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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)
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.
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.
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