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|Dosage & Administration|
Single intravenous infusion using weight-based dosing: Recommended Dosage up to 55 kg: 260 mg. > 55 kg to 85 kg: 390 mg. > 85 kg: 520 mg. Maintenance dosing: SubQ 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.. Learn more.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
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.
Most common adverse reactions are: • Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. • Crohn’s Disease, induction (≥3%): vomiting. • Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. • Ulcerative colitis, induction (≥3%): nasopharyngitis • Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea . 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.
Is STELARA® safe to use during pregnancy?
Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug-associated risk. Animal studies have not shown any adverse effects, but the background risk of major birth defects and miscarriage for the indicated population(s) is unknown. Pregnant women should only use STELARA® if the potential benefits outweigh the risks.
Is it safe to use STELARA® while breastfeeding?
There is no data on the presence of ustekinumab in human milk or the effects on milk production or the breastfed infant. Ustekinumab was present in the milk of lactating monkeys administered ustekinumab. Breastfeeding women should only use STELARA® if the potential benefits outweigh the risks.
Can children use STELARA®?
STELARA® is approved for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 to 17 years old, and psoriatic arthritis in pediatric patients 6 to 17 years old. Use in patients less than 6 years of age with psoriasis or psoriatic arthritis or in pediatric patients with Crohn’s disease or ulcerative colitis has not been established.
Is STELARA® safe for geriatric patients?
Although no overall differences in safety or efficacy were observed between older and younger patients, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients. Geriatric patients using STELARA® may have a higher frequency of serious infection, so caution should be used when treating them.