Yintarui Linperlisib Tablets

1. Indications and Usage
Recurrent or Refractory Follicular Lymphoma (FL):
Indicated for the treatment of adult patients with recurrent or refractory follicular lymphoma who have received at least two prior systemic therapies.
2. Dosage and Administration
Recommended Dosage:
Dose: 80 mg once daily (equivalent to four 20 mg tablets).
Duration: Continue treatment until disease progression or unacceptable toxicity.
Administration: Administer orally with or without food.
Prophylaxis:
PJP Prevention: Patients should receive prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment and after treatment until the absolute CD4+ T-lymphocyte count is greater than 200 cells/µL.
CMV Prevention: Consider prophylactic antiviral therapy to prevent cytomegalovirus (CMV) infection and reactivation.
3. Mechanism of Action
PI3Kδ Inhibitor:
Linperlisib is a highly selective inhibitor of the phosphoinositide 3-kinase delta (PI3Kδ) isoform.
Physiological Effect:
It inhibits the expression of the PI3Kδ protein and reduces the phosphorylation of AKT protein. This inhibition induces apoptosis and suppresses the proliferation of malignant B cells and primary tumor cells.
4. Safety and Warnings
Pneumocystis Pneumonia (PJP):
PJP can occur during treatment. Monitor patients for signs of PJP. Discontinue linperlisib in patients with suspected PJP and terminate in those with confirmed PJP.
Infections and Cytopenias:
Monitor blood counts and watch for signs of infection, including non-infectious pneumonia and severe neutropenia.
Hepatotoxicity:
Elevations in transaminases (ALT/AST) may occur. Monitor liver function regularly.
Skin Reactions:
Skin reactions may occur; monitor and manage accordingly.
5. Adverse Reactions
Most Common:
Leukopenia (decreased white blood cell count), neutropenia, increased transaminases, thrombocytopenia, anemia, diarrhea, and colitis.
6. Drug Interactions
Metabolic Interactions:
Linperlisib is metabolized by hepatic enzymes. Caution is advised when used with CYP3A inhibitors or inducers.
Contraindications:
Contraindicated in patients with known hypersensitivity to linperlisib or any excipients.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Linperlisib. Molecular Formula: C₂₈H₃₇FN₆O₅S. Molecular Weight: 588.69.
Storage:
Store in the original package to protect from light and moisture.