t any signs of new or worsening medical conditions, such as central nervous systemdemyelinating disorders, heart failure or autoimmune disorders, such as lupus-like syndrome or autoimmunehepatitis. Counsel about the risk of lymphoma and other malignancies while receiving Eticovo. Advise patients to
report any symptoms suggestive of a pancytopenia, such as bruising, bleeding, persistent fever or pallor.
Allergic Reactions
Advise patients to seek immediate medical attention if they experience any symptoms of severe allergic reactions.
Administration of Eticovo
If a patient or caregiver is to administer Eticovo, the patient or caregiver should be instructed in injection techniquesand how to measure and administer the correct dose [see the Eticovo (etanercept-ykro) “Instructions for Use”insert].
The first injection should be performed under the supervision of a qualified healthcare professional. The patient’s orcaregiver’s ability to inject subcutaneously should be assessed. Patients and caregivers should be instructed in thetechnique, as well as proper syringe and needle disposal, and be cautioned against reuse of needles and syringes.
A puncture-resistant container for disposal of needles, and syringes should be used.
Eticovo (etanercept-ykro)
Manufactured by:
Samsung Bioepis Co., Ltd.
107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea
U.S. License Number 2046
Product of Denmark
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf
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