Keytruda

Krajina: Európska únia

Jazyk: lotyština

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Pembrolizumabs

Dostupné z:

Merck Sharp & Dohme B.V.

ATC kód:

L01FF02

INN (Medzinárodný Name):

pembrolizumab

Terapeutické skupiny:

Antineoplastiski līdzekļi

Terapeutické oblasti:

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

Terapeutické indikácie:

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. Pacientiem ar EGFR vai BĀZISKĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem 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.

Prehľad produktov:

Revision: 54

Stav Autorizácia:

Autorizēts

Dátum Autorizácia:

2015-07-17

Príbalový leták

1
I
PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
KEYTRUDA
25 mg/ml
koncentrāts
infūzij
u
šķīduma pagatavošanai
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Viens flakons ar
4
ml koncentrāta
satur 100
mg pembrolizumaba
(pembrolizumab)
.
Katrs koncentrāta ml satur 25
mg pembrolizumaba.
Pembrolizumabs ir humanizēta monoklonāla anti
-
programmēta šūnu nāves
-1 (PD-1) antiviela
(IgG4/kappa izotipa ar stabilizējošas secības izmaiņām Fc
reģionā), kas iegūta no Ķīnas kāmju olnīcu
šūnām, izmantojot rekombinantās DNS tehnoloģiju.
Pilnu palīgvielu sarakstu skatīt 6.1.
apakšpunktā.
3.
ZĀĻU FORMA
Koncentrāts
infūziju šķīduma pagatavošanai.
Dzidrs
līdz
nedaudz
opalescējošs, bezkrāsains līdz
gaiši dzeltens šķīdums, pH
5,2
–
5,8.
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
Terapeitiskās indikācijas
Melanoma
KEYTRUDA monoterapijas veidā ir indicēts lietošanai progresējošas
(nerezecējamas vai
metastātiskas) melanomas ārstēšanai pieaugušajiem un pusaudžiem
no 12
gadu vecuma
.
KEYTRUDA monoterapijas veidā ir indicēts adjuvantai terapijai
pieaugušajiem un pusaudži
em no
12
gadu vecuma ar
IIB, IIC vai III
stadijas melanomu, kuriem veikta pilnīga rezekcija (skatīt
5.1.
apakšpunktu).
Nesīkšūnu plaušu vēzis (NSŠPV)
KEYTRUDA monoterapijas veidā ir indicēts nesīkšūnu plaušu vēža
adjuvantai terapijai
pieaugušajiem, kuriem ir augsts recidīva risks pēc pilnīgas
audzēja rezekcijas un platīna grupas
līdzekli saturošas ķīmijterapijas (atlases kritērijus skatīt
5.1.
apakšpunktā).
KEYTRUDA
monoterapijas veidā ir indicēts
kā pirmās izvēles terapija metastātiska nesīkšūnu plaušu
vēža ārstēšanai pieaugušajiem, kuriem audzēji ekspresē PD
-L1 ar
audzēja īpatsvara novērtējuma
punktu skait
u (
tumour proportion score,
TPS)
≥50%
bez
EGFR vai ALK pozitīvām audzēju
mutācijām.
KEYTRUDA kombinācijā ar
pemetreksedu un
platīnu saturošu ķīmijterapiju indicēts
kā pirmās
izvēles
terapija
metastātiska neplakanšūnu nesīkšūnu pla

Súhrn charakteristických

1
I
PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
KEYTRUDA
25 mg/ml
koncentrāts
infūzij
u
šķīduma pagatavošanai
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Viens flakons ar
4
ml koncentrāta
satur 100
mg pembrolizumaba
(pembrolizumab)
.
Katrs koncentrāta ml satur 25
mg pembrolizumaba.
Pembrolizumabs ir humanizēta monoklonāla anti
-
programmēta šūnu nāves
-1 (PD-1) antiviela
(IgG4/kappa izotipa ar stabilizējošas secības izmaiņām Fc
reģionā), kas iegūta no Ķīnas kāmju olnīcu
šūnām, izmantojot rekombinantās DNS tehnoloģiju.
Pilnu palīgvielu sarakstu skatīt 6.1.
apakšpunktā.
3.
ZĀĻU FORMA
Koncentrāts
infūziju šķīduma pagatavošanai.
Dzidrs
līdz
nedaudz
opalescējošs, bezkrāsains līdz
gaiši dzeltens šķīdums, pH
5,2
–
5,8.
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
Terapeitiskās indikācijas
Melanoma
KEYTRUDA monoterapijas veidā ir indicēts lietošanai progresējošas
(nerezecējamas vai
metastātiskas) melanomas ārstēšanai pieaugušajiem un pusaudžiem
no 12
gadu vecuma
.
KEYTRUDA monoterapijas veidā ir indicēts adjuvantai terapijai
pieaugušajiem un pusaudži
em no
12
gadu vecuma ar
IIB, IIC vai III
stadijas melanomu, kuriem veikta pilnīga rezekcija (skatīt
5.1.
apakšpunktu).
Nesīkšūnu plaušu vēzis (NSŠPV)
KEYTRUDA monoterapijas veidā ir indicēts nesīkšūnu plaušu vēža
adjuvantai terapijai
pieaugušajiem, kuriem ir augsts recidīva risks pēc pilnīgas
audzēja rezekcijas un platīna grupas
līdzekli saturošas ķīmijterapijas (atlases kritērijus skatīt
5.1.
apakšpunktā).
KEYTRUDA
monoterapijas veidā ir indicēts
kā pirmās izvēles terapija metastātiska nesīkšūnu plaušu
vēža ārstēšanai pieaugušajiem, kuriem audzēji ekspresē PD
-L1 ar
audzēja īpatsvara novērtējuma
punktu skait
u (
tumour proportion score,
TPS)
≥50%
bez
EGFR vai ALK pozitīvām audzēju
mutācijām.
KEYTRUDA kombinācijā ar
pemetreksedu un
platīnu saturošu ķīmijterapiju indicēts
kā pirmās
izvēles
terapija
metastātiska neplakanšūnu nesīkšūnu pla