Country: ইউরোপীয় ইউনিয়ন
ভাষা: ডেনিশ
সূত্র: EMA (European Medicines Agency)
Pembrolizumab
Merck Sharp & Dohme B.V.
L01FF02
pembrolizumab
Antineoplastiske midler
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. Patienter med EGFR eller ALK positiv tumor mutationer, burde også have modtaget en målrettet behandling, før de modtager 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
autoriseret
2015-07-17
133 B. INDLÆGSSEDDEL 134 I NDLÆGSSEDDEL: INFORM ATION TIL PATIENTEN KEYTRUDA 25 MG/ML KONC ENTRAT TIL IN FUSIO NSVÆSKE, OPLØ SNING pembrolizumab LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU FÅR DETTE LÆGEMIDDEL, DA DEN IN DEHOLDER VI GTIGE OPLYSNINGER. - Gem indlægssedlen. Du kan få brug for at læse den igen. - Det er v igtigt, at du h ar patientkortet med dig un der behandlinge n. - Spørg lægen, hvis der er mere, du vil vide. - Kontakt lægen, hvis du får bivirkninger, herun der bivirkn inger, som ikke er nævnt i denne indlægsseddel . Se punkt 4. Se den nyeste i ndlægsseddel på www.indlaegssed del.dk OVERSIGT OVER INDLÆGSSEDLEN 1. Virkning og anvendelse 2. Det skal du vide, før du f år Keytruda 3. Sådan får du Keytruda 4. Bivirkninger 5. Opbevaring 6. Pakningsstørrelse r og yd erligere oplysn inger 1. VIRKNING OG ANVENDELSE Keyt ruda indeholder det aktive stof pe mbrolizuma b, som er et monoklonalt antistof. Keytruda styrker immunsystemets evne til a t bekæmpe kræft. Keytruda anvendes til voksne til at behandle : • en bestemt type hudkræft kaldet me lanom (modermæ rkekræft) • en bestemt type lungekræft kaldet ikke-småcellet lungekræft • en bestemt type lymfeknudekræft kaldet klassisk Hodgkins lymfom • en bestemt type blære kræft kaldet urotelialt karcinom • en bestemt type hoved -halskræft kal det planocellul ært hoved-hals karcinom • en bestemt type nyrekræft kald et renalcellekarcinom • en bestemt type kræft med bekræftet høj mikrosatellitinstabilitet (MSI-H) eller mismatch repair - defekt (dMMR) i tyk- eller endetarmen (kaldet kolorektalkræft), livmoderen (kaldet endometriecancer), maven (kaldet ventrikelkræft), tyndtarmen (kaldet tyndtarmskræft), eller i galdegangene eller galdeblæren (kaldet galdevejskræft) • en bestemt t ype s piserørskræft kaldet esophagus karcinom • en bestemt type b rystkræft k aldet triple-negativ brystkræft • en bestemt type livmoderkræft kaldet endometriecancer • en bestemt type livmoderhalskræft kaldet cervixcan সম্পূর্ণ নথি পড়ুন
1 BILAG I PRODUKTRESUMÉ 2 1. LÆGEMIDLETS NAVN KEYTRUDA 25 mg/ml koncentrat til infusio nsvæske, opløsning. 2. KVALITATIV O G KVA NTITATIV SAMMENSÆTNING Et hætteglas med 4 ml koncentrat indeholder 100 mg pembrolizumab. Hver ml koncentr at indeholder 2 5 mg pembrolizumab. Pembrolizumab er et humaniseret monoklonalt anti - programmed cell death -1 (PD-1)-antistof (IgG4/kappa-isotype med en stabili serende forand rin g af sekvensen i Fc -regionen), som er fremstillet ved rekombinant dna-teknologi i ovarieceller fra kines iske hamstre. Alle hjælpestoffer er anført under pkt. 6.1. 3. LÆGEMIDDELFORM Koncentrat til infusionsv æske, opløsning . Klar til le t opaliserende , f arveløs til lysegul opløsning med pH 5,2 - 5,8. 4. KLINISKE OPL YSNINGER 4.1 T ERAPEUTISKE IN DIKATIONER Melanom KEYTRUDA som monoterapi er indiceret til behandling af voksne og unge i aldere n 12 år og derover med avanceret (ikke-resektabelt eller metastati sk) melanom . KEYTR UDA som monot erapi er indi ceret til adjuverende behandling af voksne og unge i alderen 12 år og derover med stadie IIB-, IIC- eller III-melanom, som har fået foretaget komplet resektion ( se pkt. 5.1). Ikke- småcellet lunge cancer (NSCLC) KEYTRUDA som monoterapi er indiceret til adjuverende behandling af voksne med ikke-småcellet lungecancer med høj risiko for recidiv efter komplet resektion og platinbaseret kemoterapi (se pkt. 5.1 for udvælgelseskriterier). K EYTRUDA som monoterapi er indiceret til førs telinjebehandl ing af metastatisk ikke-småcellet lungecancer hos voksne, hvis tumorer udtrykker PD-L1 med tumour proportion score (TPS) ≥ 50% uden EGFR- eller ALK- positive mutationer i tumor . KEYTRUDA , i kombination med pemetre xed og platinbaseret kemoterapi, er indiceret til førstelinjebehandling af metastatisk ikke-p lanocellulær ikke- småcellet lunge cancer hos voksne uden EGFR- eller ALK- positive mutationer i tumorer. KEYTRUDA , i k ombination med carboplatin og e nten paclitaxel eller nab-paclitaxel, er indiceret til førstelinjebehandling সম্পূর্ণ নথি পড়ুন