Humira

Humira

adalimumab

Manufacturer:

AbbVie

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
As monotherapy or in combination w/ methotrexate for 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; in case of intolerance to methotrexate or when continued treatment w/ methotrexate is inappropriate; severe, active & progressive RA in adult patients not previously treated w/ methotrexate. As monotherapy or in combination w/ methotrexate for treatment of active polyarticular juvenile idiopathic arthritis, in patients ≥2 yr who have had an inadequate response to ≥1 DMARDs. Treatment of active enthesitis-related arthritis in patients ≥6 yr who have had an inadequate response to, or who are intolerant of, conventional therapy. Treatment of adults w/ severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. Treatment of adults w/ severe axial spondyloarthritis 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 adult patients who are candidates for systemic therapy. Treatment of severe chronic plaque psoriasis in childn & adolescents ≥4 yr who have had an inadequate response to or are inappropriate candidates for topical therapy & phototherapies. Treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adult & adolescents ≥12 yr w/ an inadequate response to conventional systemic HS therapy. Treatment of moderately to severely 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. 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 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. Treatment of 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. Treatment of paed chronic non-infectious anterior uveitis in patients ≥2 yr who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Dosage/Direction for Use
Adult RA 40 mg SC as a single dose every other wk. Methotrexate should be continued during treatment w/ Humira. In monotherapy, patient who experience decrease in response may benefit from an increase in dosage to 40 mg every wk or 80 mg every other wk. Ankylosing spondylitis, axial spondyloarthritis w/o radiographic evidence of AS & psoriatic arthritis 40 mg SC as a single dose every other wk. Psoriasis 80 mg SC at wk 0, followed by 40 mg every other wk starting 1 wk after the initial dose. Patients who experience insufficient response beyond 16 wk may benefit from an increase to 40 mg every wk or 80 mg every other wk. If adequate response is achieved w/ 40 mg every wk or 80 mg every other wk, dosage can be subsequently reduced to 40 mg every other wk. Hidradenitis suppurativa 160 mg SC on day 1 & 80 mg SC on day 15, followed by 40 mg or 80 mg every other wk from day 29. Antibiotics may be continued during treatment w/ Humira if necessary. Crohn's disease 80 mg at wk 0, followed by 40 mg at wk 2 as induction regimen, then 40 mg SC every other wk thereafter. If a more rapid response is needed: 160 mg at wk 0 & 80 mg at wk 2, 40 mg SC every other wk thereafter w/ awareness of the higher risk for adverse events during induction. Patients who experience decrease in response to Humira 40 mg SC every other wk may benefit from an increase to 40 mg every wk or 80 mg every other wk. Ulcerative colitis 160 mg SC at wk 0 & 80 mg at wk 2 as induction treatment, followed by 40 mg SC every other wk. Patients who experience decrease in response to 40 mg every other wk may benefit from an increase to 40 mg every wk or 80 mg every other wk. Uveitis 80 mg SC at wk 0, followed by 40 mg every other wk, starting 1 wk after the initial dose. Paed population Polyarticular juvenile idiopathic arthritis Childn ≥2 yr, 10 to <30 kg 20 mg SC every other wk, ≥30 kg 40 mg SC every other wk. Enthesitis-related arthritis Childn ≥6 yr, 15 to <30 kg 20 mg SC every other wk, ≥30 kg 40 mg SC every other wk. Paed plaque psoriasis Childn 4-17 yr, 15 to <30 kg Initially 20 mg SC at wk 0 & 1, followed by 20 mg every other wk, ≥30 kg Initially 40 mg SC at wk 0 & 1, followed by 40 mg every other wk. Hidradenitis suppurativa Adolescent ≥12 yr, at least 30 kg 80 mg SC at wk 0, followed by 40 mg every other wk from wk 1. If response is inadequate, consider increasing to 40 mg SC every wk or 80 mg every other wk. Paed Crohn's disease Adolescent & childn 6-17 yr, <40 kg 40 mg SC at wk 0, followed by 20 mg at wk 2 as induction. If a more rapid response is needed: 80 mg at wk 0 & 40 mg at wk 2 w/ awareness of the higher risk for adverse events during induction. Maintenance: 20 mg every other wk. Patients who experience insufficient response may benefit from an increase to 20 mg every wk, ≥40 kg 80 mg SC at wk 0, followed by 40 mg at wk 2 as induction. If a more rapid response is needed: 160 mg at wk 0 & 80 mg at wk 2 w/ awareness of the higher risk for adverse events during induction. Maintenance: 40 mg every other wk. In case of insufficient response, dosage may be increased to 40 mg every wk or 80 mg every other wk. Paed uveitis Childn ≥2 yr, <30 kg 20 mg SC every other wk in combination w/ methotrexate. Loading dose of 40 mg may be administered 1 wk prior to start of maintenance therapy, ≥30 kg 40 mg SC every other wk in combination w/ methotrexate. Loading dose of 80 mg may be administered 1 wk prior to start of maintenance therapy.
Contraindications
Hypersensitivity. Active TB or other severe infections eg, sepsis & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Closely monitor patients for infections, including TB, before, during & after treatment. Do not initiate treatment until active infections are controlled. Hepatitis B reactivation; closely monitor patients who are HBV carriers for signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Use w/ caution in patients w/ pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; mild heart failure (NYHA class I/II). Discontinue in case of serious allergic reaction. Possible risk for the development of lymphomas, leukemia & other malignancies. Consider discontinuation of therapy in patients w/ confirmed significant hematologic abnormalities. Paed patients are recommended to be brought up to date w/ immunisations prior to initiation of therapy. Patients may receive concurrent vaccination except for live vaccines. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 mth following the mother's last adalimumab inj during pregnancy. Possible formation of autoimmune antibodies. Concurrent administration w/ biologic DMARDs or TNF-antagonists. Patients for surgery should be closely monitored for infections. Minor influence on ability to drive & use machines. Women of childbearing potential should consider use of adequate contraception. Pregnancy. 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), anemia; 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; leucocytosis, 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, hypoesthesia), 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
Combination is not recommended w/ anakinra; abatacept.
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Humira soln for inj (pre-filled pen) 40 mg/0.4 mL
Packing/Price
2 × 1's
Form
Humira soln for inj (pre-filled syringe) 40 mg/0.4 mL
Packing/Price
2 × 1's
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