HIGHLIGHT
Idacio

Idacio

adalimumab

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
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 (AS). 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. Ped: Monotherapy or in combination w/ MTX for active polyarticular juvenile idiopathic arthritis (pJIA) 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 conventional therapy is inappropriate. Active moderate to severe HS in adolescents from 12 yr w/ inadequate response to conventional systemic HS therapy.
Dosage/Direction for Use
SC Adult RA 40 mg every wk or 80 mg every other wk in patient not taking concomitant MTX. Psoriatic arthritis & nr-axSpA 40 mg every other wk. 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 on 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. Moderate to severe ulcerative colitis 160 mg at wk 0 (4 inj in 1 day or 2 inj 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 (four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days) followed by 80 mg 2 wk later at Day 15 (two 40 mg inj in 1 day). 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. pJIA 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. HS Adolescent from 12 yr, at least 30 kg 80 mg at wk 0 followed by 40 mg every other wk at wk 1. Adolescent w/ inadequate response to adalimumab May be increased to 40 mg every wk or 80 mg every other wk.
Contraindications
Hypersensitivity. Active TB or other severe infections eg, sepsis, abscesses & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue use if anaphylactic or other serious allergic reaction occurs; new serious infection or sepsis, preexisting or recent-onset central or peripheral nervous system demyelinating disorders; new or worsening symptoms of CHF or lupus-like syndrome develops. Not to be initiated in patients w/ active infections including chronic or localized infections. History of recurrent infection or w/ underlying conditions predisposed to infections; mild heart failure (NYHA class I/II); history of malignancy; signs & symptoms suggestive of blood dyscrasias, confirmed significant hematologic abnormalities; immunosuppression. Opportunistic infections including invasive fungal infections; HBV carriers; lymphomas, leukaemia & other malignancies. Patients undergoing surgery or arthroplasty. 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. Women of childbearing potential should use effective contraception during therapy. 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. Elderly ≥65 yr.
Adverse Reactions
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, leukocytosis; hypersensitivity, allergies; hypokalemia, increased uric acid, abnormal blood Na, 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.
Drug Interactions
Reduced apparent clearance by MTX.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Idacio soln for inj 40 mg/0.8 mL
Packing/Price
(single-use) 1's;2 × 1's;6 × 1's
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