Amgevita

Adalimumab

In combination w/ MTX (or as monotherapy in case of intolerance to MTX or when continued treatment w/ MTX is inappropriate) for the treatment of moderate to severe, active RA in adults when the response to DMARDs including MTX has been inadequate; treatment of severe, active & progressive RA in adults not previously treated w/ MTX; treatment of active polyarticular juvenile idiopathic arthritis in patients ≥2 yr who have had an inadequate response to ≥1 DMARDs. Treatment of severe active ankylosing spondylitis (AS) in adults who have had an inadequate response to conventional therapy. Treatment of severe axial spondyloarthritis in adults w/o radiographic evidence of AS but w/ objective signs of inflammation by elevated CRP &/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs. Treatment of active & progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Treatment of moderately to severely active Crohn's disease in adults 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. Treatment of moderately to severely active Crohn's disease in paed patients ≥6 yr who have had an inadequate response to conventional therapy including primary nutrition therapy & a corticosteroid &/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

SC Adult RA 40 mg single dose every other wk. In monotherapy, some patients w/ decreased response may benefit from a dose increase to 40 mg every wk or 80 mg every other wk. AS, axial spondyloarthritis w/o radiographic evidence of AS, & 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. Beyond 16 wk, patients w/ inadequate response may benefit from a dose increase to 40 mg every wk or 80 mg every other wk. If adequate response is achieved, dose may subsequently be reduced to 40 mg every other wk. Crohn's disease Induction dose: 80 mg at wk 0, followed by 40 mg at wk 2. If more rapid response to therapy is needed, increase to 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), followed by 80 mg at wk 2 (given as two 40-mg inj in 1 day). Maintenance dose: 40 mg every other wk. Some patients w/ decreased response may benefit from a dose increase to 40 mg every wk or 80 mg every other wk. Ulcerative colitis Induction dose: 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), followed by 80 mg at wk 2 (given as two 40-mg inj in 1 day). Maintenance dose: 40 mg every other wk. Some patients w/ decreased response may benefit from a dose increase to 40 mg every wk or 80 mg every other wk. Childn, adolescent & adult ≥2 yr weighing ≥30 kg Polyarticular juvenile idiopathic arthritis 40 mg every other wk. Childn & adolescent 6-17 yr weighing ≥40 kg Crohn's disease Induction dose: 80 mg at wk 0, followed by 40 mg at wk 2. If more rapid response to therapy is needed, increase to 160 mg at wk 0, followed by 80 mg at wk 2. Maintenance dose: 40 mg every other wk starting at wk 4. Patients w/ insufficient response may benefit from a dose increase to 40 mg every wk or 80 mg every other wk.

Hypersensitivity. Active TB or other severe infections eg, sepsis, & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).

Immediately discontinue administration if an anaphylactic reaction or other serious allergic reaction occurs. Increased susceptibility to serious infections. Closely monitor for infections including TB before, during & after treatment. Do not initiate treatment in patients w/ active infections including chronic or localised infections until infections are controlled. Discontinue administration if a new serious infection or sepsis develops. Caution when considering use in patients w/ history of recurring infection or w/ underlying conditions which may predispose patients to infections, including use of concomitant immunosuppressive medications. Evaluate for both active or inactive (latent) TB infection before initiation of therapy. Risk of hepatitis B reactivation. Test for HBV infection before initiating treatment. Closely monitor HBV carriers for signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Associated in rare instances w/ new onset or exacerbation of clinical symptoms &/or radiographic evidence of CNS demyelinating disease including multiple sclerosis & optic neuritis, & peripheral demyelinating disease, including Guillain-Barré syndrome. Possible risk for the development of lymphomas, leukaemia, & other malignancies cannot be excluded. Risk of haematologic reactions. Consider discontinuation of therapy in patients w/ confirmed significant haematologic abnormalities. Reports of worsening CHF. Caution in patients w/ mild heart failure (NYHA class I/II). Discontinue treatment in patients who develop new or worsening symptoms of CHF. Treatment may result in the formation of autoimmune Abs. Patients who require surgery while on Amgevita should be closely monitored for infections. Failure to respond to treatment for Crohn's disease may indicate the 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 the mother's last Amgevita inj during pregnancy. Concomitant administration w/ other biologic DMARDs (eg, anakinra & abatacept) or other TNF-antagonists is not recommended. Needle cover of pre-filled pen is made from dry natural rubber (derivative of latex), which may cause allergic reactions. Minor influence on the ability to drive & use machines. Has not been studied in patients w/ renal &/or hepatic impairment. Women of childbearing potential should consider the use of adequate contraception & continue its use for at least 5 mth after the last Amgevita treatment. Should only be used during pregnancy if clearly needed. No relevant use in patients <2 yr for polyarticular juvenile idiopathic arthritis; childn <6 yr for Crohn's disease; paed population for ankylosing spondylitis & psoriatic arthritis. Higher frequency of serious infections in elderly >65 yr.

Resp tract infections (eg, lower & URTI, pneumonia, sinusitis, pharyngitis, nasopharyngitis & pneumonia herpes viral); leukopenia (eg, neutropenia & agranulocytosis), anaemia; increased lipids; 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), UTIs (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, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration; mood alterations (eg, depression), anxiety, insomnia; paraesthesia (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 psoriasis (eg, palmoplantar pustular psoriasis), urticaria, bruising (eg, purpura), dermatitis (eg, eczema), onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms (eg, increased blood creatine phosphokinase); renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders (eg, prolonged aPTT), +ve autoantibody test (eg, double-stranded DNA Ab), increased blood LDH; impaired healing.

Administration w/o MTX resulted in increased formation of Abs, increased clearance & reduced efficacy of adalimumab. Possible increased risk for infections including serious infections & other potential pharmacological interactions w/ other biologic DMARDs (eg, anakinra & abatacept) or other TNF-antagonists.

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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