-natal day 4 was unaffected at doses that achieved exposures 48 times the exposurein patients treated with 50 mg etanercept once weekly (on an AUC basis with maternal subcutaneous doses up to 30mg/kg/day).
8.2 Lactation
Risk Summary
Limited data from published literature show that etanercept is present in low levels in human milk and minimallyabsorbed by a breastfed infant. No data are available on the effects of etanercept products on the breastfed child or theeffects on milk production. The developmental and health benefits of breastfeeding should be considered along with themother’s clinical need for Eticovo and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
8.4 Pediatric Use
Etanercept has been studied in 69 children with moderately to severely active polyarticular JIA aged 2 to 17 years.
Etanercept has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years.
Etanercept has not been studied in children < 2 years of age with JIA and < 4 years of age with PsO.
For pediatric specific safety information concerning malignancies and inflammatory bowel disease, [see Warningsand Precautions (5.3) and Adverse Reactions (6.2]).
The clinical significance of infant exposure to etanercept products in utero is unknown. The safety of administeringlive or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior toadministering live or live-attenuated vaccines to exposed infants. For pediatric specific safety information concerningvaccinations, [see Warnings and Precautions (5.8) and Drug Interactions (7.1]).
8.5 Geriatric Use
A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In PsO randomized clinical trials,
a total of 138 out of 1965 patients treated with etanercept or placebo were age 65 or older. No overall differences insafety or effectiveness were observed between these patients and younger patients, but the number of geriatric PsOpatients is too small to determine whether they respond differently from younger patients. Because there is a higherincidence of infections in the elderly population in general, caution should be used in treating the elderly.
8.6 Use in Diabetics
There have been reports of hypoglycemia following initiation of etanercept therapy in patients receiving medicationfor diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
10 OVERDOSAGE
No dose-limiting toxicities have been observed during clinical trials of etanercept. Single IV doses up to 60 mg/m2(approximately twice the recommended dose) have been administered to healthy volunteers in an endotoxemia studywithout evidence of dose-limiting toxicities.
11 DESCRIPTION
Etanercept-ykro, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellularligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fcportion of human IgG1. The Fc component of etanercept-ykro contains the CH2 domain, the CH3 domain and hingeregion, but not the CH1 domain of IgG1. Etanercept-ykro is produced by recombinant DNA technology in a Chinesehamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparentmolecular weight of approximately 150 kilodaltons.
Eticovo (etanercept-ykro) Injection in the single- |
