Amgevita

Adalimumab

Adult: Monotherapy or in combination w/ MTX or other DMARDs in patients w/ moderate to severe active RA. Monotherapy or in combination w/ DMARDs in patients w/ active psoriatic arthritis. Active ankylosing spondylitis. Non-radiographic axial spondyloarthritis (nr-axSpA) in patients w/ inadequate response to or are intolerant to NSAIDs. Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic or phototherapy & when other systemic therapies are medically less appropriate. Moderate to severe active Crohn's disease in patients w/ inadequate response to conventional therapy, or who have lost response to or are infliximab-intolerant. Moderate to severe active ulcerative colitis in patients w/ inadequate response to conventional therapy including corticosteroids &/or 6-mercaptopurine or azathioprine, or who are intolerant to, or have medical CI for such therapies. Active moderate to severe hidradenitis suppurativa (HS) in patients w/ inadequate response to conventional systemic HS therapy. Non-infectious intermediate, posterior & panuveitis in patients w/ inadequate response to corticosteroids, in need of corticosteroid-sparing or in whom corticosteroids is inappropriate. Paed: Monotherapy or in combination w/ MTX for active polyarticular juvenile idiopathic arthritis (JIA) in patients >2 yr w/ inadequate response to ≥1 DMARDs. Active enthesitis-related arthritis in patients ≥6 yr w/ inadequate response to or who are intolerant of conventional therapy. Moderate to severe active Crohn's disease in ped patients 6-17 yr w/ inadequate response to conventional therapy eg, primary nutrition therapy, corticosteroids &/or immunomodulator, or who are intolerant to or have CI for such therapies. Severe chronic plaque psoriasis in childn & adolescents from 4 yr w/ inadequate response to or are inappropriate candidates for topical- & phototherapy. Chronic non-infectious anterior uveitis in patients from 2 yr w/ inadequate response to or are intolerant to conventional therapy, or in whom corticosteroid therapy is inappropriate.

SC Adult RA, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis & nr-axSpA) 40 mg every other wk. RA 40 mg every wk or 80 mg every other wk in patient not taking concomitant MTX. Plaque psoriasis Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose. May be increased to 40 mg every wk or 80 mg every other wk. Dose may be subsequently reduced to 40 mg every other wk if adequate response is achieved. Crohn's disease Induction: Initially 80 mg at wk 0 followed by 40 mg at wk 2. For more rapid response to therapy: 160 mg at wk 0 (160 mg in 1 day or 80 mg daily for 2 consecutive days) & 80 mg at wk 2. After induction, 40 mg every other wk. May be increased to 40 mg every wk or 80 mg every other wk. Moderate to severe ulcerative colitis 160 mg at wk 0 (160 mg in 1 day or 80 mg daily for 2 consecutive days) & 80 mg at wk 2. After induction, 40 mg every other wk. May be increased to 40 mg every wk or 80 mg every other wk. HS Initially 160 mg at Day 1 (160 mg in 1 day or 80 mg daily for 2 consecutive days), followed by 80 mg 2 wk later at Day 15. Continue w/ 40 mg every wk or 80 mg every other wk on Day 29. Uveitis Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose. JIA Ped from 2 yr, ≥30 kg 40 mg every other wk, 10 to <30 kg 20 mg every other wk. Enthesitis-related arthritis Ped from 6 yr, ≥30 kg 40 mg every other wk, 15 to <30 kg 20 mg every other wk. Ped Crohn's disease Ped from 6-17 yr, ≥40 kg 80 mg at wk 0 & 40 mg at wk 2. For more rapid response to therapy: 160 mg at wk 0 & 80 mg at wk 2. Maintenance: 40 mg every other wk starting wk 4, <40 kg 40 mg at wk 0 & 20 mg at wk 2. For more rapid response to therapy: 80 mg at wk 0 & 40 mg at wk 2. Maintenance: 20 mg every other wk starting wk 4. Ped plaque psoriasis Ped from 4-17 yr, ≥30 kg Initially 40 mg, followed by 40 mg every other wk starting 1 wk after initial dose, 15 to <30 kg Initially 20 mg, followed by 20 mg every other wk starting 1 wk after initial dose. Ped uveitis Ped ≥2 yr, ≥30 kg 40 mg every other wk in combination w/ MTX. Loading dose: 80 mg 1 wk prior to maintenance therapy, <30 kg 20 mg every other wk in combination w/ MTX. Loading dose: 40 mg 1 wk prior to maintenance therapy.

Hypersensitivity.

Discontinue use if anaphylactic or other serious allergic reaction occurs; new serious infection or sepsis, pre-existing or recent-onset central or peripheral nervous system demyelinating disorders, lupus-like syndrome develops. Not to be initiated in patients w/ active infections including chronic or localized infections. History of recurring infection or w/ underlying conditions predisposed to infections; worsening & new onset CHF; history of malignancy; signs & symptoms suggestive of blood dyscrasias, confirmed significant hematologic abnormalities; immunosuppression; formation of autoimmune Ab. Opportunistic infections including invasive fungal infections; HBV carriers & reactivation; lymphomas, leukemia & other malignancies. Perform neurologic evaluation in patients w/ non-infectious intermediate uveitis prior to therapy. Evaluate for active or inactive/latent TB infection prior to initiation. Closely monitor for signs & symptoms of active HBV infection during & for several mth after therapy; infections including TB before, during & after treatment. Examine for presence of non-melanoma skin cancer prior to & during treatment in patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment. Screen patients w/ ulcerative colitis at increased risk or w/ prior history for dysplasia or colon carcinoma. Not recommended in concomitant use w/ other biologic DMARDs (eg, anakinra, abatacept) or other TNF-antagonists. Pregnancy & lactation. Not recommended w/ live vaccines & live vaccination in infants for 5 mth following mother's last adalimumab inj during pregnancy. Childn <2 yr.

Resp tract infections; leucopenia, anemia; increased lipids; headache; abdominal pain, nausea, vomiting; elevated liver enzymes; rash; musculoskeletal pain; inj site reaction. Systemic, intestinal, skin, soft tissue, ear, oral, reproductive tract, fungal & joint infections, UTI; benign neoplasm, skin cancer excluding melanoma; thrombocytopenia, leucocytosis; hypersensitivity, allergies; hypokalemia, increased uric acid, abnormal blood Na & K, hypocalcemia, hyperglycemia, hypophosphatemia, dehydration; mood alterations, anxiety, insomnia; paraesthesias, 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, dermatitis, onychoclasis, hyperhidrosis; muscle spasms; haematuria, renal impairment; chest pain, edema; coagulation & bleeding disorders, +ve autoAb tests, increased blood lactate dehydrogenase; impaired healing.

Reduced apparent clearance by MTX.

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

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

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