Enbrel

Enbrel

etanercept

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
RA, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, adult & ped plaque psoriasis.
Dosage/Direction for Use
SC Adult RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis 50 mg once wkly or 25 mg twice wkly. Plaque psoriasis 50 mg once wkly or 25 mg twice wkly. Higher responses: Initially, 50 mg twice wkly for up to 12 wk, followed by 50 mg once wkly or 25 mg twice wkly if necessary. Juvenile idiopathic arthritis in childn ≥2 yr 0.4 mg/kg (max: 25 mg/dose) twice wkly or 0.8 mg/kg (max: 50 mg/dose) once wkly. Plaque psoriasis in childn ≥6 yr 0.8 mg/kg (max: 50 mg/dose) once wkly for up to 24 wk. All twice wkly doses should be given 72-96 hr apart.
Contraindications
Hypersensitivity. Sepsis or risk of sepsis; patients w/ serious active infections including chronic or localized infections.
Special Precautions
Closely monitor patients who develop new infection while undergoing treatment. Discontinue use if serious infection develops; any serious allergic or anaphylactic reaction occurs; blood dyscrasias are confirmed. History of recurring or chronic infections or w/ underlying conditions which may predispose patients to infections. Evaluate patients for infections before, during & after treatment. Opportunistic infections including invasive fungal infections. Evaluate active or latent infection in patients at risk for TB before initiation of therapy. Initiate latent TB infection prophylaxis prior to therapy. Monitor signs & symptoms of active TB including patients who tested -ve for latent TB infection; active HBV infection. Patient previously infected w/ HBV; who have previous history of blood dyscrasias; CHF. Worsening of hepatitis C. Not recommended as treatment of Wegener's granulomatosis; alcoholic hepatitis. Patients w/ moderate to severe alcoholic hepatitis. Immunosuppression. Possible risk of lymphomas or other hematopoietic or solid malignancies (Hodgkin's & non-Hodgkin's lymphoma). Periodic skin exam is recommended for all patients at increased risk of skin cancer. Previous history of blood dyscrasias or infections. Autoantibody formation. Careful risk/benefit evaluation including a neurological assessment in patients w/ pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease. Concurrent use w/ anakinra, abatacept; live vaccines. Hypoglycemia in patients treated for diabetes. Contains latex (needle cover; dry natural rubber), known or possible hypersensitivity to latex. Pregnancy & lactation. Childn <2 yr.
Adverse Reactions
Pneumonia, cellulitis, bacterial arthritis, sepsis, & parasitic infection; TB; hepatitis B reactivation; upper resp tract infection, bronchitis, cystitis, skin infection; opportunistic infection; listeria; malignant melanoma, Merkel cell carcinoma, lymphoma, leukemia, non-melanoma skin cancers; aplastic anemia, pancytopenia, thrombocytopenia, anemia, leukopenia, neutropenia, hematophagic histiocytosis; serious allergic/anaphylactic reactions including bronchospasm, vasculitis including ANCA +ve vasculitis, sarcoidosis, allergic reactions, autoantibody formation; CNS demyelinating events including multiple sclerosis & localized demyelinating conditions eg, optic neuritis & transverse myelitis; peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, & multifocal motor neuropathy; seizure, headache; uveitis, scleritis; new onset/worsening of congestive cardiac failure; ILD including pulmonary fibrosis & pneumonitis; inflammatory bowel disease; autoimmune hepatitis, elevated liver enzymes; SJS, TEN, angioedema, cutaneous vasculitis, erythema multiforme, psoriasis, urticaria, pruritus, psoriasiform rash, rash; cutaneous & subacute cutaneous lupus erythematosus, lupus-like syndrome; inj site reactions, pyrexia.
Drug Interactions
Higher rate of serious infections & neutropenia w/ anakinra. Increased incidences of serious adverse events w/ abatacept. Significant decrease in mean 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.
Presentation/Packing
Form
Enbrel soln for inj 25 mg/0.5 mL
Packing/Price
1 mL x 1's (P41,271.77/box)
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