Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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ENBREL |
| Manufacturer |
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Amgen, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tumor necrosis factor (TNF) blocker. |
| Generic Name |
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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). |
| Indications |
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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. |
| Children |
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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. |
| Adults |
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Use prefilled syringe. Inject 50mg SC once weekly into thigh, abdomen, or upper arm; rotate inj sites. |
| Contraindications |
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Sepsis. Serious or active infection. Concurrent live vaccines. Concurrent anakinra: not recommended. |
| Precautions |
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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. Latex allergy (syringe). Supervise 1st dose. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Concurrent cyclophosphamide: not recommended. |
| Adverse Reactions |
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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, others. Children: also varicella, headache, GI disturbances, skin ulcer, depression, personality disorder, esophagitis, gastritis. |
| How Supplied |
Multi-use vials—4 (w. supplies)
Single-use prefilled syr (1mL)—4 (w. needles)
Single-use prefilled SureClick autoinjector—4 (w. needles) |
| Additional Resources |
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• Related Prescribing Note |
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