Etanercept

Class
TNFα inhibitors
Subclass
TNF receptor / IgG1 Fc fusion protein
Substance name
Etanercept, etanercept‑szzs, etanercept‑ykro
Brand names
Enbrel®
Common formulations
Solution
Dosage and administration
Adults patients
Symptomatic relief
Axial spondyloarthritis
•
50 mg SC weekly
Treatment
Plaque psoriasis
•
Start at: 50 mg SC 2× per week for 3 months
•
Maintenance: 50 mg SC weekly
Psoriatic arthritis
•
50 mg SC weekly
Rheumatoid arthritis • Moderate-to-severe, active
•
50 mg SC weekly
Indications for use
Labeled indications
Adults
•
Symptomatic relief of axial spondyloarthritis
•
Treatment of plaque psoriasis
•
Treatment of psoriatic arthritis
•
Treatment of rheumatoid arthritis (moderate-to-severe, active)
Children
•
Treatment of plaque psoriasis
•
Treatment of polyarticular JIA
Safety risks
Boxed warnings
Immunosuppression
Infections
•
Maintain a high level of suspicion, as etanercept has been associated with as increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
Malignancies
•
Use extreme caution in all the patients, especially in children and adolescent patients.
Opportunistic infections
•
Use extreme caution in patients with chronic or recurrent infection, with a history of an opportunistic infection, or with underlying conditions that may predispose them to infection.
Contraindications
Granulomatosis with polyangiitis receiving immunosuppressive agents
Latex hypersensitivity
Warnings and precautions
Autoimmune disorders
•
Use caution in patients with risk factors for autoimmune diseases.
Exacerbation of HF
•
Use extreme caution in patients with HF or who are at increased risk for developing HF.
Hematologic abnormalities
•
Use caution in patients who have a previous history of significant hematologic abnormalities.
Neurologic abnormalities
•
Use caution in patients with preexisting or recent-onset central or PNS demyelinating disorders.
Reactivation of HBV infection
•
Use caution in patients who are identified as carriers of the HBV or those with moderate to severe alcoholic hepatitis.
Reactivation of tuberculosis
•
Use caution in patients with a history of tuberculosis infection.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available.
Substantial chronic alcohol consumption
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Women of childbearing potential should be advised to use appropriate contraception during therapy and for 3 weeks after discontinuation of therapy.
•
This drug crosses the placenta and has been detected in the serum of infants born to female patients treated during pregnancy. The clinical impact of this is unknown; however, infants may be at increased risk of infection.
•
Administration of live vaccines to infants for 16 weeks after the mother's last dose of this drug is generally not recommended.
Breastfeeding
Unlikely to have adverse effects in breastfed infants.
Unknown amount excreted in breastmilk.
Undetectable levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Influenza virus infection, pharyngitis, diarrhea, injection site reactions, skin rash, sinusitis
Common 1-10%
•
↓ blood neutrophil count, fever, itching, urticaria
Uncommon < 1%
•
Aplastic anemia, Guillain-Barré syndrome, heart failure, hepatitis, inflammatory bowel disease, myelitis, optic neuritis, pancytopenia, paresthesia, seizure
Unknown frequency
•
Anemia, angioedema, aseptic meningitis, candidiasis, ↓ WBC count, ↓ platelet count, ecchymosis, erythema multiforme, hepatitis exacerbation, interstitial lung disease, ↑ liver enzymes, leukemia, lymphadenopathy, merkel cell carcinoma, psoriasis, chest pain, headache, skin cancer, Stevens-Johnson syndrome, toxic epidermal necrolysis, uveitis, vasculitis
Interactions
Drug(s)
Check Interactions
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