Keytruda (pembrolizumab) concentrate for infusions 25 mg/ml. 4 ml. vial №1

Description

melanoma The drug Chitroda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. Non-small cell lung cancer Kitruda in combination with pemetrexed chemotherapy and platinum is indicated as a first-line drug for patients with metastatic non-small cell lung cancer (NSCLC) in the absence of mutations in the epidermal growth factor (EGFR) gene or anaplastic lymphoma kinase (aLK). Kitruda in combination with carboplatin and paclitaxel or nab-paclitaxel is indicated as a first-line drug for patients with metastatic squamous cell NSCLC. Kitruda as a monotherapy is a first-line drug for the treatment of patients with metastatic NSCLC with high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], which is confirmed by a validated test, in the absence of mutations in the EGFR or ALK gene. Kitruda as a monotherapy is indicated for the treatment of patients with metastatic NSCLC when tumors Express PD-L1 (TPS ≥ 1%), which is confirmed by a validated test, in the case of disease progression during or after platinum-containing chemotherapy. For patients with EGFR or ALK genomic aberrations, Kitruda may be prescribed after progression on targeted therapy in accordance with the standards for the treatment of these aberrations. Squamous cell carcinoma of the head and neck Kitruda is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck that progresses during or after platinum-containing chemotherapy. Classic Hodgkin’s lymphoma Kitruda is indicated for the treatment of adults and children with treatment-resistant classic Hodgkin’s lymphoma or if a relapse occurs after 3 or more lines of therapy. Primary mediastinal B-large cell lymphoma Kitruda is indicated for the treatment of adults and children with refractory primary mediastinal B-large cell lymphoma (PMBCL) or if it recurs after 2 or more lines of previous therapy. Obmezhennya for the drug Chitroda is not recommended for the treatment of patients with primary mediastinal large b-cell lymphoma who are in urgent need of cytoreductive therapy. Urothelial carcinoma Kitruda is indicated for the treatment of patients with locally progressive or metastatic urothelial carcinoma who are not shown cisplatin-based chemotherapy and when tumors Express PD-L1 [Combine Positive Score (CPS) ≥ 10], as confirmed by a validated test, or patients who are not eligible for any platinum-containing chemotherapy, regardless of the PD-L1 protein expression status. Kitruda is indicated for the treatment of patients with locally progressive or metastatic urothelial carcinoma whose disease progressed during or after the completion of platinum-containing chemotherapy, or during 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Cancer with high microsatellite instability Kitruda is indicated for the treatment of adults and children with unresectable or metastatic cancer with high microsatellite instability (MSI-H) or deficiency of repair mechanisms: o solid tumors that have progressed with previous treatment, as well as in the absence of alternative treatment options, or o colorectal cancer, progressed after treatment with fluoropyrimidines, oxaliplatin, and irinotecan. Restriction of use: the safety and efficacy of Kitruda in children with Central nervous system cancer MSI-H has not been established. stomach cancer Kitruda is indicated for the treatment of patients with recurrent locally progressive or metastatic gastric or gastroesophageal adenocarcinoma when tumors Express PD-L1 (CPS ≥ 1), which is confirmed by a validated test, and the disease progresses during or after two or more courses of chemotherapy, including fluoropyrimidine or platinum, and therapy directed at the HER2 / neu protein. Cervical cancer Kitruda is indicated for the treatment of patients with recurrent or metastatic cervical cancer if this disease progresses during or after chemotherapy, when the tumors Express PD-L1 (CPS ≥ 1), which is confirmed by a validated test. hepatocellular carcinoma Kitruda is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.