Compare drug alternatives
|Dosage & Administration|
Initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks.. Learn more.
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)
Is ADBRY safe to use during pregnancy?
There is limited data on the use of ADBRY in pregnant women to determine if there is a drug-associated risk of adverse developmental outcomes. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in a pregnancy exposure registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Human IgG antibodies, such as those in ADBRY, are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown, and all pregnancies have a background risk of adverse outcomes.
Has ADBRY been tested in animals for pregnancy and developmental effects?
In animal studies, intravenous doses of up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys without observing any maternal or developmental toxicity at doses up to 100 mg/kg/week. No treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age in another enhanced pre- and post-natal development study.
Is it safe to use ADBRY while breastfeeding?
There is no data on the presence of tralokinumab-ldrm in human milk or its effects on breastfed infants or milk production. Maternal IgG is present in breast milk, and the effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown. Healthcare providers should consider the development and health benefits of breastfeeding along with the mother's clinical need for ADBRY and any potential adverse effects on the breastfed child from ADBRY or from the underlying maternal condition.
Is ADBRY safe for use in pediatric patients?
The safety and effectiveness of ADBRY have not been established in pediatric patients.
Is ADBRY safe for use in geriatric patients?
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Healthcare providers should exercise caution in dose selection for elderly patients, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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.