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ENBREL
Arthritis/rheumatic disorders
Psoriasis
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Drug Name:

ENBREL Rx

Generic Name and Formulations:
Etanercept 25mg; per vial (pwd for SC inj after reconstitution; preservative-free; diluent contains benzyl alcohol); 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).

Company:
Amgen, Inc.

Therapeutic Use:

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. To reduce signs/symptoms of: ankylosing spondylitis, and of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA).

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. JIA: ≥2yrs: (<63kg): 0.8mg/kg (max 50mg) weekly; (≥63kg): 50mg weekly. May continue concomitant glucocorticoids, NSAIDs, or analgesics.

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 (consider initiating anti-viral therapy), or hematological 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. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate-to-severe alcoholic hepatitis. Latex allergy. Supervise 1st dose. Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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 (0.5mL, 1mL)—4 (w. needles); Single-use prefilled SureClick autoinjector—4 (w. needles); Single-use prefilled cartridge—4 (w. reusable autoinjector)

Indications for ENBREL:

Moderate-to-severe chronic plaque psoriasis in patients ≥4yrs who are candidates for systemic and phototherapy.

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.

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 (consider initiating anti-viral therapy), or hematological 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. Wegener's granulomatosis patients receiving immunosuppressive agents: not recommended. Moderate-to-severe alcoholic hepatitis. Latex allergy. Supervise 1st dose. Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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 (0.5mL, 1mL)—4 (w. needles); Single-use prefilled SureClick autoinjector—4 (w. needles); Single-use prefilled cartridge—4 (w. reusable autoinjector)

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