Tsoi LC, Rodriguez E, Degenhardt F, et al. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Poster presented at 4th Annual Revolutionizing Atopic Dermatitis Conference, April 9-11, 2022. Long-term improvements in disease severity, itch, and quality of life after 3 years of tralokinumab treatment in adults with moderate-to-severe atopic dermatitis.

Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Wollenberg A, Blauvelt A, Guttman-Yassky E, et al ECZTRA 1 and ECZTRA 2 study investigators. Adbry Prescribing Information, LEO Pharma.

Pediatric Use: The safety and effectiveness of ADBRY have not been established in pediatric patients.ġ.

The effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown.

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.

Human IgG antibodies are known to cross the placental barrier therefore, ADBRY may be transmitted from the mother to the developing fetus. There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-87 or visiting. Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy.The most common adverse reactions (incidence ≥1%) are upper respiratory infections, conjunctivitis, injection site reactions, and eosinophilia.Limited data are available regarding coadministration of ADBRY with non-live vaccines. Avoid use of live vaccines in patients treated with ADBRY. Prior to initiating therapy with ADBRY, complete all age appropriate vaccinations according to current immunization guidelines. Risk of Infection with Live Vaccines: ADBRY may alter a patient’s immunity and increase the risk of infection following administration of live vaccines.If patients become infected while receiving ADBRY and do not respond to antihelminth treatment, discontinue treatment with ADBRY until the infection resolves. Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with ADBRY.Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Conjunctivitis was the most frequently reported eye disorder. Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY.If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy. Hypersensitivity: Hypersensitivity reactions, including anaphylaxis and angioedema have occurred after administration of ADBRY.ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.IMPORTANT SAFETY INFORMATION CONTRAINDICATION: Program may not be combined with any third-party rebate, coupon or offer. Patient may be required to submit documentation of income and insurance coverage status. LEO Pharma reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.ĬPatient is not eligible for the Program if enrolled in any federally or state funded health care program, including but not limited to Medicare (including Medicare Part D), Medicaid, VA, DOD, TRICARE or CHIP.ĭIncome eligibility requirements apply. Patient or healthcare provider may not seek reimbursement for the benefit received from any party. For all other patient support programs, enrollment in Adbry Advocate is required. Enrollment in Adbry Advocate is not required to obtain copay support. Patients who have been initiated on therapy with samples are not eligible for Rapid Access Product.īAdditional terms, conditions, and eligibility rules apply.

A Nurse Advocate must coordinate shipment to a patient, which may extend delivery time. AThe initial dose of Adbry may be shipped either to your office or to the patient after submission of a completed Enrollment and Prescription Form or annual Healthcare Provider eRx Program Certification Form, as applicable, and Patient Authorization.

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