Paishuning Senaparib Capsules

1. Indications and Usage
Ovarian Cancer: Indicated for adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response following first-line platinum-based chemotherapy.
2. Dosage and Administration
Route of Administration: Oral administration.
Recommended Dosage: 100 mg once daily.
Administration Details: Should be taken on an empty stomach. Swallow capsules whole; do not crush or chew.
Missed Dose: If a dose is missed, it may be taken within 4 hours of the scheduled time. If more than 4 hours have passed, skip the missed dose and resume at the next scheduled time. Do not take extra doses if vomiting occurs.
Duration: Continue treatment until disease progression, development of unacceptable toxicity, or completion of 2 years of therapy.
3. Mechanism of Action
PARP Inhibition: Senaparib is a selective inhibitor of Poly (ADP-ribose) polymerase (PARP) 1 and PARP2.
Synthetic Lethality: By inhibiting PARP, it prevents the repair of single-strand DNA breaks. This leads to the accumulation of DNA damage and cell death, particularly in tumor cells with homologous recombination deficiency (e.g., BRCA mutations).
4. Safety and Warnings
Hematologic Toxicity: Myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), anemia, leukopenia, and thrombocytopenia may occur. Regular blood count monitoring is required.
Pregnancy and Lactation: Can cause fetal harm. Effective contraception is required during treatment and for at least 6 months after the last dose.
Hepatic and Renal Impairment: Dose adjustments may be necessary for severe hepatic or renal impairment.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Anemia, nausea, fatigue, vomiting, thrombocytopenia, leukopenia, constipation, diarrhea, abdominal pain, and headache.
Clinical Research Highlights: Clinical trials have demonstrated significant improvements in progression-free survival (PFS) as a maintenance therapy in the first-line setting.
6. Drug Interactions
CYP3A4: Senaparib is primarily metabolized by CYP3A4. Strong CYP3A4 inhibitors should be avoided; if unavoidable, the senaparib dose should be reduced.
P-gp and BCRP: Senaparib is a substrate of P-gp and BCRP; concurrent use may affect its pharmacokinetics.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Senaparib.
Appearance: Capsules are white to off-white.
Packaging: Available in various bottle sizes.
Storage: Store at controlled room temperature (20°C to 25°C); protect from moisture.