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|Dosage & Administration
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Most common adverse reactions are: • Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. • Crohn’s Disease (>3%): o Induction: upper respiratory infections, headache, and arthralgia. o Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. . Learn more.
Mechanism of Actions (MoA)
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.
Is there a pregnancy exposure registry for SKYRIZI?
Yes, there is a pregnancy exposure registry for SKYRIZI that monitors outcomes in women who become pregnant while treated with the medication. Patients can enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.
What is the risk of using SKYRIZI during pregnancy?
Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. However, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. Additionally, there are adverse pregnancy outcomes in women with inflammatory bowel disease.
What is the 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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Is SKYRIZI detected in human milk?
There is no data on the presence of risankizumab in human milk. However, maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from the medication or from the underlying maternal condition.
Is SKYRIZI safe and effective in pediatric patients?
The safety and efficacy of SKYRIZI in pediatric patients (less than 18 years of age) have not been established.
Is there a difference in safety and efficacy of SKYRIZI between older and younger subjects?
Of the subjects with plaque psoriasis or psoriatic arthritis exposed to SKYRIZI, a total of 185 subjects were 65 years or older, and 13 subjects were 75 years or older. No overall differences in safety or effectiveness were observed between older and younger subjects who received SKYRIZI. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.