Atezolizumab

　　Antilizumab[Indications]

　　TECENTRIQ is a programmed death ligand 1(PD-L1)blocking antibody used to treat the following patients:

　　Urothelial carcinoma

　　Adult patients with locally advanced or metastatic urothelial carcinoma:

　　Not suitable for cisplatin based chemotherapy and with PD-L1 expression in the tumor[PD-L1 stained tumor infiltrating immune cells(IC)covering≥5%of the tumor area],or

　　Does not meet any conditions for platinum based chemotherapy,and regardless of PD-L1 status,

　　Metastatic non-small cell lung cancer(NSCLC)

　　As an adjuvant therapy after resection and platinum based chemotherapy,used for stage II to IIIA non-small cell lung cancer patients,whose tumor cells express PD-L≥1%.

　　Adult patients with first-line treatment for metastatic NSCLC have tumors with high PD-L1 expression[tumor cells with PD-L1 staining≥50%(TC≥50%)or tumor infiltrating immune cells(IC)with PD-L1 staining covering≥10%of the tumor area(IC≥10%)],and no EGFR or ALK genomic tumor abnormalities.

　　Combination therapy with bevacizumab,paclitaxel,and carboplatin for first-line treatment of metastatic non-small cell lung cancer in adult patients without EGFR or ALK genomic tumor abnormalities.

　　Combination therapy with paclitaxel albumin and carboplatin for first-line treatment of adult patients with metastatic non squamous NSCLC,without EGFR or ALK genomic tumor abnormalities.

　　Adult patients with metastatic NSCLC may experience disease progression during or after platinum based chemotherapy.Patients with EGFR or ALK gene tumor abnormalities may experience disease progression after receiving FDA approved treatment with atezolizumab(TECENTRIQ)prior to treatment.

　　Small cell lung cancer(SCLC)

　　Used in combination with carboplatin and etoposide for first-line treatment of adult patients with extensive stage small cell lung cancer(ES-SCLC).

　　Hepatocellular carcinoma(HCC)

　　Combination therapy with bevacizumab for unresectable or metastatic hepatocellular carcinoma patients who have not received systemic treatment

　　Melanoma

　　Combination therapy of cobimetinib and vemurafenib for BRAFV600 mutation positive unresectable or metastatic melanoma patients.

　　Recommended dosage

　　The first intravenous infusion of this product should last for at least 60 minutes.If the patient's tolerance is good after the first infusion,then subsequent

　　The infusion time can be appropriately shortened,but it should last at least 30 minutes.

　　Urothelial carcinoma

　　TECENTRIQ,as a monotherapy,is recommended to be used every 2 weeks at a dose of 840mg every 3 weeks at a dose of 1200mg or every 4 weeks at a dose of 1680mg.

　　Non small cell lung cancer(NSCLC)

　　In adjuvant therapy,this product is administered every 2 weeks after resection,with a recommended dose of 840mg every 3 weeks,a recommended dose of 1200mg or every 4 weeks,and a recommended dose of 1680mg for 1 year.Platinum based chemotherapy for up to 4 cycles.

　　In the case of transfer,the recommended dose is 840mg every 2 weeks,1200 mg every 3 weeks,or 1680 mg every 4 weeks.

　　When using chemotherapy with or without bevacizumab,use atezolizumab(TECENTRIQ)before starting chemotherapy and bevacizumab.

　　Small cell lung cancer(SCLC)

　　TECENTRIQ should be used every 2 weeks at a recommended dose of 840mg every 3 weeks at a recommended dose of 1200mg or every 4 weeks at a recommended dose of 1680mg.When TECENTRIQ is used in combination with carboplatin and etoposide,TECENTRIQ should be administered before chemotherapy.

　　Hepatocellular carcinoma(HCC)

　　TECENTRIQ is recommended to be used every 2 weeks at a recommended dose of 840mg every 3 weeks at a recommended dose of 1200mg or every 4 weeks at a recommended dose of 1680mg.If bevacizumab is used on the same day,TECENTRIQ should be used before bevacizumab.

　　Melanoma

　　After completing one course(28 days)of treatment with cobimetinib and vemurafenib,atezolizumab(TECENTRIQ)840 mg once every 2 weeks,1200 mg once every 3 weeks,or 1680 mg once every 4 weeks,and cobimetinib 60 mg orally once a day(21 days/7 days off)and vemurafenib 720 mg orally twice a day were administered.

　　Adverse reactions

　　The most common adverse reactions(≥20%)of atezolizumab as a single drug are fatigue/weakness,nausea,cough,difficulty breathing,and decreased appetite.

　　The most common adverse reactions(≥20%)when used in combination with other anti-tumor drugs to treat non-small cell lung cancer(NSCLC)and small cell lung cancer(SCLC)patients are fatigue/weakness,nausea,hair loss,constipation,diarrhea,and decreased appetite.

　　The most common adverse reactions(≥20%)in patients with liver cancer treated with TECENTRIQ combined with bevacizumab include hypertension,fatigue,and proteinuria.

　　The most common adverse reactions(≥20%)of TECENTRIQ combined with cobimetinib and vemurafenib in the treatment of melanoma patients are rash,musculoskeletal pain,fatigue,hepatotoxicity,fever,nausea,itching,edema,stomatitis,hypothyroidism,and photosensitivity reaction

　　Pharmacological effects

　　Atezolizumab/Tecentriq is a monoclonal antibody that can directly bind to PD-L1.PD-L1 can be expressed on tumor cells and tumor infiltrating immune cells,which helps to suppress anti-tumor immune responses in the tumor microenvironment.When PD-L1 binds to PD-1 and B7.1 receptors on T cells and antigen-presenting cells,it can inhibit cytotoxic T cell activity,T cell proliferation,and cytokine release.

　　Antilizumab is a monoclonal antibody that can directly bind to PD-L11 and block the interaction between PD-1 and B7.1 acceptors,relieving immune response suppression caused by PD-L1/PD-1,including reactivation of anti-tumor immune response without activating antibody dependent cytotoxicity.In homologous mouse tumor models,blocking PD-L1 activity can cause a slowdown in tumor growth.

　　[Storage]

　　Store small bottles in the refrigerator at 2°C to 8°C(36°F to 46°F)in the original paper box for light protection.

　　Cannot be frozen.

　　Do not shake.