Etanercept

Etanercept is a tumor necrosis factor (TNF) blocker. This is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1.

Etanercept is a TNF alpha inhibitor that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors. 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 RA patients.

• Rheumatoid Arthritis: Reduces signs and symptoms, improves physical function, and inhibits structural damage in moderately to severely active RA.
• Juvenile Idiopathic Arthritis: Used for treatment of polyarticular-course JIA in children and adolescents from age 2 years.
• Psoriatic Arthritis: Reduces signs and symptoms, inhibits structural damage, and improves physical function in active PsA.
• Ankylosing Spondylitis: Reduces signs and symptoms in active AS.
• Plaque Psoriasis: Used for chronic moderate to severe plaque psoriasis in adults and children from age 6 years.

Immunosuppressant

TNF Inhibitor (Biologic)

Etanercept is a tumor necrosis factor (TNF) blocker. This is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. Etanercept is a TNF alpha inhibitor that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors.

Etanercept binds to TNF and blocks its interaction with TNF receptors, thereby reducing inflammatory responses.

Adult Dose (RA, PsA, AS):

• 50 mg per week once weekly (as one 50 mg syringe or two 25 mg injections at the same time) OR 25 mg twice weekly (72-96 hours apart).

Plaque Psoriasis:

• 50 mg once weekly OR 25 mg twice weekly; for higher response, 50 mg twice weekly for first 12 weeks.

Juvenile Idiopathic Arthritis (2-18 years):

• 0.4 mg/kg (max 25 mg/dose) twice weekly (72-96 hours apart).

Pediatric Plaque Psoriasis (6-18 years):

• 0.8 mg/kg (max 50 mg/dose) once weekly for up to 24 weeks.

Administer as subcutaneous injections in the thigh, abdomen or upper arm. Give each new injection at least 3 cm from a previous site. Do not use in areas where skin is tender, bruised, red or hard. Allow syringe to reach room temperature (15-30 minutes) before injection.

If you miss a dose of Etanercept, please consult your doctor.

Very Common (>10%):

• Infections (colds, sinusitis, bronchitis, UTI, skin infections)
• Injection site reactions (bleeding, bruising, redness, itching, pain, swelling)

Common (1-10%):

• Allergic reactions
• Fever
• Itching
• Autoantibody formation

Uncommon: Serious infections (pneumonia, deep skin infections, joint infections, blood infection), low platelet count, skin cancer, angioedema, hives, eye inflammation, psoriasis (new or worsening), rash, lung inflammation or scarring, blood vessel inflammation.

Precautions:

• Allergic reactions: Serious allergies may occur.
• Infections: Do not initiate in active infections; monitor if infection occurs during treatment.
• Tuberculosis: Test for TB before starting treatment.
• Hepatitis B: Screen for HBV.
• Blood disorders: Monitor blood cell counts.
• Nervous system and eye disorders: Caution required.
• Congestive heart failure: Use with caution.
• Cancer: Consider cancer risk.
• Chickenpox: Avoid exposure.

Contraindications:

• Hypersensitivity
• Sepsis or risk of sepsis
• Serious active infections

Drug Interactions:

• Anakinra (interleukin-1 receptor antagonist): Increased risk of serious infections; avoid concomitant use.
• Abatacept: May increase risk of infections.
• Live vaccines: Avoid co-administration.

Food Interactions: It is not known whether it is safe to consume alcohol with Etanercept. Consult your doctor.

Use in Pregnancy: Category B2. Safe use during pregnancy has not been established; use only if clearly needed.

Use in Lactation: Safe use during lactation has not been established. It is not known whether Etanercept is excreted in human milk.

Pediatric Use: JIA: 2 years and older; Plaque Psoriasis: 6 years and older. Not studied in children under 2 years.

Geriatric Use: No dosage adjustment required for elderly patients.

Renal Impairment: No dosage adjustment required for patients with kidney disease.

Hepatic Impairment: No dosage adjustment required for patients with liver disease.

Overdose: Maximum tolerated dose not established. Single IV doses up to 60 mg/m2 have been administered. No known antidote to etanercept.

Storage: Store in refrigerator at 2-8 degree C. Do not freeze. Do not shake. Keep away from light. Keep out of reach of children.

Etanercept