Formulation and specifications: Tablets: 100 mg, 150 mg
Indications: For adult patients with metastatic desmoplastic-resistant prostate cancer who carry germline or somatic BRCA mutations and who have failed prior therapy, including a novel endocrine agent.
Key points for rational drug use:
1. Olaparib must be used to confirm the presence of germline and/or somatic BRCA1/2 mutations in patients prior to use in metastatic desmoplastic-resistant prostate cancer using NDA-approved or other validated assays.
2. The recommended dose is 300 mg/dose twice daily, i.e., a total daily dose of 600 mg, used until disease progression or intolerable toxicity occurs.
3. Treatment course for metastatic desmoplastic-resistant prostate cancer with BRCA1/2 mutation: continued treatment is recommended until existing disease progression or intolerable toxicity occurs. For patients who have not undergone surgical debulking, pharmacologic debulking with luteinizing hormone-releasing hormone analogs should be continued during treatment.
4. Tablets should be swallowed whole and should not be chewed, crushed, dissolved, or broken off. It can be taken with a meal or on an empty stomach. If a patient misses a dose of medication, there is no need to make up the dose and the next dose will still be taken normally at the scheduled time and will not affect the overall efficacy.
5. The most common adverse reactions (≥20%) to olaparib in clinical trials were: anemia, nausea, fatigue (including malaise), vomiting, diarrhea, taste disturbance, and dyspepsia. The most common biochemical abnormalities (≥25%) were: increased creatinine, elevated mean red blood cell volume, decreased hemoglobin, decreased lymphocytes, decreased absolute neutrophil count, and decreased platelets. To manage adverse events, such as anemia, nausea, and malaise, treatment interruption or dose reduction may be considered. Patients should start treatment with this product only after recovery from hematologic toxicity caused by previous antineoplastic therapy (hemoglobin, platelet and neutrophil levels should recover to ≤ CTCAE grade l). Monthly monitoring of complete blood counts at baseline and for the first 12 months of treatment is recommended, followed by periodic monitoring for any clinically significant changes during treatment.
6. If dose reduction is required, the recommended dose is reduced to 250 mg/dose (1 150 mg tablet, 1 100 mg tablet) twice daily, or a total daily dose of 500 mg. If further dose reduction is required, the recommended dose is reduced to 200 mg/dose (2 100 mg tablets) twice daily, or a total daily dose of 400 mg.
7. It is not recommended to combine this product with strong or moderate CYP3A inhibitors. If strong or moderate CYP3A inhibitors must be combined, it is recommended to reduce the dose of this product to 100mg twice daily, and if moderate CYP3A inhibitors must be combined, it is recommended to reduce the dose of this product to 150mg twice daily.