Keytruda

Country: Եվրոպական Միություն

language: իսլանդերեն

source: EMA (European Medicines Agency)

active_ingredient:

Pembrolizumab

MAH:

Merck Sharp & Dohme B.V.

ATC_code:

L01FF02

INN:

pembrolizumab

therapeutic_group:

Æxlishemjandi lyf

therapeutic_area:

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

therapeutic_indication:

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. Sjúklingar með EGFR eða T jákvæð æxli stökkbreytingar ætti líka að hafa fengið miða meðferð áður en þú færð 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.

leaflet_short:

Revision: 54

authorization_status:

Leyfilegt

authorization_date:

2015-07-17

PIL

136
B.
FYLGISEÐILL
137
FYLGISEÐILL: UPPLÝSINGAR FYRIR SJÚKLING
KEYTRUDA 25
MG/ML INNRENNSLISÞYKKNI, LAUSN
pembrolizumab
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið
fylgiseðilinn. Nauðsynlegt getur verið að lesa hann síðar.
-
Mikilvægt er að hafa kortið meðferðis meðan á meðferðinni
stendur.
-
Leitið til læknisins ef þörf er á frekari upplýsingum.
-
Látið lækninn vita um allar aukaverkanir. Þetta gildir einnig um
auka
verkanir sem ekki er
minnst á í þessum fylgiseðli. Sjá kafla
4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR
:
1.
Upplýsingar um KEYTRUDA og við hverju það er notað
2.
Áður en byrjað er að nota KEYTRUDA
3.
Hvernig nota á KEYTRUDA
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á KEYTRUDA
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM KEYTRUDA OG VIÐ HVERJU ÞAÐ ER NOTAÐ
KEYTRUDA inniheldur virka efnið pembrolizumab, sem er einstofna
mótefni. KEYTRUDA hjálpar
ónæmiskerfinu að vinna á
krabbameininu.
KEYTRUDA er notað hjá fullorðnum til meðferðar á:
•
tegund húðkrabbameins sem kallast sortuæxli
•
tegund lungnakrabbameins sem kallað er lungnakrabbamein sem ekki er
af smáfrumugerð
•
tegund krabbameins sem kallað er hefðbundið Hodgkins eitlaæxli
•
tegund krabbameins sem kallað er blöðrukrabbamein
(þvagfæraþekjukrabbamein)
•
tegund krabbameins sem kallað er flöguþekjukrabbamein í höfði og
hálsi
•
tegund nýrnakrabbameins sem kallað er nýrnafrumukrabbamein
•
tegund krabbameins sem ákvarðað hefur verið að
sé með MSI
-H (mikinn
óstöðugleika í
örtunglum) eða MMR-óvirkni (
óvirkni í mispörunarviðgerð
)
í ristli eða endaþarmi
, í legi
(kallað legslímukrabbamein), í maga, í sm
áþörmum eða
í
gallrás eða gallblöðru
(kallað
krabbamein í gallvegi
)
•
tegund krabbameins sem
kallað er krabbamein í vélinda
•
tegund krabbameins sem kallað er þríneikvætt brjóstakrabbamein
•
tegund legkrabbam

SPC

1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
KEYTRUDA 25
mg/ml innrennslisþykkni, lausn.
2.
INNIHALDSLÝSING
Eitt hettuglas með 4
ml af þykkni inniheldur 100
mg pembrolizumab.
Hver ml af þykkni
inniheldur 25
mg pembrolizumab.
Pembrolizumab er einstofna manna and
-PD-1 (anti-
programmed cell death
-
1) mótefni (IgG4/kappa
mótefnaflokkur með stöðuga breytingu á röð á Fc svæði)
framleitt í eggjastokkafrumum kínverskra
hamstra með DNA
raðbrigðatækni.
Sjá lista yfir öll hjálparefni í kafla
6.1.
3.
LYFJAFORM
Innrennslisþykkni, lausn.
Tær eða lítið eitt ópallýsandi, litlaus til lítið eitt gulleit
lausn, pH
5,2
–
5,8.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Sortuæxli
KEYTRUDA er ætlað sem einlyfjameðferð við langt gengnu sortuæxli
(óskurðtæku eða með
meinvörpum) hjá fullorðnum
og unglingum
12
ára og eldri
.
KEYTRUDA sem einlyfjameðferð er ætlað sem viðbótarmeðferð við
sortuæxli á stigi
IIB, IIC eða
III
hjá fullorðnum
o
g unglingum 12
ára og eldri
sem gengist hafa undir algjört brottnám (sjá kafla
5.1).
Lungnakrabbamein sem ekki er af smáfrumugerð (NSCLC)
KEYTRUDA
sem einlyfjameðferð er ætlað sem viðbótarmeðferð
við
lungnakrabbamein
i
sem ekki er
af smáfrumugerð
hjá fullorðnum sem eru í m
ikilli hættu á endurkomu
eftir
algjört brottnám
og
krabbameinslyfjameðferð með platínu
lyfi
(forsendur fyrir vali, sjá kafla
5.1).
KEYTRUDA sem einlyfjameðferð er ætlað sem fyrstavalsmeðferð
(first
-
line treatment) við
lungnakrabbameini sem ekki er af smáfrumugerð með meinvörpum, hjá
fullorðnum með æxli með
PD-
L1 tjáningu ≥50% TPS (
tumour proportion score
), án EGFR eða ALK jákvæðra stökkbreytinga í
æxli.
KEYTRUDA í samsettri meðferð með pemetrexed og
krabbameinslyfjameðferð með platínu er ætlað
sem fyrstavalsmeðferð við lungnakrabbameini sem ekki er af
smáfrumugerð
og ekki af
flöguþekjugerð
,
með meinvörpum, hjá fullorðnum með æxli án EGFR eða ALK
jákvæðra
stökkbreyt