Formulation and specifications: Capsules: 50mg
Indications:
1. Maintenance therapy for adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after achieving complete remission or partial remission with platinum-containing chemotherapy.
2. Treatment of platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer patients with germline BRCA mutations who have been previously treated with second-line chemotherapy or higher.
Key points for rational drug use:
1. The recommended dose is 150 mg/dose twice daily (once in the morning and once in the evening), or a total daily dose of 300 mg. After starting treatment with this product, patients should continue treatment until disease progression or intolerable toxic reactions occur. For maintenance treatment of platinum-sensitive recurrent ovarian cancer, patients should start this product within 4 to 8 weeks after the end of platinum-containing chemotherapy.
2. For oral administration, the drug should be swallowed whole. It can be taken with a meal or on an empty stomach (recommended to be taken after a meal).
3. If the patient misses a dose of the drug, there is no need to make up the dose and the next dose will still be taken as normal at the scheduled time.
4. Patients should start treatment with this product only after recovery from hematological toxicity caused by previous antineoplastic therapy (hemoglobin, platelet and neutrophil levels should recover to ≤ CTCAE grade 1). Whole blood cell testing is recommended at baseline during the initial 3 months of treatment, followed by monitoring every 2 weeks, and then periodically thereafter for clinically meaningful changes in parameters that occur during treatment.
If a patient develops severe or transfusion-dependent hematologic toxicity, treatment should be interrupted and relevant hematologic testing should be performed. If clinically abnormal blood parameters remain after a 4-week interruption in the administration of this product, bone marrow analysis and/or blood cytogenetic analysis is recommended.
5. The common types of adverse reactions during dosing (incidence ≥ 10%, in order of incidence) are anemia, nausea, leukopenia, malaise, thrombocytopenia, neutropenia, vomiting, loss of appetite, lymphocytopenia, elevated blood creatinine, and elevated ALT. Most adverse reactions were Grade 1 to 2. Grade 3 and above adverse reactions (incidence ≥ 2%) included: anemia, thrombocytopenia, neutropenia, leukopenia, and lymphocytopenia. Most of the adverse reactions can be recovered by dose suspension or corrective treatment.
6. Grade 3 to 4 adverse reactions can be managed by dose interruption. When symptoms recover to ≤ grade 1, restart the original dose or reduce the dose of treatment.
7. If dose reduction is required, the recommended dose should be reduced to 100 mg/dose twice daily, i.e., a total daily dose of 200 mg. If further dose reduction is required, the recommended dose should be reduced to 50 mg/dose twice daily, i.e., a total daily dose of 100 mg.
8. Avoid the combination of CYP3A4 strong inhibitors during the treatment of this product. If necessary, fludzoparib may be discontinued; after discontinuation of the combination with a strong CYP3A4 inhibitor and until the drug has cleared for 5 to 7 half-lives, fludzoparib may be resumed at the original dose and frequency of administration. If combined with an intermediate inhibitor of CYP3A4, a downward adjustment of the dose of fluzoparib to 50 mg is recommended.