Država: Europska Unija
Jezik: slovački
Izvor: EMA (European Medicines Agency)
Pembrolizumab
Merck Sharp & Dohme B.V.
L01FF02
pembrolizumab
Antineoplastické činidlá
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. U pacientov s EGFR alebo ALKALICKÝM pozitívne nádor mutácie by tiež dostali cielenú liečbu pred prijatím 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
oprávnený
2015-07-17
137 B. PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA 138 Písomná informácia pre používateľa KEYTRUDA 25 MG/ML KONCENTRÁT NA INFÚZNY ROZTOK pembrolizumab Pozorne si prečítajte celú písomnú informáciu predtým, ako vám podajú tento liek, pretože obsahuje pre vás dôležité informácie. - Túto písomnú informáciu si uschovajte. Možno bu de potrebné, aby ste si ju znovu prečítali. - Je dôležité, aby ste počas liečby mali pri sebe k artu pacienta. - Ak máte akékoľvek ďalšie otázky, obráťte sa na svojho lekára. - Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa na svojho lekára. To sa týka aj akýchkoľvek vedľajších účinkov, ktoré nie sú uvedené v tejto písomnej informácii. Pozri časť 4. V TEJTO PÍSOMNEJ INFORMÁCII SA DOZVIETE : 1. Čo je KEYTRUDA a na čo sa používa 2. Čo potrebujete vedieť predtým, ako vám podajú KEYTRUDU 3. Ako sa KEYTRUDA podáva 4. Možné vedľajšie účinky 5. Ako uchovávať KEYTRUDU 6. Obsah balenia a ďalšie informácie 1. Čo je KEYTRUDA a na čo sa používa KEYTRUDA obsahuje liečivo pembrolizumab, ktorý je monoklonálna protilátka. KEYTRUDA účinkuje tak, že pomáha vášmu imunitnému systému bojovať proti rakovine. KEYTRUDA sa používa u dospelých na liečbu: • typu rakoviny kože nazývanej melanóm, • typu rakoviny pľúc nazývanej nemalobunkový karcinóm pľúc , • typu rakoviny nazývan ej klasický Hodgkinov lymfóm , • typu rakoviny nazývanej rakovina močového mechúra (uroteliálny karcinóm) , • typu rakoviny hlavy a krku nazývanej skvamocelulárny karcinóm hlavy a krku, • typu rakoviny obličiek nazývanej karcinóm z renálnych buniek , • typu rakoviny v hrubom čreve alebo konečníku (nazývanej rakovina hrubého čreva alebo konečníka), maternici (nazývanej endometriálny karcinóm), žalúdku (nazývanej žalúdočný karcinóm), tenkom čreve (nazývanej karcinóm tenkého čreva) alebo žlčovode či žlčníku (nazývanej ka rcinóm biliárneho traktu) , pri Pročitajte cijeli dokument
1 PRÍLOHA I SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU 2 1. NÁZOV LIEKU KEYTRUDA 25 mg/ml koncentrát na infúzny roztok 2. KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE Jedna injekčná liekovka so 4 ml koncentrátu obsahuje 100 mg pembrolizumabu. Každý ml koncentrátu obsahuje 25 mg pembrolizumabu. Pembrolizumab je humanizovaná monoklonálna protilátka proti receptoru programovanej bunkovej smrti-1 (PD- 1) (IgG4/izotyp kapa so stabilizujúcou úpravou sekvencie v Fc regióne) produkovaná v bunkách ovárií čínskeho škrečka technológiou rekombinantnej DNA. Úplný zoznam pomocných látok, pozri časť 6 .1. 3. LIEKOVÁ FORMA Koncentrát na infúzny roztok. Číry až slabo opalescenčný, bezfarebný až svetložltý roztok , pH 5,2 – 5,8. 4. KLINICKÉ ÚDAJE 4.1 TERAPEUTICKÉ INDIKÁCIE Melanóm KEYTRUDA je v monoterapii indikovaná na liečbu pokročilého (neresekovateľného alebo metastatického) melanómu u dospelých a dospievajúcich vo veku 12 rokov a starších . KEYTRUDA je v monoterapii indikovaná na adjuvantnú liečbu dospelých a dospievajúcich vo veku 12 rokov a starších s melanómom v štádi ách IIB, IIC alebo III, ktorí podstúpili úplnú resekciu (pozri časť 5.1) . Nemalobunkový karcinóm pľúc (non - small cell lung carcinoma, NSCLC) KEYTRUDA je v monoterapii indikovaná na adjuvant nú liečbu dospelých s nemalobunkov ým karcinómom pľúc s vysokým rizikom rekurencie po úplnej resekcii a chemoterapii na báze platiny (selekčné kritériá, pozri časť 5.1) . KEYTRUDA je v monoterapii indikovaná ako liečba prvej línie metastatického nemalobunko vého karcinómu pľúc u dospelých s expresiou PD -L1 v nádoroch, s proporčným skóre nádoru (tumour proportion score, TPS) ≥ 50 %, bez pozitivity mutácií EGFR alebo ALK v nádorových bunkách. KEYTRUDA je v kombinácii s chemoterapiou obsahujúcou pemetrexed a pl atinu indikovaná ako liečba prvej línie metastatického neskvamózneho nemalobunkového karcinómu pľúc u dospelých bez pozitivity mutáci Pročitajte cijeli dokument