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Enbrel Generic Name & Formulations
Legal Class
Rx
General Description
Etanercept 25mg; per vial (pwd for SC inj after reconstitution; preservative-free; diluent contains benzyl alcohol); 25mg/0.5mL vial (soln for SC inj; preservative-free), 25mg/0.5mL, 50mg/mL prefilled syringe (soln for SC inj; preservative free); 50mg/mL prefilled syringe SureClick autoinjector (soln for SC inj; preservative-free); 50mg/mL Enbrel Mini prefilled cartridge (soln for use with AutoTouch autoinjector only; preservative-free).
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Multi-dose vials—4 (w. supplies); Single-dose vials—4; Single-dose prefilled syringes (0.5mL, 1mL)—4; Single-dose prefilled SureClick autoinjectors—4 (w. needles); Single-dose prefilled cartridges—4 (w. reusable autoinjector)
Manufacturer
Mechanism of Action
Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface receptors for TNF, rendering TNF biologically inactive.
Enbrel Indications
Indications
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 adults with psoriatic arthritis; for both: may be used with or without methotrexate. To reduce signs/symptoms of: ankylosing spondylitis, and of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Active juvenile psoriatic arthritis (JPsA).
Enbrel Dosage and Administration
Adult
Inject SC into thigh, abdomen, or upper arm; rotate inj sites. 50mg once weekly. May continue concomitant methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics.
Children
<2yrs: not established. Inject SC into thigh, abdomen, or upper arm; rotate inj sites. pJIA, JPsA: ≥2yrs: (<63kg): 0.8mg/kg (max 50mg) weekly; (≥63kg): 50mg weekly. May continue concomitant glucocorticoids, NSAIDs, or analgesics.
Enbrel Contraindications
Contraindications
Sepsis.
Enbrel Boxed Warnings
Not Applicable
Enbrel Warnings/Precautions
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 (consider initiating anti-viral therapy), or hematologic abnormality develops. Suspend if significant exposure to varicella occurs (consider varicella prophylaxis). Malignancies (eg, lymphoma). Consider periodic skin exams in those with skin cancer risk. 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 (monitor). Attempt to complete childhood immunizations first. Granulomatosis with polyangiitis patients receiving immunosuppressive agents: not recommended. Moderate to severe alcoholic hepatitis. Latex allergy. Supervise 1st dose. Elderly. Pregnancy. Nursing mothers.
Enbrel Pharmacokinetics
See Literature
Enbrel Interactions
Interactions
Concurrent cyclophosphamide, anakinra, abatacept, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection. May need to reduce dose of concomitant anti-diabetic drugs.
Enbrel Adverse Reactions
Adverse Reactions
Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory infections, headache; worsening psoriasis; rare: CNS demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella.
Enbrel Clinical Trials
See Literature
Enbrel Note
Not Applicable
Enbrel Patient Counseling
See Literature
Enbrel Generic Name & Formulations
Legal Class
Rx
General Description
Etanercept 25mg; per vial (pwd for SC inj after reconstitution; preservative-free; diluent contains benzyl alcohol); 25mg/0.5mL vial (soln for SC inj; preservative-free), 25mg/0.5mL, 50mg/mL prefilled syringe (soln for SC inj; preservative free); 50mg/mL prefilled syringe SureClick autoinjector (soln for SC inj; preservative-free); 50mg/mL Enbrel Mini prefilled cartridge (soln for use with AutoTouch autoinjector only; preservative-free).
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Multi-dose vials—4 (w. supplies); Single-dose vials—4; Single-dose prefilled syringes (0.5mL, 1mL)—4; Single-dose prefilled SureClick autoinjectors—4 (w. needles); Single-dose prefilled cartridges—4 (w. reusable autoinjector)
Manufacturer
Mechanism of Action
Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-α and TNF-β (lymphotoxin alpha [LT-α]) to cell surface receptors for TNF, rendering TNF biologically inactive.
Enbrel Indications
Indications
Moderate to severe chronic plaque psoriasis in patients ≥4yrs who are candidates for systemic and phototherapy.
Enbrel Dosage and Administration
Adult
Inject SC into thigh, abdomen, or upper arm; rotate inj sites. ≥18yrs: initially 50mg twice weekly for 3 months (also: initial doses of 25mg or 50mg per week were shown to be efficacious). Maintenance: 50mg once weekly.
Children
<4yrs: not established. Inject SC into thigh, abdomen, or upper arm; rotate inj sites. ≥4yrs: (<63kg): 0.8mg/kg (max 50mg) weekly; (≥63kg): 50mg weekly.
Enbrel Contraindications
Contraindications
Sepsis.
Enbrel Boxed Warnings
Not Applicable
Enbrel Warnings/Precautions
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 (consider initiating anti-viral therapy), or hematologic abnormality develops. Suspend if significant exposure to varicella occurs (consider varicella prophylaxis). Malignancies (eg, lymphoma). Consider periodic skin exams in those with skin cancer risk. 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 (monitor). Attempt to complete childhood immunizations first. Granulomatosis with polyangiitis patients receiving immunosuppressive agents: not recommended. Moderate to severe alcoholic hepatitis. Latex allergy. Supervise 1st dose. Elderly. Pregnancy. Nursing mothers.
Enbrel Pharmacokinetics
See Literature
Enbrel Interactions
Interactions
Concurrent cyclophosphamide, anakinra, abatacept, live vaccines, other TNF blockers: not recommended. Immunosuppressants increase risk of infection. May need to reduce dose of concomitant anti-diabetic drugs.
Enbrel Adverse Reactions
Adverse Reactions
Inj site reactions, infections (eg, sepsis, osteomyelitis, cellulitis, pneumonia, pyelonephritis), antibody formation, respiratory infections, headache; worsening psoriasis; rare: CNS demyelinating disorders, pancytopenia, aplastic anemia, tuberculosis, malignancies (eg, lymphoma; esp. children), others. Children: also varicella.
Enbrel Clinical Trials
See Literature
Enbrel Note
Not Applicable
Enbrel Patient Counseling
See Literature
