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|Dosage & Administration|
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Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections. . Learn more.
Mechanism of Actions (MoA)
What is the risk of using SILIQ during pregnancy?
There are no human data on SILIQ use in pregnant women to inform a drug-associated risk. SILIQ may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of brodalumab during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD). However, the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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.
What is the risk of using SILIQ during lactation?
There are no data on the presence of brodalumab in human milk, the effects on the breastfed infant, or the effects on milk production. Brodalumab 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 SILIQ and any potential adverse effects on the breastfed infant from SILIQ or from the underlying maternal condition.
Is SILIQ safe and effective for pediatric patients?
The safety and effectiveness of SILIQ have not been evaluated in pediatric patients.
Is SILIQ safe and effective for geriatric patients?
Of the 3066 plaque psoriasis subjects initially randomized to SILIQ in clinical trials, 192 (6%) were ≥ 65 years old and no subjects were ≥ 75 years old. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects.
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.