SUMMARY

• Alternative Formats of Information
  • A summary of the information provided in this response is provided as a video and infographic that can be accessed by clicking the following links:
    • Video: Mixing ERLEADA 240 mg Tablet with Orange Juice, Applesauce, or Additional Water
    • Infographic: Alternate Method of Administration
• Johnson & Johnson cannot recommend any practices, procedures, or dosage administration techniques that deviate from the approved product labeling. Please refer to local labeling for additional guidance and considerations.
• ERLEADA is not commercially available as a solution or suspension.
• For patients who cannot swallow the tablet whole, the recommended dose of one tablet can be dispersed in non-carbonated water and then administered with either orange juice, applesauce, or additional water. Place the whole tablet in a cup. Do not crush or split the tablet. Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water. Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture. Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture. Swallow the mixture immediately. Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately. Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use.¹
• Results from in vitro compatibility studies to evaluate the dose accuracy, stability, purity, and appearance of ERLEADA 240 mg tablet dispersed in various aqueous food vehicles for alternative administration are summarized below.²

ALTERNATE METHOD OF ADMINISTRATION

Clinical data

Phase 1 Study

Yu et al (2024)² evaluated alternative administration of ERLEADA 240 mg tablet in applesauce, yogurt, orange juice, and green tea aqueous media for feasibility and intervehicle comparability, per in vitro compatibility studies.

Study Design/Methods

• Feasibility of mixing the ERLEADA 240 mg tablet with the selected food vehicles were evaluated by first dispersing the tablet in a glass container of 10 mL of water and then adding the specified amount of food vehicle: 30 g of applesauce, 30 g of yogurt, or 30 mL of orange juice or green tea extract. After emptying the food/tablet mixture into a volumetric flask, the container was rinsed with water (15 mL for soft foods and 10 mL for liquids) to ensure the full content was transferred and analyzed. The wash liquid was then added to the volumetric flask before adding the dilution solvent as a part of sample preparation for the high-performance liquid chromatography (HPLC) analysis.
• Testing for dose accuracy (in triplicate) and in-use stability (assay and chromatographic purity) evaluated the impact of mixing ERLEADA 240 mg tablet in aqueous food vehicles and subsequent storage of the total dose.
• For dose accuracy testing, the reference content value was an ERLEADA 240 mg whole tablet, without using a food vehicle. The acceptance criterion for the individual assay (ERLEADA 240 mg tablet mixed with food vehicle) was ±15% of assay from the target assay value (no food vehicle).
• For in-use stability testing, the sample mixtures were tested immediately after dispersion in water and the respective food vehicle (T0) and then after a hold time of 1 hour (test repeated twice) at room temperature to verify the chemical stability of the product in contact with the food vehicle.

Results

Dose Accuracy

• Results of dose accuracy for the dispersed 240 mg tablets in food vehicles ranged from 100.9% to 104.4% compared to a whole tablet dispersed in 10 mL of water without use of a food vehicle, indicating stability (acceptance criterion, 85.7%-115.5%).

In-Use Stability and Purity

• There were no significant changes to stability during the in-use study. All samples tested met the acceptance criteria (85%-115%), ranging from 100.6% to 103.3% compared to a whole tablet dispersed in 10 mL of water without use of a food vehicle. Additionally, no unspecified degradants were observed above the reporting limit of 0.05%.

Appearance of Mixture

• No noticeable changes were observed during the in-use period of the applesauce, yogurt, orange juice, and green tea mixtures. The colors of the mixtures with applesauce, orange juice, and green tea were slightly changed to yellowish brown, yellowish orange, and yellowish white in color, respectively, and the yogurt mixture was changed to white in color.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 17 May 2024.