Simponi

Golimumab

In combination w/ MTX for moderate to severe active RA in adults. Monotherapy or in combination w/ MTX for active psoriatic arthritis (PsA) in adults. Active ankylosing spondylitis (AS) in adults. In combination w/ MTX for polyarticular juvenile idiopathic arthritis (pJIA) in childn at least 40 kg who have responded inadequately to previous therapy w/ MTX. 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 had inadequate response to or are intolerant to NSAIDs. Moderate to severe active ulcerative colitis (UC) in adults who have had inadequate response to conventional therapy.

SC RA, PsA, AS & nr-Axial SpA Adult 50 mg once mthly on the same date each mth. UC Adult ≥80 kg Initially 200 mg, followed by 100 mg at wk 2, then 100 mg every 4 wk thereafter, <80 kg Initially 200 mg, followed by 100 mg at wk 2, then 50 mg every 4 wk thereafter. pJIA Childn of at least 40 kg 50 mg once mthly on the same date each mth.

Hypersensitivity. Active TB or other severe (eg, sepsis) & opportunistic infections; moderate or severe heart failure (NYHA class III/IV).

Discontinue use if anaphylactic or other serious allergic reactions occur; symptoms suggestive of lupus-like syndrome develop & if patient is +ve for Ab against double-stranded DNA. Bacterial, mycobacterial, invasive fungal & opportunistic infections; discontinue use if patient develops new serious infection or sepsis; not to be given in patients w/ clinically important, active infection; caution w/ use in patients w/ chronic infection or history of recurrent infection. TB; evaluate patients for both active & inactive (latent) TB prior to treatment; not to be initiated if active TB is diagnosed; treat inactive (latent) TB if diagnosed prior to therapy. HBV reactivation; test patients for HBV infection prior to treatment. Malignancies & lymphoproliferative disorders; ped malignancy; lymphoma & leukemia; patients at increased risk of or w/ history of dysplasia or colon carcinoma, w/ severe persistent asthma, w/ COPD & heavy smokers; melanoma & Merkel cell carcinoma. CHF; patients w/ mild heart failure (NYHA class I/II); discontinue use if new or worsening symptoms of heart failure develop. New onset or exacerbation of clinical symptoms &/or radiographic evidence of CNS & peripheral demyelinating disorders; consider discontinuing use if these disorders develop. Immunosuppression. Pancytopenia, leukopenia, neutropenia, agranulocytosis & thrombocytopenia; consider discontinuing use if significant hematologic abnormalities are confirmed. Patients who have undergone surgery including arthroplasty. Not recommended in concurrent administration w/ etanercept, anakinra; abatacept; other biological therapeutics to treat same conditions; live vaccines & therapeutic infectious agents eg, live attenuated bacteria. Switching between biological DMARDs. Latex sensitivity. Not to be taken by patients w/ fructose intolerance. May have minor influence on ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential must use adequate contraception during & for at least 6 mth after treatment. Not recommended during pregnancy. Do not breastfeed during & for at least 6 mth after treatment. Childn ≤17 yr w/ indications other than pJIA.

URTI (eg, nasopharyngitis, pharyngitis, laryngitis & rhinitis). Bacterial (eg, cellulitis), lower resp tract (eg, pneumonia), viral (eg, flu & herpes) & superficial fungal infections, bronchitis, sinusitis; leukopenia (including neutropenia), anemia; allergic reactions (eg, bronchospasm, hypersensitivity, urticaria), auto-Ab +ve; depression, insomnia; dizziness, headache, paresthesia; HTN; asthma & related symptoms (eg, wheezing & bronchial hyperactivity); dyspepsia, GI & abdominal pain, nausea, GI inflammatory disorders (eg, gastritis & colitis), stomatitis; increased ALT & AST; pruritus, rash, alopecia, dermatitis; pyrexia, asthenia, inj site reaction (eg, inj site erythema, urticaria, induration, pain, bruising, irritation), chest discomfort; bone fractures.

Serious infections & neutropenia w/ etanercept & potentially anakinra. Increased risk of infections w/ abatacept; other biological therapeutics. Clinical infections w/ live vaccines & therapeutic infectious agents.

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

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

Rx