Erelzi

Erelzi

etanercept

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
Reduction of signs & symptoms & inhibiting the progression of structural damage in patients w/ moderately to severely active RA in combination w/ methotrexate or as monotherapy. Moderate to severe active RA in adult in combination w/ methotrexate, when response to DMARDs is inadequate. Severe, active & progressive RA in adults not previously treated w/ methotrexate. Polyarticular-course juvenile idiopathic arthritis (JIA) in childn & adolescent ≥2 yr when the response to ≥1 DMARDs is inadequate. Polyarthritis (rheumatoid factor positive or negative) & extended oligoarthritis in childn & adolescents ≥2 yr who have had an inadequate response to, or who have proved intolerant of methotrexate. Psoriatic arthritis in adolescent ≥12 yr who have had an inadequate response to or intolerance to methotrexate. Enthesis-related arthritis in adolescent ≥12 yr who have had an inadequate response to, or who have proved intolerance of conventional therapy. Reduction of signs & symptoms of active psoriatic arthritis in psoriatic arthritis patients; may be used in combination w/ methotrexate in patients who do not respond adequately to methotrexate alone. Active & progressive psoriatic arthritis in adults when response to previous DMARDs has been inadequate. Reduction of signs & symptoms in patients w/ active ankylosing spondylitis. Adults w/ severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Adults w/ severe non-radiographic axial spondyloarthritis w/ objective signs of inflammation who have had an inadequate response to, or are intolerant to conventional therapy. Adult ≥18 yr w/ moderate to severe plaque psoriasis who have failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen & UV-A light (PUVA). Chronic severe plaque psoriasis in childn & adolescent ≥6 yr who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.
Dosage/Direction for Use
SC RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis Adult & patient ≥18 yr 50 mg once wkly. Plaque psoriasis Initially, 50 mg once wkly or 25 mg twice wkly (at least 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. Juvenile idiopathic arthritis Childn 2 to <18 yr 0.4 mg/kg, up to a max of 25 mg/dose, twice wkly w/ an interval of 72-96 hr between doses or 0.8 mg/kg, up to a max of 50 mg/dose, once wkly. Ped plaque psoriasis Childn 6 to <18 yr 0.8 mg/kg, up to a max of 50 mg/dose, once wkly for up to 24 wk. Re-treatment: 0.8 mg/kg, up to a max of 50 mg/dose, once wkly.
Contraindications
Hypersensitivity. Sepsis or risk of sepsis. Should not initiate in patients w/ active infections, including chronic or localised infections.
Special Precautions
Serious allergic or anaphylactic reactions. History of recurring or chronic infections or w/ underlying conditions that may predispose patients to infections eg, advanced or poorly controlled diabetes; monitor patients who develop a new infection during treatment. Discontinue use if serious infection develops; HBV infection & blood dyscrasias occur. Evaluate for both active & inactive TB prior to starting therapy. Perform appropriate screening test ie, tuberculin skin test & chest X-ray; risk of false negative tuberculin skin test results especially in severely ill or immunocompromised patients. Patients previously infected w/ HBV; history of hepatitis C; w/ immunosuppression. Test for HBV infection before initiating treatment. Concomitant use w/ anakinra & abatacept; live vaccines; other systemic therapies or phototherapy. Caution in considering TNF-antagonist therapy for patient w/ history of malignancy or continuing treatment in patients who develop malignancy; history of blood dyscrasias; CHF; moderate to severe alcoholic hepatitis. Perform periodic skin exam especially those w/ risk factors for skin cancer. Autoantibody formation. Preexisting or recent onset of demyelinating disease or those considered to have increased risk of demyelinating disease development. Long-term use in combination w/ other DMARDs. Not recommended for Wegener's granulomatosis treatment. Hypoglycaemia in patients treated for diabetes. Women of childbearing potential should avoid pregnancy during therapy & 3 wk after discontinuation. Pregnancy & lactation. Inflammatory bowel disease & uveitis in ped patients w/ juvenile idiopathic arthritis. Elderly.
Adverse Reactions
Upper resp tract infection, bronchitis, cystitis, skin infection; inj site bleeding, bruising, erythema, itching, pain, swelling. Allergic reactions; pruritus, rash; pyrexia. Non-melanoma skin cancers; worsening & new onset of congestive cardiac failure. Malignant melanoma, lymphoma, leukaemia; CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions eg, optic neuritis & transverse myelitis, peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, multifocal motor neuropathy; Stevens-Johnson syndrome. Toxic epidermal necrolysis.
Drug Interactions
Higher rate of serious infection 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
Erelzi soln for inj 25 mg/0.5 mL
Packing/Price
2 × 1's
Form
Erelzi soln for inj 50 mg/mL
Packing/Price
2 × 1's
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