Eticovo (etanercept-ykro) “Instructions for Use” insert for detailed information on injection site selection anddose administration [see Dosage and Administration (2.3) and Patient Counseling Information (17)].
Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis PatientsMethotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may becontinued during treatment with Eticovo.
Based on a study of 50 mg etanercept twice weekly in patients with RA that suggested higher incidence of adversereactions but similar American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week arenot recommended.
Adult Plaque Psoriasis Patients
In addition to the 50 mg twice weekly recommended starting dose, starting doses of 25 mg or 50 mg per week wereshown to be efficacious. The proportion of responders was related to etanercept dosage [see Clinical Studies (14.5)].
2.2 Pediatric Patients
Eticovo is administered by subcutaneous injection.
Table 2. Dosing and Administration for Pediatric Patients (PsO or JIA)
Pediatric Patients Weight Recommended Dose
63 kg (138 pounds) or more 50 mg weekly
Note: There is no dosage form for Eticovo that allows weight base dosing for pediatric patients below 63 kg(138 pounds). To achieve pediatric doses other than 50 mg, use other reconstituted etanercept productslyophilized powder.
Doses of etanercept products higher than those described in Table 2 have not been studied in pediatric patients.
In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Eticovo.
2.3 Preparation of Eticovo
Eticovo is intended for use under the guidance and supervision of a physician. Patients may self-inject when deemedappropriate and if they receive medical follow-up, as necessary. Patients should not self-administer until they receiveproper training in how to prepare and administer the correct dose. Administer injections subcutaneously in the thigh,abdomen or outer area of the upper arm.
The Eticovo (etanercept-ykro) “Instructions for Use” insert for each presentation contains more detailed instructionson injection site selection and the preparation of Eticovo.
Preparation of Eticovo Single-dose Prefilled Syringe
For a more comfortable injection, leave Eticovo single-dose prefilled syringe at room temperature for at least 30minutes before injecting. DO NOT remove the needle cover while allowing the prefilled syringe to reach roomtemperature.
Inspect visually for particulate matter and discoloration prior to administration. There may be small white particles ofprotein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discoloredor cloudy, or if foreign particulate matter is present.
2.4 Monitoring to Assess Safety
Prior to initiating Eticovo and periodically during therapy, patients should be eva luated for active tuberculosis andtested for latent infection [see Warnings and Precautions (5.1)].
3 DOSAGE FORMS AND STRENGTHS
Injection: 25 mg/0.5 mL and 50 mg/mL clear to opalescent, colorless to pale yellow solution in a single-dose prefilledsyringe
4 CONTRAINDICATIONS
Eticovo should not be administered to patients with sepsis.
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Patients treated with Eticovo are at increased risk for developing s |
