Monograph Details
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Dermatological Disorders
> Psoriasis
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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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Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic and phototherapy. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Inject SC into thigh, abdomen, or upper arm; rotate inj sites. Initially 50mg twice weekly (3–4 days apart) (use prefilled syringe), or 25mg or 50mg per week; both for 3 months; then 50mg/week (maintenance). |
| 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) |
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