Keytruda

Land: Europese Unie

Taal: Sloveens

Bron: EMA (European Medicines Agency)

Werkstoffen:

Pembrolizumab

Beschikbaar vanaf:

Merck Sharp & Dohme B.V.

ATC-code:

L01FF02

INN (Algemene Internationale Benaming):

pembrolizumab

Therapeutische categorie:

Antineoplastična sredstva

Therapeutisch gebied:

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

therapeutische indicaties:

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. Pri bolnikih z EGFR ali ALK pozitivnih tumorjev mutacije, ki naj bi prav tako prejel usmerjena terapija pred prejemom 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.

Product samenvatting:

Revision: 54

Autorisatie-status:

Pooblaščeni

Autorisatie datum:

2015-07-17

Bijsluiter

138
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v hladilniku (2
°C - 8 °C).
Ne zamrzujte.
Shranjujte v originalni škatli za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI,
KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
EU/1/15/1024/00
2 (1 viala)
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
17.
EDINSTVENA OZNAKA
–
DVODIMENZIONALNA ČRTNA KODA
Vsebuje
dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA
–
V BERLJIVI OBLIKI
PC
SN
NN
139
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
VIALA
1.
IME ZDRAVILA IN POT(I) UPORABE
KEYTRUDA
25 mg/ml
koncentrat za raztopino za infundiranje
p
embrolizumab
100 mg/4 ml
i.v.
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
6.
DRUGI
PODATKI
140
B. NAVODILO ZA UPORABO
141
NAVODILO ZA UPORABO
KEYTRUDA 25
MG/ML KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
pembrolizumab
Preden prejmete to zdravilo, natančno preberite navodilo, ker vsebuje
za vas pomembne
PODATKE!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Pomembno je, da imate kartico ves čas pri sebi.
-
Če imate dodatna vprašanja, se posvetujte z zdravnikom.
-
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
Posvetujte se tudi, če
opazite
katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte
poglavje
4.
KAJ VSEBUJE NAVODILO
1.
Kaj je zdravilo KEYTRUDA in za kaj ga uporabljamo
2.
Kaj morate vedeti, preden boste prejeli zdravilo KEYTRUDA
3.
Kako boste prejeli zdravilo
KEYTRUDA
4.
Možni neželeni učinki
5.
Shranjevanje zdravila KEYTRUDA
6.
Vsebina paki

Productkenmerken

1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
KEYTRUDA 25
mg/ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena viala s 4
ml koncentrata vsebuje 100
mg
pembrolizumaba.
En ml koncentrata vsebuje 25
mg pembrolizumaba.
Pembrolizumab je humanizirano monoklonsko protitelo proti receptorjem
programirane celične
smrti 1 (PD-
1) (IgG4 izotip kapa s spremembo zaporedja za stabilizacijo v predelu
Fc), pridobljeno s
tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Za celoten seznam pomožnih snovi glejte poglavje
6.1.
3.
FARMACEVTSKA OBLIKA
koncentrat za raztopino za infundiranje
bistra do nekoliko opalescentna, brezbarvna do rahlo
rumenkasta raztopina, pH 5,2
-5,8
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Melanom
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za
zdravljenje
odraslih in
mladostnikov, starih 12
let ali več, z
napredoval
im
(neoperabiln
im
ali metastatsk
im) melanomom.
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za
adjuvantno zdravljenje odraslih
in
mladostnikov, starih 12
let ali več,
z melanomom
v stadiju
IIB, IIC ali
III, in sicer
po popolni kirurški
odstranitvi (glejte poglavje
5.1).
Nedrobnocelični pljučni rak (NSCLC
–
non-
small cell lung carcinoma
)
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za
adjuvantno zdravljenje odraslih z
nedrobnoceličnim pljučnim rakom, ki imajo visoko tveganje za
ponovitev bolezni po popolni kirurški
odstranitvi in kemoterapiji na osnovi platine (glede kriterij
ev izbire glejte poglavje
5.1).
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za prvo
linijo zdravljenja
metastatskega nedrobnoceličnega pljučnega raka pri odraslih, ki
imajo tumorje z ≥
50
% izraženostjo
PD-L1 (TPS
–
tumour proportion score
) in brez pozitivnih tumorskih mutacij EGFR ali ALK.
Zdravilo KEYTRUDA je v kombinaciji s pemetreksedom in kemoterapijo na
osnovi platine indicirano
za prvo linijo zdravljenja metastatskega neploščatoceličnega
nedrobnoceličn