Land: Europeiska unionen
Språk: italienska
Källa: EMA (European Medicines Agency)
Pembrolizumab
Merck Sharp & Dohme B.V.
L01FF02
pembrolizumab
Agenti antineoplastici
Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
MelanomaKeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC)Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. I pazienti con EGFR o ALK positivo mutazioni tumorali devono, inoltre, hanno ricevuto la terapia mirata prima di ricevere KEYTRUDA. Classical Hodgkin lymphoma (cHL)Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinomaKeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC)Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ≥ 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC)Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancersColorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinomaKeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC)Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC)Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancerKeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinomaKEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
Revision: 54
autorizzato
2015-07-17
140 B. FOGLIO ILLUSTRATIVO 141 FOGLIO ILLUSTRATIVO: INFORMAZIONI PER IL PAZIENTE KEYTRUDA 25 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE pembrolizumab LEGGA ATTENTAMENTE QUESTO FOGLIO PRIMA CHE LE VENGA SOMMINISTRATO QUESTO MEDICINALE PERCHÉ CONTIENE IMPORTANTI INFORMAZIONI PER LEI. - Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo. - È importante che tenga la s cheda con lei durante il trattamento. - Se ha qualsiasi dubbio, si rivolga a l medico. - Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si rivolga al medico. Vedere paragrafo 4. CONTENUTO DI QUESTO FOGLIO 1. Cos ’ è KEYTRUDA e a cosa serve 2. Cosa deve sapere prima che le venga sommi nistrato KEYTRUDA 3. Come le verrà somministrato KEYTRUDA 4. Possibili effetti indesiderati 5. Come conservare KEYTRUDA 6. Contenuto della confezione e altre informazioni 1. COS ’ È KEYTRUDA E A COSA SERVE KEYTRUDA contiene il principio attivo pembrolizumab, che è un anticorpo monoclonale. KEYTRUDA agisce aiutando il sistema immunitario a combattere il cancro. KEYTRUDA è u sato negli adulti per trattare: • un tipo di cancro della pelle chiamato melanoma • un tipo di cancro del polmone chiamato cancro del polmone non a piccole cellule • un tipo di cancro chiamato linfoma di Hodgkin classico • un tipo di cancro chiamato cancro della vescica (carcinoma uroteliale) • un tipo di cancro della testa e del collo chiamato carcinoma a cellule squamose della testa e del collo • un tipo di cancro del rene chiamato carcinoma a cellule renali • un tipo di cancro caratterizzato da elevata instabilità dei microsatelliti ( MSI-H, microsatellite instability-high ) o da deficit di riparaz ione del mismatch (dMMR, mismatch repair deficient ) del colon o del retto (chiamato carcinoma del colon-retto), dell’ utero (chiamato carcinoma dell ’ endometrio), dello stomaco (chiamato ca rcinoma gastrico), dell’ intestino tenue (chiamato carcinoma dell ’ intestino tenue) o del dotto biliare o della ci Läs hela dokumentet
1 ALLEGATO I RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO 2 1. DENOMINAZIONE DEL MEDICINALE KEYTRUDA 25 mg/mL concentrato per soluzione per infusione. 2. COMPOSIZIONE QUALITATIVA E QUANTITATIVA Un flaconcino da 4 mL di concentrato contiene 100 mg di pembrolizumab. Ogni mL di concentrato contiene 25 mg di pembrolizumab. Pembrolizumab è un anticorpo monoclonale umanizzato anti PD-1 ( morte cellulare programmata/ programmed cell death -1) (isotipo IgG4/kappa con un’alterazione della sequenza stabilizzante nella regione Fc), prodotto in cellule ovariche di criceto cinese con la tecnologia del DNA ricombinante. Per l’elenco completo degli eccipienti, vedere paragrafo 6.1. 3. FORMA FARMACEUTICA Concentrato per soluzione per infusione. Soluzione da limpida a leggermente opalescente , da incolore a leggermente gialla , pH 5,2 – 5,8. 4. INFORMAZIONI CLINICHE 4.1 INDICAZIONI TERAPEUTICHE Melanoma KEYTRUDA in monoterapia è indicato nel trattamento di adulti e adolescenti di età pari o superiore a 12 anni con melanoma avanzato (non resecabile o metastatico). KEYTRUDA in monoterapia è indicato nel trattamento adiuvante di adulti e adolescenti di età pari o superiore a 12 anni con melanoma in Stadio IIB, IIC o III e che sono stati sottoposti a resezione completa (vedere paragrafo 5.1). Carcinoma polmonare non a piccole cellule (NSCLC) KEYTRUDA in monoterapia è indicato nel trattamento adiuvante di adulti con carcinoma polmonare non a piccole cellule ad alto rischio di recidiva dopo resezione completa e chemioterapia a base di platino ( per i criteri di selezione, vedere paragrafo 5.1). KEYTRUDA in monoterapia è indicato nel trattamento di prima linea del carcinoma polmonare non a piccole cellule metastatico negli adulti i l cui tumore esprime PD- L1 con tumour proportion score (TPS) ≥ 50 % in assenza di tumore positivo per mutazione di EGFR o per ALK. KEYTRUDA, in associazione a pemetrexed e chemioterapia contenente platino, è indicato nel trattamento di prima linea del carcinoma polmonare non a p iccole cellul Läs hela dokumentet