Adbry Drug Information

ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age 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.

Vaccination Prior to Treatment

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with ADBRY.

Important Administration Instructions ADBRY is administered by subcutaneous injection. ADBRY is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of ADBRY prior to use according to the "Instructions for Use".

Use of the Autoinjector The ADBRY autoinjector is for use in adults only. A caregiver or adult patient may inject ADBRY using the autoinjector. Use of the Prefilled Syringe The ADBRY prefilled syringe is for use in adults and pediatric patients 12 years of age and older.

A caregiver or patient 12 years of age and older may inject ADBRY using the prefilled syringe. In pediatric patients 12 years of age and older, administer ADBRY under the supervision of an adult. Administration Instructions Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.

The upper arm can also be used if a caregiver administers the injection. DO NOT inject ADBRY into skin that is tender, damaged, bruised, or scarred. For adults taking the initial loading dose of 600 mg, administer each of the injections (four ADBRY 150 mg injections using prefilled syringes or two ADBRY 300 mg injections using autoinjectors) at different injection sites within the same body area.

For the subsequent 300 mg doses using the prefilled syringe, administer the two ADBRY 150 mg injections at different injection sites within the same body area, rotating the body area with each subsequent set of injections. For the subsequent 150 mg doses, use a prefilled syringe to administer one ADBRY 150 mg injection, rotating the body area with each subsequent injection. The ADBRY "Instructions for Use" contains more detailed instructions on the preparation and administration of ADBRY.

Recommended Dosage Dosage in Adults

The recommended dosage for adults is: After 16 weeks of treatment, for adult patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

Missed Doses If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Preparation for Use

Before injection, remove ADBRY prefilled syringes or autoinjectors from the refrigerator and allow to reach room temperature (at least 30 minutes for the prefilled syringes and at least 45 minutes for the autoinjectors) without removing the needle cover or cap, respectively. After removal from the refrigerator, ADBRY may be kept at room temperature up to 30°C (86°F) and must be used within 14 days or discarded. Inspect ADBRY visually for particulate matter and discoloration prior to administration.

ADBRY injection is a clear to opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible particulate matter, is discolored or cloudy (other than clear to opalescent, colorless to pale yellow). ADBRY does not contain preservatives; therefore, discard any unused product.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials in Adults The safety of ADBRY was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis including three phase 3 Eczema Tralokinumab trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3), a dose-finding trial, and a vaccine response trial. In these 5 atopic dermatitis trials, 1964 subjects were treated with subcutaneous injections of ADBRY, with or without concomitant topical corticosteroids (TCS).

A total of 807 subjects were treated with ADBRY for at least 1 year. ECZTRA 1 and ECZTRA 2 compared the safety of ADBRY monotherapy to placebo through Week 52. ECZTRA 3 compared the safety of ADBRY + TCS to placebo + TCS through Week 32.

Of the 289 subjects, 195 were treated with ADBRY and 94 were treated with matching placebo. The safety profile of ADBRY in these subjects, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. Safety through 268 weeks (ECZTEND) ECZTEND was an open-label, multicenter, long-term extension trial that further assessed the safety of ADBRY for up to 5 years of treatment in adults and pediatric subjects 12 years of age and older with moderate-to-severe atopic dermatitis who had previously participated in ADBRY trials.

The long-term safety profile was consistent with the safety profile observed up to week 16. In the ADBRY group, 126 subjects reported 145 events of conjunctivitis, with 114 events resolved at the end of initial treatment period. Conjunctivitis led to discontinuation of treatment in 2 subjects.

A comparable pattern was seen during the continuation treatment period of an additional 16 weeks in the ADBRY combination trial ECZTRA 3. Keratoconjunctivitis was reported as resolved in 2 out of 5 subjects by the end of trials. Keratitis was reported as resolved in all but 1 subject by the end of trials.

None of the events were serious or led to treatment discontinuation. No events of keratitis or keratoconjunctivitis was reported in ADBRY every 4 weeks or placebo groups. Eosinophil Counts ADBRY-treated subjects had a greater mean initial increase from baseline in eosinophil count compared to subjects treated with placebo.

The mean and median increases in blood eosinophils from baseline to Week 4 were 190 and 100 cells/mcL, respectively. The increase in the ADBRY-treated subjects declined to baseline level with continued treatment. The safety profile for subjects with eosinophilia was comparable to the safety profile for all subjects included in the pool of 5 atopic dermatitis trials.

Pregnancy Pregnancy Exposure Registry 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/. Risk Summary There are limited data from the use of Adbry in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ). In an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the indicated population is unknown.

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 respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester.

Therefore, Adbry may be present in infants exposed in utero. The potential clinical impact of tralokinumab-ldrm exposure in infants exposed in utero should be considered. Data Animal Data In a pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys once every week from gestation day 20 to parturition.

No maternal or developmental toxicity was observed at doses up to 100 mg/kg/week (10 times the MRHD on a mg/kg basis of 10 mg/kg/week). In an enhanced pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm (10 times the MRHD on a mg/kg basis of 10 mg/kg/week) were administered to pregnant cynomolgus monkeys once every week from the beginning of organogenesis to parturition. 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.

Pediatric Use The safety and effectiveness of ADBRY have been established for the treatment of moderate-to-severe atopic dermatitis in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Of the 289 subjects, 195 were treated with ADBRY and 94 were treated with matching placebo. The safety and effectiveness were consistent between subjects 12 to 17 years of age and adult subjects.

Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.

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

There is no specific treatment for ADBRY overdose. In the event of overdosage, contact Poison Control (1-800-222-1222) for latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.