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Assessing Tolerability and Clinical Considerations in Abiraterone Formulation Selection

A panelist discusses how adherence considerations are crucial when selecting between different abiraterone formulations, emphasizing that the microformulation offers flexibility by allowing administration with or without food compared with the traditional fasting requirements.

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      Abiraterone Formulation Options and Patient Adherence

      This segment provides detailed information about the 3 main abiraterone acetate formulations available for treating metastatic castration-resistant prostate cancer. The traditional formulation requires 1000 mg daily (four 250-mg tablets) taken on an empty stomach with strict fasting requirements—no food 2 hours before and 1 hour after administration—combined with prednisone 5 mg twice daily. The microformulation offers 500 mg daily (four 125-mg tablets) that can be taken with food, utilizing cell matrix technology for improved absorption and combined with prednisolone 4 mg twice daily.

      The off-label low-dose option involves 250 mg once daily with a low-fat meal and prednisone 5 mg daily, supported by phase 2 clinical trial data showing bioequivalence to the standard fasting dose. However, this approach faces challenges with variable absorption depending on meal fat content and lacks FDA approval. Patient adherence emerges as a critical factor, particularly regarding the fasting requirements of the traditional formulation and the dietary restrictions of the low-dose option.

      The case patient selected the microformulation due to concerns about fasting adherence, leading to successful outcomes at 3-month follow-up with prostate-specific antigen reduction from 12.1 to 4.8, improved pain scores, and stable renal function. The segment emphasizes that effective prostate cancer treatment depends not only on drug selection but also on realistic assessment of patient ability to adhere to specific dosing requirements and lifestyle modifications.

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