Composition
Inj 25 mg/50 mg: Etanercept 25 mg/50 mg; pre-filled syringe.
Indications & Dosage
Alone or in combination with methotrexate to treat; Severe and progressive rheumatoid arthritis, Active polyarticular-course juvenile idiopathic arthritis, Active and progressive psoriatic arthritis, refractory to PUVA or DMARDs including methotrexate, Severe active anylosingspondylitis: BY SC INJ: Adults: 25 mg twice weekly or 50 mg once weekly Children 4-18 yr: 0.4 mg/kg twice weekly. Dose interval should be 3-4 days; max 25 mg per dose. Chronic severe plaque psoriasis where other therapies are inappropriate: BY SC INJ: Adults: 25 mg twice weekly or 50 mg once weekly. Alternatively, 50 mg twice weekly for up to 12 weeks then, if necessary, 25 mg twice weekly or 50 mg once weekly. Continue treatment until remission; max up to 24 weeks unless longer treatment is appropriate. Discontinue if no response after 12 weeks. Re-treatment, 25 mg twice weeklyor 50 mg once weekly for up to 24 weeks. Children 8-18 yrs: 0.8 mg/kg (up to max 50 mg) once weekly for up to 24 weeks; Discontinue if no response after 12 weeks; Re-treatment, 0.8 mg/kg (up to max 50 mg) once weekly for up to 24 wk.
Administration
A 50 mg dose may be given as 1 SC injection using a 50 mg single-use prefilled syringe or a 50 mg single-use prefilled auto injector, or two 25 mg SC injections using 25 mg single-use prefilled syringes or multiple-use vials. The two 25 mg injections are given either on the same day or 3 or 4 days apart. Sites for injection (thigh, abdomen, or upper arm) should be rotated. Never inject into areas where the skin is tender, bruised, red or hard. Reconstitute aseptically with 1 ml sterile bacteriostatic water for injection, USA Do not filter reconstituted solution during preparation or administration.
Stability
Do not use beyond the expiration date stamped on the carton or syringe barrel label. It must be refrigerated at 2C-8C (36F-46F). Do not freeze. Keep the prefilled syringes in the original carton to protect from light until the time of use. Do not shake. Multiple-use vial: Do not use a dose tray beyond the date stamped on the carton, dose tray label, vial label or diluent syringe label. The dose tray containing etanercept (sterile powder) must be refrigerated at 2C-8C (36F-46F). Do not freeze. Reconstituted solutions prepared with bacteriostatic water for injection may be stored for up to 14 days if refrigerated at 2C-8C (36F-46F). Discard reconstituted solution after 14 days.
Contraindications
Sepsis or risk of sepsis, active infection, active or recurrent GI bleeding or ulceration, cerebrovascular disease, history of GI bleeding or GI perforation related to previous NSAID therapy, history of recurrent GI haemorrhage, ischaemic heart disease, heart failure, peripheral arterial disease, moderate to severe renal impairment Ensure adequate contraception.
Precautions
Pre-existing, recent onset or increased risk of CNS demyelinating disorders; perform careful risk/benefit evaluation including neurological assessment, heart failure, moderate to severe alcoholic hepatitis, perform periodic skin examination in patients with increased risk of skin cancer including those-with psoriasis or history of PUVA therapy, history of blood dyscrasias; withdraw if blood dyscrasias confirmed or serious infection develops, varicella exposure; discontinue temporarily, history of recurrent infection, predisposition to infection, chronic infections, immune suppression. If new infection develops during treatment, monitor closely; discontinue treatment if serious. Screen for active and latent TB and hepatitis prior to imitating therapy. If latent TB, start treatment prior to initiation of Etanercept; if active TB, do not start Etanercept therapy,
Interactions
Anakinra, live vaccines, abatacept, sulfesalazine
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated or not recommended.
Side Effects
Injection site reactions, infection, headache, ab-dominal pain, GI disturbance, pruritus, fever, allergic reactions; if serious, discontinue immediately, reports of malignancies, cardiovascular symptoms, cholecystitis, pancreatitis, GI haemorrhage, bursitis, depression, dyspnoea, seizures, angioedema, interstitial lung disease, CNS demyelinating disorders including multiple sclerosis and optic neuritis, pancy-topenia, aplastic anaemia, serious skin reactions