Fresenius Kabi


Concise Prescribing Info
In combination w/ methotrexate for the treatment of moderate to severe, active RA in adults w/ inadequate response to DMARDs including methotrexate; severe, active & progressive RA in adults not previously treated w/ methotrexate; active polyarticular juvenile idiopathic arthritis in adolescents 13-17 yr w/ inadequate response to ≥1 DMARDs. Monotherapy in case of methotrexate intolerance or when continued methotrexate treatment is inappropriate. Severe active ankylosing spondylitis in adults w/ inadequate response to conventional therapy. Active & progressive psoriatic arthritis in adults w/ inadequate response to previous DMARDs. Moderate to severe chronic plaque psoriasis in adults w/ failed response, contraindication, or intolerance to other systemic therapy including cyclosporine, methotrexate or PUVA. Severe, active Crohn's disease in adults w/o response despite a full & adequate course of therapy w/ a corticosteroid &/or an immunosuppressant or w/ intolerance to or contraindications for such therapies.
Dosage/Direction for Use
SC Adult RA, ankylosing spondylitis & psoriatic arthritis 40 mg single dose every other wk. Psoriasis Initially 80 mg, followed by 40 mg every other wk starting 1 wk after the initial dose. Crohn's disease Induction dose: 80 mg at wk 0, followed by 40 mg at wk 2. In case there is need for a more rapid response, administer 160 mg at wk 0 (four 40-mg inj in 1 day or two 40-mg inj daily for 2 consecutive days), followed by 80 mg at wk 2 (two 40-mg inj in 1 day). Recommended dose after induction: 40 mg every other wk. Adolescent 13-17 yr weighing ≥30 kg Polyarticular juvenile idiopathic arthritis 40 mg every other wk.
Hypersensitivity. Active TB or other severe infections eg, sepsis, & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue immediately if hypersensitivity occurs. Caution in patients w/ history of recurring infection or w/ underlying conditions predisposing them to infections, including concomitant use of immunosuppressants; pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; mild heart failure (NYHA class I/II); history of malignancy. Risk of serious bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections; reactivation & new onset of TB; hepatitis B reactivation; lymphomas, leukaemia & other malignancies; haematologic reactions. Closely monitor for infections before, during & after treatment. Do not initiate in patients w/ active infections. Evaluate for active or inactive/latent TB infection before treatment initiation. Test for HBV infection before treatment initiation. Closely monitor HBV carriers for signs & symptoms of active HBV infection during & for several mth after therapy. Examine for the presence of non-melanoma skin cancer prior to & during treatment in patients w/ a medical history of extensive immunosuppressant therapy or psoriasis patients w/ a history of PUVA treatment. Exercise caution when using any TNF-antagonist in COPD patients & patients w/ increased risk for malignancy due to heavy smoking. Discontinue treatment in patients who develop new or worsening symptoms of CHF. May result in the formation of autoimmune Abs. Failed treatment response for Crohn's disease may indicate the presence of fixed fibrotic stricture. Possible increased risk for infections w/ anakinra; abatacept. Patients undergoing surgical procedures including arthroplasty. Minor influence on the ability to drive & use machines. Patients w/ renal &/or hepatic impairment. Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy & continue its use for at least 5 mth after the last treatment. Pregnancy. Patients on adalimumab may receive concurrent vaccination except for live vaccines. Administration of live vaccines (eg, BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 mth following mother's last adalimumab inj during pregnancy. No relevant use for polyarticular juvenile idiopathic arthritis in childn <2 yr. Elderly.
Adverse Reactions
Resp tract infections; leucopaenia, anaemia; 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, urinary tract, fungal, joint infections; skin cancer excluding melanoma, benign neoplasm; leucocytosis, thrombocytopenia; hypersensitivity, allergies; hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration; mood alterations, anxiety, insomnia; paraesthesias, migraine, nerve root compression; visual impairment, conjunctivitis, blepharitis, eye swelling; vertigo; tachycardia; HTN, flushing, haematoma; asthma, dyspnoea, cough; GI haemorrhage, dyspepsia, GERD, sicca syndrome; worsening or new-onset psoriasis, urticaria, bruising, dermatitis, onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms; renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders, positive autoantibody test, increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
Lower Ab formation w/ methotrexate. Not recommended w/ anakinra; abatacept.
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.
Idacio soln for inj 40 mg/0.8 mL
2 × 1's
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