Etveza 25

Etveza 25

etanercept

Manufacturer:

Mega Lifesciences

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Etanercept
Indications/Uses
Moderate to severe active RA in adults in combination w/ methotrexate when response to disease-modifying antirheumatic drugs is inadequate. Monotherapy in case of intolerance to methotrexate or continued treatment w/ methotrexate is inappropriate. Severe, active & progressive RA in adults not previously treated w/ methotrexate. Monotherapy or in combination w/ methotrexate to reduce the rate of joint damage progression as measured by x-ray & improve physical function. Adults w/ severe active ankylosing spondylitis who have had inadequate response to conventional therapy. Adults w/ moderate to severe plaque psoriasis who failed to respond to, or contraindicated or intolerant to other systemic therapy including ciclosporin, methotrexate or PUVA.
Dosage/Direction for Use
SC RA & ankylosing spondylitis 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 may be used if necessary. Continue up to 24 wk until remission is achieved.
Contraindications
Hypersensitivity. Sepsis or risk of sepsis. Patients w/ active infections including chronic or localised infections.
Special Precautions
History of recurring or chronic infections or underlying conditions that may predispose patients to infections (eg, advanced or poorly controlled diabetes). Evaluate patients for active & inactive (latent) TB prior to treatment. Risk of reactivation on patients previously infected w/ HBV. Patients w/ history of hepatitis C; blood dyscrasias; malignancy or who develop malignancy. Discontinue use if any serious allergic or anaphylactic reaction occurs; blood dyscrasias are confirmed. Immunosuppression & CHF. Periodic skin exam for all patients particularly those w/ risk factors for skin cancer. May result in the formation of autoimmune antibodies. Patients w/ preexisting or recent onset of demyelinating disease or those w/ increased risk of developing demyelinating disease. Not to be used in treatment of alcoholic hepatitis. Not recommended for the treatment of Wegener's granulomatosis. Hypoglycaemia in patients treated for diabetes. Not recommended in concomitant use w/ anakinra; abatacept. Not to be given concurrently w/ live vaccines. Renal & hepatic impairment. Use appropriate contraception during & 3 wk after therapy in women of childbearing potential. Not recommended during pregnancy. Lactation. May cause inflammatory bowel disease & uveitis in juvenile idiopathic arthritis patients. Elderly.
Adverse Reactions
Infections (eg, upper resp tract infections, bronchitis, cystitis, skin infections); inj site reactions (eg, bleeding, bruising, erythema, itching, pain, swelling). Allergic reactions, autoantibody formation; pruritus; fever.
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)
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Etveza 25 powd for inj 25 mg
Packing/Price
1's
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