Kevzara(sarilumab)
KEVZARA 150 MG in 1.14 mL Auto-Injector
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Kevzara FAQs
What is the risk of using KEVZARA during pregnancy?The limited human data with KEVZARA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. Monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. From animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers. In an animal reproduction study, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 84 times the maximum recommended human dose (MRHD). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. KEVZARA should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
What should be considered prior to administering live or live-attenuated vaccines to infants exposed to KEVZARA in utero?Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to KEVZARA in utero.
What is the risk of using KEVZARA during lactation?No information is available on the presence of sarilumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Maternal IgG is present in human milk. If sarilumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to sarilumab are unknown. The lack of clinical data during lactation precludes clear determination of the risk of KEVZARA to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KEVZARA and the potential adverse effects on the breastfed child from KEVZARA or from the underlying maternal condition.
Is KEVZARA safe and effective for use in pediatric patients?Safety and efficacy of KEVZARA in pediatric patients have not been established.
What is the recommended caution for use of KEVZARA in the elderly population?Of the total number of patients with RA exposed to KEVZARA in clinical studies, no overall differences in safety and efficacy were observed between older and younger patients. The frequency of serious infections among KEVZARA and placebo-treated patients 65 years of age and older was higher than those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Has the safety and efficacy of KEVZARA been studied in patients with hepatic impairment?The safety and efficacy of KEVZARA have not been studied in patients with hepatic impairment, including patients with positive HBV or HCV serology.
Is there a dose adjustment required for patients with renal impairment?No dose adjustment is required in patients with mild to moderate renal impairment. KEVZARA has not been studied in patients with severe renal impairment.
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