Keytruda

Ülke: Avrupa Birliği

Dil: İspanyolca

Kaynak: EMA (European Medicines Agency)

Aktif bileşen:

Pembrolizumab

Mevcut itibaren:

Merck Sharp & Dohme B.V.

ATC kodu:

L01FF02

INN (International Adı):

pembrolizumab

Terapötik grubu:

Agentes antineoplásicos

Terapötik alanı:

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

Terapötik endikasyonlar:

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. Los pacientes con EGFR o ALK positivo tumor mutaciones debe también han recibido terapia dirigida antes de recibir 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.

Ürün özeti:

Revision: 54

Yetkilendirme durumu:

Autorizado

Yetkilendirme tarihi:

2015-07-17

Bilgilendirme broşürü

146
B.
PROSPECTO
147
PROSPECTO: INFORMACIÓN PARA EL PACIENTE
KEYTRUDA
25 MG/ML
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
pembrolizumab
LEA TODO EL PROSPECTO DETENIDAMENTE ANTES DE QUE SE LE ADMINISTRE ESTE
MEDICAMENTO, PORQUE
CONTIENE INFORMACIÓN IMPORTANTE PARA USTED.
-
Conserve este prospecto, ya que puede tener que volver a leerlo
.
-
Es importante que lleve siempre consigo la tarjeta de información
para el paciente durante el
tratamiento.
-
Si tiene alguna dud
a, consulte a su médico
.
-
Si experimenta efectos adversos, consulte a su médico, incluso si se
trata de efectos adversos
que no aparecen en este prospecto. Ver sección
4.
CONTENIDO DEL PROSPECTO
1.
Qué es
KEYTRUDA
y para qué se utiliza
2.
Qué necesita sa
ber antes de que se le administre
KEYTRUDA
3.
Cómo se le administra
KEYTRUDA
4.
Posibles efectos adversos
5.
Conservación de KEYTRUDA
6.
Contenido del envase e información adicional
1.
QUÉ ES KEYTRUDA Y PARA QUÉ SE UTILIZA
KEYTRUDA contiene el principio activo pembrolizumab,
que es un
anticuerpo monoclonal
.
KEYTRUDA
actúa ayudando a su sistema inmunitario a combatir su cáncer.
KEYTRUDA se usa en adultos para tratar
:
•
un tipo de cáncer de piel llamado melanoma
•
un tipo de cánc
er de pulmón llamado cáncer de pulmón no microcítico
•
un tipo de cáncer llamado linfoma de Hodgkin clásico
•
un tipo de cáncer llamado cáncer de vejiga (carcinoma urotelial)
•
un tipo de cáncer
de cabeza y cuello
llamado carcinoma
de células escamosas de
cabeza y cuello
•
un tipo de cáncer de
riñón llamado
carcinoma de células renales
•
un tipo de cáncer que se caracteriza por tener
inestabilidad de microsatélites alta (MSI
-H, por
sus siglas en inglés) o por deficiencia del sistema de reparación de
apareamient
o (dMMR, por
sus siglas en inglés)
en el colon o
en el
recto (llamado cáncer colorrectal), en el útero (llamado
cáncer de endometrio), en el estómago (llamado cáncer gástrico),
en el intestino delgado
(llamado cáncer de intestino delgado) o en la vía bilia
r

Ürün özellikleri

1
ANEXO I
FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
2
1.
NOMBRE DEL MEDICAMENTO
KEYTRUDA 25
mg/ml
concentrado para solución para
perfusión.
2.
COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
Un vial de 4
ml de concentrado contiene 100
mg de pembrolizumab.
Cada ml de concentrado contiene 25
mg de pembrolizumab.
Pembrolizumab es un anticuerpo monoclonal humanizado (IgG4/isotipo
kappa con una alteración de
la secuencia estabilizadora en la región Fc) frent
e a la muerte celular programada
-1 (PD-1
), producido
en células de ovario de hámster chino mediante tecnología de ADN
recombinante.
Para consultar la lista completa de excipientes, ver sección
6.1
3.
FORMA FARMACÉUTICA
C
oncentrado para solución para pe
rfusión.
S
olución transparente a ligeramente opalescente, incolora a
ligeramente amarilla
, con pH entre
5,2 y 5,8.
4.
DATOS CLÍNICOS
4.1
INDICACIONES TERAPÉUTICAS
Melanoma
KEYTRUDA en monoterapia está indicado para el tratamiento
en
adultos y adolescentes
a partir de
12 años de edad con
melanoma avanzado (irresecable o metastásico).
KEYTRUDA en monoterapia está indicado para el tratamiento adyuvante
en adultos
y adolescentes
a
partir de 12 años de edad con
melanoma en estadio
IIB, IIC o III y
que hayan sido sometidos a
resección completa (ver sección
5.1).
Cáncer de pulmón no m
icrocítico (CPNM)
KEYTRUDA en monoterapia está indicado para el tratamiento adyuvante
en adultos con cáncer de
pulmón no microcítico con alto riesgo de
recidiva después de resección completa y quimioterapia
basada en platino (para los criterios de selección,
ver sección 5.1).
KEYTRUDA
en monoterapia
está indicado para el tratamiento
de primera línea
del cáncer de pulmón
no microcítico metastásico en adul
tos
cuyos tumores expres
en PD-L1
con una proporción de marcador
tumoral (TPS, por sus siglas en inglés)
≥
50%
sin mutaciones
tumorales positivas
de EGFR o ALK
.
KEYTRUDA, en combinación con pemetrexed y quimioterapia basada en
platino está indicado para el
tratamiento de primera l�