Keytruda

Nazione: Unione Europea

Lingua: slovacco

Fonte: EMA (European Medicines Agency)

Principio attivo:

Pembrolizumab

Commercializzato da:

Merck Sharp & Dohme B.V.

Codice ATC:

L01FF02

INN (Nome Internazionale):

pembrolizumab

Gruppo terapeutico:

Antineoplastické činidlá

Area terapeutica:

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

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Revision: 54

Stato dell'autorizzazione:

oprávnený

Data dell'autorizzazione:

2015-07-17

Foglio illustrativo

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

Scheda tecnica

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