BRIEF SUMMARY

TRALKINMAB-(Dec 2021)

Indn-    To treat moderate to severe dermatitis

Comp-    Injection: 150 mg/mL solution in a single-dose prefilled syringe with needle guard.  The recommended dosage of ADBRY is an 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 of treatment

ADR-  Most common adverse reactions (incidence = 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.

CI-   Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

WARNINGS-

 • Hypersensitivity: Hypersensitivity reaction.Discontinue ADBRY in the event of a hypersensitivity reaction.

 • Conjunctivitis and Keratitis: Patients should report new onset or worsening eye symptoms to their healthcare provider.

Pat Inform-

Hypersensitivity-                                                                                                            Advise patients to discontinue and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.

Conjunctivitis and Keratitis -                                                                                         Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop

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U.S. FDA APPROVED DRUGS SURING 2021                                          

Serial No 51

Name of the Drug-    ADBRY

Active Ingredient -    Tralokinumab

Pharmacological Classification-    To treat moderate to severe dermatitis

                                                                                                                                               Date of Approval-         12/27/2021

HIGHLIGHTS OF PRESCRIBING INFORMATION-                                                         

These highlights do not include all the information needed to use                                ADBRY safely and effectively.                                                                                        

 See full prescribing information for ADBRY. ADBRY™ (tralokinumab-ldrm) injection, for subcutaneous use

Initial U.S. Approval: 2021

INDICATIONS AND USAGE-

 ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients 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.

ADVERSE REACTIONS-

 Most common adverse reactions (incidence = 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.

CONTRAINDICATIONS-

 Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.

WARNINGS AND PRECAUTIONS-

 • Hypersensitivity: Hypersensitivity reaction.Discontinue ADBRY in the event of a hypersensitivity reaction.

 • Conjunctivitis and Keratitis: Patients should 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 anti-helminth treatment, discontinue treatment with ADBRY until the infection resolves.

 • Risk of Infection with Live Vaccines: Avoid use of live vaccines.

DOSAGE AND ADMINISTRATION--

 • Prior to ADBRY initiation, complete all age appropriate vaccinations as recommended by current immunization guidelines

 • The recommended dosage of ADBRY is an 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 of treatment.

 • Administer by subcutaneous injection.

DOSAGE FORMS AND STRENGTHS-

 Injection: 150 mg/mL solution in a single-dose prefilled syringe with needle guard. 

PATIENT COUNSELING INFORMATION -

Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Administration Instructions-                                                                                    Instruct patients or caregivers:                                                                                         

 • to perform the first self-injection under the supervision and guidance of a qualified healthcare provider for proper training in subcutaneous injection technique.

• to inject the full dose of ADBRY.

• to follow sharps disposal recommendations [see Instructions for Use].

Hypersensitivity-                                                                                                            Advise patients to discontinue ADBRY and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.

Conjunctivitis and Keratitis -                                                                                         Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop..

Risk of Infection with Live Vaccines-                                                                             Advise patients that ADBRY may increase the risk of infection following administration of live vaccines and that vaccination with live vaccines is not recommended during ADBRY treatment.

Instruct patients to inform the healthcare provider that they are taking ADBRY prior to a potential vaccination.

Manufactured by: LEO Pharma A/S Industriparken 55 Ballerup, Denmark DK-2750 U.S. License No. 2169 Distributed by: LEO Pharma Inc. Madison, NJ 07940, USA ADBRY™ is a trademark of LEO Pharma A/S. © 2021 LEO Pharma Inc. All rights reserved.

CLINICAL PHARMACOLOGY -

1. Mechanism of Action-                                                                                         Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin13 (IL-13) and inhibits its interaction with the IL-13 receptor a1 and a2 subunits (IL-13Ra1 and IL13Ra2). IL-13 is a naturally occurring cytokine of the Type 2 immune response.

Tralokinumab-ldrm inhibits the bioactivity of IL-13 by blocking IL-13 interaction with IL-13Ra1/IL-4Ra receptor complex. Tralokinumab-ldrm inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE.

2. Pharmacodynamics-                                                                                                 ADBRY was associated with decreased concentrations of Th2 and Th22 immunity biomarkers in the blood, such as thymus and activation-regulated chemokine (TARC/CCL17), periostin, IL-22, lactate dehydrogenase (LDH) and serum IgE.

3. Pharmacokinetics-                                                                                                    The mean (SD) steady-state trough concentration of tralokinumab-ldrm ranged from 98.0 (41.1) mcg/mL to 101.4 (42.7) mcg/mL following administration of ADBRY at 300 mg every other week.

Tralokinumab-ldrm exposure increased proportionally over a dosage range up to 2100 mg for a 70 kg subject (30 mg/kg IV) (3.5 times the maximum approved recommended dosage).

Steady-state tralokinumab-ldrm concentrations were achieved by week 16 following a 600 mg starting dose and 300 mg every other week.

Absorption-                                                                                                                    The absolute bioavailability of tralokinumab-ldrm was estimated to be 76%. The time to maximum tralokinumab-ldrm concentrations (tmax) was 5 to 8 days after administration.

Distribution-                                                                                                                   The volume of distribution of tralokinumab-ldrm was estimated to be approximately 4.2 L.

Elimination-                                                                                                                     The half-life of tralokinumab-ldrm was 3 weeks and systemic clearance was estimated to be 0.149 L/day.

Metabolism-                                                                                                             Tralokinumab-ldrm is expected to be metabolized into small peptides by catabolic pathways.

Specific Populations-                                                                                                     No clinically significant differences in the pharmacokinetics of tralokinumab-ldrm were observed based on age (ranged from 18 – 92 years), sex, mild to moderate renal impairment, or mild hepatic impairment.

The effect of severe renal impairment or moderate to severe hepatic impairment on the pharmacokinetics of tralokinumab-ldrm is unknown.

Body Weight The exposure of tralokinumab-ldrm decreases with increasing body weight. After 300 mg dose every 4 weeks, the median tralokinumab-ldrm exposure (AUC) of subjects with body weight of above 100 kg is expected to be 1.46-fold lower than that of subjects weighing below 100 kg.

Drug Interaction Studies-                                                                                               Drug interactions with ADBRY has not been assessed.

USE IN SPECIFIC POPULATIONS

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

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 2% to 4% and 15% to 20%, respectively.

2. Lactation Risk Summary -                                                                                       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. The development and health benefits of breastfeeding should be considered 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.

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

4. Geriatric Use-                                                                                                               Of the 1605 subjects exposed to ADBRY in 5 atopic dermatitis trials in the initial treatment period of up to 16 weeks, 77 subjects were 65 years or older. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects..

OVERDOSAGE-                                                                                                           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.