- Indications and Usage Niraparib is indicated for the treatment of adult patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
- Dosage and Administration Recommended Dosage: The standard recommended dosage is 300 mg orally once daily. Weight and Platelet-Based Dosing: For patients weighing less than 77 kg or with a baseline platelet count less than 150 × 10⁹/L, the recommended dosage is 200 mg orally once daily. Administration: The capsule should be swallowed whole and can be taken with or without food. Missed Dose: If a dose is missed, do not take an extra dose. Take the next dose at the regular time. Dose Modifications: Dose interruptions or reductions (down to 200 mg or 100 mg) are required based on the severity of hematologic and non-hematologic adverse reactions.
- Mechanism of Action Niraparib is a small molecule inhibitor of poly (ADP-ribose) polymerase (PARP), specifically PARP-1 and PARP-2. By inhibiting PARP enzymes, it prevents the repair of single-strand DNA breaks, leading to the accumulation of DNA damage and ultimately cell death, particularly in cells with homologous recombination repair deficiencies (such as BRCA mutations).
- Safety and Warnings Myelodysplastic Syndrome/Acute Leukemia: Cases of MDS/AML have been reported. Monitor blood counts and discontinue if these conditions occur. Hemorrhage: Serious or fatal hemorrhagic events have occurred. Monitor for signs of bleeding and manage accordingly. Fetal/Embryotoxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception during and for at least 6 months after the last dose. Hypertension: Monitor blood pressure regularly and manage as clinically indicated. Intestinal Obstruction/Perforation: Monitor for symptoms of gastrointestinal obstruction or perforation.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include nausea, thrombocytopenia, anemia, fatigue, constipation, abdominal pain, vomiting, and neutropenia. Serious Adverse Reactions: Serious events include thrombocytopenia, anemia, and intestinal obstruction.
- Drug Interactions CYP Metabolism: Niraparib is primarily metabolized by carboxylesterases. No dose adjustment is necessary when used with CYP inducers or inhibitors. QTc-Prolonging Drugs: Concomitant use with drugs that prolong the QTc interval may increase the risk of arrhythmia.
- Pharmaceutical Information Composition: The active ingredient is Niraparib Tosylate. Excipients include lactose monohydrate, maize starch, magnesium stearate, and gelatin. Appearance: The capsules are hard gelatin capsules with printed markings. Storage: Store at controlled room temperature in the original packaging.
Zele Niraparib Tosylate Capsules
Brand Name: 则乐 ®（Zele®）
Generic Name: Niraparib Tosylate
Strength: 100 mg per capsule, 30 capsules per box
Manufacturer: Glaxo Operations UK Limited
Marketing Authorization Holder: Zai Lab (Shanghai) Co., Ltd.
Approval Date in China: December 27, 2019
Registration Number:国药准字 H20190035
Storage: Seal tightly, store below 25°C, protect from light. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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