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).
Adult Dose for ENBREL:
Use prefilled syringe. Inject 50mg SC once weekly into thigh, abdomen, or upper arm; rotate inj sites.
Children's Dose for ENBREL:
Inject SC into thigh, abdomen, or upper arm; rotate inj sites. <2yrs: not recommended. JIA: <63kg: 0.8mg/kg per week; max 50mg/week. ≥63kg: may use 50mg prefilled syringe or SureClick autoinjector.
Pharmacological Class:
Tumor necrosis factor (TNF) blocker.
Contraindications:
Sepsis.
Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection (eg, diabetes, immunosuppression). Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Suspend if significant exposure to varicella occurs (consider varicella prophylaxis). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders (eg, multiple sclerosis, myelitis, optic neuritis), seizures. Heart failure. Malignancies. Attempt to complete childhood immunizations first. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate to severe alcoholic hepatitis. Latex allergy (syringe). Supervise 1st dose. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions:
Concurrent cyclophosphamide, anakinra, abatacept, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection.
Adverse Reactions:
Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory disorders; worsening psoriasis; rare: CNS demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella, headache, GI disturbances.
How Supplied:
Multi-use vials—4 (w. supplies); Single-use prefilled syr (1mL)—4 (w. needles); Single-use prefilled SureClick autoinjector—4 (w. needles)
Indications for ENBREL:
Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic and phototherapy.
Adult Dose for ENBREL:
≥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).
Children's Dose for ENBREL:
<18yrs: not recommended.
Pharmacological Class:
Tumor necrosis factor (TNF) blocker.
Contraindications:
Sepsis.
Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection (eg, diabetes, immunosuppression). Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Suspend if significant exposure to varicella occurs (consider varicella prophylaxis). Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders (eg, multiple sclerosis, myelitis, optic neuritis), seizures. Heart failure. Malignancies. Attempt to complete childhood immunizations first. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate to severe alcoholic hepatitis. Latex allergy (syringe). Supervise 1st dose. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions:
Concurrent cyclophosphamide, anakinra, abatacept, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection.
Adverse Reactions:
Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory disorders; worsening psoriasis; rare: CNS demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella, headache, GI disturbances.
How Supplied:
Multi-use vials—4 (w. supplies); Single-use prefilled syr (1mL)—4 (w. needles); Single-use prefilled SureClick autoinjector—4 (w. needles)
