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Enbrel

Enbrel

etanercept

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
Reduction of signs & symptoms & inhibiting progression of structural damage in patients w/ moderate to severe active RA as monotherapy or in combination w/ MTX. Reduction of signs & symptoms of active psoriatic arthritis in combination w/ MTX in patients who do not respond adequately to MTX alone. Reduction of signs & symptoms in patients w/ ankylosing spondylitis. Adults w/ severe non-radiographic axial spondyloarthritis w/ objective signs of inflammation who have had inadequate response to, or are intolerant to, conventional therapy. Adults ≥18 yr w/ chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Polyarticular-course juvenile idiopathic arthritis (JIA) in childn & adolescents from 2 yr proved to have inadequate response to ≥1 DMARDs. Polyarthritis (rheumatoid factor +ve or -ve) & extended oligoarthritis in childn & adolescents from 2 yr, & psoriatic arthritis in adolescents from 12 yr, who have had inadequate response to, or who have proved intolerant of MTX. Enthesitis-related arthritis in adolescents from 12 yr who have had inadequate response to, or who have proved intolerant of conventional therapy. Chronic severe plaque psoriasis in childn & adolescents from 6 yr who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.
Dosage/Direction for Use
SC Administer in thigh, abdomen or upper arm. Give each new inj at least 3 cm from previous site. RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis Adult ≥18 yr 50 mg once wkly. Plaque psoriasis Adult 50 mg once wkly or 25 mg twice wkly (72-96 hr apart). Higher responses may be achieved from initial treatment w/ 50 mg twice wkly for up to 12 wk, followed by 50 mg once wkly or 25 mg twice wkly. Intermittent use: Treatment cycles subsequent to initial cycle should use 50 mg once wkly or 25 mg twice wkly. JIA Childn ≥2 yr to <18 yr 0.4 mg/kg (up to max of 25 mg/dose) twice wkly (72-96 hr apart), or 0.8 mg/kg (up to max of 50 mg/dose) once wkly. Ped plaque psoriasis Childn ≥6 yr to <18 yr 0.8 mg/kg (up to max of 50 mg/dose) once wkly for up to 24 wk. Discontinue if no response after 12 wk. Re-treatment: 0.8 mg/kg (up to max of 50 mg/dose) once wkly.
Contraindications
Hypersensitivity. Sepsis or risk of sepsis. Serious active infection including chronic or localized infections.
Special Precautions
Not to inj in areas where skin is tender, bruised, red or hard. Discontinue treatment if serious allergic or anaphylactic reactions occur; patient develops serious infection; blood dyscrasias are confirmed. Not recommended in treatment of Wegener's granulomatosis & alcoholic hepatitis. Serious infections including sepsis & TB (including disseminated or extrapulmonary presentation); opportunistic infections including listeriosis, legionellosis & invasive fungal infections. Worsening of hepatitis C; CHF. Immunosuppression. Increased risk of lymphoma & leukemia in RA patients w/ long standing, highly active, inflammatory disease; development of lymphomas or other hematopoietic or solid malignancies; Hodgkin's & non-Hodgkin's lymphomas; melanoma & non-melanoma skin cancer. Auto-Ab formation. Hepatitis B reactivation in patients w/ previous HBV infection. Hypoglycemia in patients receiving medication for diabetes. Patients w/ history of recurring or chronic infections or w/ underlying conditions which may predispose to infections; moderate to severe alcoholic hepatitis; history of blood dyscrasias; CHF; previous HBV infection. Closely monitor patients who develop new infection while undergoing treatment. Monitor for signs & symptoms of active TB including patients who tested -ve for latent TB infection; active HBV infection. Evaluate patients for infections before, during & after treatment; active or latent TB infection in any patient at increased risk for TB; prior evidence of HBV infection before therapy in patients at risk of hepatitis B infection. Perform periodic skin exam in patients at increased risk for skin cancer; careful risk/benefit evaluation including neurological assessment in patients w/ pre-existing or recent onset of demyelinating disease, or to those w/ increased risk of developing demyelinating disease. Initiate prophylaxis of latent TB infection prior to therapy. Not recommended in concomitant use w/ anakinra & abatacept. Not to be given concurrently w/ live vaccines. Pregnancy & lactation. Not recommended to administer live vaccines to infants for 16 wk after mother's last dose. Childn <2 yr.
Adverse Reactions
Infection including URTI, bronchitis, cystitis, skin infection; inj site reactions including bleeding, bruising, erythema, itching, pain & swelling; headache. Allergic reactions (pruritus, rash), auto-Ab formation; pyrexia. SJS, erythema multiforme, TEN.
Drug Interactions
Higher rate of serious infections & neutropenia w/ anakinra. Increased incidences of serious adverse events w/ abatacept. Decreased mean WBC counts w/ sulfasalazine.
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 MYCLIC soln for inj 50 mg
Packing/Price
((MYCLIC)) 2 × 1's
Form
Enbrel soln for inj 25 mg
Packing/Price
2 × 1's
Form
Enbrel soln for inj 50 mg
Packing/Price
2 × 1's
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