HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Eticovosafely and effectively. See full prescribing information for Eticovo.
Eticovo(etanercept-ykro)injection, for subcutaneous use
Initial U.S. Approval: 2019
Eticovo (etanercept-ykro) is biosimilar* to Enbrel (etanercept).
WARNING: SERIOUS INFECTIONS and MALIGNANCIESSee full prescribing information for complete boxed warning.
SERIOUS INFECTIONS
Increased risk of serious infections leading to hospitalization ordeath, including tuberculosis (TB), bacterial sepsis, invasivefungal infections (such as histoplasmosis), and infections due toother opportunistic pathogens. (5.1)
Eticovo should be discontinued if a patient develops a seriousinfection or sepsis during treatment. (5.1)
Perform test for latent TB; if positive, start treatment for TBprior to starting Eticovo. (5.1)
Monitor all patients for active TB during treatment, even ifinitial latent TB test is negative. (5.1)
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have beenreported in children and adolescent patients treated with TNFblockers, including etanercept products. (5.3)
INDICATIONS AND USAGE
Eticovo is a tumor necrosis factor (TNF) blocker indicated for the treatmentof:
Rheumatoid Arthritis (RA) (1.1)
Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 yearsor older (1.2)
Psoriatic Arthritis (PsA) (1.3)
Ankylosing Spondylitis (AS) (1.4)
Plaque Psoriasis (PsO) in patients 4 years or older (1.5)
DOSAGE AND ADMINISTRATION
Eticovo is administered by subcutaneous injection.
Patient Population Recommended Dose and
Frequency
Adult RA and PsA (2.1) 50 mg once weekly with or without
methotrexate (MTX)
AS (2.1) 50 mg once weekly
Adult PsO (2.2) 50 mg twice weekly for 3 months,
followed by 50 mg once weekly
Pediatric PsO or JIA (patients who
weigh 63 kg or more) (2.2)
50 mg once weekly
DOSAGE FORMS AND STRENGTHS
Injection: 25 mg/0.5 mL and 50 mg/mL solution in a single-doseprefilled syringe (3)
CONTRAINDICATIONS
Sepsis (4)
WARNINGS AND PRECAUTIONS
Do not start Eticovo during an active infection. If an infection develops,monitor carefully and stop Eticovo if infection becomes serious. (5.1)
Consider empiric anti-fungal therapy for patients at risk for invasivefungal infections who develop a severe systemic illness on Eticovo(those who reside or travel to regions where mycoses are endemic).(5.1)
Demyelinating disease, exacerbation or new onset, may occur. (5.2)
Cases of lymphoma have been observed in patients receiving TNFblockingagents. (5.3)
Congestive heart failure, worsening or new onset, may occur. (5.4)
Advise patients to seek immediate medical attention if symptoms ofpancytopenia or aplastic anemia develop, and consider stoppingEticovo. (5.5)
Monitor patients previously infected with hepatitis B virus forreactivation during and several months after therapy. If reactivationoccurs, consider stopping Eticovo and beginning anti-viral therapy. (5.6)
Anaphylaxis or serious allergic reactions may occur. (5.7)
Stop Eticovo if lupus-like syndrome or autoimmune hepatitis develops.(5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 5%): infections and injectionsite reactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact SamsungBioepis Co.,