Keytruda

Nchi: Umoja wa Ulaya

Lugha: Kiestonia

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

Pembrolizumab

Inapatikana kutoka:

Merck Sharp & Dohme B.V.

ATC kanuni:

L01FF02

INN (Jina la Kimataifa):

pembrolizumab

Kundi la matibabu:

Antineoplastilised ained

Eneo la matibabu:

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

Matibabu dalili:

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. Patsiendid, kellel on EGFR-või KRISTALLIMISE positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud 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.

Bidhaa muhtasari:

Revision: 54

Idhini hali ya:

Volitatud

Idhini ya tarehe:

2015-07-17

Taarifa za kipeperushi

133
B. PAKENDI INFOLEHT
134
PAKENDI INFOLEHT: TEAVE PATSIENDILE
KEYTRUDA 25
MG/ML INFUSIOONILAHUSE KONTSENTRAAT
pembrolizumab
ENNE KUI TEILE RAVIMIT
MANUSTATAKSE, LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE VAJALIKKU
TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Oluline on kanda kaarti ravi ajal kaasas.
-
Kui teil on lisaküsimusi, pidage nõu oma arstiga.
-
Kui teil tekib ükskõik millin
e kõrvaltoime, pidage nõu oma arstiga. Kõrvaltoime võib olla ka
selline, mida selles infolehes ei ole nimetatud. Vt lõik
4.
INFOLEHE SISUKORD
1.
Mis ravim on KEYTRUDA ja milleks seda kasutatakse
2.
Mida on vaja teada enne kui teile KEYTRUDAt manustatakse
3.
Kuidas teile KEYTRUDAt manustatakse
4.
Võimalikud kõrvaltoimed
5.
Kuidas KEYTRUDAt säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON KEYTRUDA JA MILLEKS SEDA KASUTATAKSE
KEYTRUDA sisaldab toimeainena pembrolizumabi, mis on monoklonaalne
antikeha
. KEYTRUDA
aitab teie immuunsüsteemil teie vähiga võidelda.
KEYTRUDAt kasutatakse täiskasvanutel järgmiste haiguste raviks:
•
teatud tüüpi nahavähk (nimetatakse melanoomiks)
•
teatud tüüpi kopsuvähk (nimetatakse mitteväikerakk
-
kopsuvähiks)
•
teatud tüüpi
vähk (nimetatakse klassikaliseks Hodgkini lümfoomiks)
•
teatud tüüpi kusepõie vähk (nimetatakse uroteliaalseks
kartsinoomiks)
•
teatud tüüpi pea
-
ja kaelapiirkonna vähk (nimetatakse pea
-
ja kaelapiirkonna
lamerakk-
kartsinoomiks)
•
teatud tüüpi neeruvähk (nimetatakse neerurakk
-
kartsinoomiks)
•
teatud tüüpi vähk, mille puhul on kindlaks tehtud
mikrosatelliitide
kõrge
ebastabiilsus (MSI
-H)
või valepaardumisreparatsiooni
geeni defektsus (dMMR)
käärsooles või pärasooles
(nimetatakse kolorektaalvähiks), emakas (nimetatak
se endomeetriumi vähiks), maos
(nimetatakse maovähiks), peensooles (nimetatakse peensoole vähiks)
või sapijuhas või
sapipõies (nimetatakse sapiteede vähiks)
•
teatud tüüpi vähk (nimetatakse söögitoru kartsinoomiks)
•
teatud tüüpi vähk (nimetatakse kolmiknegat

Tabia za bidhaa

1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
KEYTRUDA 25
mg/ml infusioonilahuse kontsentraat
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks 4
ml kontsentraadi viaal sisaldab 100
mg
pembrolizumabi.
Üks ml kontsentraati sisaldab 25
mg pembrolizumabi.
Pembrolizumab on humaniseeritud monoklonaalne programmeeritud
rakusurma
-1 (
programmed cell
death-1, PD-
1) vastane antikeha (IgG4/kapa isotüüp stabiliseeriva järjestuse
muutusega Fc
-regioonis),
mis on toodetud rekombinantse DNA
-
tehnoloogia abil hiina hamstri munasarjarakkudes.
Abiainete täielik loetelu vt lõik
6.1.
3.
RAVIMVORM
Infusioonilahuse kontsentraat.
Selge kuni kergelt opalestseeruv värvitu kuni kergelt kollane lahus,
pH
5,2…5,8.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Melanoom
KEYTRUDA monoteraapia
on
näidustatud kaugelearenenud (mitteresetseeritav või metastaatili
ne)
melanoomiga
täiskasvanute
ja 12-
aastaste või vanemate noorukite raviks
.
KEYTRUDA monoteraapia
on näidustatud
IIB, IIC või
III staadiumi melanoomiga
täiskasvanute
ja
12-
aastaste või vanemate noorukite
adjuvantraviks pärast
täielikku resektsiooni (vt lõik 5.1).
Mitteväikerakk
-
kopsuvähk (
non-
small cell lung carcinoma
, NSCLC)
KEYTRUDA
monoteraapia on näidustatud adjuvantraviks
mitteväikerakk
-kopsuvähiga
täiskasvanutele,
kellel on suur risk retsidiivi tekkeks pärast kasvaja
täielikku resektsiooni ja
plaatinapõhist keemiaravi (valikukriteeriumid vt lõik
5.1).
KEYTRUDA
monoteraapia
on
näidustatud esimese rea ravina metastaatilise
mitteväikerakk
-
kopsuvähi raviks täiskasvanutele, kelle kasvaja ekspresseerib PD
-
L1 kasvaja
proportsiooni skooriga (TPS) ≥
50% ning kellel ei esine EGFR
- ega ALK-
positiivseid kasvaja
mutatsioone.
KEYTRUDA kombinatsioonis pemetrekseedi ja plaatinat sisaldava ke
emiaravi
ga on näidustatud
metastaatilise
mittelamerak
ulise
mitteväikerakk
-kopsuvähi
esimese rea raviks täiskasvanutele, kellel ei
esine EGFR- ega ALK-
positiivseid kasvaja
mutatsioone.
KEYTRUDA kombinatsioonis karboplatiini ja kas paklitaks