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|Dosage & Administration|
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia. Chronic Rhinosinusitis with Nasal Polyposis (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis. Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea. . Learn more.
Mechanism of Actions (MoA)
Are there any data available on the use of DUPIXENT during pregnancy?
There are no available data on DUPIXENT use in pregnant women to inform any drug-associated risk. Human IgG antibodies are known to cross the placental barrier, so DUPIXENT may be transmitted from the mother to the developing fetus. However, in an enhanced pre- and post-natal developmental study in pregnant monkeys, no adverse developmental effects were observed in offspring born after subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha (IL-4Rα) during organogenesis through parturition at doses up to 10-times the maximum recommended human dose.
What is the estimated background risk of major birth defects and miscarriage for the indicated population?
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 DUPIXENT safe to use while breastfeeding?
There are no data on the presence of dupilumab (the active ingredient in DUPIXENT) in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to dupilumab on the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Can DUPIXENT be used in pediatric patients?
Safety and efficacy in pediatric patients under 18 years of age have not been established.
Is there any information on the use of DUPIXENT in geriatric patients?
Of the 1472 subjects with atopic dermatitis exposed to DUPIXENT in a dose-ranging study and placebo-controlled trials, 67 subjects were 65 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.
What is the risk of using EUCRISA during pregnancy?
There is no available data with EUCRISA in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse developmental effects were observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD). All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Is EUCRISA safe to use while breastfeeding?
There is no information available on the presence of EUCRISA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of EUCRISA to women who are breastfeeding. EUCRISA is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of EUCRISA to a breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EUCRISA and any potential adverse effects on the breastfed infant from EUCRISA or from the underlying maternal condition.
Is EUCRISA safe for pediatric use?
The safety and effectiveness of EUCRISA have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic dermatitis. Use of EUCRISA in this age group is supported by data from two 28-day adequate, vehicle-controlled safety and efficacy trials which included 1,313 pediatric subjects ages 2 years to 17 years of whom 874 received EUCRISA. The most commonly reported adverse reaction in subjects 2 years and older was application site pain. Additionally, use of EUCRISA in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 subjects. No new safety signals were identified in subjects 3 months to less than 2 years of age. The safety and effectiveness of EUCRISA in pediatric patients below the age of 3 months have not been established.
What is the geriatric use of EUCRISA?
Clinical studies of EUCRISA did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.
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