Zuellig Pharma
Concise Prescribing Info
Signs & symptoms & inhibiting the progression of structural damage in moderately to severely active rheumatic arthritis (RA) as monotherapy or in combination w/ methotrexate (MTX) in patients w/ inadequate response to MTX alone. Active polyarticular juvenile idiopathic arthritis in childn & adolescent from 2 yr w/ inadequate response to or who have proved intolerant of MTX. Reduction of signs & symptoms of active psoriatic arthritis as monotherapy or in combination w/ MTX in patients w/ inadequate response to MTX alone. Active ankylosing spondylitis in adult. Active non-radiographic axial spondyloarthritis w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI evidence, who have had inadequate response to NSAID. Active disease defined as Bath Ankylosing Spondylitis Disease Activity Index score of ≥4. Moderate to severe plaque psoriasis in adult who failed to respond to, who have a contraindication to or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Chronic severe plaque psoriasis in childn & adolescent from 6 yr who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.
Dosage/Direction for Use
SC Adult 18-64 yr & elderly ≥65 yr RA, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis 25 mg twice wkly or 50 mg wkly. Plaque psoriasis 25 mg twice wkly or 50 mg once wkly. Alternatively, 50 mg twice wkly for up to 12 wk followed by 25 mg twice wkly or 50 mg once wkly, if necessary, for up to 24 wk. Polyarticular juvenile idiopathic arthritis 0.4 mg/kg twice wkly w/ 3-4 days interval between doses. Max: 25 mg/dose. Paed plaque psoriasis ≥6 yr 0.8 mg/kg once wkly for up to 24 wk. Max: 50 mg/dose.
Hypersensitivity. Sepsis or risk of sepsis; serious active infections including chronic or localised infections.
Special Precautions
Not recommended in Wegener's granulomatosis & moderate to severe alcoholic hepatitis. Allergic reactions; immunosuppression. History of recurring or chronic infections, underlying conditions which may predispose patients to infections; opportunistic infections including invasive fungal infections. Risk of development of lymphomas or other hematopoietic or solid malignancies. Interstitial lung disease including pneumonitis & pulmonary fibrosis, some w/ fatal outcomes. Previous history of blood dyscrasias; formation of autoimmune Ab, preexisting or recent onset of CNS demyelinating disease or patients at increased risk of developing demyelinating disease. CHF; hypoglycemia; inflammatory bowel disease. Monitor for signs & symptoms of active TB & HBV reactivation. Perform periodic skin exam for patients who are at risk of skin cancer. Avoid concurrent use w/ live vaccines. Concurrent treatment w/ anakinra & abatacept. Women of childbearing potential should use appropriate contraception during & 3 wk after discontinuation of therapy. Avoid use during pregnancy & lactation. Childn <2 yr.
Adverse Reactions
Infections including upper resp tract infections, bronchitis, cystitis, skin infections; inj site reactions including erythema, itching, pain & swelling. Allergic reactions, autoantibody formation; pruritus; rash; pyrexia.
Drug Interactions
Higher rate of serious infections & neutropenia w/ anakinra. Increased serious adverse event incidence w/ abatacept. Decreased WBC counts w/ sulfasalazine.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Enbrel inj (pre-filled syringe) 25 mg
4 × 1's
Enbrel inj (pre-filled syringe) 50 mg
4 × 1's
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