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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.
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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 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.
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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