Humira

Adalimumab

Adult: As monotherapy or in combination w/ MTX or other DMARDs to reduce signs & symptoms, inducing major clinical response & remission, inhibiting progression of structural damage & improving physical function in patients w/ moderately to severely active RA. As monotherapy or in combination w/ DMARDS to reduce signs & symptoms of active arthritis in patients w/ psoriatic arthritis (PsA); rate of progression of peripheral joint damage as measured by X-ray in patients w/ polyarticular symmetrical subtypes of the disease & to improve physical function. Reduce signs & symptoms in patients w/ active ankylosing spondylitis (AS) or active non-radiographic axial spondyloarthritis (axial spondyloarthritis w/o radiographic evidence of AS). Reduce signs & symptoms & inducing & maintaining clinical remission in patients w/ moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy & for those who also lost response to or are intolerant to infliximab. Moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids &/or 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. Moderate to severe nail psoriasis in patients who are candidates for systemic therapy. Active moderate to severe hidradenitis suppurative (acne inversa) including treatment of inflammatory lesions & prevention of worsening of abscesses & draining fistulas. Non-infectious intermediate, posterior & panuveitis. Ped: As monotherapy or in combination w/ MTX for reducing signs & symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 yr. Enthesitis-related arthritis in patients ≥6 yr who have had an inadequate response or intolerant of conventional therapy. Reduce signs & symptoms & inducing & maintaining clinical remission in patients ≥6 yr w/ moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Severe chronic plaque psoriasis in childn & adolescent from 4 yr who had an inadequate response to or are inappropriate candidates for topical therapy & phytotherapy. Active moderate to severe hidradenitis suppurative (acne inversa) in adolescents from 12 yr w/ an inadequate response to conventional systemic hidradenitis suppurative therapy. Chronic non-infectious uveitis in patients ≥2 yr.

SC Adult RA, PsA & axial spondyloarthritis (AS & non-radiographic axial spondyloarthritis) 40 mg every other wk as a single dose. May increase dosing frequency for RA to 40 mg every wk if not taken concomitantly w/ MTX. Crohn's disease & hidradenitis suppurativa Initially 160 mg at day 1 (given as four 40 mg inj in 1 day or as two 40 mg inj/day for 2 days), followed by 80 mg 2 wk later at day 15 (given as two 40 mg inj/day). Another 2 wk later (day 29), begin maintenance dose of 40 mg every other wk. Moderate to severe ulcerative colitis 160 mg at wk 0 (given as 4 inj in 1 day or 2 inj/day for 2 days) & 80 mg at wk 2. After induction treatment, 40 mg every other wk. Plaque psoriasis Initially 80 mg, followed by 40 mg every other wk, starting 1 wk after the initial dose. May increase dosing frequency to 40 mg every wk in patient w/ inadequate response after 16 wk. Uveitis Initially 80 mg, followed by 40 mg every other wk, starting 1 wk after the initial dose. Polyarticular juvenile idiopathic arthritis Ped ≥2 yr, ≥30 kg 40 mg every other wk, 15 kg to <30 kg 20 mg every other wk, 10 kg to <15 kg 10 mg every other wk. Enthesitis-related arthritis Ped ≥6 yr 24 mg/m². Max single dose: 40 mg every other wk. Ped Crohn's disease ≥40 kg Day 1: 160 mg (four 40 mg inj in 1 day or two 40 mg inj/day for 2 days), followed by 80 mg 2 wk later (day 15). 2 wk later (day 29), begin maintenance dose of 40 mg every other wk. <40 kg Day 1: 80 mg (two 40 mg inj in 1 day), followed by 40 mg 2 wk later (day 15). 2 wk later (day 29), begin maintenance dose of 20 mg every other wk. Ped plaque psoriasis 0.8 mg/kg wkly for the 1st 2 doses & every other wk thereafter. Max: 40 mg/dose. Hidradenitis suppurativa Adolescent (from 12 yr & at least 30 kg) 80 mg at wk 0 followed by 40 mg every other wk, starting at wk 1. Chronic non-infectious uveitis Ped ≥2 yr, ≥30 kg 40 mg every other wk. Loading dose: 80 mg, <30 kg 20 mg every other wk. Loading dose: 40 mg.

Hypersensitivity.

Discontinue immediately if an anaphylactic reaction or other serious allergic reaction occurs. Do not initiate therapy in patients w/ active infections including chronic or localized infections until infections are controlled; active TB is diagnosed. Patients exposed to TB & those who have traveled in areas of high risk of TB or endemic mycoses. Closely monitor patients for infections including TB before, during & after treatment; & undergo complete diagnostic evaluation those who develop new infection while undergoing treatment. Discontinue if patient develops a new serious infection or sepsis; HBV reactivation; in patients w/ confirmed significant hematologic abnormalities; development of symptoms suggestive of a lupus-like syndrome. Evaluate for both active or inactive (latent) TB infection before initiation of therapy. Opportunistic infections, including invasive fungal infections. Reactivation of HBV in patients who are chronic carriers. Preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Perform neurological evaluation in patients w/ non-infectious intermediate uveitis prior to initiation of therapy to assess for preexisting central demyelinating disorders. Malignancies including lymphoma. Examine patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment for the presence of non-melanoma skin cancer prior to & during treatment. Screen patients w/ ulcerative colitis who are at increased risk for, or who have a prior history of dysplasia or colon carcinoma at regular intervals before therapy & throughout their disease course. Carefully monitor patients w/ heart failure. Combination w/ azathioprine or 6-mercaptopurine. Not recommended w/ concomitant use w/ other biologic DMARDS (eg, anakinra & abatacept) or other TNF antagonists. Live vaccines. Pregnancy & lactation. Childn <2 yr. Elderly.

Lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis, viral pneumonia herpes; leukopenia (including neutropenia & agranulocytosis), anemia; increased lipids; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash (including exfoliative rash); musculoskeletal pain; inj site reaction (including inj site erythema). Sepsis, candidiasis, flu, viral gastroenteritis, paronychia, cellulitis, impetigo, necrotising fasciitis, herpes zoster, ear infections, herpes simplex, oral herpes, tooth infections, vulvovaginal mycotic infection, UTI (including pyelonephritis), fungal & joint infections; benign neoplasm, skin cancer excluding melanoma (including basal/squamous cell carcinoma); thrombocytopenia, leucocytosis; hypersensitivity, allergies (including seasonal allergy); hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycemia, hypophosphatemia, dehydration; mood alterations (including depression), anxiety, insomnia; paraesthesias (including hypoesthesia), migraine, nerve root compression; visual impairment, conjunctivitis, blepharitis, eye swelling; vertigo; tachycardia; HTN, flushing, haematoma; cough, asthma, dyspnoea; GI hemorrhage, dyspepsia, GERD, sicca syndrome; pruritus, urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis; muscle spasms (including increased blood creatine phosphokinase); haematuria, renal impairment; chest pain, edema; coagulation & bleeding disorders (including prolonged aPTT), autoantibody tests +ve (including double stranded DNA Ab), increased blood LDH; impaired healing.

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

L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

Rx