.jpeg)
{{ variable.name }}
【Indications】
Combined with platinum based chemotherapy as neoadjuvant therapy,followed by monotherapy with this product as adjuvant therapy after surgery,for the treatment of resectable(tumor≥4cm and/or lymph node positive)non-small cell lung cancer(NSCLC)in adult patients without known epidermal growth factor receptor(EGFR)mutations or anaplastic lymphoma kinase(ALK)rearrangements.
Adult patients with unresectable stage III non-small cell lung cancer(NSCLC)who have not progressed after receiving platinum based chemotherapy and radiotherapy as monotherapy.
Used in combination with tremelimumab actl and platinum based chemotherapy to treat adult patients with metastatic non-small cell lung cancer(NSCLC)without sensitive EGFR mutations or ALK gene tumor aberrations.
Adult patients with limited stage small cell lung cancer(LS-SCLC)who did not progress after receiving platinum based chemotherapy and radiotherapy as monotherapy
Combination therapy with etoposide and carboplatin or cisplatin for first-line treatment of adult patients with extensive stage small cell lung cancer(ES-SCLC).
Combination therapy with gemcitabine and cisplatin for the treatment of locally advanced or metastatic cholangiocarcinoma(BTC)in adult patients.
Combination therapy with tremelimumab actl for unresectable hepatocellular carcinoma(uHCC)in adults.
•Used in combination with carboplatin and paclitaxel,followed by monotherapy with this product,for the treatment of adult patients with primary advanced or recurrent endometrial cancer with mismatch repair defects(dMMR).
•Combined with gemcitabine and cisplatin as a new adjuvant treatment,and then the single drug of this product is applicable as an adjuvant treatment after radical cystectomy for adult patients with myometrial invasive bladder cancer(MIBC).
Recommended dosage
Dilute and intravenously administer this product for at least 60 minutes.
Neoadjuvant therapy and adjuvant therapy for resectable non-small cell lung cancer(NSCLC):
Weight≥30 kg:
Neoadjuvant therapy:Preoperative combined chemotherapy is administered every 3 weeks,with a dose of 1500 mg per session,for a maximum of 4 cycles.
Adjuvant therapy:Single drug use after surgery,once every 4 weeks,1500 mg each time,for a maximum of 12 cycles.
Weight<30 kg
Neoadjuvant therapy:Preoperative combined chemotherapy once every 3 weeks,20mg/kg each time,for a maximum of 4 cycles.
Adjuvant therapy:Single drug use every 4 weeks after surgery,20mg/kg each time,for a maximum of 12 cycles.
Unresectable stage III non-small cell lung cancer(NSCLC),after receiving platinum based chemotherapy and radiotherapy simultaneously:
Weight≥30 kg:This product is administered once every 2 weeks at a dose of 10mg/kg or once every 4 weeks at a dose of 1500 mg.
Weight<30 kg:This product is administered once every 2 weeks at a dose of 10mg/kg each time.
•Metastatic non-small cell lung cancer(NSCLC):
Body weight≥30 kg:Combination therapy with 75 mg tremelimumab actl and platinum chemotherapy every 3 weeks,1500 mg each time,for a total of 4 cycles,followed by monotherapy every 4 weeks,1500 mg each time,and histological based pemetrexed maintenance therapy every 4 weeks.At week 16,the fifth dose of tremelimumab actl was administered in combination with the sixth dose of this product.
Body weight<30 kg:Combination therapy with 1 mg/kg tremelimumab actl and platinum chemotherapy every 3 weeks,20mg/kg each time,for a total of 4 cycles,followed by monotherapy every 4 weeks,20mg/kg each time,and histological based pemetrexed maintenance therapy every 4 weeks.At week 16,the fifth dose of tremelimumab actl was given in combination with the sixth dose of this product,1 mg/kg.
After undergoing platinum based chemotherapy and radiation therapy for locally limited small cell lung cancer(LS-SCLC):
Weight≥30 kg:1500 mg once every 4 weeks.
Body weight<30 kg:once every 4 weeks,20 mg/kg each time.
Widespread small cell lung cancer(ES-SCLC):
Body weight≥30 kg:Combination use of etoposide and carboplatin or cisplatin,once every 3 weeks,1500 mg each time,followed by monotherapy once every 4 weeks,1500 mg each time.
Body weight<30 kg:Combination use of etoposide and carboplatin or cisplatin,once every 3 weeks at a dose of 20 mg/kg each time,followed by monotherapy every 2 weeks at a dose of 10 mg/kg each time.
•Cholangiocarcinoma(BTC):
Body weight≥30 kg:Combination chemotherapy is administered every 3 weeks at a dose of 1500 mg each time,followed by monotherapy every 4 weeks at a dose of 1500 mg each time.
Body weight<30 kg:Combination chemotherapy is administered every 3 weeks at a dose of 20 mg/kg each time,followed by monotherapy every 4 weeks at a dose of 20 mg/kg each time.
Unresectable hepatocellular carcinoma(uHCC):
Body weight≥30 kg:In the first cycle/day,1500 mg of this product is used in combination with a single dose of tremelimumab actl 300 mg,followed by monotherapy every 4 weeks.
Body weight<30 kg:In the first cycle/day,this product is used in combination with a single dose of 4mg/kg tremelimumab actl at a dose of 20 mg/kg,followed by monotherapy every 4 weeks.
DMMR endometrial cancer:
Body weight≥30 kg:Combination therapy with carboplatin and paclitaxel once every 3 weeks,1120mg each time,for 6 cycles,followed by monotherapy once every 4 weeks,1500 mg each time.
Body weight<30 kg:Combination therapy with carboplatin and paclitaxel once every 3 weeks at a dose of 15mg/kg each time for 6 cycles,followed by monotherapy once every 4 weeks at a dose of 20mg/kg each time.
Muscular invasive bladder cancer(MIBC)
Weight≥30 kg:Neoadjuvant therapy:1500 mg of this product is used in combination with gemcitabine and cisplatin,once every 3 weeks before surgery,for a total of 4 cycles.
Adjuvant therapy:This product is 1500 mg,monotherapy,once every 4 weeks after surgery,for a maximum of 8 cycles.
Body weight<30 kg:Neoadjuvant therapy:This product is used in combination with gemcitabine and cisplatin at a dose of 20 mg/kg,once every 3 weeks before surgery,for a total of 4 cycles.
Adjuvant therapy:This product is administered at a dose of 20 mg/kg as monotherapy.After surgery,it should be administered every 4 weeks for a maximum of 8 cycles.
Please refer to the complete prescription information for preparation and administration instructions,as well as dosage adjustments for adverse reactions.
Adverse reactions
This product is used in combination with chemotherapy
The most common adverse reactions(≥20%)in resectable stage II/III NSCLC patients(neoadjuvant/adjuvant therapy)are anemia,nausea,constipation,fatigue,musculoskeletal pain,and rash.
This product is used as a monotherapy
The most common adverse reactions(≥20%)in patients with unresectable stage III NSCLC are cough,fatigue,pneumonia/radiation pneumonitis,upper respiratory tract infection,dyspnea,and rash.
This product is used in combination with tremelimumab actl and platinum based chemotherapy
The most common adverse reactions(≥20%)in patients with metastatic NSCLC are nausea,fatigue,musculoskeletal pain,loss of appetite,rash,and diarrhea.
This product is used as a monotherapy
The most common adverse reactions(≥20%)in SCLC patients with a local time limit are pneumonia or radiation pneumonitis and fatigue.
This product is used in combination with platinum based chemotherapy
The most common adverse reactions(≥20%)in patients with extensive SCLC are nausea,fatigue/weakness,and hair loss.
This product is used in combination with gemcitabine and cisplatin
The most common adverse reactions(≥20%)in patients with cholangiocarcinoma are fatigue,nausea,constipation,loss of appetite,abdominal pain,rash,and fever.
This product is used in combination with tremelimumab actl
The most common adverse reactions(≥20%)in patients with unresectable liver cancer are rash,diarrhea,fatigue,itching,musculoskeletal pain,and abdominal pain.
This product is used in combination with carboplatin and paclitaxel,and subsequently used as a monotherapy
The most common adverse reactions(≥20%)in patients with endometrial cancer are peripheral neuropathy,musculoskeletal pain,nausea,hair loss,fatigue,abdominal pain,constipation,rash,decreased magnesium,increased ALT,increased AST,diarrhea,vomiting,cough,decreased potassium,difficulty breathing,headache,and increased alkaline phosphatase.
This product is used in combination with gemcitabine and cisplatin,and then used alone
•The most common adverse reactions(≥20%of myometrial invasive bladder cancer patients)are lower hemoglobin,neutropenia,higher creatinine,lower sodium,nausea,higher ALT,lower calcium,thrombocytopenia,fatigue,higher potassium,lymphocyte reduction,higher AST,constipation,lower magnesium,decreased appetite,increased alkaline phosphatase,rash,fever,diarrhea,vomiting and abdominal pain.
Pharmacological effects
Programmed cell death ligand-1(PD-L1)can be expressed on tumor cells and tumor associated immune cells in the tumor microenvironment,and its expression can be induced by inflammatory signals such as IFN-γ.PD-L1 blocks T cell function and activation by interacting with PD-1 and CD80(B7.1).PD-L1 reduces the activity,proliferation,and cytokine production of cytotoxic T cells by binding to its receptors.
Duvalimumab is a human immunoglobulin G1 kappa(IgG1 kappa)monoclonal antibody that can bind to PD-L1 and block its interaction with PD-1 and CD80(B7.1).Blocking the interaction between PD-L1/PD-1 and PD-L1/CD80 can avoid immune suppression,and Duvalimumab does not induce antibody dependent cell-mediated cytotoxicity(ADCC).
In a mouse model of co transplantation of human tumors and immune cell xenografts,blocking PD-L1 with Duvalimumab can increase in vitro T cell activation and reduce tumor volume.
[Storage]
Store in the dark at 2°C to 8°C.Do not freeze.Do not oscillate.