Yuflyma

In combination w/ MTX for treatment of moderate to severe, active RA in adult patients when the response to DMARDs including MTX has been inadequate; severe, active & progressive RA in adults not previously treated w/ MTX; active polyarticular juvenile idiopathic arthritis, in patients from 2 yr who have had inadequate response to ≥1 DMARDs. Monotherapy in case of intolerance to MTX or when continued treatment w/ MTX is inappropriate. Active enthesitis-related arthritis in patients ≥6 yr who have had an inadequate response to, or who are intolerant of, conventional therapy. Adults w/ severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. Adults w/ severe axial spondyloarthritis w/o radiographic evidence of AS but w/ objective inflammation signs by elevated CRP &/or MRI, who have had inadequate response to or are intolerant to NSAIDs. Active & progressive psoriatic arthritis in adults when the response to previous DMARDs therapy has been inadequate. Reduce rate of progression of peripheral joint damage as measured by X-ray in patients w/ polyarticular symmetrical subtypes of disease. 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 inadequate response to or are inappropriate candidates for topical therapy & phototherapies. Active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults & adolescents from 12 yr w/ inadequate response to conventional systemic HS therapy. Moderately to severely active Crohn's disease, in adult patients who have not responded despite a full & adequate course of therapy w/ corticosteroid &/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Moderately to severely active Crohn's disease in paed patients (from 6 yr) who have had inadequate response to conventional therapy including primary nutrition therapy & corticosteroid &/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Moderately to severely active ulcerative colitis in adult patients who have had 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. Moderately to severely active ulcerative colitis in paed patients (from 6 yr) who have had inadequate response to conventional therapy including corticosteroids &/or 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Non-infectious intermediate, posterior & panuveitis in adult patients who have had inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paed chronic non-infectious anterior uveitis in patients from 2 yr who have had inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

RA Adult 40 mg every other wk as single dose SC inj. Continue MTX; glucocorticoids, salicylates, NSAIDs, or analgesics during treatment. Monotherapy: May benefit from increase 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 every other wk as a single dose SC inj. Psoriasis Adult Initially 80 mg SC, followed by 40 mg SC given every other wk starting 1 wk after initial dose. Beyond 16 wk, may increase to 40 mg every wk or 80 mg every other wk in patients w/ inadequate response to 40 mg every other wk. Subsequently, reduce dose to 40 mg every other wk if adequate response is achieved. HS Adult Recommended dose: 160 mg initially at day 1 (given as four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days), followed by 80 mg 2 wk later at day 15 (given as two 40 mg inj in 1 day). 2 wk later (Day 29): Continue w/ 40 mg every wk or 80 mg every other wk (given as two 40 mg inj in 1 day). Crohn's disease Adult w/ moderately to severely active Crohn's disease Induction dose: 80 mg at wk 0 followed by 40 mg at wk 2. In case there is a need for 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 daily for 2 consecutive days), followed by 80 mg at wk 2 (given as two 40 mg inj in 1 day). After induction treatment: 40 mg every other wk SC inj. Patients who experience decrease in response to 40 mg Increase to 40 mg every wk or 80 mg every other wk. Ulcerative colitis Adult w/ moderate to severe ulcerative colitis Induction dose: 160 mg at wk 0 (given as four 40 mg inj in 1 day or as two 40 mg inj daily for two consecutive days) & 80 mg at wk 2 (given as two 40 mg inj in 1 day). After induction treatment: 40 mg every other wk SC inj. Patients who experience decrease in response to 40 mg every other wk Increase to 40 mg every wk or 80 mg every other wk. Uveitis Adult Initially 80 mg, followed by 40 mg every other wk starting 1 wk after initial dose. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis from 2 yr, ≥30 kg 40 mg every other wk. Ethesitis-related arthritis Patients from 6 yr, ≥30 kg 40 mg every other wk. Psoriatic arthritis & axial spondyloarthritis including AS Paed plaque psoriasis from 4-17 yr, ≥30 kg Initially 40 mg, followed by 40 mg given every other wk starting 1 wk after initial dose. Adolescent HS (from 12 yr, weighing at least 30 kg) 80 mg at wk 0 followed by 40 mg every other wk starting at wk 1 SC inj. Adolescent w/ inadequate response 40 mg every other wk, may consider increasing dose to 40 mg every wk or 80 mg every other wk. May continue to use antibiotics during treatment if necessary. Paed Crohn's disease from 6-17 yr, if patients weighing ≥40 kg Induction dose: 80 mg at wk 0 & 40 mg at wk 2. In case there is a need for a more rapid response to therapy w/ awareness that the risk for adverse events may be higher w/ use of higher induction dose: 160 mg at wk 0 & 80 mg at wk 2. Maintenance dose starting at wk 4: 40 mg every other wk. If patients experience insufficient response may increase to 40 mg every wk or 80 mg every other wk; <40 kg Induction dose: 40 mg at wk 0 & 20 mg at wk 2. In case there is a need for a more rapid response to therapy w/ awareness that the risk for adverse events may be higher w/ use of higher induction dose: 80 mg at wk 0 & 40 mg at wk 2. Paed ulcerative colitis from 6-17 yr, ≥40 kg Induction dose: 160 mg at wk 0 (given as four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days) & 80 mg at wk 2 (given as two 40 mg inj in 1 day). Maintenance dose starting at wk 4: 80 mg every other wk; <40 kg Induction dose: 80 mg at wk 0 (given as two 40 mg injections in 1 day) & 40 mg at wk 2 (given as one 40 mg inj). Maintenance dose starting at wk 4: 40 mg every other wk. Paed uveitis from 2 yr, ≥30 kg Loading dose: 80 mg may be administered 1 wk prior to start of maintenance therapy w/ 40 mg every other wk in combination w/ MTX; <30 kg Loading dose: 40 mg may be administered.

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

Promptly discontinue treatment for patients who develop signs & symptoms eg, fever, malaise, wt loss, sweats, cough, dyspnoea, &/or pulmonary infiltrates or other serious systemic illness w/ or w/o concomitant shock an invasive fungal infection. Discontinue treatment if patient develops new serious infection or sepsis, anaphylactic reaction or other serious allergic reaction occurs; in patients w/ pre-existing or recent-onset central or peripheral nervous system demyelinating disorders, confirmed significant haematologic abnormalities, who develop new or worsening symptoms of CHF. Stop treatment in patients who develop HBV reactivation. Not to be initiated in patients w/ active infections including chronic or localised infections until infections are controlled; if active TB is diagnosed. Not to be given further treatment if patient develops symptoms suggestive of lupus-like syndrome following treatment & is +ve for Ab against double-stranded DNA. Closely monitor for infections, including TB, before, during & after treatment; signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy; infections in patient who requires surgery while on treatment. Consider patients who have been exposed to TB & travelled in areas of high risk of TB or endemic mycoses, eg, histoplasmosis, coccidioidomycosis, or blastomycosis prior to initiating therapy. Evaluate patients for both active & inactive (latent) TB infection before therapy initiation. Test patients for HBV infection before treatment initiation. Start appropriate anti-TB prophylaxis treatment if latent TB is suspected; in patients w/ several or significant risk factors for TB despite -ve test for TB & past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, before treatment initiation. Screen for dysplasia at regular intervals before therapy & throughout their disease course in all patients w/ ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (eg, patients w/ long-standing ulcerative colitis or primary sclerosing cholangitis), or who had prior history of dysplasia or colon carcinoma. Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections eg, listeriosis, legionellosis, & pneumocytis; other serious infections eg, pneumonia, pyelonephritis, septic arthritis & septicaemia. 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. History of recurring infection or underlying conditions which may predispose patients to infections, including use of concomitant immunosuppressive medications; malignancy. TB, including reactivation & new onset of TB; cases of reactivated TB; opportunistic infections, including invasive fungal infections; melanoma & Merkel cell carcinoma; pancytopenia including aplastic anaemia; small bowel obstruction; COPD patients, as well as in patients w/ increased risk for malignancy due to heavy smoking. False -ve tuberculin skin test results in patients who are severely ill or immunocompromised. Perform screening tests (ie, tuberculin skin test & chest X-ray) in all patients. Instruct patients to seek medical advice if signs/symptoms suggestive of a TB infection (eg, persistent cough, wasting/wt loss, low grade fever, listlessness) occur during or after therapy. Perform neurologic evaluation in patients w/ non-infectious intermediate uveitis prior to therapy initiation & regularly during treatment to assess for pre-existing or developing central demyelinating disorders. Examine for presence of non-melanoma skin cancer prior to & during treatment in all patients, & in particular patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment. Not recommended in combination w/ anakinra; w/ other biologic DMARDs (eg, anakinra & abatacept) or other TNF-antagonists. May affect ability to drive & use machines. Women of childbearing potential should consider use of adequate contraception to prevent pregnancy & continue use for at least 5 mth after last treatment. Not recommended the administration of live vaccines (eg, BCG vaccine) to infants exposed to therapy in utero for 5 mth following mother’s last treatment inj during pregnancy. Elderly.

Resp tract infections (including lower resp tract infections & URTI, 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); musculoskeletal pain; inj site reaction (including inj site erythema). Systemic infections (including sepsis, candidiasis & flu), intestinal infections (including viral gastroenteritis), skin & soft tissue infections (including paronychia, cellulitis, impetigo, necrotizing fasciitis & herpes zoster), ear & oral infections (including herpes simplex, oral herpes & tooth infections), reproductive tract infections (including vulvovag mycotic infection), UTI (including pyelonephritis), fungal & joint infections; skin cancer excluding melanoma (including basal cell carcinoma & squamous cell carcinoma), benign neoplasm; leucocytosis, thrombocytopenia; hypersensitivity, allergies (including seasonal allergy); hypokalemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, 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; 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), onycholasis, hyperhidrosis, alopecia, pruritus; muscle spasms (including increased blood creatine phosphokinase); renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders (including prolonged aPTT), +ve auto-Ab test (including double stranded DNA Ab), increased blood LDH; impaired healing.

Lowered Ab formation w/ MTX. Combination w/ anakinra; abatacept.

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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