Airuiyi Fluzoparib Capsules

1. Indications and Usage
Fluzoparib capsules are indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) recurrent platinum-sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received at least two prior chemotherapy regimens. It is also indicated for maintenance treatment in adult patients with platinum-sensitive recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response to last-line platinum-based chemotherapy.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 150 mg taken orally twice daily.
Administration: Capsules should be swallowed whole and can be taken with or without food (postprandial administration is recommended).
Missed Dose: If a dose is missed, do not make up for it. Take the next dose at the regular scheduled time.
Dose Modifications: For intolerable adverse reactions, the dose may be interrupted and reduced to 100 mg twice daily, and further to 50 mg twice daily.
3. Mechanism of Action
Fluzoparib is a potent, selective, and reversible inhibitor of poly (ADP-ribose) polymerase (PARP). It inhibits PARP1 and PARP2 enzymes, thereby blocking the repair of single-strand DNA breaks. This leads to the accumulation of DNA damage and ultimately triggers apoptosis in tumor cells harboring BRCA mutations.
4. Safety and Warnings
Hematologic Toxicity: Anemia, leukopenia, neutropenia, and thrombocytopenia are common adverse reactions. Complete blood counts should be monitored regularly.
Hepatotoxicity: Elevated liver enzymes have been reported. Liver function tests should be monitored before and during treatment.
Embryo-Fetal Toxicity: Fluzoparib can cause fetal harm. Effective contraception is required for females during treatment and for 6 months after the last dose.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions (incidence ≥10%) include anemia, nausea, leukopenia, fatigue, thrombocytopenia, neutropenia, vomiting, anorexia, lymphopenia, and increased serum creatinine.
Clinical Research: Efficacy was established in clinical trials for recurrent ovarian cancer, demonstrating improved progression-free survival compared to placebo.
6. Drug Interactions
CYP3A4 Inhibitors: Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice) should be avoided during treatment.
CYP3A4 Inducers: Strong and moderate CYP3A4 inducers (e.g., rifampin, carbamazepine) should be avoided as they may significantly reduce fluzoparib efficacy.
7. Pharmaceutical Information
Composition: The active ingredient is fluzoparib.
Appearance: The capsules contain white powder.
Storage: Store in a tightly closed container at temperatures below 30°C.