Formulation and specifications: Tablets: 100mg, 150mg
Indications:
1. Maintenance therapy for adult patients carrying germline or somatic BRCA mutations in advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in primary treatment after achieving complete remission or partial remission with first-line platinum-containing chemotherapy.
2. Maintenance therapy for adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer after complete or partial remission with platinum-containing chemotherapy.
3. Maintenance therapy in combination with bevacizumab in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer with positive combined homologous recombination repair defects after complete or partial remission with first-line platinum-containing chemotherapy (not yet approved by the State Drug Administration).
4. Treatment of adult patients with advanced ovarian cancer carrying germline BRCA mutations who have undergone three or more lines of chemotherapy (not yet approved by the State Drug Administration).
Key points for rational drug use:
1. The indication for olaparib in combination with bevacizumab regimen for first-line maintenance therapy is based on the results of the Phase III PAOLA-1 study; the indication for olaparib for postline ovarian cancer treatment is based on the results of the Phase III SOLO-3 study. The above indications have been approved by the US FDA, but have not yet been approved by the State Drug Administration, and may be considered under adequate communication with patients.
2. The recommended dose is 300 mg/dose twice daily for normal adults, i.e., a total daily dose of 600 mg. Treatment with this product should be started within 8 weeks after the end of platinum-containing chemotherapy. Recommended duration of therapy: First-line maintenance therapy for advanced ovarian cancer with BRCA mutations may be continued until disease progression or intolerable toxicities occur, or until completion of 2 years of therapy. 2 years of therapy should be discontinued in patients in complete remission (no evidence of tumor on imaging), and treatment may be continued beyond 2 years if imaging shows a tumor and the clinician believes the patient would benefit further from continued therapy. Maintenance therapy for platinum-sensitive recurrent ovarian cancer may be continued until disease progression or intolerable toxicities occur.
3. Tablets should be swallowed whole and should not be chewed, crushed, dissolved, or broken. It may be taken with a meal or on an empty stomach.
4. 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. Patients should start this product only after recovery from hematologic toxicity caused by previous antineoplastic therapy (hemoglobin, platelet and neutrophil levels should be restored to ≤ CTCAE grade 1). Whole blood cell testing is recommended at baseline during the first 12 months of treatment, followed by monthly monitoring, and then periodically thereafter for clinically meaningful changes in parameters that occur during treatment.
6. The common types of adverse reactions during drug administration are anemia, thrombocytopenia, neutropenia, nausea, vomiting, diarrhea, upper respiratory tract infection, fatigue, decreased appetite, arthralgia, myalgia, taste disturbance and headache, etc. The most frequent adverse reactions are nausea, fatigue and anemia in order of incidence, mostly grade 1 to 2 adverse reactions, and the incidence of grade 3 to 4 anemia is about 20%.
7. Grade 3 to 4 adverse reactions can be managed by dose interruption. When symptoms return to ≤ grade 1, restart the original dose or reduce the dose of treatment.
8. If dose reduction is required, the recommended dose is reduced to 250 mg/dose (1 150 mg tablet, 1 100 mg tablet) twice daily, i.e., 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, i.e., a total daily dose of 400 mg.
9. It is not recommended to combine this product with strong or moderate CYP3A inhibitors. If strong CYP3A inhibitors must be combined, it is recommended to reduce the dose of this product to 100mg/dose twice daily, and if moderate CYP3A inhibitors must be combined, it is recommended to reduce the dose of this product to 150mg/dose twice daily.