1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]
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people also ask
Is there a pregnancy exposure registry for ENSPRYNG?Yes, there is a pregnancy exposure registry for ENSPRYNG that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Healthcare providers are encouraged to register patients, and pregnant women are encouraged to register themselves by calling 1-833-277-9338.
What is the risk of using ENSPRYNG during pregnancy?There are no adequate data on the developmental risk associated with the use of ENSPRYNG in pregnant women. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Is satralizumab-mwge present in human milk?No information is available on the presence of satralizumab-mwge in human milk. Satralizumab-mwge was excreted in the milk of lactating monkeys administered satralizumab-mwge throughout pregnancy. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ENSPRYNG and any potential adverse effects on the breastfed infant from ENSPRYNG or from the underlying maternal condition.
Is ENSPRYNG safe and effective for use in pediatric patients?Safety and effectiveness in pediatric patients have not been established.
Are there any specific considerations for dosing ENSPRYNG in elderly patients?Clinical studies of ENSPRYNG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, caution should be used when dosing the elderly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.
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