Keytruda

Country: Եվրոպական Միություն

language: ֆրանսերեն

source: EMA (European Medicines Agency)

active_ingredient:

Pembrolizumab

MAH:

Merck Sharp & Dohme B.V.

ATC_code:

L01FF02

INN:

pembrolizumab

therapeutic_group:

Agents antinéoplasiques

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. Les Patients avec l'EGFR ou ALK positif de la tumeur mutations devrait également avoir reçu la thérapie ciblée avant de recevoir 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:

Autorisé

authorization_date:

2015-07-17

PIL

145
B. NOTICE
146
NOTICE :
INFORMATION DU PATIENT
KEYTRUDA 25
MG/ML SOLUTION À DILUER POUR PERFUSION
pembrolizumab
VEUILLEZ LIRE ATTENTIVEMENT CETTE NOTICE AVANT DE RECEVOIR CE
MÉDICAMENT
CAR ELLE CONTIENT DES
INFORMATIONS IMPORTANTES POUR VOUS
.
•
Gardez cette notice. Vous pourriez avoir besoin de la relire.
•
Il est important que vous gardiez la
c
arte avec vous pendant le traitement.
•
Si vous avez d’autres questions, interrogez votre médecin.
•
Si vous
ressentez un quelconque
effet indésirable, parlez
-
en à votre médecin
. Ceci s’applique aussi à
tout effet indésirable qui ne serait pas mentionné dans cette notice
.
Voir rubrique
4.
QUE CONTIENT
CETTE NOTICE ?
:
1.
Qu’est
-
ce que KEYTRUDA et
dans quel cas est
-il utilisé
2.
Quelles sont les informations à connaître avant de recevoir KEYTRUDA
3.
Comment utiliser KEYTRUDA
4.
Quels sont les effets indésirables éventuels
5.
Comment conserver KEYTRUDA
6.
Contenu de l’emballage et autres informations
1.
Qu’est
-
CE QUE KEYTRUDA ET DANS QUEL CAS EST
-IL UTILISÉ ?
KEYTRUDA contient la substance active pembrolizumab, qui est un
anticorps monoclonal.
KEYTRUDA fonctionne en aidant
votre système immunitaire à combattre votre cancer.
KEYTRUDA est utilisé chez l’adulte pour traiter
:
•
un type de cancer de la peau appelé mélanome
•
un type de cancer du poumon appelé cancer bronchique non à petites
cellules
•
un type de cancer appelé
lymphome de Hodgkin classique
•
un type de cancer appelé cancer de la vessie (carcinome urothélial)
•
un type de cancer de la tête et du cou appelé
carcinome épidermoïde de la tête et du cou
•
un type de cancer du rein appelé carcinome à cellules rénales
•
un typ
e de cancer qui est défini comme étant à instabilité
microsatellitaire élevée (MSI
-H) ou avec
déficience de
réparation des mésappariements
de l’ADN
(dMMR)
dans le côlon ou le rectum (appelé
cancer colorectal), l'utérus (appelé cancer de l'endomètre), l'est
omac (appelé cancer
gastrique), de
l'intesti

SPC

1
ANNEXE I
RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT
2
1.
DÉNOMINATION DU MÉDICAMENT
KEYTRUDA 25
mg/mL solution à diluer pour perfusion.
2.
COMPOSITION QUALITATIVE ET QUANTITATIVE
Un flacon de 4
mL de
solution à diluer contient 100
mg de pembrolizumab.
Chaque
mL de solution à diluer contient 25
mg de pembrolizumab.
Pembrolizumab est un anticorps monoclonal humanisé (IgG4 isotype
kappa avec altération stabilisatrice de
séquence dans la région Fc) anti
-PD-
1 (programmed cell death
-
1), produit dans des cellules d’ovaires de
hamster chinois par la technique de l’ADN recom
binant.
Pour la liste complète des excipients, voir rubrique
6.1.
3.
FORME PHARMACEUTIQUE
Solution à diluer pour perfusion.
Solution limpide à légèrement opalescente, incolore à légèrement
jaune, pH
5,2
–
5,8.
4.
DONNÉES CLINIQUES
4.1
INDICATIONS
THÉRAPEUTIQUES
Mélanome
KEYTRUDA est indiqué en monothérapie dans le
traitement des patients adultes
et des adolescents âgés de
12 ans et plus
atteints d’un mélanome avancé (
non résécable ou
métastatique)
.
KEYTRUDA est indiqué en monothérapie dans le
traitement adjuvant
des patients adultes
et des adolescents
âgés de 12 ans et plus
atteints d’un mélanome
de stade
IIB, IIC ou
III, ayant eu une résection complète (voir
rubrique 5.1).
Cancer
bronchique non à petites cellules (CBNPC)
KEYTRUDA est indiqué en monothérapie dans le traitement adjuvant des
patients
adultes atteints d
’
un
cancer bronchique
non à petites cellules
à haut risque de récidive
après résection complète et
une
chimiothérapie à base de sels de platine
(pour les critères de sélection, voir rubrique 5.1).
KEYTRUDA est indiqué en monothérapie dans le traitement de première
ligne des patients adultes atteints
d’un cancer bronchique no
n à petites cellules métastatique dont les tumeurs expriment PD
-
L1 avec un score
de proportion tumorale (TPS)

50
%, sans mutations tumorales d’EGFR ou d’ALK.
KEYTRUDA, en association à une chimiothérapie pemetrexed et sel de
platin