taltz 80 MG in 1 ML Auto-Injectortaltz 80 MG in 1 ML Prefilled Syringe
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people also ask
What is the Pregnancy Exposure Registry?It is a registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy.
How can pregnant women enroll in the TALTZ Pregnancy Registry?Pregnant women exposed to TALTZ can enroll in the registry by calling 1-800-284-1695. Contact information for the registry is also available on https://www.taltz.com.
What is the risk associated with TALTZ use in pregnant women?Available data from the published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
Is there a risk of harm to the developing fetus with TALTZ use in pregnant women?An embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD. However, the clinical significance of these nonclinical findings is unknown.
What is the background risk of major birth defects and miscarriage in the U.S. general population?The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies in the U.S. general population is 2 to 4% and 15 to 20%, respectively.
Is TALTZ present in human milk and what are its effects on breastfed infants?There are no available data on the presence of ixekizumab (TALTZ) in human milk, the effects on the breastfed infant, or the effects on milk production. However, ixekizumab was detected in the milk of lactating cynomolgus monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TALTZ and any potential adverse effects on the breastfed infant from TALTZ or from the underlying maternal condition.
Is TALTZ safe and effective for use in pediatric patients?TALTZ is approved for use in pediatric patients aged 6-18 years with moderate-to-severe plaque psoriasis. Its safety and effectiveness have not been established in other pediatric indications or in patients less than 6 years of age.
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