Formulation and Specifications: Capsules: 100mg
Indications:
1. This product is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after achieving complete remission or partial remission on first-line platinum-containing chemotherapy.
2. This product is indicated for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after achieving complete remission or partial remission with platinum-containing chemotherapy.
Key points for rational drug use:
1. Recommended dose introduction: (1) First-line maintenance therapy for ovarian cancer: for patients with body weight <77 kg or baseline platelet count <150×109/L, the recommended dose of this product is 200 mg orally once daily; for patients with body weight ≥77 kg and baseline platelet count ≥150×109/L, the recommended dose is 300 mg orally once daily until disease progression or intolerable adverse reactions occur. Patients should begin treatment with this product within 12 weeks after the end of platinum-containing chemotherapy. (2) Maintenance therapy for recurrent ovarian cancer: The recommended dose of this product is 300 mg orally once daily until disease progression or intolerable adverse reactions occur. For patients weighing less than 58 kg, a starting dose of 200 mg may be considered. Patients on maintenance therapy for recurrent ovarian cancer should start this product within 8 weeks after the end of platinum-containing chemotherapy. (3) Treatment of advanced ovarian cancer after three or more chemotherapies: the recommended dose is 300 mg orally once daily.
2. Taken at approximately the same time each day, the capsule should be swallowed whole and should not be dissolved or opened. It can be taken with a meal or on an empty stomach. Administration at bedtime may be beneficial in controlling nausea.
3. If the patient vomits or misses a dose, the dose should not be made up but the next prescribed dose should be taken at the usual time the next day.
4. Patients should not start treatment with this product until they have recovered from hematologic toxicity caused by prior antineoplastic therapy (baseline hematologic parameters must meet the following criteria: absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L, and hemoglobin ≥90 g/L). Weekly testing of complete blood counts is recommended during the first 12 months of treatment, monthly for the next 11 months of treatment, and periodically after 1 year. If a patient experiences a severe persistent hematologic toxicity reaction that does not improve within 28 days of drug suspension, the product should be discontinued and the patient referred to the hematology department for further testing, including bone marrow analysis and genetic analysis of blood samples.
5. The common types of adverse reactions during dosing are anemia, thrombocytopenia, neutropenia, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain/distention, dyspepsia, dry mouth, fatigue, loss of appetite, urinary tract infection, elevated AST/ALT, arthralgia, myalgia, headache, dizziness, taste disturbance, insomnia, etc. Data from the NORA study of niraparib in the maintenance treatment of platinum-sensitive recurrent ovarian cancer in China showed that the most frequent adverse reactions were leukocyte count reduction, neutrophil count reduction and thrombocytopenia, mostly grade 1 to 2 adverse reactions, and the incidence of grade 3 to 4 thrombocytopenia was 11.3%.
6. Grade 3 to 4 adverse reactions can be managed by dose interruption and symptomatic management. For non-hematologic toxicity, restart the original dose or reduce the dose when symptoms recover to ≤ grade 1. For hematologic toxicity, restart original dose or dose reduction therapy when absolute neutrophil count recovers to ≥1.5×109/L, platelets recover to ≥100×109/L, and hemoglobin recovers to ≥90 g/L.
7. If dose reduction is required, the recommended dose is reduced to 200 mg/dose once daily. If further reduction is required, the recommended dose is reduced to 100 mg/dose once daily.
8. This product is metabolized by carboxylesterase and no dose adjustment is required when used in combination with CYP inducers and CYP inhibitors.
9. For patients with mild to moderate hepatic and renal impairment, no dose adjustment is required. For patients with severe hepatic or renal impairment, it should be used with caution.
*10. Treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer with a tumor homologous recombination repair deficiency who have received ≥ three prior chemotherapies with one of the following characteristics: deleterious or suspected deleterious BRCA mutation, or genomic instability and more than 6 months of progression after response to last platinum-containing chemotherapy. Progression more than 6 months after response to last platinum-containing chemotherapy.