Classifications: biologic response modifier; tumor necrosis factor modifier; Therapeutic: disease-modifying antirheumatic drug (dmard)
Pregnancy Category: B
25 mg, 50 mg injection; 50 mg/mL prefilled syringe
Produced by recombinant DNA technology. Binds specifically to tumor necrosis factor (TNF) and blocks it from attaching to
cell surface TNF receptors. This naturally occurring cytokine (e.g., TNF) is part of the normal immune and inflammatory response.
TNF mediates inflammation and modulates cellular immune responses. Elevated levels of TNF are found in the synovial fluids
of rheumatoid arthritis (RA) patients.
Effectiveness is indicated by improved RA symptomatology and/or decreased inflammation in other inflammatory disorders.
Reduction of the signs and symptoms of RA and psoriatic RA in adults, and polyarticular juvenile RA (JRA) in children with
inadequate response to other disease-modifying antirheumatic drugs. Treatment of ankylosing spondylitis.
Patients with sepsis or other active infection; agranulocytosis; hypersensitivity to etanercept; malignancy; benzyl alcohol
hypersensitivity; bleeding, hematologic disease, fever, infection; intramuscular administration, intravenous administration;
latex hypersensitivity; sepsis; varicella; lactation.
Immunosuppression; autoimmune disease, bone marrow suppression; diabetes mellitus; hamster protein hypersensitivity; heart
failure; multiple sclerosis, neoplastic disease, neurological disease, seizure disorder, seizures; pregnancy (category B).
Safety and efficacy in children <4 y of age are not established.
Route & Dosage
|Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Adult: SC 25 mg twice weekly; or 0.08 mg/kg or 50 mg once weekly
Child (>4 y): SC 0.4 mg/kg (max: 25 mg/dose) twice weekly
- Do not administer to a patient who has known or suspected sepsis.
- Reconstitute by slowly injecting the supplied diluent into the vial. Swirl gently to dissolve and do not shake. Reconstituted
solution should be clear and colorless. Use within 6 h.
- Inject into thigh, abdomen, upper arm; rotate injection sites and never inject into an old injection site or where skin is
tender, bruised, red, or hard.
- Store reconstituted solution up to 6 h refrigerated at 2°8° C (36°46° F). Store unopened
dose tray refrigerated at 2°8° C (36°46° F).
Adverse Effects (≥1%)Body as a Whole:
Asthenia, serious infections,
sepsis, monitor for reactivation of tuberculosis
Headache, dizziness, cerebral
, demyelinating disorders (multiple sclerosis, myelitis, optic neuritis). CV:
Heart failure, MI
, myocardial ischemia, hypertension, hypotension. GI:
Abdominal pain, dyspepsia, cholecystitis, pancreatitis
, GI hemorrhage. Respiratory:
Rhinitis, URI, pharyngitis, cough, respiratory disorder, sinusitis
may reactivate latent tuberculosis
Rash; injection site reactions (erythema, itching, pain, swelling
Bursitis. Hematologic: Pancytopenia
Concurrent or recent use with azathioprine, cyclophosphamide, leflunomide, methotrexate
has been associated with pancytopenia
12 wk. Peak:
72 h. Half-Life:
Assessment & Drug Effects
- Monitor carefully for and immediately report S&S of infection.
Patient & Family Education
- A PPD test is recommended before starting therapy to check for TB.
- Discard all needles and syringes after use; do not reuse.
- Withhold etanercept and notify physician before resuming drug if you develop an infection or are exposed to varicella virus.
- Avoid vaccinations, in general, and live vaccines, in particular, while on etanercept.
- Note: Injection site reactions (e.g., redness, pain, swelling) are common in the first month of therapy but generally decrease over