Warnings & Precautions
- Do not start etanercept during an active infection. If an infection develops, monitor carefully, and stop etanercept if the infection becomes serious.
- Consider empiric anti-fungal therapy for patients at risk (those who reside in or travel to regions where mycoses are endemic) for invasive fungal infections or who develop a severe systemic illness on etanercept.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cases of lymphoma have been observed in patients receiving TNFi’s.
- Congestive heart failure, worsening or new onset, may occur.
- Advise patients to seek immediate medical attention if symptoms of pancytopenia or aplastic anemia develop, and consider stopping etanercept.
- Monitor hepatitis B virus carriers for reactivation during and following therapy. If reactivation occurs, consider stopping etanercept and beginning anti-viral therapy.
- Anaphylaxis or serious allergic reactions may occur.
- Stop etanercept if lupus-like syndrome or autoimmune hepatitis develops.
Commentary: The U.S. Food and Drug Administration (FDA) approved etanercept for the reduction of signs and symptoms in patients with active PsA. The approval was based on two clinical trials, both comparing the efficacy of etanercept vs. placebo. The most common adverse reactions (≥5%) are infections and injection-site reactions.