ions (5.1) and Adverse Reactions (6)]. Most patients whodeveloped these infections were taking concomitant immunosuppressants such as methotrexate or
corticosteroids.
Eticovo should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis havefrequently presented with disseminated or extrapulmonary disease. Patients should be tested forlatent tuberculosis before Eticovo use and during therapy. Treatment for latent infection should beinitiated prior to Eticovo use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis,blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infectionsmay present with disseminated, rather than localized, disease. Antigen and antibody testing forhistoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapyshould be considered in patients at risk for invasive fungal infections who develop severe systemicillness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella andListeria.
The risks and benefits of treatment with Eticovo should be carefully considered prior to initiating therapy inpatients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and aftertreatment with Eticovo, including the possible development of tuberculosis in patients who tested negative forlatent tuberculosis infection prior to initiating therapy.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treatedwith TNF blockers, including etanercept products.
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
Eticovo is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression ofstructural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis(RA). Eticovo can be initiated in combination with methotrexate (MTX) or used alone.
1.2 Polyarticular Juvenile Idiopathic Arthritis
Eticovo is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenileidiopathic arthritis (JIA) in patients ages 2 and older.
1.3 Psoriatic Arthritis
Eticovo is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of activearthritis, and improving physical function in patients with psoriatic arthritis (PsA). Eticovo can be used with orwithout methotrexate.
1.4 Ankylosing Spondylitis
Eticovo is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
1.5 Plaque Psoriasis
Eticovo is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis(PsO) who are candidates for systemic therapy or phototherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
Eticovo is administered by subcutaneous injection.
Table 1. Dosing and Administration for Adult Patients
Patient Population Recommended Dosage Strength and Frequency
Adult RA, AS, and PsA 50 mg weekly
Adult PsO Starting Dose: 50 mg twice weekly for 3 months
Maintenance Dose: 50 mg once weekly
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