Description: ENBREL (Etanercept) is a biologic medicine produced by Pfizer, indicated for the treatment of several autoimmune diseases. It is a tumor necrosis factor (TNF) inhibitor that works by targeting and neutralizing the activity of TNF, a substance in the body that causes inflammation and damage in autoimmune conditions.
Indications: ENBREL is used for the treatment of the following conditions:
- Rheumatoid Arthritis (RA): For reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
- Polyarticular Juvenile Idiopathic Arthritis (JIA): For reducing signs and symptoms of moderately to severely active polyarticular JIA in patients aged 2 years and older.
- Psoriatic Arthritis (PsA): For reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
- Ankylosing Spondylitis (AS): For reducing signs and symptoms in adult patients with active AS.
- Plaque Psoriasis (PsO): For the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Mechanism of Action: Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kD (p75) TNF receptor linked to the Fc portion of human IgG1. This fusion protein binds to TNF, rendering it biologically inactive, thereby reducing inflammation and altering the immune response.
Dosage and Administration:
- Rheumatoid Arthritis and Psoriatic Arthritis: The recommended dose is 25 mg administered twice weekly or 50 mg once weekly.
- Ankylosing Spondylitis: The recommended dose is 25 mg administered twice weekly or 50 mg once weekly.
- Juvenile Idiopathic Arthritis: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) administered twice weekly.
- Plaque Psoriasis: The recommended dose is 50 mg administered twice weekly for 3 months, followed by 50 mg once weekly.
Administration Instructions: ENBREL should be administered by subcutaneous injection. Suitable sites for injection include the front of the thighs, the abdomen (except for the 2-inch area around the navel), or the outer area of the upper arms. Rotate injection sites to avoid injecting the same site consecutively.
Storage: ENBREL vials should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the vials in the original carton to protect from light.
Contraindications:
- Patients with sepsis or risk of sepsis.
- Patients with known hypersensitivity to etanercept or any of its components.
Warnings and Precautions:
- Infections: Serious infections and sepsis, including tuberculosis (TB) and opportunistic infections, have been reported with the use of ENBREL.
- Malignancies: There is an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.
- Hematologic Reactions: Cases of pancytopenia and aplastic anemia have been reported.
- Demyelinating Disorders: Use with caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders.
- Heart Failure: Worsening and new-onset congestive heart failure (CHF) have been reported.
Adverse Reactions: Common adverse reactions include:
- Injection site reactions (pain, swelling, redness)
- Upper respiratory infections
- Headache
- Rash
Serious adverse reactions may include serious infections, malignancies, neurologic events, and hematologic abnormalities.
Packaging: ENBREL 25 mg is available in a packaging containing 4 vials, each vial containing 25 mg of Etanercept.
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