קיטרודה 100 מ"ג/4 מ"ל - Keytruda 100 mg/4 ml

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מינונים נוספים
קבוצה פרמקולוגית (ATC4)

L01XC
Monoclonal antibodies

מרכיב פעיל (ATC5) *Pembrolizumab 100MG / 4 ML ‏L01XC18
צורת מתן I.V; I.V
צורת מינון CONCENTRATE FOR SOLUTION FOR INFUSION
התוויה
- Melanoma:Keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma . - Non-Small Cell Lung Cancer:Keytruda is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as determined by a validated test. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving Keytruda.Keytruda is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving Keytruda.- Head and Neck Cancer :Keytruda is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.- Classical Hodgkin LymphomaKeytruda is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy .- Urothelial CarcinomaKeytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carainoma who are not eligible for cisplatin-containing chemotherapy- Microsatellite Instability-High Cancer:Keytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient• solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options, or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan Limitation of Use: The safety and effectiveness of Keytruda in pediatric patients with MSI-H central nervous system cancers have not been established- Gastric Cancer:Keytruda is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy

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עלון לרופא
*עלון לצרכן קיטרודה 100 מ"ג/4 מ"ל ® במאגר משרד הבריאות
ערכים בוויקירפואה ערכים קשורים בוויקירפואה
חיפוש מאמרים מאמרים ב-PubMed
מידע ברשת RxList WebMD Drugs.com
שם יצרן MERCK SHARP & DOHME CORP., USA
שם בעל הרישום MERCK SHARP & DOHME ISRAEL LTD
רישיון תאריך הגשה: 03/2015. רישיון מתאריך: 09/2015
תמונת אריזה

תמונת אריזה

תאריך עדכון: 14/05/19


קיטרודה - Keytruda true