Humira

Adult: As monotherapy or in combination w/ MTX or other DMARDs to reduce signs & symptoms & inhibit progression of structural damage & improve physical function in patients w/ moderately to severely active RA w/ inadequate response to ≥1 DMARDs. Used in combination w/ MTX in patients w/ recently diagnosed moderate to severely active RA who have not received MTX. As monotherapy or in combination w/ DMARDS to reduce signs & symptoms of active arthritis in patients w/ moderate to severe psoriatic arthritis when response to previous DMARD therapy is inadequate. Reduce rate of progression of peripheral joint damage as measured by X-ray in patients w/ polyarticular symmetrical subtypes of the disease & to improve physical function. Reduce signs & symptoms in patients w/ active ankylosing spondylitis (AS) w/ inadequate response to conventional therapy. Reduce signs & symptoms & induce & maintain clinical remission in patients w/ moderately to severely active Crohn's disease w/ inadequate response to conventional therapy & for those who also lost response to or are intolerant to infliximab. Moderately to severely active ulcerative colitis in patients w/ inadequate response to conventional therapy including corticosteroids &/or 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. Active moderate to severe hidradenitis suppurativa (acne inversa) w/ inadequate response to conventional systemic HS therapy. Non-infectious intermediate, posterior & panuveitis in patients w/ inadequate response to corticosteroids, those in need of corticosteroid-sparing, or whom corticosteroid treatment is inappropriate. Ped: As monotherapy or in combination w/ MTX for active polyarticular juvenile idiopathic arthritis in patients ≥2 yr, w/ inadequate response to ≥1 DMARDs. Enthesitis-related arthritis in patients ≥6 yr who have had an inadequate response or intolerant of conventional therapy. Reduce signs & symptoms & inducing & maintaining clinical remission in patients ≥6 yr w/ moderately to severely active Crohn's disease w/ inadequate response to conventional therapy. Severe chronic plaque psoriasis in childn & adolescent from 4 yr w/ inadequate response to or are inappropriate candidates for topical therapy & phytotherapy. Active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 yr w/ an inadequate response to conventional systemic hidradenitis suppurativa therapy. Chronic non-infectious uveitis in patients ≥2 yr or those w/ inadequate response to or are intolerant to conventional therapy or in whom conventional therapy is inappropriate. Inducing & maintaining clinical remission in patients ≥5 yr w/ moderate to severe active ulcerative colitis w/ inadequate response to conventional therapy including corticosteroids &/or 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

SC Adult RA, psoriatic arthritis & ankylosing spondyloarthritis 40 mg every other wk as a single dose. May increase dosing frequency for RA to 40 mg every wk or 80 mg every other wk if not taken concomitantly w/ MTX. Crohn's disease Induction: Initially 80 mg on day 0, & 40 mg on day 14. Maintenance: 40 mg starting day 28 & continuing fortnightly. In case there is a need for a more rapid response to therapy, may use the regimen 160 mg at wk 0 (given as 160 mg in 1 day or as 80 mg/day for 2 consecutive days), 80 mg at wk 2, w/ the awareness that the risk for adverse events is higher during induction. Moderate to severe ulcerative colitis 160 mg at wk 0 (given as 160 mg in 1 day or as 80 mg/day for 2 consecutive days) & 80 mg at wk 2. After induction treatment, 40 mg every other wk. Plaque psoriasis Initially 80 mg, followed by 40 mg every other wk, starting 1 wk after the initial dose. May increase dosing frequency to 40 mg every wk or 80 mg every other wk in patient w/ inadequate response after 16 wk. Hidradenitis suppurativa Initially 160 mg at day 1 (given as 160 mg in 1 day or as 80 mg/day for 2 consecutive days), followed by 80 mg 2 wk later at day 15. Another 2 wk later (day 29), continue dose of 40 mg every wk or 80 mg every other wk. Uveitis Initially 80 mg, followed by 40 mg every other wk, starting 1 wk after the initial dose. Polyarticular juvenile idiopathic arthritis Ped from 2 yr weighing ≥30 kg 40 mg every other wk, 10 kg to <30 kg 20 mg every other wk. Enthesitis-related arthritis Ped from 6 yr weighing ≥30 kg 40 mg every other wk, 15 kg to <30 kg 20 mg every other wk. Crohn's disease Ped 6- 17 yr weighing ≥40 kg 80 mg at wk 0 & 20 mg at wk 2. May use dose 160 mg at wk 0 & 80 mg at wk 2 in case there is a need for a more rapid response to therapy. Maintenance dose: Starting at wk 4, 20 mg every other wk, <40 kg 40 mg at wk 0 & 20 mg at wk 2. May use dose 80 mg at wk 0 & 40 mg at wk 2 in case there is a need for a more rapid response to therapy. Maintenance dose: Starting at wk 4, 20 mg every other wk. Plaque psoriasis 4-17 yr weighing ≥30 kg Initially 40 mg, followed by 40 mg every other wk starting 1 wk after the initial dose, 15 kg to <30 kg Initially 20 mg, followed by 20 mg every other wk starting 1 wk after the initial dose. Hidradenitis suppurativa Adolescent from 12 yr & at least 30 kg 80 mg at wk 0 followed by 40 mg every other wk, starting at wk 1. May increase to 40 mg every wk or 80 mg every other wk in patient w/ inadequate response to treatment. Chronic non-infectious uveitis Ped ≥2 yr weighing ≥30 kg 40 mg every other wk in combination w/ MTX. Loading dose: 80 mg, <30 kg 20 mg every other wk in combination w/ MTX. Loading dose: 40 mg. Ulcerative colitis Ped 5-17 yr weighing ≥40 kg Induction dose: 160 mg at wk 0 & 80 mg at wk 2. Maintenance dose: Starting at wk 4, 80 mg every other wk or 40 mg every wk, <40 kg Induction dose: 80 mg at wk 0 & 40 mg at wk 2. Maintenance dose: Starting at wk 4, 40 mg every other wk or 20 mg every wk.

Hypersensitivity. Active TB or other severe infections eg, sepsis, abscesses, & opportunistic infections.

Discontinue immediately if an anaphylactic reaction or other serious allergic reaction occurs. Do not initiate therapy in patients w/ active infections including chronic or localized infections until infections are controlled; active TB is diagnosed. Patients exposed to TB & those who have traveled in areas of high risk of TB or endemic mycoses. Closely monitor patients for infections including TB before, during & after treatment; & undergo complete diagnostic evaluation those who develop new infection while undergoing treatment. Discontinue if patient develops a new serious infection or sepsis; HBV reactivation; central or peripheral nervous system demyelinating disorders; in patients w/ confirmed significant hematologic abnormalities; development of symptoms suggestive of a lupus-like syndrome. Evaluate for both active or inactive (latent) TB infection before initiation of therapy. Opportunistic infections, including invasive fungal infections. Reactivation of HBV in patients who are chronic carriers. Preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Perform neurological evaluation in patients w/ non-infectious intermediate uveitis prior to initiation of therapy to assess for preexisting central demyelinating disorders. Malignancies including lymphoma. Examine patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment for the presence of non-melanoma skin cancer prior to & during treatment. Screen patients w/ ulcerative colitis who are at increased risk for, or who have a prior history of dysplasia or colon carcinoma at regular intervals before therapy & throughout their disease course. Carefully monitor patients w/ heart failure. Combination w/ azathioprine or 6-mercaptopurine. Not recommended w/ concomitant use w/ other biologic DMARDS (eg, anakinra & abatacept) or other TNF antagonists. Live vaccines. Pregnancy & lactation. Childn <2 yr. Elderly ≥65 yr.

Lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis, viral pneumonia herpes; leukopenia (including neutropenia & agranulocytosis), anemia; increased lipids; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash (including exfoliative rash); musculoskeletal pain; inj site reaction (including inj site erythema). Sepsis, candidiasis, flu, viral gastroenteritis, paronychia, cellulitis, impetigo, necrotising fasciitis, herpes zoster, ear infections, herpes simplex, oral herpes, tooth infections, vulvovag mycotic infection, UTI (including pyelonephritis), fungal & joint infections; benign neoplasm, skin cancer excluding melanoma (including basal/squamous cell carcinoma); thrombocytopenia, leucocytosis; hypersensitivity, allergies (including seasonal allergy); hypokalemia, increased uric acid, abnormal blood Na, hypocalcemia, hyperglycemia, hypophosphatemia, dehydration; mood alterations (including depression), anxiety, insomnia; paraesthesias (including hypoesthesia), migraine, nerve root compression; visual impairment, conjunctivitis, blepharitis, eye swelling; vertigo; tachycardia; HTN, flushing, haematoma; cough, asthma, dyspnoea; GI hemorrhage, dyspepsia, GERD, sicca syndrome; pruritus, urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis; muscle spasms (including increased blood creatine phosphokinase); haematuria, renal impairment; chest pain, edema; coagulation & bleeding disorders (including prolonged aPTT), auto Ab tests +ve (including double stranded DNA Ab), increased blood LDH; impaired healing.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

Rx