Baihuize Pamiparib Capsules

1. Indications and Usage
Ovarian Cancer: Indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated advanced ovarian cancer who have been treated with two or more prior chemotherapy regimens.
Gastric Cancer: In combination with chemotherapy and/or immunotherapy, indicated for the treatment of adult patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal cancer.
2. Dosage and Administration
Recommended Dosage: 450 mg orally once daily.
Administration Details: Tablets should be swallowed whole with water. It can be taken with or without food.
Missed Dose: If a dose is missed, the dose can be taken on the same day if it is within 6 hours of the regular dosing time. If more than 6 hours have passed, skip the dose and take the next dose at the regularly scheduled time.
Dose Adjustments: Dose interruptions, reductions (to 300 mg or 150 mg), or permanent discontinuations may be required based on individual safety and tolerability, particularly for hematologic toxicities.
3. Mechanism of Action
PARP Inhibition: Pamiparib is a potent, selective inhibitor of poly (ADP-ribose) polymerase (PARP).
Synthetic Lethality: It traps PARP on DNA and inhibits DNA repair. In tumor cells with BRCA mutations (defective homologous recombination repair), this leads to the accumulation of DNA damage and subsequent cell death.
4. Safety and Warnings
Bone Marrow Suppression: Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) may occur. Monitor complete blood counts (CBC) regularly.
Hepatotoxicity: Elevations in liver enzymes (ALT/AST) and bilirubin may occur. Liver function should be monitored periodically.
Embryo-Fetal Toxicity: Can cause fetal harm. Effective contraception is required during and for 6 months after the final dose.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Nausea, anemia, fatigue, vomiting, constipation, and diarrhea.
Serious Adverse Reactions: Myelodysplastic syndrome, acute myeloid leukemia, and hepatotoxicity.
Clinical Research Highlights: Clinical trials have demonstrated significant improvement in progression-free survival in patients with BRCA-mutated ovarian cancer and gastric cancer when used in combination with chemotherapy.
6. Drug Interactions
CYP3A Inhibitors/Inducers: Strong CYP3A inhibitors may increase pamiparib exposure; strong CYP3A inducers may decrease exposure. Dose adjustments may be required.
P-gp Inhibitors: Concomitant use with P-gp inhibitors may increase pamiparib exposure.
Sensitive CYP3A Substrates: Concomitant use with sensitive CYP3A substrates may require dose adjustments.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Pamiparib.
Appearance: Film-coated tablets.
Packaging: Supplied in blister packs or bottles.
Storage: Store at room temperature. Protect from moisture and light.