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|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
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.
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.