HIGHLIGHT
Hulio

Hulio

adalimumab

Manufacturer:

Mylan

Distributor:

DKSH

Marketer:

Viatris
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Monotherapy or in combination w/ methotrexate (MTX) &/or DMARDs for moderate to severe active RA in adult patients. Monotherapy or in combination w/ MTX for active polyarticular juvenile idiopathic arthritis (pJIA) in patients from 2 yr. Active enthesitis-related arthritis in patients ≥6 yr. Adults w/ severe active ankylosing spondylitis (AS); axial spondyloarthritis. Moderate to severe chronic plaque psoriasis; active Crohn's disease & ulcerative colitis. Non-infectious intermediate, posterior & panuveitis. Severe chronic plaque psoriasis in childn & adolescents from 4 yr. Active moderate to severe hidradenitis suppurativa in adults from 12 yr. Moderate to severe active Crohn's disease in ped patient from 6 yr. Ped chronic non-infectious anterior uveitis in patients from 2 yr.
Dosage/Direction for Use
SC Adult RA 40 mg every other as single dose. Monotherapy: May increase dose to 40 mg every wk or 80 mg every other wk. AS, axial spondyloarthritis w/o radiographic evidence of AS & psoriatic arthritis 40 mg every other wk as single dose. Psoriasis Initially 80 mg, followed by 40 mg every other wk starting 1 wk after initial dose. May increase dose to 40 mg every wk or 80 mg every other wk in patients w/ inadequate response beyond 16 wk. Subsequently reduce to 40 mg every wk or 80 mg every other wk if adequate response is achieved. Hidradenitis suppurativa Initially 160 mg at Day 1, followed by 80 mg 2 wk later at Day 15. Continue w/ 40 mg every wk or 80 mg every other wk after 2 wk. Moderate to severe active Crohn's disease 80 mg at wk 0 followed by 40 mg at wk 2, if a more rapid response is needed, 160 mg at wk 0, 80 mg at wk 2. After induction treatment, 40 mg every other wk. Increased to 40 mg every wk or 80 mg every other wk in patients w/ decreased response to 40 mg every other wk & continue maintenance therapy through wk 12 in patients who have not responded by wk 4. Moderate to severe ulcerative colitis 160 mg at wk 0 & 80 mg at wk 2. After induction treatment, 40 mg every other wk. Uveitis Initially 80 mg, followed by 40 mg given every other wk starting 1 wk after the initial dose. Hidradenitis suppurativa Adolescents from 12 yr weighing at least 30 kg 80 mg at wk 0 followed by 40 mg every other wk starting at wk 1 in patients w/ inadequate response. May increase dose to 40 mg every wk or 80 mg every other wk. Polyarticular juvenile idiopathic arthritis Paed patient from 2 yr weighing ≥30 kg 40 mg every other wk, 10-<30 kg 20 mg every other wk. Enthesitis-related arthritis Paed patient from 6 yr weighing ≥30 kg 40 mg every other wk, 15-<30 kg 20 mg every other wk. Plaque psoriasis Paed patient 4-17 yr weighing ≥30 kg Initially 40 mg, followed by 40 mg every other wk starting 1 wk after initial dose, 15-<30 kg Initially 20 mg, followed by 20 mg every other wk starting 1 wk after initial dose. Crohn's disease Paed patient 6-17 yr weighing ≥40 kg Induction dose: 80 mg at wk 0 & 40 mg at wk 2, if a more rapid response is needed, 160 mg at wk 0 & 80 mg at wk 2. Maintenance dose starting at wk 4: 40 mg every other wk, <40 kg 40 mg at wk 0 & 20 mg at wk 2, if a more rapid response is needed, 80 mg at wk 0 & 40 mg at wk 2. Maintenance dose starting at wk 4: 20 mg every other wk. Uveitis In combination w/ methotrexate: Paed patient from 2 yr weighing ≥30 kg 40 mg every other wk, <30 kg 20 mg every other wk.
Contraindications
Hypersensitivity. Active TB or other severe infections eg, sepsis & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue if anaphylactic or other serious allergic reactions occur; develops new serious infection or sepsis; 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; w/ preexisting or recent-onset central or peripheral nervous system demyelination disorders; w/ confirmed significant haematologic abnormalities; develops new or worsening symptoms of CHF. Not to be initiated in patients w/ active chronic or localized infections; active TB; who develops symptoms suggestive of lupus-like syndrome. Increased risk for developing infections w/ impaired lung function; malignancy due to heavy smoking; dysplasia or colon carcinoma in patients w/ ulcerative colitis. Patient w/ history of recurring infection or underlying conditions which may predispose to infections; several or significant risk factors for TB; moderate to severe chronic COPD. History of latent or active TB; malignancy; extensive immunosuppressant therapy or PUVA treatment. Serious infections including sepsis; reactivation & new onset of TB; hepatitis B reactivation; presence of fixed fibrotic stricture. Patients undergoing arthroplasty. Perform neurologic evaluation in patients w/ infectious intermediate uveitis prior to initiation of, & regularly during treatment. Fructose intolerance. Not recommended w/ anakinra & abatacept or other TNF-antagonists. May affect ability to drive & use machines. Hepatic or renal impairment. Women of childbearing potential should use adequate contraception at least 5 mth after treatment. Not recommended in coadministration w/ live vaccines to infants for 5 mth following mother's last inj during pregnancy. Not recommended during pregnancy. Not to breastfed for at least 5 mth after treatment. Childn <2 yr. Elderly >65 yr.
Adverse Reactions
Resp tract infections eg, lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis & herpes viral pneumonia; leukopenia (eg, neutropenia & agranulocytosis), anaemia; increased lipids; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash eg, exfoliative rash; musculoskeletal pain; inj erythema. Systemic infections (eg, sepsis, candidiasis & influenza), intestinal infections (eg, viral gastroenteritis), 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, vulvovag mycotic infection), UTI (eg, pyelonephritis), fungal & joint infections; skin cancer excluding melanoma (eg, basal & squamous cell carcinoma), benign neoplasm; leucocytosis, thrombocytopenia; hypersensitivity, allergies eg, seasonal allergy; hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphataemia, 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, hyperhydrosis, alopecia, pruritus; muscle spasms (eg, increased phosphokinase); renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders (eg, prolonged activated partial thromboplastin time), auto-Ab test positive (eg, double stranded DNA Ab), increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
Lowered Ab formation w/ methotrexate. Concomitant use w/ anakinra & abatacept.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Hulio soln for inj 40 mg
Packing/Price
1's
/thailand/image/info/hulio soln for inj 40 mg/40 mg?id=7683da19-d1e0-4af8-8216-ae1e007d6b7a
/thailand/image/info/hulio soln for inj 40 mg/40 mg?id=de479c9f-4e4d-4990-9dc2-ae1e007d6b7a
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