1 ML eptinezumab-jjmr 100 MG/ML Injection [Vyepti]
NO BLACK BOX WARNING
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people also ask
Is it safe to use VYEPTI during pregnancy?There is no adequate data on the developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed in animals receiving eptinezumab-jjmr at doses greater than those used clinically. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy, according to published data. It is important to discuss with your healthcare provider if VYEPTI is necessary during pregnancy.
Are there any risks to the fetus if the mother receives VYEPTI?Animal studies have shown no adverse effects on embryofetal development when eptinezumab-jjmr was administered to pregnant animals at doses greater than those used clinically. However, there is no adequate data on the developmental risks associated with the use of VYEPTI in pregnant women. The estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies in the U.S. general population is 2%-4% and 15%-20%, respectively.
Is it safe to breastfeed while using VYEPTI?There are no data on the presence of eptinezumab-jjmr in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYEPTI and any potential adverse effects on the breastfed infant from VYEPTI or from the underlying maternal condition. It is important to discuss with your healthcare provider if VYEPTI is necessary while breastfeeding.
Is VYEPTI safe for use in pediatric patients?Safety and effectiveness in pediatric patients have not been established for VYEPTI. It is important to discuss with your healthcare provider if VYEPTI is necessary for pediatric patients.
Is VYEPTI safe for use in geriatric patients?Clinical studies of VYEPTI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. It is important to discuss with your healthcare provider if VYEPTI is necessary for geriatric patients.
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