ETANERCEPT
ETANERCEPT  (e-tan'er-cept)  Enbrel Classifications: biologic response modifier; tumor necrosis factor modifier; Therapeutic: disease-modifying antirheumatic drug (dmard) Pregnancy Category: B |
Availability
25 mg, 50 mg injection; 50 mg/mL prefilled syringe
Action
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.
Therapeutic Effect
Effectiveness is indicated by improved RA symptomatology and/or decreased inflammation in other inflammatory disorders.
Uses
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.
Contraindications
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.
Cautious Use
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 |
Administration
Subcutaneous- 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. CNS: Headache, dizziness, cerebral ischemia, depression, 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, dyspnea may reactivate latent tuberculosis (TB). Skin: Rash; injection site reactions (erythema, itching, pain, swelling). Musculoskeletal: Bursitis. Hematologic: Pancytopenia.Interactions
Drug: Concurrent or recent use with azathioprine, cyclophosphamide, leflunomide, methotrexate has been associated with pancytopenia.Pharmacokinetics
Onset: 1–2 wk. Peak: 72 h. Half-Life: 115 h.Nursing Implications
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 time.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; Prototype drug