Keytruda

Valsts: Eiropas Savienība

Valoda: maltiešu

Klimata pārmaiņas: EMA (European Medicines Agency)

Aktīvā sastāvdaļa:

Pembrolizumab

Pieejams no:

Merck Sharp & Dohme B.V.

ATĶ kods:

L01FF02

SNN (starptautisko nepatentēto nosaukumu):

pembrolizumab

Ārstniecības grupa:

Aġenti antineoplastiċi

Ārstniecības joma:

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

Ārstēšanas norādes:

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. Pazjenti b'EGFR jew ALKALINI pożittivi tat-tumur mutazzjonijiet għandu wkoll rċevew terapija immirata qabel ma tirċievi 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.

Produktu pārskats:

Revision: 54

Autorizācija statuss:

Awtorizzat

Autorizācija datums:

2015-07-17

Lietošanas instrukcija

138
B. FULJETT TA’ TAGĦRIF
139
Fuljett ta’ tagħrif
:
Informazzjoni għall
-PAZJENT
KEYTRUDA 25
mg/mL konċentrat għal soluzzjoni għall
-
infużjoni
pembrolizumab
AQRA SEW DAN
IL-
fuljett kollu qabel tibda tingħata din il
-
mediċina peress li fih informazzjoni
importanti għalik
.
-
Żomm dan il
-
fuljett. Jista’ jkollok bżonn terġa’ taqrah
.
-
Huwa importanti li żżomm il
-
kard miegħek waqt it
-trattament.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit
-
tabib tiegħek
.
-
Jekk ikollok xi effett sekondarju kellem lit
-
tabib tiegħek
.
Dan jinkludi xi effett sekondarju
possibbli li mhuwiex elenkat f’dan il
-ful
jett. Ara sezzjoni
4.
F’dan il
-FULJETT:
1.
X’inhu
KEYTRUDA
u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tingħata
KEYTRUDA
3.
Kif se tingħata KEYTRUDA
4.
Effetti sekondarji possibbli
5.
Kif taħżen
KEYTRUDA
6.
Kontenut tal
-
pakkett u informazzjoni oħra
1.
X’inhu KEYTRUDA u għalxiex jintuża
KEYTRUDA fih is
-
sustanza attiva pembrolizumab, li huwa antikorp monoklonali. KEYTRUDA
jaħdem billi jgħin lis
-
sistema immuni tiegħek tiġġieled il
-
kanċer.
KEYTRUDA jintuża fl
-
adulti għat
-
trattament ta’
:
•
tip ta’ kanċer tal
-
ġilda msejjaħ melanoma
•
tip ta’ kanċer tal
-
pulmun imsejjaħ kanċer tal
-
pulmun mhux taċ
-
ċelluli ż
-
żgħar
•
tip ta’ kanċer imsejjaħ limfoma klassika ta’
Hodgkin
•
tip ta’ kanċer imsejjaħ kanċer tal
-
bużżieqa tal
-
awrina (karċinoma uroteljali)
•
tip ta’ kanċe
r tar-ras u l-
għonq imsejjaħ karċinoma taċ
-
ċelluli skwamużi tar
-ras u l-
għonq
•
tip ta’ kanċer tal
-
kliewi msejjaħ karċinoma taċ
-
ċelluli tal
-kliewi
•
tip ta’ kanċer determinat li jkollu instabilità mikrosatellita
kbira (MSI
-
H microsatellite
instability-high) je
w nuqqas ta’ tiswija tal
-
pari jew ta’ partijiet tad
-
DNA mhux imqabbla
(dMMR, mismatch repair deficient)
fil-musrana l-
kbira jew fir
-rektum
(imsejjaħ kanċer tal
-
musrana l-
kbira jew tar
-rektum), fl-utru (im
sejjaħ kanċer tal
-
endo

Produkta apraksts

1
ANNESS I
SOMMARJU TAL
-
KARATTERISTIĊI TAL
-PRODOTT
2
1.
ISEM IL-
PRODOTT MEDIĊINALI
KEYTRUDA 25
mg/mL konċentrat għal soluzzjoni għall
-
infużjoni
.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kunjett wieħed ta’
4
mL ta’ konċentrat fih 100
mg
ta’ pembrolizumab.
Kull mL ta’ konċentrat ikun fih 25
mg ta’ pembrolizumab.
Pembrolizumab huwa antikorp monoklonali umanizzat kontra mewt
iprogrammat taċ
-
ċellula
-1 (PD-1-
programmed cell death
-1)
(isotip IgG4/kappa b’modifikazzjoni fis
-
sekwenza biex tistabilizza fiż
-
żona
Fc) magħmul f’ċelluli tal
-ovarju tal-
ħamster Ċiniż permezz ta’ teknoloġija tad
-
DNA rikombinanti.
Għal
-
lista sħiħa ta’ eċċipjenti, ara sezzjoni
6.1.
3.
GĦAMLA FARMAĊEWTIKA
Konċentrat għal soluzzjoni għall
-
infużjoni.
Soluzzjoni ċara sa ftit tkanġi, minn bla kulur sa kemxejn safra,
pH 5.2
–
5.8.
4.
TAGĦRIF KLINIKU
4.1
Indikazzjonijiet terapewtiċi
Melanoma
KEYTRUDA bħala monoterapija huwa indikat għat
-
trattament ta’
adulti u adolexxenti
b’età ta’
12-il
sena u aktar b’melanoma avvanzata (li ma tistax titneħħa
b’operazzjoni jew li hija metastatika).
KEYTRUDA
bħala monoterapija huwa indikat għat
-trattament
addizzjonali
ta’ adulti
u adolexxenti
b’età ta’ 12
-il
sena u aktar
b’melanoma ta’ Stadju
IIB, IIC jew
III u li sari
tilhom operazzjoni bi
tneħħija sħiħa tat
-tumur
(ara sezzjoni
5.1).
Karċinoma tal
-
pulmun mhux taċ
-
ċelluli ż
-
żgħar (NSCLC
- non-
small cell lung carcinoma
)
KEYTRUDA bħala monoterapija huwa indikat għat
-
trattament addizzjonali ta’ adulti b’karċinoma tal
-
pulm
un mhux taċ
-
ċelluli ż
-
żgħar li huma f’riskju għoli ta’ rikorrenza wara tneħħija
kompluta
b’operazzjoni u kimoterapija abbażi tal
-
platinum (għall
-
kriterji ta’ għażla, ara sezzjoni
5.1).
KEYTRUDA bħala monoterapija huwa indikat bħala t
-
trattament preferut t
a’ karċinoma tal
-pulmun
mhux taċ
-
ċelluli ż
-
żgħar metastatika f’adulti li t
-
tumuri tagħhom jesprimu PD
-
L1 b’punteġ