colitis. IV: RA, AS, PsA.

IV RA, AS & PsA 2 mg/kg as 30-min infusion at wk 0 & 4, then every 8 wk thereafter. SC RA 50 mg inj once a mth (same date each mth), should be given concomitantly w/ MTX. PsA, AS & nr-Axial SpA 50 mg inj once a mth (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. Patient who have inadequate response may benefit from 100 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).

Infections, caution in patients residing or travelling to endemic regions, do not give to patients w/ clinically important, active infection. TB, evaluate patients for TB risk factors & test patients for latent TB infections prior therapy, treat latent TB prior to therapy. Malignancies. Ped malignancy. Lymphoma. Leukemia. Malignancies other than lymphoma. Colon dysplasia/carcinoma. Skin cancers, to perform periodic skin exam. HBV reactivation, test patients for HBV infection before treatment. CHF, use w/ caution in patients w/ heart failure, monitor closely during therapy, discontinue if new or worsening symptoms of heart failure develop. Demyelinating disorders, discontinue if central or peripheral nervous system demyelinating disorders develop. Autoimmune processes, discontinue if patients develop symptom suggestive of lupus-like syndrome. Concomitant administration w/ anakinra, abatacept, other biological therapeutics. Switching between biological therapeutics, monitor for risk of infection. Hematologic reactions, exercise caution in patients who have current or past history of significant cytopenias. Live vaccines/therapeutic infectious agents, do not administer therapeutic infectious agents. Allergic reactions, latex sensitivity, hypersensitivity reactions, discontinue if anaphylactic or other serious allergic reaction occurs. Renal & hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly.

URTI. Bacterial, lower resp tract infections, viral & superficial fungal infections, bronchitis, sinusitis, abscess; increased ALT & AST; leukopenia, anemia; autoAb +ve, non-serious allergic reaction; dizziness, paraesthesia; HTN; rash, alopecia; pyrexia, inj site erythema, urticaria, induration, pain, bruising, pruritus, irritation, paraesthesia.

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.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB06 - golimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

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