Keytruda

Riik: Euroopa Liit

keel: portugali

Allikas: EMA (European Medicines Agency)

Toimeaine:

Pembrolizumab

Saadav alates:

Merck Sharp & Dohme B.V.

ATC kood:

L01FF02

INN (Rahvusvaheline Nimetus):

pembrolizumab

Terapeutiline rühm:

Agentes antineoplásicos

Terapeutiline ala:

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

Näidustused:

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. Pacientes com EGFR ou ALK positivo tumor mutações também deve ter recebido a terapia direcionada antes de receber 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.

Toote kokkuvõte:

Revision: 54

Volitamisolek:

Autorizado

Loa andmise kuupäev:

2015-07-17

Infovoldik

1
ANEXO I
RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO
2
1.
NOME DO MEDICAMENTO
K
EYTRUDA
25 mg/ml
concentrado para solução para perfusão.
2.
COMPOSIÇÃ
O QUALIT
ATIVA E QUA
NTITATIV
A
Um frasco para injetáveis de 4 ml de concentrado contém 100
mg de pembrolizum
ab.
Cada ml de concentrado contém 25
mg de pembrolizumab.
O pembrolizumab é
u
m anticorpo monoclonal humanizado, anti
r
recetor da proteín
a de morte
programada-1 (PD-1) (isótopo IgG4/kapp
a com uma alte
ração de sequ
ência
estabilizadora n
a região Fc)
produzido e
m células de o
vário de hamster chinês por tecnologia de ADN recombinante.
L
ista completa de excipientes, ver secção
6.1.
3.
FORMA FARMACÊUTICA
Concentrado para solução para perfusão.
Solução
transparente a
lige
iramente opalesce
nte,
incolor a amare
lo-pálido, pH 5,2
–
5,8.
4.
INFORMAÇÕES CLÍNICAS
4.1
INDICAÇÕES TERAPÊUTICA
S
Melanoma
K
EYTRUDA em monoterapia
é
indicado para o tra
tamento de adultos e adolescentes com idade igual ou
superior a 12 anos com melanoma avançado (irressecável ou
metastático).
KEYTRUDA
em monoterapia
é indicado para o tratamento adjuvante
de adultos
e adolescentes com idade
igual ou superior a
12 anos com melanoma em estadio IIB, IIC ou III que fo
ram submetidos a resse
cção
completa (ver secção 5.1).
Carcinoma do pulmão de células não-
pequenas (CPCNP)
KEYTRUDA
em monoterapia é indicado para o tratamento adjuvante de adultos com
carcinoma do
pulmão de células não
-pequenas
com risco elevado de re
c
orrência após ressecção
completa e
quimioterapia co
ntendo platina (
para critérios de
sele
ção, ver secção
5.1).
KEYTRUDA
em monoterapia
é in
dicado para o trat
amento em prim
eira linha do
carcinoma do p
ulmão de
células não-pequenas meta
stático em adultos cujos
tumores expressam PD
-L1 co
m proporção d
e
marcação das células tumorais (TPS - tumour pr
oportion score
) ≥
50% sem
mutações tumor
ais positivas
EGFR ou ALK.
KEYTRUDA em co
mbinação com quimiot
erapia contendo pl
atina e pemetrexedo
é

Toote omadused

1
ANEXO I
RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO
2
1.
NOME DO MEDICAMENTO
K
EYTRUDA
25 mg/ml
concentrado para solução para perfusão.
2.
COMPOSIÇÃ
O QUALIT
ATIVA E QUA
NTITATIV
A
Um frasco para injetáveis de 4 ml de concentrado contém 100
mg de pembrolizum
ab.
Cada ml de concentrado contém 25
mg de pembrolizumab.
O pembrolizumab é
u
m anticorpo monoclonal humanizado, anti
r
recetor da proteín
a de morte
programada-1 (PD-1) (isótopo IgG4/kapp
a com uma alte
ração de sequ
ência
estabilizadora n
a região Fc)
produzido e
m células de o
vário de hamster chinês por tecnologia de ADN recombinante.
L
ista completa de excipientes, ver secção
6.1.
3.
FORMA FARMACÊUTICA
Concentrado para solução para perfusão.
Solução
transparente a
lige
iramente opalesce
nte,
incolor a amare
lo-pálido, pH 5,2
–
5,8.
4.
INFORMAÇÕES CLÍNICAS
4.1
INDICAÇÕES TERAPÊUTICA
S
Melanoma
K
EYTRUDA em monoterapia
é
indicado para o tra
tamento de adultos e adolescentes com idade igual ou
superior a 12 anos com melanoma avançado (irressecável ou
metastático).
KEYTRUDA
em monoterapia
é indicado para o tratamento adjuvante
de adultos
e adolescentes com idade
igual ou superior a
12 anos com melanoma em estadio IIB, IIC ou III que fo
ram submetidos a resse
cção
completa (ver secção 5.1).
Carcinoma do pulmão de células não-
pequenas (CPCNP)
KEYTRUDA
em monoterapia é indicado para o tratamento adjuvante de adultos com
carcinoma do
pulmão de células não
-pequenas
com risco elevado de re
c
orrência após ressecção
completa e
quimioterapia co
ntendo platina (
para critérios de
sele
ção, ver secção
5.1).
KEYTRUDA
em monoterapia
é in
dicado para o trat
amento em prim
eira linha do
carcinoma do p
ulmão de
células não-pequenas meta
stático em adultos cujos
tumores expressam PD
-L1 co
m proporção d
e
marcação das células tumorais (TPS - tumour pr
oportion score
) ≥
50% sem
mutações tumor
ais positivas
EGFR ou ALK.
KEYTRUDA em co
mbinação com quimiot
erapia contendo pl
atina e pemetrexedo
é