Idelalisib

　　【Indications】

　　This product is a kinase inhibitor indicated for:

　　•Use in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia(CLL)in patients for whom rituximab monotherapy is considered only after careful assessment due to underlying comorbidities.

　　Limitations of Use:

　　This product is not indicated for first-line treatment of any patient population,including patients with CLL,small lymphocytic lymphoma(SLL),follicular lymphoma(FL),and other indolent non-Hodgkin lymphomas.

　　This product is not indicated and is not recommended for use in combination with bendamustine and rituximab.It is also not recommended for use in combination with rituximab for the treatment of FL,SLL,and other indolent non-Hodgkin lymphomas.

　　【Recommended Dosage】

　　150 mg taken orally twice daily

　　【Adverse Reactions】

　　•The most common adverse reactions(incidence≥30%)reported in clinical trials of this product as part of combination therapy are diarrhea,pneumonia,pyrexia,fatigue,rash,cough,and nausea.

　　•The most common laboratory abnormalities are neutropenia,elevated alanine aminotransferase(ALT),and elevated aspartate aminotransferase(AST).

　　【Pharmacological Action】

　　This product is an inhibitor of phosphatidylinositol 3-kinase delta(PI3Kδ),a kinase expressed in both normal and malignant B cells.Idelalisib(Zydelig)induces apoptosis and inhibits proliferation in malignant B-cell-derived cell lines and primary tumor cells.It suppresses multiple cellular signaling pathways,including B-cell receptor(BCR)signaling,as well as CXCR4 and CXCR5 signaling,which are involved in the trafficking and homing of B cells to lymph nodes and bone marrow.Treatment of lymphoma cells with idelalisib(Zydelig)inhibits chemotaxis and adhesion,and reduces cell viability.

　　【Storage】

　　Store at 20°C to 30°C(68°F to 86°F).Excursions between 15°C and 30°C(59°F and 86°F)are permitted for short-distance transport.

　　•Keep in original container only

　　•Do not use the medication if the sealed bottle is damaged or leaking