Enbrel

Enbrel

etanercept

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
Signs & symptoms & inhibiting the progression of structural damage in adults w/ moderately to severely active RA as monotherapy or in combination w/ methotrexate (MTX) in patients w/ inadequate response to MTX alone. Polyarthritis (rheumatoid factor positive or negative) & extended oligoarthritis in childn & adolescents from 2 yr who have had an inadequate response to, or who have proved intolerant of MTX. Psoriatic arthritis in adolescents from 12 yr who have had an inadequate response to, or who have proved intolerant of MTX. Enthesitis-related arthritis in adolescents from 12 yr who have had an inadequate response to, or who have proved intolerant of conventional therapy. Reduction of signs & symptoms of active arthritis in adults w/ psoriatic arthritis as monotherapy or in combination w/ MTX in patients w/ inadequate response to MTX alone. Signs & symptoms of active ankylosing spondylitis in adults w/ inadequate response to conventional therapy. Severe non-radiographic axial spondyloarthritis w/ objective inflammation signs (as indicated by elevated CRP &/or MRI evidence), who have had an inadequate response to NSAIDs in adults. Adults w/ moderate to severe chronic plaque psoriasis who are unresponsive, w/ CI to, or 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 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 once 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. May be used for up to 24 wk. Discontinue treatment if no response after 12 wk. Follow the same treatment guide if re-treatment is indicated. Childn Juvenile idiopathic arthritis 0.4 mg/kg (max: 25 mg/dose) twice wkly w/ 3-4 days interval between doses or 0.8 mg/kg (max: 50 mg/dose) given once wkly. Discontinue treatment if no response after 4 mth. Paed Individualized dosage based on body wt. ≥6 yr Plaque psoriasis 0.8 mg/kg (max: 50 mg/dose) once wkly for up to 24 wk. Discontinue treatment if no response after 12 wk.
Contraindications
Hypersensitivity. Active TB or other severe infections eg, sepsis, abscesses & opportunistic infections.
Special Precautions
History of recurring or chronic infections or w/ underlying conditions which may predispose patients to infections. Discontinue use if a serious infection develops. Evaluate infections before, during & after treatment. Evaluate active or latent infection in patients at increased risk for TB before initiation of therapy. Monitor for signs & symptoms of active TB including patients tested negative for latent TB infection. Previous HBV infection. Monitor patients for signs & symptoms of active HBV infection throughout therapy & for several mth following termination. Worsening of hepatitis C. Concurrent treatment w/ anakinra & abatacept. Not recommended for the treatment of Wegener's granulomatosis. Discontinue immediately if serious allergic or anaphylactic reaction occurs. Patients w/ immunosuppression or chronic infections. Possible risk for development of lymphomas or other haematopoietic or solid malignancies in patients treated w/ a TNF-antagonist. Malignancies (particularly Hodgkin's & non-Hodgkin's), some fatal, among childn & adolescents. Perform periodic skin exam in patients at increased risk for skin cancer. History of blood dyscrasias. May be associated w/ autoimmune Ab formation. Live vaccines should not be given concurrently. Careful risk/benefit evaluation including a neurologic assessment in patients w/ preexisting or recent onset of demyelinating disease. CHF; hypoglycemia (diabetes patients). Long-term combination w/ disease-modifying antirheumatic drugs. Moderate to severe alcoholic hepatitis. Combination w/ other systemic therapies or phototherapy for psoriasis treatment. Women of childbearing potential should be advised not to get pregnant during therapy. Not recommended during pregnancy. Lactation. Childn <2 yr (juvenile idiopathic arthritis); <6 yr (paed plaque psoriasis).
Adverse Reactions
Infections (including upper resp tract infections, bronchitis, cystitis, skin infection); headache; inj site reactions (including bleeding, bruising, erythema, itching, pain, swelling). Allergic reactions, autoantibody formation; pruritus, rash; pyrexia.
Drug Interactions
Increased incidences of serious adverse events w/ abatacept. Not to be administered in combination w/ MTX for psoriasis treatment. Higher rate of serious infections & neutropenia w/ anakinra. Significantly decreased in mean WBC counts w/ sulfasalazine. Not to be given concurrently w/ live vaccines.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Enbrel inj 25 mg
Packing/Price
4 × 1's
/singapore/image/info/enbrel inj 25 mg/25 mg?id=36e239af-6fe2-49e4-b584-9faa01404023
/singapore/image/info/enbrel inj 25 mg/25 mg?id=7d251d7e-5b6a-4d51-a0e7-9faa0140d2ee
Form
Enbrel inj 50 mg
Packing/Price
4 × 1's
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