Concise Prescribing Info
As monotherapy or in combination w/ methotrexate for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate; treatment of severe, active & progressive RA in adults not previously treated w/ methotrexate; treatment of active polyarticular juvenile idiopathic arthritis in adolescents 13-17 yr who have had an inadequate response to ≥1 DMARDs. Treatment of adults w/ severe active ankylosing spondylitis who have had an inadequate response to conventional therapy; active & progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate; moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA; severe, active Crohn's disease, in adult patients who have not responded despite a full & adequate course of therapy w/ a corticosteroid &/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Dosage/Direction for Use
SC Adult RA 40 mg single dose every other wk. In monotherapy, dose can be increased to 40 mg every wk. 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 a need for a more rapid response to therapy: 160 mg at wk 0 (given as four 40 mg inj in 1 day or as two 40 mg inj per day for 2 consecutive days), 80 mg at wk 2 (given as two 40 mg inj in 1 day). After induction treatment: 40 mg every other wk. In case of decrease in response, can be increased to 40 mg every 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
Increased risk of serious infections. Closely monitor for infections, including TB, before, during & after treatment. Do not initiate in patients w/ active infections until infections are controlled. Hepatitis B reactivation. HBV carriers should be closely monitored for signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Possible risk for the development of lymphomas, leukaemia & other malignancies; neurological events; serious allergic reactions; haematologic reactions. Risk of worsening CHF; caution in patients w/ mild heart failure (NYHA class I/II). May result in the formation of autoimmune Abs. Patients who require surgery should be closely monitored for infections. Failure to respond to treatment for Crohn's disease may indicate presence of fixed fibrotic stricture that may require surgical treatment. Patients may receive concurrent vaccinations except for live vaccines. Administration of live vaccines to infants exposed to Amgevita in utero is not recommended for 5 mth following mother's last Amgevita inj during pregnancy. Not recommended w/ other biologic DMARDs (eg, anakinra & abatacept) or other TNF-antagonists. Minor influence on the ability to drive & use machines. Women of childbearing potential should consider use of adequate contraception & continue use for at least 5 mth after last Amgevita treatment. Pregnancy. Higher frequency of serious infections in elderly >65 yr.
Adverse Reactions
Resp tract infections (eg, lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis & pneumonia herpes viral); leukopenia (eg, neutropenia & agranulocytosis), anaemia; lipids increased; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash (eg, exfoliative rash); musculoskeletal pain; inj site reaction (eg, inj site erythema). Systemic infections (eg, sepsis, candidiasis & flu), intestinal infections (eg, gastroenteritis viral), skin & soft tissue infections (eg, paronychia, cellulitis, impetigo, necrotising fasciitis & herpes zoster), ear infections, oral infections (eg, herpes simplex, oral herpes & tooth infections), reproductive tract infections (eg, vulvovaginal mycotic infection), UTI (eg, pyelonephritis), fungal infections, joint infections; skin cancer excluding melanoma (eg, basal cell carcinoma & squamous cell carcinoma), benign neoplasm; leukocytosis, thrombocytopenia; hypersensitivity, allergies (eg, seasonal allergy); hypokalaemia, uric acid increased, blood Na abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration; mood alterations (eg, depression), anxiety, insomnia; paraesthesias (eg, hypoaesthesia), 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 of psoriasis (eg, palmoplantar pustular psoriasis), urticaria, bruising (eg, purpura), dermatitis (eg, eczema), onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms (eg, blood creatine phosphokinase increased); renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders (eg, activated partial thromboplastin time prolonged), autoantibody test positive (eg, double stranded DNA Ab), blood lactate dehydrogenase increased; impaired healing.
Drug Interactions
Possible increased risk for infections & other potential pharmacological interactions w/ anakinra & abatacept.
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Amgevita soln for inj 40 mg/0.8 mL
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