Enbrel (etanercept)
ENBREL (etanercept) – a biologic anti-inflammatory agent that binds specifically to TNF-alpha and blocks its interaction with the p75 cell surface TNF receptor. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases.
FDA approved uses:
1. Rheumatoid arthritis (RA)
2. Polyarticular Juvenile idiopathic arthritis (JIA)
3. Psoriatic arthritis (PsA)
4. Ankylosing spondylitis (AS)
5. Plaque psoriasis (PS)
Available dosage forms:
50 mg Single-use Prefilled Syringe – 0.98 mL of a 50 mg/mL solution of etanercept.
50 mg Single-use Prefilled SureClick® Autoinjector – 0.98 mL of a 50 mg/mL solution of etanercept.
25 mg Single-use Prefilled Syringe – 0.51 mL of a 50 mg/mL solution of etanercept.
25 mg Multiple-use Vial (3) – 25 mg of .
Usual dosage: Adult RA and PsA – 50 mg once weekly with or without methotrexate (MTX). AS – 50 mg once weekly. Adult PsO – 50 mg twice weekly for 3 months, followed by 50 mg once weekly. JIA – 0.8 mg/kg weekly, with a maximum of 50 mg per week.
Contraindications: The use of Enbrel in contraindicated in sepsis.
Special Warnings: SERIOUS INFECTIONS – Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue ENBREL if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting ENBREL. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including ENBREL.
Adverse reactions (side effects) of these medications: The most common side effects of Enbrel include infections and injection site reactions. Other adverse reactions reported in clinical trial data include blood disorders (anemia, pancytopenia, etc.), lymphadenopathy, congestive heart failure, inflammatory bowel disease, angiodenema, chest pain, hepatitis, elevated transaminases, systemic vasculitis, lupus-like syndrome, melanoma and non-melanoma skin cancers, Merkel cell carcinoma, convulsions, multiple sclerosis, parasthesias, optic neuritis, and Stevens-Johnson syndrome.
Common drug interactions: Abatacept and anakinra increase the likelihood of serious infections when used with etanercept. Live vaccines should not be given to patients taking etanercept. The use of cyclophosphamide in patients on Enbrel is not recommended.
Special instructions for patients: Use exactly as directed by physician. Do not try to inject ENBREL yourself until you have been shown the right way to give the injections. Enbrel may lower the ability of the immune system to fight infections. The patient’s doctor should be contacted if they develop any symptoms of infection, tuberculosis or reactivation of hepatitis B virus infections. Patients should report any signs of new or worsening meical conditions, such as central nervous system demyelinating disorders, heart failure or autoimmune disorders, such as lupus-like syndrome or autoimmune hepatitis. Seek immediate medical attention for symptoms of severe allergic reactions. Report any symptoms suggestive of a pancytopenia, such as bruising, bleeding, persistent fever or pallor.
Full prescribing information may be found at the manufacturer‘s official website Enbrel.com or at the U.S. Food and Drug Administration’s website at Enbrel Info at Drugs@FDA
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