Đăng xuất
Advanced endometrial carcinoma
Adult: In combination with lenvatinib for treatment of patients with a case that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after prior chemotherapy and are not candidates for surgery or radiation: 200 mg once every 3 weeks over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in metastatic gastric adenocarcinoma, PD-L1 expression in metastatic gastrooesophageal junction adenocarcinoma, PD-L1 expression in recurrent locally advanced gastric adenocarcinoma, PD-L1 expression in recurrent locally advanced gastrooesophageal junction adenocarcinoma
Adult: As monotherapy in patients with disease progression on or after 2 or more prior therapy (e.g. fluoropyrimidine- and platinum-containing chemotherapy, HER2/neu-targeted therapy): 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in metastatic cervical cancer, PD-L1 expression in recurrent cervical cancer
Adult: As monotherapy in patients with disease progression on or following chemotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in metastatic squamous cell carcinoma of the head and neck, PD-L1 expression in unresectable recurrent squamous cell carcinoma of the head and neck
Adult: As 1st-line treatment: As monotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks. In combination with platinum and 5-fluorouracil chemotherapy: 200 mg every 3 weeks. All doses are to be given via infusion over 30 minutes. Continue therapy until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic melanoma, Unresectable melanoma
Adult: As monotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks. Alternatively, 2 mg/kg every 3 weeks. Continue therapy until disease progression or unacceptable toxicity. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Adjuvant treatment of melanoma
Adult: In patients with melanoma with lymph node involvement who have undergone complete resection: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease recurrence or unacceptable toxicity, or for up to 12 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
ALK negative metastatic non-squamous non-small cell lung carcinoma, EGFR negative metastatic non-squamous non-small cell lung carcinoma
Adult: As 1st-line treatment, in combination with pemetrexed and platinum chemotherapy: 200 mg once every 3 weeks, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, 400 mg once every 6 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic squamous cell carcinoma of the head and neck, Recurrent squamous cell carcinoma of the head and neck
Adult: As monotherapy in patients with disease progression on or following platinum-containing chemotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic squamous non-small cell lung carcinoma
Adult: As 1st-line treatment, in combination with carboplatin and paclitaxel or nab-paclitaxel: 200 mg once every 3 weeks, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, 400 mg once every 6 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma
Adult: As monotherapy in patients who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are ineligible for transplant and have failed BV: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in refractory case or in patients that have relapsed following 2 or more lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in refractory case or in patients that have relapsed following 2 or more lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Primary mediastinal large B-cell lymphoma
Adult: As monotherapy in patients with refractory cases or who have relapsed following 2 or more prior lines of therapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with refractory cases or who have relapsed following 2 or more prior lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with refractory cases or who have relapsed following 2 or more prior lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic microsatellite instability-high solid malignant tumour, Unresectable microsatellite instability-high solid malignant tumour
Adult: As monotherapy in patients who have progressed after prior treatment and when there are no satisfactory alternative options: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with non-CNS solid tumours who have progressed after prior treatment and when there are no satisfactory alternative options: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with non-CNS solid tumours who have progressed after prior treatment and when there are no satisfactory alternative options: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma
Adult: As monotherapy: In patients with disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in patients with PD-L1 expressing tumours who are not qualified for cisplatin-containing chemotherapy, or who are not qualified for any platinum-containing chemotherapy regardless of PD-L1 status: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continue until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in metastatic non-small cell lung carcinoma
Adult: As monotherapy: As 1st-line treatment in patients with EGFR or ALK negative tumour mutations; in patients with disease progression on or after platinum-containing chemotherapy or with EGFR or ALK positive tumour mutations who have received prior chemotherapy for these aberrations: 200 mg once every 3 weeks or 400 mg once every 6 weeks. Alternatively, in previously treated patients, 2 mg/kg every 3 weeks. Continue therapy until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in metastatic squamous cell carcinoma of the oesophagus, PD-L1 expression in recurrent locally advanced squamous cell carcinoma of the oesophagus
Adult: In patients with disease progression following 1 or more prior lines of systemic treatment: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Advanced renal cell carcinoma
Adult: As 1st-line treatment, in combination with axitinib: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic microsatellite instability-high colorectal cancer, Unresectable microsatellite instability-high colorectal cancer
Adult: As 1st-line treatment; as monotherapy in patients who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: In patients who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: In patients who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
PD-L1 expression in locally advanced non-small cell lung carcinoma
Adult: As monotherapy for 1st-line treatment in patients with EGFR or ALK negative mutation who are not qualified for surgical resection or definitive chemoradiation; in patients who have received at least 1 prior chemotherapy or those with EGFR or ALK positive tumour mutations who have received prior chemotherapy for these aberrations: 200 mg once every 3 weeks or 400 mg once every 6 weeks, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, in previously treated patients, 2 mg/kg every 3 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Intravenous
Metastatic cutaneous squamous cell carcinoma, Recurrent cutaneous squamous cell carcinoma
Adult: In patients with case that is not curable by surgery or radiation: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
