Simponi

Golimumab

In combination w/ MTX for moderate to severe active RA in adults when response to 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.

IV RA, AS & PsA 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).

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 with caution in patients w/ heart failure, monitor closely during therapy, discontinue if develop new or worsening symptoms of heart failure. 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. 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, viral & superficial fungal infections, bronchitis, sinusitis, abscess; increased ALT & AST; leukopenia, anemia; autoantibody +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.

B