Etanercept

DEA Class; Rx

Common Brand Names; Enbrel, Erelzi, Eticovo, etanercept-szzs, etanercept-ykro

• Antipsoriatics, Systemic; 
• DMARDs, TNF Inhibitors; 
• Immunosuppressants

TNF-blocker fusion protein; used subcutaneously
Used for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis (JIA), and plaque psoriasis
Boxed warnings for increased risk of serious infection and potential for malignancy

Sepsis

Hypersensitivity

RA

• Infection (81%)

• Upper respiratory infections (65%)

• Non-upper respiratory infections (54%)

• Injection site reactions (43%)

• Diarrhea (16%)

• Rash (13%)

PsO (Enbrel and Eticovo only)

• Infection (27%)

• Upper respiratory infections (17%)

• Injection site reactions (15%)

• Non-upper respiratory infections (12%)

HBV-positive status, history of or susceptibility to recurring infections, history of blood dyscrasias

Consider empiric anti-fungal therapy for patients at risk for invasive fungal infections who develop a systemic severe illness while receiving therapy

Monitor closely for signs or symptoms of demyelinating disease (eg, confusion, numbness, vision changes); use caution in patients with preexisting or recent-onset CNS demyelinating disorders; therapy associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders; cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barre syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders reported in postmarketing experience with etanercept products therapy

Increased risk of TB; monitor for TB

Possibility of lupuslike symptoms or development of autoimmune hepatitis; discontinue if such symptoms develop

Use with caution in patients with history of significant hematologic abnormalities; consider discontinuing if hematologic disorders (eg, pancytopenia, leukopenia, thrombocytopenia, aplastic anemia) occur; consider stopping therapy

Diluent for multidose vial contains benzyl alcohol as preservative

Children should be up to date with immunizations before starting drug

Increased risk of lymphoma and other cancers reported in children and adolescents; occurrence of leukemia and new-onset psoriasis reported in patients treated with TNF blockers

Enhanced safety surveillance requirements to capture malignancy data; manufacturers required to report all malignancies to FDA for complete and consistent analysis

Worsening or new onset congestive heart failure reported with TNF blockers; Exercise caution when using in patients who have heart failure; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then only consider in patients with compensated HF

Available studies during pregnancy do not reliably support an association between therapy and major birth defects

Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant; no data are available on effects of therapy on breastfed child or on milk production

Etanercept

injection solution, prefilled syringe

• 25mg/0.5mL (Enbrel, Erelzi, Eticovo)
• 50mg/mL (Enbrel, Erelzi, Eticovo)

injection solution, prefilled autoinjector

• 50mg/mL (Enbrel, Erelzi)

injection, lyophilized powder for reconstitution

• 25mg/vial (Enbrel)

injection, prefilled single-dose prefilled cartridge with reusable autoinjector

• 50mg/mL (Enbrel Mini)

Biosimilars to Enbrel

• Erelzi (etanercept-szzs)
• Eticovo (etanercept-ykro)