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people also ask
What is the risk of using SYLVANT during pregnancy?The limited available information on SYLVANT use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage. However, infants born to pregnant women treated with SYLVANT may be at increased risk of infection. It is advised to inform pregnant women of the potential risk to a fetus.
What is the estimated background risk of birth defects and miscarriage in the general population?In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
What are the fetal/neonatal adverse reactions of SYLVANT?Monoclonal antibodies like SYLVANT are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Infants born to pregnant women treated with SYLVANT may be at increased risk of infection. It is advised to consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to SYLVANT in utero.
Is it safe to use SYLVANT during lactation?There are no data on the presence of siltuximab in human milk, the effects on the breastfed child, or the effects on milk production. However, low levels of the human antibody to IL-6 were present in the milk of lactating cynomolgus monkeys. Because of the potential for serious adverse reactions in the breastfed child including gastrointestinal perforations, it is advised to not breastfeed during treatment with SYLVANT and for 3 months after the last dose.
What is the recommended contraception for female patients of reproductive potential using SYLVANT?SYLVANT may cause embryo-fetal harm when administered to pregnant women. Female patients of reproductive potential should use effective contraception during treatment with SYLVANT and for 3 months after the last dose.
Is SYLVANT safe to use in pediatric patients?The safety and efficacy of SYLVANT have not been established in pediatric patients.
Is there a difference in safety profile between elderly and younger patients using SYLVANT?No overall differences in safety profile were observed between elderly patients and younger patients in clinical studies. However, clinical studies did not include sufficient numbers of patients aged 65 years and older to determine the effect of age on efficacy in MCD population.
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