ENBREL

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Generic Name for ENBREL Etanercept 25mg; per vial (pwd for SC inj after reconstitution; preservative-free; diluent contains benzyl alcohol); 50mg/mL prefilled syringe (soln for SC inj; preservative free); 50mg/mL prefilled syringe SureClick autoinjector (soln for SC inj; preservative-free). Legal Classification: Rx Pharmacological Class for ENBREL Tumor necrosis factor (TNF) blocker. Manufacturer of ENBREL Amgen, Inc.

Indications for ENBREL

To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis; to reduce signs/symptoms, inhibit progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis; for both: may be used with or without methotrexate in patients who have not responded adequately to methotrexate alone. To reduce signs/symptoms of: ankylosing spondylitis, and of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients who have had an inadequate response to one or more DMARDs.

Adult dose for ENBREL

Use prefilled syringe. Inject 50mg SC once weekly into thigh, abdomen, or upper arm; rotate inj sites.

Children's dosing for ENBREL

Inject SC into thigh, abdomen, or upper arm; rotate inj sites. <2yrs: not recommended. JIA: 2–17yrs: 0.8mg/kg per week; max 50mg/week. ≥63kg: may use 50mg prefilled syringe or SureClick autoinjector.

Contraindications for ENBREL

Sepsis.

Warnings/Precautions for ENBREL

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: not recommended. Chronic or recurring infections. Conditions that predispose to infection (eg, diabetes, immunosuppression). Test for and treat latent tuberculosis prior to initiating therapy. Monitor closely if new infection, or reactivation of hepatitis B virus (HBV) develop; discontinue if serious infection, sepsis, HBV reactivation, or lupus-like syndrome develops. Suspend if significant exposure to varicella occurs (consider varicella prophylaxis). Attempt to complete childhood immunizations first. CNS demyelinating disorders (eg, multiple sclerosis, myelitis, optic neuritis), seizures. Heart failure. Hematologic abnormalities (consider discontinuing if occur). Malignancies. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate to severe alcoholic hepatitis. Latex allergy (syringe). Supervise 1^st dose. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions for ENBREL

Concurrent cyclophosphamide, anakinra, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection.

Adverse Reactions for ENBREL

Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory disorders, dyspepsia; worsening psoriasis; rare: CNS demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella, headache, GI disturbances, skin ulcer, depression, personality disorder, esophagitis, gastritis.

How is ENBREL supplied?

Multi-use vials—4 (w. supplies)
Single-use prefilled syr (1mL)—4 (w. needles)
Single-use prefilled SureClick autoinjector—4 (w. needles)

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