Etveza Special Precautions

Serious infections (sepsis, lethal and life threatening infections) occurred in the patients who received the like product abroad, therefore the administration of Etanercept should be cautious to the patients with history of repeated infectious diseases or latent diseases easily leading to infection.
When repeated upper respiratory tract infection or obvious tendency of infection occurs during administration of Etanercept, consultation of a doctor is recommended.
When serious infection occurs such as infection secondary to diabetes, tuberculosis infection etc, the administration of Etanercept should be discontinued temporarily.
During the using of Etanercept, allergic reactions including angio-edema, urticaria and other reactions should be concerned. Once the allergic reaction occurs, Etanercept therapy should be discontinued immediately and appropriate medical treatment should be given.
Since Etanercept can regulate inflammatory and cell immune reactions, its influence on anti-infection and anti-tumor therapy should be considered when using Etanercept.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Etanercept. The concurrent vaccination of live vaccines is not recommended when receiving Etanercept.
It was reported overseas that Etanercept may lead to the exacerbation of patients with congestive heart failure, so administration of Etanercept in patients with heart failure should be extremely cautious.
Women of childbearing potential: Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Etanercept therapy and for three weeks after discontinuation of therapy.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Pregnancy & Lactation: Etanercept is not recommended for use in pregnant and lactating women.
Use in Children: There are no drug application data in children of 2 years and under. It is reported in foreign literatures that the dose for children (4 to 17 years old) is 0.8mg/kg, given twice weekly by 3-4 days apart.
Use in the Elderly: It was reported in a foreign literature that it is demonstrated in a clinical trial conducted in 197 elderly patients above 65 years that there were no significant differences in efficacy and safety between young and elderly patients. Because elder patients are susceptible to infections, attention should be paid to the elder patients during their treatment with Etanercept.