jects who achieved PASI75 response at Week 36 were re-randomized toeither etanercept or placebo during a 12-week randomized withdrawal period. The maintenance of PASI 75response was eva luated at Week 48. The proportion of subjects who maintained PASI75 response at Week 48 washigher for subjects treated with etanercept (65%) compared to those treated with placebo (49%).
15 REFERENCES
1. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEERIncidence Crude Rates, 13 Registries, 1992-2002.
2. Bröms G, Granath F, Ekbom A, et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated WithAnti-Tumor Necrosis Factor Agents During Pregnancy. Clin Gastroenterol Hepatol. 2016;14:234-241.e5 16 HOW SUPPLIED/STORAGE AND HANDLINGAdministration of one 50 mg Eticovo single-dose prefilled syringe provides a dose equivalent to two 25 mg Eticovosingle-dose prefilled syringes.
Eticovo Single-Dose Prefilled Syringe
Each Eticovo (etanercept-ykro) injection is supplied as a clear to opalescent, colorless to pale yellow, sterile, andpreservative-free solution for subcutaneous administration in single-dose prefilled syringes with a 27-gauge, ½-inchneedle.
50 mg/mL single-dose prefilled
syringe
Carton of 4 NDC 71202-003-04
25 mg/0.5 mL single-dose
prefilled syringe
Carton of 4 NDC 71202-004-04
Eticovo should be refrigerated at 36°F to 46°F (2°C to 8°C). Do not use Eticovo beyond the expiration datestamped on the carton or barrel label. DO NOT SHAKE. Store Eticovo in the original carton to protect from light orphysical damage.
For convenience, storage of individual single-dose prefilled syringes at room temperature between 73°F to 81°F(23°C to 27°C) for a maximum single period of 14 days is permissible, with protection from light and sources ofheat. Once a single-dose prefilled syringe has been stored at room temperature, it should not be placed back into therefrigerator. If not used within 14 days at room temperature, the single-dose prefilled syringe should be discarded.
Do not store Eticovo in extreme heat or cold. DO NOT FREEZE. Keep out of the reach of children.
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructionsfor Use) before the patient starts using Eticovo, and each time the prescription is renewed, as there may be newinformation they need to know.
Patients or their caregivers should be provided the Eticovo “Medication Guide” and provided an opportunity to readit and ask questions prior to initiation of therapy. The healthcare provider should ask the patient questions todetermine any risk factors for treatment. Patients developing signs and symptoms of infection should seek medical
eva luation immediately.
Patient Counseling
Patients should be advised of the potential benefits and risks of Eticovo. Physicians should instruct their patients to
read the Medication Guide before starting Eticovo therapy and to reread each time the prescription is renewed.
Infections
Inform patients that Eticovo may lower the ability of their immune system to fight infections. Advise patients of theimportance of contacting their doctor if they develop any symptoms of infection, tuberculosis or reactivation ofhepatitis B virus infections.
Other Medical Conditions
Advise patients to repor |
