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IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATION

ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis and angioedema have occurred after administration of ADBRY. If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to antihelminth treatment, discontinue treatment with ADBRY until the infection resolves.
Risk of Infection with Live Vaccines: ADBRY may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ADBRY, complete all age appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines during treatment with ADBRY. Limited data are available regarding coadministration of ADBRY with non-live vaccines.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%) are upper respiratory infections, conjunctivitis, injection site reactions, and eosinophilia.

USE IN SPECIFIC POPULATIONS

Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is present in breast milk. The effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown.
Pediatric Use: Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.

INDICATION

ADBRY^® (tralokinumab-Idrm) injection is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.

Please see full Prescribing Information.

References:

1. Davis DMR, et al. J Am Dermatol. 2024:90(2):e43-e56. doi: 10.1016/j.jaad.2023.08.102 2. Bieber T. Allergy. 2020;75(1):54-62. doi: 10.1111/all.13954 3. Tsoi LC, et al. J Invest Dermatol. 2019;139(7):1480-1489. doi: 10.1016/j.jid.2018.12.018 4. Kim BE, et al. Clin Immunol. 2008;126(3):332-337. doi: 10.1016/j.clim.2007.11.006 5. Szegedi K, et al. J Eur Acad Dermatol Venereol. 2015;29(11):2136-2144. doi: 10.1111/jdv.13160 6. Silverberg JI, et al. Dermatol Clin. 2017;35(3):327-334. doi: 10.1016/j.det.2017.02.005 7. Weidinger S, et al. Nat Rev Dis Primers. 2018;4(1):1. doi: 10.1038/s41572-018-0001-z 8. ADBRY. Prescribing information. LEO Pharma Inc. 9. Popovic B, et al. J Mol Biol. 2017;429(2):208-219. doi: 10.1016/j.jmb.2016.12.005 10. Data on file. LEO Pharma Inc. 11. Wollenberg A, et al. Br J Dermatol. 2021;184(3):437-449. doi: 10.1111/bjd.19574 12. Soung J, et al. Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis. Poster presented at: Winter Clinical Dermatology Conference; February 16-19, 2024; Miami, FL. 13. Simpson EL, et al. Ann Allergy Asthma Immunol. 2022;129(5):592-604.e5. doi: 10.1016/j.anai.2022.07.007 14. Blauvelt A, et al. Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long term disease control. Poster presented at: 32nd annual Congress of the European Academy of Dermatology and Venereology (EADV): October 11-14, 2023; Berlin, Germany. 15. Paller AS, et al. JAMA Dermatol. 2023;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627 16. Hanifin JM, et al. Exp Dermatol. 2001;10(1):11-18. doi: 10.1034/j.1600-0625.2001.100102.x 17. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353-1357. doi:10.1111/bjd.13662 18. Chopra R, et al. Br J Dermatol. 2017;177(5):1316-1321. doi:10.1111/bjd.15641 19. Futamura M, et al. J Am Acad Dermatol. 2016;74(2):288-294. doi: 10.1016/j.jaad.2015.09.062 20. Phan NQ, et al. Acta Derm Venereol. 2012;92(5):449-581. doi: 10.2340/00015555-1246 21. Silverberg JI, et al. Br J Dermatol. 2021;184(3):450-463. doi: 10.1111/bjd.19573