Compare drug alternatives
|Dosage & Administration
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Most common (≥1%) adverse reactions associated with TREMFYA include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. . 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 TREMFYA safe to use during pregnancy?
There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6- to 30-times the MRHD. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should discuss the potential risks and benefits of TREMFYA with their healthcare provider.
Is there a pregnancy exposure registry for TREMFYA?
Yes, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to TREMFYA during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972.
What is the estimated background risk of major 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.
What animal data is available for TREMFYA use during pregnancy?
In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison) and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.
What are the risks associated with guselkumab use during lactation?
There is no data on the presence of guselkumab in human milk or the effects on the breastfed infant or milk production. 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 TREMFYA and any potential adverse effects on the breastfed infant from TREMFYA or from the underlying maternal condition.
Is TREMFYA safe and effective for use in pediatric patients?
The safety and efficacy of TREMFYA in pediatric patients (less than 18 years of age) have not been established.
Are there differences in safety or effectiveness of TREMFYA in geriatric patients?
No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA. However, the number of subjects aged 65 years and older was not sufficient to determine whether they respond differently from younger subjects.