Etanercept

Anti-rheumatic, Systemic · Cytokine modulator

Indications

For use alone or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis refractory to PUVA or DMARDs including methotrexate. Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Active polyarticular-course juvenile idiopathic arthritis refractory to methotrexate. Active and progressive psoriatic arthritis refractory to DMARDs. Severe active ankylosing spondylitis refractory to conventional therapy. Moderate to severe plaque psoriasis in adults where cyclosporin, methotrexate or PUVA are ineffective, not tolerated or contraindicated. Chronic severe plaque psoriasis in children and adolescents >8 years where other therapies are ineffective, not tolerated or contraindicated.

Dosage

Rheumatoid arthritis: Adults: 25 mg twice weekly or 50 mg once weekly by SC inj. Children: Under 4 yr, not recommended; 4-18 yr, 0.4 mg/kg twice weekly by SC inj. Dose interval should be 3-4 days; max 25 mg per dose. Psoriasis: Adults: 25 mg twice weekly or 50 mg once weekly by SC inj. Alternatively, 50 mg twice weekly by SC inj for up to 12 wk then, if necessary, 25 mg twice weekly or 50 mg once weekly. Continue treatment until remission; max up to 24 wk unless longer treatment is appropriate. Discontinue if no response after 12 wk. Re-treatment, 25 mg twice weekly or 50 mg once weekly by SC inj for up to 24 wk. Children: Under 8 yr, not recommended; 8-18 yr, 0.8 mg/kg (up to max 50 mg) by SC inj once weekly for up to 24 wk. Discontinue if no response after 12 wk. Re-treatment, 0.8 mg/kg (up to max 50 mg) by SC inj once weekly for up to 24 wk.

Administration

A 50 mg dose should be given as 1 SC injection using a 50 mg single-use prefilled syringe or a 50 mg single-use prefilled autoinjector. A 50 mg dose can also be given as two 25 mg SC injections using 25 mg single-use prefilled syringes or multiple-use vials. The two 25 mg injections should be 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. Reconstitution: Reconstitute aseptically with 1 mL sterile bacteriostatic water for injection, USP. Do not filter reconstituted solution during preparation or administration. Stability: Single-use prefilled syringe and single-use prefilled autoinjector: Do not use etanercept beyond the expiration date stamped on the carton or syringe barrel label. Etanercept must be refrigerated at 2°C-8°C (36°F-46°F). Do not…

Adverse Effects

Inj site reactions, infection, headache, abdominal pain, GI upset, 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, pancytopenia, aplastic anaemia, serious skin reactions, CHF, autoimmune hepatitis, uveitis.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Sepsis or risk of sepsis, active infection. Ensure adequate contraception. Precautions: History of recurrent infection, predisposition to infection, chronic infections, immunosuppression. 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. Advise patients to report signs of TB during and after treatment. History of blood dyscrasias. Instruct patients to report symptoms of blood dyscrasias or infection immediately; investigate urgently and withdraw if blood dyscrasias confirmed or serious infection develops. Varicella exposure, discontinue temporarily.…

Interactions

Anakinra, live vaccines, abatacept, sulfasalazine.

Advice to Patient

If you are self-administering this medication, follow directions for injection and disposal of needles as prescribed. Discontinue medication and inform prescriber immediately if there is stomach pain, cramps, constant fever, unusual bruising or bleeding, blood in vomit/stool/urine, paleness of skin. Also report if there is unusual muscle weakness, bone weakness, chills, fever, sore throat, unhealed sores, skin rash. Rotate injection sites among thigh, stomach, and upper arms and avoid areas that are tender, red, bruised, or hard. Do not get vaccinated while taking this medication.

Pharmacokinetics

Onset of action: Approx. 2 to 3 weeks; RA: 1 to 2 weeks; Maximum effect: RA: Full effect is usually seen within 3 months. Absorption: Absorbed slowly after SubQ injection. Bioavailability: SubQ: 60%. Half-life elimination: SubQ: Children =4 years and adolescents (JIA): Mean range: 70 to 94.8 hours (range: 3.12 to 104.8 hours); Adults (RA): 102 ± 30 hours. Time to peak: RA: SubQ: 69 ± 34 hours.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.