Keytruda

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Ρουμανικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Pembrolizumab

Διαθέσιμο από:

Merck Sharp & Dohme B.V.

Φαρμακολογική κατηγορία (ATC):

L01FF02

INN (Διεθνής Όνομα):

pembrolizumab

Θεραπευτική ομάδα:

Agenți antineoplazici

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. Pacienții cu EGFR sau ALK pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi 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.

Περίληψη προϊόντος:

Revision: 54

Καθεστώς αδειοδότησης:

Autorizat

Ημερομηνία της άδειας:

2015-07-17

Φύλλο οδηγιών χρήσης

141
B. PROSPECTUL
142
PROSPECT: INFORM
aţii PENTRU PACIENT
KEYTRUDA 25 MG/ML CONCENTRAT PENTRU SOL
uţ
IE PERFUZABIL
ă
pembrolizumab
CITI
ţ
I CU A
tenţi
E
ş
I ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A VI SE ADMINISTRA ACEST
MEDICAMENT
DEOARECE CO
nţ
INE INFORMA
ţ
II IMPORTANTE PENTRU DUMNEAVOAST
ră
.
-
Pă
stra
ţ
i acest prospect. S-ar putea s
ă
fie necesar
să
-l reciti
ţ
i.
-
Este import
ant să
p
ăs
tra
ț
i la dumneavoastr
ă
cardul în timpul tratamentului.
-
Dac
ă
a
veţ
i orice întreb
ă
ri suplimentare, adres
aţ
i-
vă
medicului dumneavoastr
ă.
-
Dac
ă
manifes
taţ
i orice reac
ţ
ii adverse, adre
saţ
i-v
ă
medicului dumneavoast
ră
. Acestea includ
orice posibile rea
cţ
ii adverse nemen
ţi
onate în acest prospect. Vezi pct. 4.
CE G
ă
SI
ţi ÎN ACEST PROSPECT
1.
Ce este KEYTRUD
A şi
pentru ce se utilizea
ză
2.
Ce trebuie
să
ştiţi
înai
nte să
vi se administreze KEYTRUDA
3.
Cum vi se administreaz
ă K
EYTRUDA
4.
Reac
ţi
i adverse posibile
5.
Cum se p
ă
strea
ză KE
YTRUDA
6.
Con
ţin
utul ambalajul
ui şi
alte inform
aţi
i
1.
CE ESTE KEYTRUDA
ş
I PENTRU CE SE UTILIZE
ază
KEYTRUDA c
onține substanța
activ
ă
pembrolizumab, care este un anticorp monoclonal.
KEYTRUDA a
cți
onea
ză aj
utând sistemul dumneavoastr
ă
imunitar s
ă
lupte împotriva cancerului.
KEYTRUDA se utili
zează
la ad
ulț
i pentru a trata:
•
un tip de cancer de piele denumit melanom
•
un tip de cancer de pl
ăm
ân denumit cancer pulmonar altul decât cel cu celule mici
•
un tip de cancer denumit limfom Hodgkin clasic
•
un tip de cancer denumit cancer de v
ezică
urin
ară (c
arcinom urotelial)
•
un tip de cancer de cap
ș
i gât denumit carcinom cu celul
e scuamoas
e al capului
ş
i gâtului
•
un tip ce cancer de rinichi denumit carcinom renal
•
un tip de cancer care s-a demonstrat a fi cu instabilitate
microsatelit
ă d
e grad înalt (MSI-H) sau
cu defici
ență
de reparare a nepotrivirii ADN-ului (dMMR) la nivelul colonul
ui sau rectului
(denumit cancer colorectal)
, uterului (denu

Αρχείο Π.Χ.Π.

1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
1.
DENUMIREA COMERCIAL
Ă A ME
DICAMENTULUI
KEYTRUDA 25 mg/ml concentrat pentru s
oluţie perf
uzabi
lă.
2.
COMPOZI
ŢI
A CALITAT
IVĂ ŞI
CANTITA
TIVĂ
Un flacon cu 4 ml d
e concentrat
co
nține
pembrolizumab 100 mg.
Fiecare ml de concentrat con
ține pe
mbrolizumab 25 mg.
Pembrolizumab este un anticorp monoclonal umanizat
cu acț
iune împotriva receptorului 1 cu rol în
controlul mo
rții
celulare programate (PD-1
–
programmed cell death-1) (izotipul IgG4/kappa cu o
modificare a secven
ţei
de stabilizare în regiunea Fc) produs în celule ovariene de hamster
chinezesc
prin tehnologia ADN recombinat.
Pentru lista tuturor excipien
ţ
ilor, vezi pct. 6.1.
3.
FORMA FARMACEUTIC
Ă
Conce
ntrat pentru soluţ
ie perfuzabil
ă.
Solu
ţie
limpede pâ
nă l
a u
şor
opalescent
ă,
incolor
ă până
la
ușo
r g
ălbuie
, cu pH-ul 5,2-5,8.
4.
DATE CLINICE
4.1
Indicaţii terapeutice
Melanom
KEYTRUDA
este indicat în monoterapie pentru t
ratamentul
adulților și
adolescenți
lor cu vârsta de
12 ani
ș
i peste, cu melanom
avansat (nerezecabil sau metastatic)
.
KEYTRUDA
este indicat în monoterapie pentru tratamentul
adjuvant al
adulților și
adolescenți
lor cu
vârsta de 12
ani și peste,
cu melanom stadiul IIB, IIC sau
III și
la care s-
a efectuat rezec
ți
e co
mpletă
(vezi pct. 5.1).
Carcinom
pulmonar, altul decâ
t cel cu
celule mici
(NSCLC, non-
small cell lung carcinoma
)
KEYTRUDA
este indicat
în monoterapie
pentru tratamentul
adjuvant al adulților cu
carcinom
pulmonar, altul decât cel cu celule mici
, care prezint
ă
risc crescut de recu
rență
în urma
rezecției
complete
și administrării
chimioterapie
i
pe bază de
săruri de platină
(
pentru criteriile de selec
ție,
vezi
pct. 5.1).
KEYTRUDA
este indicat
în monoterapie
pentru tratamentul de primă linie al
carcinomului
pulmonar,
altul decât cel cu celule mici
, metastatic, l
a adulţi ale căror tumori exprimă PD
-L1 cu un scor tumoral
prop
orţional
(STP)
≥
50%, fără mutații
tumorale EGFR s