Keytruda

Country: Unjoni Ewropea

Lingwa: Daniż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

Pembrolizumab

Disponibbli minn:

Merck Sharp & Dohme B.V.

Kodiċi ATC:

L01FF02

INN (Isem Internazzjonali):

pembrolizumab

Grupp terapewtiku:

Antineoplastiske midler

Żona terapewtika:

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

Indikazzjonijiet terapewtiċi:

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. Patienter med EGFR eller ALK positiv tumor mutationer, burde også have modtaget en målrettet behandling, før de modtager 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.

Sommarju tal-prodott:

Revision: 54

L-istatus ta 'awtorizzazzjoni:

autoriseret

Data ta 'l-awtorizzazzjoni:

2015-07-17

Fuljett ta 'informazzjoni

133
B. INDLÆGSSEDDEL
134
I
NDLÆGSSEDDEL: INFORM
ATION TIL PATIENTEN
KEYTRUDA 25 MG/ML KONC
ENTRAT TIL IN
FUSIO
NSVÆSKE, OPLØ
SNING
pembrolizumab
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU FÅR DETTE LÆGEMIDDEL,
DA DEN IN
DEHOLDER VI
GTIGE
OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Det er v
igtigt, at du h
ar patientkortet med dig un
der behandlinge
n.
-
Spørg lægen, hvis der er mere, du vil vide.
-
Kontakt lægen, hvis du får bivirkninger, herun
der bivirkn
inger, som ikke er nævnt
i denne
indlægsseddel
. Se punkt 4.
Se den nyeste i
ndlægsseddel på
www.indlaegssed
del.dk
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du f
år Keytruda
3.
Sådan får du Keytruda
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelse
r og yd
erligere oplysn
inger
1.
VIRKNING OG ANVENDELSE
Keyt
ruda indeholder
det aktive stof pe
mbrolizuma
b, som er et monoklonalt antistof. Keytruda styrker
immunsystemets evne til a
t bekæmpe kræft.
Keytruda anvendes til voksne til at behandle
:
•
en bestemt type
hudkræft kaldet
me
lanom (modermæ
rkekræft)
•
en bestemt
type lungekræft
kaldet ikke-småcellet lungekræft
•
en bestemt type lymfeknudekræft kaldet klassisk Hodgkins lymfom
•
en bestemt type blære
kræft kaldet urotelialt karcinom
•
en bestemt type hoved
-halskræft kal
det planocellul
ært hoved-hals karcinom
•
en bestemt type
nyrekræft kald
et renalcellekarcinom
•
en bestemt type kræft med bekræftet høj mikrosatellitinstabilitet
(MSI-H) eller
mismatch repair
-
defekt (dMMR) i tyk-
eller endetarmen
(kaldet kolorektalkræft), livmoderen (kaldet
endometriecancer), maven (kaldet ventrikelkræft), tyndtarmen (kaldet
tyndtarmskræft), eller i
galdegangene eller galdeblæren (kaldet galdevejskræft)
•
en bestemt t
ype s
piserørskræft kaldet
esophagus karcinom
•
en bestemt type b
rystkræft k
aldet triple-negativ brystkræft
•
en bestemt type livmoderkræft kaldet endometriecancer
•
en bestemt type livmoderhalskræft kaldet cervixcan

Karatteristiċi tal-prodott

1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
KEYTRUDA 25
mg/ml
koncentrat til infusio
nsvæske, opløsning.
2.
KVALITATIV O
G KVA
NTITATIV
SAMMENSÆTNING
Et
hætteglas med 4
ml koncentrat
indeholder 100
mg pembrolizumab.
Hver ml koncentr
at indeholder 2
5 mg pembrolizumab.
Pembrolizumab er et humaniseret monoklonalt anti
-
programmed cell death
-1 (PD-1)-antistof
(IgG4/kappa-isotype med en stabili
serende forand
rin
g af sekvensen i Fc
-regionen),
som er fremstillet ved
rekombinant
dna-teknologi
i ovarieceller
fra kines
iske hamstre.
Alle hjælpestoffer er anført under pkt.
6.1.
3.
LÆGEMIDDELFORM
Koncentrat
til infusionsv
æske, opløsning
.
Klar til le
t opaliserende
, f
arveløs til lysegul opløsning
med pH 5,2 - 5,8.
4.
KLINISKE OPL
YSNINGER
4.1
T
ERAPEUTISKE IN
DIKATIONER
Melanom
KEYTRUDA som monoterapi er indiceret til behandling af
voksne
og unge i aldere
n 12
år og derover
med avanceret (ikke-resektabelt
eller metastati
sk) melanom
.
KEYTR
UDA som monot
erapi er indi
ceret til adjuverende
behandling af voksne
og unge i alderen
12 år
og derover med
stadie IIB-, IIC- eller III-melanom, som har
fået foretaget
komplet resektion (
se pkt. 5.1).
Ikke-
småcellet lunge
cancer (NSCLC)
KEYTRUDA
som monoterapi
er indiceret til
adjuverende
behandling af voksne med ikke-småcellet
lungecancer med høj risiko for recidiv efter komplet resektion og
platinbaseret kemoterapi (se pkt. 5.1 for
udvælgelseskriterier).
K
EYTRUDA
som monoterapi er indiceret til førs
telinjebehandl
ing af metastatisk ikke-småcellet
lungecancer hos voksne, hvis tumorer udtrykker PD-L1 med tumour
proportion score (TPS)
≥
50% uden
EGFR- eller ALK-
positive mutationer i tumor
.
KEYTRUDA
, i kombination
med pemetre
xed og platinbaseret
kemoterapi,
er indiceret til
førstelinjebehandling af metastatisk
ikke-p
lanocellulær
ikke-
småcellet lunge
cancer
hos voksne uden
EGFR- eller ALK-
positive mutationer
i tumorer.
KEYTRUDA
, i k
ombination
med carboplatin og e
nten paclitaxel
eller nab-paclitaxel,
er indiceret til
førstelinjebehandling