About this Information

This section provides supporting information for the Adbry (tralokinumab) Dosing Calculator. It details the dosing regimens, administration instructions, and other clinical considerations based on the product’s prescribing information. This content is for educational purposes and should not replace clinical judgment or the official product label.

Outputs

The calculator provides tailored dosing recommendations based on user selections:

• Patient Population: It distinguishes between dosing for adults (≥18 years) and pediatric patients (12-17 years).
• Treatment Phase: It calculates the specific dose in milligrams (mg) and the number of subcutaneous injections required for both the initial loading dose and the subsequent maintenance doses.
• Missed Dose Guidance: It provides the standard recommendation for a missed dose, which is to administer it as soon as possible and resume the regular dosing schedule.
• Dosing Schedule Planner: If an initial dose date is entered, the tool calculates and displays the date for the first maintenance dose, which is 14 days later.

How to Use

To use the calculator, follow these steps:

1. Select Patient Population: Choose either “Adult” or “Pediatric”.
2. Select Treatment Phase: Choose “Initial (Loading) Dose,” “Maintenance Dose,” or “Missed Dose Guidance.”
3. Enter Optional Weight: You can enter the patient’s weight in kg or lbs. This is for reference only and does not change the recommended mg dose.
4. Use Schedule Planner (Optional): If calculating a loading dose, you may enter the administration date to find the due date for the first maintenance dose.
5. Calculate: The tool will display the recommended dose, administration details, and schedule information.

Dosing Overview

The recommended dosing for Adbry (tralokinumab) is administered by subcutaneous injection.

Adult Patients (≥18 years)

• Loading Dose: An initial dose of 600 mg, administered as four 150 mg injections.
• Maintenance Dose: 300 mg (two 150 mg injections) administered every other week.

Pediatric Patients (12 to 17 years)

• Loading Dose: An initial dose of 300 mg, administered as two 150 mg injections.
• Maintenance Dose: 150 mg (one 150 mg injection) administered every other week.

Switching Therapies

There is no specific guidance in the prescribing information regarding washout periods when switching to Adbry from other systemic therapies or biologics. The decision to switch, and the timing of the transition, should be based on the treating physician’s clinical judgment, considering the previous therapy’s mechanism of action and half-life.

Missed Dose

If a dose of Adbry is missed, the patient should be instructed to administer the injection as soon as possible. After that, they should resume dosing at their regular scheduled time. No dose adjustment is needed.

Safety Alerts

This tool is not a substitute for the full Prescribing Information (PI). Healthcare providers must consult the PI for complete details on warnings, precautions, contraindications, and adverse reactions. Common adverse reactions include upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. Adbry should not be administered to patients with a known hypersensitivity to tralokinumab or any of its excipients.

FAQ

1. Does body weight affect the prescribed Adbry dose in milligrams?
   No. As noted in the tool, body weight is for reference only and does not alter the recommended dose of 600/300 mg for adults or 300/150 mg for pediatric patients.
2. What is the purpose of the initial loading dose?
   The higher loading dose is designed to quickly achieve therapeutic drug concentrations in the body, leading to a faster onset of clinical effect.
3. How many injections are required for an adult maintenance dose?
   An adult maintenance dose of 300 mg requires two separate 150 mg subcutaneous injections.
4. Can this calculator be used for patients under 12 years old?
   No. The safety and efficacy of Adbry have not been established in patients younger than 12 years of age. The tool is only for approved age groups (12+).
5. How often is the maintenance dose administered?
   The maintenance dose for both adult and pediatric populations is administered every other week (Q2W).
6. Is Adbry administered intravenously or subcutaneously?
   Adbry is administered via subcutaneous injection only.
7. What if I select “Maintenance Dose” and enter a start date in the planner?
   The tool will provide a note indicating that the schedule planner is intended for use with the initial loading dose selection to calculate the *next* dose.
8. Does the tool provide dosing for patients with renal or hepatic impairment?
   No dose adjustment is recommended for patients with renal or hepatic impairment. However, this tool does not cover special populations, and the full PI should be consulted.
9. Can a patient’s maintenance dose be increased to weekly?
   For adult patients who achieve clear or almost clear skin, dosing every four weeks may be considered. This tool only calculates the standard every-other-week dosing. Clinical judgment is required for any dosing adjustments.
10. Does this tool replace the official Prescribing Information?
    Absolutely not. It is an educational aid designed to supplement, not replace, the complete, official Prescribing Information, which is the sole source for dosage and administration guidance.

References

1. Adbry (tralokinumab-ldrm) Prescribing Information. U.S. Food and Drug Administration. Rev. 01/2022.
2. Adtralza (tralokinumab) Summary of Product Characteristics (SmPC). European Medicines Agency.
3. Adbry (tralokinumab-ldrm) Official Healthcare Professional Website. LEO Pharma Inc.
4. Wollenberg A, Blauvelt A, Guttman-Yassky E, et al. 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). Br J Dermatol. 2021;184(3):437-449. doi:10.1111/bjd.19574