Adbry®(Tralokinumab-Ldrm) | ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Subcutaneous Injection. Learn more. | |
Dosing | |
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. | |
Latin Shorthand | |
600 mg q0 (4 x 150 mg), 300 mg q2w (2 x 150 mg). 300 mg q4w (consider for patients <100 kg with clear/almost clear skin after 16 wks of tx). Learn more. | |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
$15,000. Learn more. | |
Assistance Expiration | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.. Learn more. | |
Mechanism of Actions (MoA) | |
Agents for dermatitis excluding corticosteroids. Learn more. | |
Special Populations | |
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. | |