Keytruda

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Κροατικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Пембролизумаб

Διαθέσιμο από:

Merck Sharp & Dohme B.V.

Φαρμακολογική κατηγορία (ATC):

L01FF02

INN (Διεθνής Όνομα):

pembrolizumab

Θεραπευτική ομάδα:

Antineoplastična sredstva

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

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. Pacijenata sa EGFR ili ALA pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. 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.

Περίληψη προϊόντος:

Revision: 54

Καθεστώς αδειοδότησης:

odobren

Ημερομηνία της άδειας:

2015-07-17

Φύλλο οδηγιών χρήσης

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
KEYTRUDA 25
mg/ml koncentrat za otopinu za
infuziju.
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna bočica s 4
ml koncentrata sadrži 100
mg pembrolizumaba.
Jedan
ml koncentrata sadrži 25
mg pembrolizumaba.
Pembrolizumab je humanizirano monoklonsko protutijelo koje se veže na
receptor programirane
stanične smrti
-1 (engl.
programmed cell death
-1, PD-
1) (izotip IgG4/kapa s promjenom u slijedu
sekvence za stabiliz
aciju u Fc
regiji) i koje se proizvodi u stanicama jajnika kineskog hrčka
tehnologijom rekombinantne DN
A.
Za cjeloviti popis pomoćnih tvari vidjeti dio
6.1.
3.
FARMACEUTSKI OBLIK
Koncentrat za otopinu za infuziju.
Bistra do blago opalescentna, bezbojn
a do blijedo žuta otopina (pH 5,2
–
5,8).
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Melanom
KEYTRUDA kao monoterapija je indicirana za liječenje uznapredovalog (
neresektabilnog
ili
metastatskog) melanoma u odraslih
i adolescenata u dobi od 12
ili vi
š
e godina.
KEYTRUDA kao monoterapija je indicirana za adjuvantno liječenje
melanoma
stadija
IIB, IIC ili
III u
odraslih
i adolescenata u dobi od 12
ili
više godina
koji su podvrgnuti potpunoj resekciji (vidje
ti
dio 5.1).
Karcinom pluća nemalih stanica (
engl. non-
small cell lung carcinoma
, NSCLC)
KEYTRUDA
kao monoterapija
je indicirana za
adjuvantno liječenje
karcinoma
pluća nemalih stanica
u odraslih koji su
izloženi
visokom riziku od re
cidiva nakon
potpune resekcij
e i
kemoterapije
utemeljene na
platini (
za kriterije za odabir bolesnika vidjeti dio
5.1).
KEYTRUDA
kao monoterapija
je indicirana za prvu liniju liječenja metastatskog karcinoma pluća
nemalih stanica u odraslih čiji tumori eksprimiraju PD
-
L1 uz udio tumors
kih stanica s ekspresijom
(engl. tumour proportion score, TPS)
≥
50% i koji nisu pozitivni na tumorske mutacije gena EGFR ili
ALK.
KEYTRUDA je u kombinaciji s pemetreksedom i kemoterapijom
koja sadrži
platinu
indicirana za
prvu liniju liječenja metastatsk
og neskvamoznog
karcinoma pl
uća nema
lih s

Αρχείο Π.Χ.Π.

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
KEYTRUDA 25
mg/ml koncentrat za otopinu za
infuziju.
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna bočica s 4
ml koncentrata sadrži 100
mg pembrolizumaba.
Jedan
ml koncentrata sadrži 25
mg pembrolizumaba.
Pembrolizumab je humanizirano monoklonsko protutijelo koje se veže na
receptor programirane
stanične smrti
-1 (engl.
programmed cell death
-1, PD-
1) (izotip IgG4/kapa s promjenom u slijedu
sekvence za stabiliz
aciju u Fc
regiji) i koje se proizvodi u stanicama jajnika kineskog hrčka
tehnologijom rekombinantne DN
A.
Za cjeloviti popis pomoćnih tvari vidjeti dio
6.1.
3.
FARMACEUTSKI OBLIK
Koncentrat za otopinu za infuziju.
Bistra do blago opalescentna, bezbojn
a do blijedo žuta otopina (pH 5,2
–
5,8).
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Melanom
KEYTRUDA kao monoterapija je indicirana za liječenje uznapredovalog (
neresektabilnog
ili
metastatskog) melanoma u odraslih
i adolescenata u dobi od 12
ili vi
š
e godina.
KEYTRUDA kao monoterapija je indicirana za adjuvantno liječenje
melanoma
stadija
IIB, IIC ili
III u
odraslih
i adolescenata u dobi od 12
ili
više godina
koji su podvrgnuti potpunoj resekciji (vidje
ti
dio 5.1).
Karcinom pluća nemalih stanica (
engl. non-
small cell lung carcinoma
, NSCLC)
KEYTRUDA
kao monoterapija
je indicirana za
adjuvantno liječenje
karcinoma
pluća nemalih stanica
u odraslih koji su
izloženi
visokom riziku od re
cidiva nakon
potpune resekcij
e i
kemoterapije
utemeljene na
platini (
za kriterije za odabir bolesnika vidjeti dio
5.1).
KEYTRUDA
kao monoterapija
je indicirana za prvu liniju liječenja metastatskog karcinoma pluća
nemalih stanica u odraslih čiji tumori eksprimiraju PD
-
L1 uz udio tumors
kih stanica s ekspresijom
(engl. tumour proportion score, TPS)
≥
50% i koji nisu pozitivni na tumorske mutacije gena EGFR ili
ALK.
KEYTRUDA je u kombinaciji s pemetreksedom i kemoterapijom
koja sadrži
platinu
indicirana za
prvu liniju liječenja metastatsk
og neskvamoznog
karcinoma pl
uća nema
lih s