Amgevita

Amgevita

adalimumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Moderate to severe, active RA in adults when the response to DMARDs including methotrexate has been inadequate; severe, active & progressive RA in adults not previously treated w/ methotrexate. Reduces the progression rate of joint damage in combination w/ methotrexate. Monotherapy in case of intolerance to methotrexate or when continued treatment w/ methotrexate is inappropriate. In combination w/ methotrexate for active polyarticular juvenile idiopathic arthritis, in patients from 2 yr who have had an inadequate response to ≥1 DMARDs. Active enthesitis-related arthritis in ≥6 yr who have had an inadequate response to, or who are intolerant of, conventional therapy. Severe active ankylosing spondylitis (AS) in adults who have had an inadequate response to conventional therapy; & severe axial spondyloarthritis w/o radiographic evidence of AS but w/ objective signs of inflammation in adults who have had an inadequate response to, or are intolerant to conventional therapy or NSAIDs. Active & progressive psoriatic arthritis in adults when response to previous DMARD therapy has been inadequate; reduce rate of progression of peripheral joint damage in patients w/ polyarticular symmetrical subtypes of the disease & improves physical function. Moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Severe chronic plaque psoriasis in childn & adolescents from 4 yr who have had an inadequate response to or are inappropriate candidates for topical therapy & phototherapies. Active moderate to severe hidradenitis suppurativa (acne inversa) in adults w/ an inadequate response to conventional systemic HS therapy. Moderate to severe active Crohn's disease, in adults who have not responded despite a full and adequate course of therapy w/ a corticosteroid &/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Moderate to severe active Crohn's disease in ped patients from 6 yr who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid & an immunomodulator, or who are intolerant to or have contraindications for such therapies. Moderate to severe active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Non-infectious intermediate, posterior & panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Dosage/Direction for Use
Adult RA 40 mg every other wk as a single dose via SC inj. Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics can be continued during treatment. Patients who experience a decrease in their response Monotherapy: May increase dose to 40 mg every wk. Ankylosing spondylitis, axial spondyloarthritis w/o radiographic evidence of AS & psoriatic arthritis 40 mg every other wk as a single dose via SC inj. Psoriasis Initially 80 mg SC, followed by 40 mg every other wk starting 1 wk after the initial dose. Hidradenitis suppurativa Initially 160 mg at day 1 (4 inj in 1 day or as two 40 mg inj/day 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, 2 wk later (day 29). Moderate to severe active Crohn's disease 80 mg at wk 0 followed by 40 mg at wk 2. For more rapid response to therapy: 160 mg at wk 0 (4 inj in 1 day or as 2 inj/day for 2 consecutive days), 80 mg at wk 2. After induction treatment: 40 mg every other wk via SC inj. Moderate to severe ulcerative colitis Induction dose: 160 mg at wk 0 (4 inj in 1 day or as 2 inj/day for 2 consecutive days) & 80 mg at wk 2. After induction treatment: 40 mg every other wk via SC inj. Uveitis Initially 80 mg, followed by 40 mg every other wk starting 1 wk after the initial dose. Childn Polyarticular juvenile idiopathic arthritis ≥13 yr 40 mg every other wk regardless of BSA, 2-12 yr 24 mg/m2 up to a max single dose of 20 mg (for patients 2 to <4 yr) & up to a max single dose of 40 mg (for patients 4-12 yr) every other wk via SC inj. Enthesitis-related arthritis ≥6 yr 24 mg/m2 up to a max single dose of 40 mg every other wk via SC inj. Ped plaque psoriasis 0.8 mg/kg up to a max of 40 mg/dose via SC wkly for the first 2 doses & every other wk thereafter. Crohn's disease ≥40 kg 80 mg at wk 0 followed by 40 mg at wk 2. For a more rapid response: 160 mg at wk 0 (4 inj in 1 day or as 2 inj/day for 2 consecutive days), 80 mg at wk 2. <40 kg 40 mg at wk 0 followed by 20 mg at wk 2. For more rapid response therapy: 80 mg at wk 0 (2 inj in 1 day), 40 mg at wk 2. After induction treatment: 20 mg every other wk via SC inj.
Contraindications
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 or other serious allergic reaction occurs. Closely monitor for infections, including TB, before, during & after treatment. Do not initiate in patients w/ active infections including chronic or localised infections until infections are controlled. Consider risk in patients who have travelled in areas of high risk of TB or endemic mycoses eg, histoplasmosis, coccidioidomycosis, or blastomycosis prior to initiating therapy. Patients w/ history of recurring infection or w/ underlying conditions which may predispose patients to infections including the use of concomitant immunosuppressive medications. Serious infections. Evaluate all patients for active or inactive TB before initiation of therapy; consider anti-TB prophylaxis treatment before initiation of therapy in patients w/ several or significant risk factors for TB despite negative test for TB & in patients w/ a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Test for HBV infection before initiating treatment; discontinue therapy in patients who develop HBV reactivation. Preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinue if this occurs. Perform neurologic evaluation in patients w/ non-infectious intermediate uveitis prior to initiating therapy & regularly during treatment. History of malignancy or in whom treatment is continued following development of malignancy. Examine patients w/ history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment prior to & during treatment. COPD patients & w/ increased risk for malignancy due to heavy smoking. Screen patient w/ ulcerative colitis who are at increased risk for or prior history of dysplasia or colon carcinoma at regular intervals before therapy & during disease course. Discontinue use in patients w/ confirmed significant haematologic abnormalities. Administration of live vaccines to infants exposed to Amgevita in utero is not recommended for 5 mth following mother's last inj during pregnancy. Patients w/ mild heart failure (NYHA class I/II); discontinue in patients who develop new or worsening symptoms of CHF. Should not give further treatment if patient develops symptoms suggestive of lupus-like syndrome following treatment. Concomitant use w/ other biologic DMARDs (eg, anakinra, abatacept) or other TNF-antagonist. Surgery. Minor influence on the ability to drive or use machines. Women of childbearing potential should use adequate contraception & continuously use for at least 5 mth after last dose. Pregnancy & lactation (do not breastfeed at least 5 mth after last dose).
Adverse Reactions
Resp tract infections (including lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis & pneumonia herpes viral); leukopenia (including neutropenia & agranulocytosis), anaemia; increased lipids; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash (including exfoliative rash); muskuloskeletal pain; inj site reaction (including inj site erythema). Systemic infections (including sepsis, candidiasis & influenza), intestinal infections (including gastroenteritis viral), skin & soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis & herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes & tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), UTI (including pyelonephritis), fungal & joint infections; skin cancer excluding melanoma (including basal cell carcinoma & squamous cell carcinoma), benign neoplasm; leukocytosis, thrombocytopenia; hypersensitivity, allergies (including seasonal allergy); hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration; mood alterations (including depression), anxiety, insomnia; paraesthesias (including hypoaesthesia), migraine, nerve root compression; visual impairment, conjunctivitis, blepharitis, eye swelling; vertigo; tachycardia; HTN, flushing, hematoma; asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, GERD, sicca syndrome; worsening or new onset of psoriasis (including palmoplantar pustular psoriasis), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms (including increased blood creatine phosphokinase); renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Amgevita soln for inj 20 mg/0.4 mL
Packing/Price
1's
Form
Amgevita soln for inj 40 mg/0.8 mL
Packing/Price
((auto-injector)) 1's;1's
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