Formulation and Specifications: Capsules: 20 mg
Indications: Pamiparib is indicated for the treatment of patients with recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer with germline BRCA mutations who have been previously treated with second-line or higher chemotherapy.
Key points for rational drug use:
1. The recommended dose of pamipril is 60 mg/dose twice daily, and treatment is continued until disease progression or intolerable adverse reactions occur.
2. Patients are advised to administer the drug orally at approximately the same time point each day. The product should be swallowed whole and the capsule should not be chewed, crushed, dissolved, or opened. This product may be taken with a meal or on an empty stomach.
3. If the patient vomits or misses a dose, no additional dose should be taken and the next prescribed dose should be taken at the scheduled time as normal.
4. Among the 317 patients treated with this product [BGB-290-102 patient cases (N) = 128, BGB-290-AU-002 (N) = 101 and BGB-290-201 (N) = 88], adverse reactions with an incidence of ≥10% included: anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia disorders, loss of appetite, diarrhea, abdominal pain, elevated AST, elevated ALT, elevated blood bilirubin, and lymphopenia.
5. To manage the hematologic adverse effects of pamipril, periodic testing of complete blood counts is required. Weekly testing is recommended for the first 3 months of treatment, followed by periodic monitoring for clinically significant changes in parameters that occur during treatment.
6. To manage adverse drug reactions, treatment suspension or dose reduction may be considered depending on the severity of the adverse reaction. The first recommended dose is reduced to 40 mg/dose twice daily. If further dose reduction is required, the recommended dose is reduced to 20 mg/dose twice daily. See Tables 10 and 11 for dose adjustment requirements for non-hematologic and hematologic adverse reactions.
Table 10 Dose Adjustment for Non-Hematologic Adverse Reactions
Resume treatment with the product at the adjusted dose
* Note: Severity grading was determined according to the National Cancer Institute’s Common Terminology Criteria for the Evaluation of Adverse Events, version 4.03 (NCI-CTCAEv4.03).
Table 11 Dose Adjustment for Hematologic Adverse Reactions
(hemoglobin <90g/L)
Withhold dosing and treat as directed until hemoglobin returns to ≥90 g/L, adjusting downward by one dose level to 40 mg twice daily
Give appropriate supportive therapy based on clinical assessment and continue dosing at 40 mg twice daily, or
Suspend dosing and treat as prescribed until hemoglobin returns to ≥90 g/L and continue dosing at 40 mg twice daily, or
Suspend and treat as directed until hemoglobin returns to ≥ 90 g/L, then adjust downward by one dose level to 20 mg twice-daily
If anemia is life-threatening and requires emergency treatment.
Suspend and treat as directed until hemoglobin returns to ≥ 90 g/L, adjusting downward by one dose level to 20 mg twice daily
If life-threatening anemia recurs at the 20 mg twice-daily dose level and the anemia is not due to another disruptive event (e.g., gastrointestinal bleeding), discontinue the product
7. Combination of potent/medium/light CYP3A inhibitors is allowed without dose adjustment.