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|Dosage & Administration
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Mechanism of Actions (MoA)
What is the risk of taking COSENTYX during pregnancy?
Limited human data are available on the use of COSENTYX during pregnancy. The available data from an embryo-fetal development study in monkeys showed no adverse developmental effects in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose. However, the background risk of major birth defects and miscarriage in the indicated population is unknown.
Is COSENTYX safe to use while breastfeeding?
It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COSENTYX and any potential adverse effects on the breastfed child from COSENTYX or from the underlying maternal condition.
Can COSENTYX be used in pediatric patients?
The safety and effectiveness of COSENTYX have been established in pediatric subjects aged 6 years and older with moderate to severe plaque psoriasis, as well as in patients weighing 15 kg or more with juvenile psoriatic arthritis (JPsA) aged 2 years and older and enthesitis-related arthritis (ERA) aged 4 years and older. However, the safety and effectiveness of COSENTYX in pediatric patients below the age of 6 years or with body weight less than 15 kg have not been established.
Is there any information on the use of COSENTYX in geriatric patients?
Although no differences in safety or efficacy were observed between older and younger subjects in clinical trials, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older.
What is the maximum recommended human dose of COSENTYX?
The maximum recommended human dose (MRHD) of COSENTYX is not specified in the information provided. However, in an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the MRHD.
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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