Keytruda

Country: European Union

Language: Greek

Source: EMA (European Medicines Agency)

Active ingredient:

Pembrolizumab

Available from:

Merck Sharp & Dohme B.V.

ATC code:

L01FF02

INN (International Name):

pembrolizumab

Therapeutic group:

Αντινεοπλασματικοί παράγοντες

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 indications:

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. Ασθενείς με EGFR ή ALK θετική καρκινικών μεταλλάξεων θα πρέπει επίσης να έχουν λάβει στοχευμένη θεραπεία πριν από τη λήψη 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.

Product summary:

Revision: 54

Authorization status:

Εξουσιοδοτημένο

Authorization date:

2015-07-17

Patient Information leaflet

151
Β. ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ
152
Φύλλο οδηγιών χρήσης: Πληροφορίες για
τον ασθενή
KEYTRUDA 25 MG/ML
πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Πεμπρολιζουμάμπη
(
pembrolizumab
)
Διαβάστε προσεκτικά ολόκληρο το φύλλο
οδηγιών χρήσης πριν σας δοθεί αυτό το
φάρμακο,
διότι περιλαμβάνει σημαντικές
πληροφορίες για σας.
-
Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το διαβάσετε ξανά.
-
Είναι σημαντικό να φυλάξετε την κάρτα
μαζί σας κατά τη διάρκεια της
θεραπείας.
-
Εάν έχετε περαιτέρω απορίες, ρωτήστε
τον γιατρό
σας
.
-
Εάν παρατηρήσετε κάποια ανεπιθύμητη
ενέργεια, ενημερώστε
τον γιατρό σας. Αυτό ισχύει
και για κάθε πιθανή ανεπιθύμητη
ενέργεια που δεν αναφέρεται στο παρόν
φύλλο οδηγιών
χρήσης. Βλέπε παράγραφο
4.
Τι περιέχει το παρόν φύλλο οδηγιών
1.
Τι είναι το
KEYTRUDA
και ποια είναι η χρήση του
2.
Τι πρέπει να γνωρίζετε πριν σας δοθεί
το
K
EYTRUDA
3.
Πώς σας χορηγείται το
KEYTRUDA
4.
Πιθανές ανεπιθύμητες ενέργειες
5.
Πώς να φυλάσσετε
το
KEYTRUDA
6.
Περιεχόμενα
της συσκευασίας και λοιπές
πληροφορίες
1.
Τι είναι το
KEYTRUDA
και ποια είναι η χρήση του
Το
KEYTRUDA
περιέχει τη δραστική ουσία
πεμπρολιζουμάμπη
,
η οποία είναι ένα μονοκλωνικό
αντίσωμα. Τ

Summary of Product characteristics

1
ΠΑΡΑΡΤΗΜΑ Ι
ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ
ΠΡΟΪΟΝΤΟΣ
2
1.
ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ
KEYTRUDA
25 mg/ml
πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση.
2.
ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ
Ένα φιαλίδιο των 4
ml
πυκνού διαλύματος περιέχει 100
mg
πεμπρολιζουμάμπης
(
pembrolizumab
).
Κάθε
ml
πυκνού διαλύματος περιέχει 25
mg
πεμπρολιζουμάμπης
.
Η πεμπρολιζουμάμπη
είναι ένα εξανθρωποποιημένο
μονοκλωνικό αντίσωμα κατά του
προγραμματισμένου κυτταρικού θανάτου
-1 (PD-1) (IgG
4/ισότυπος κάππα με σταθεροποιητική
αλλαγή της αλληλουχίας στην περιοχή
Fc
) το οποίο παράγεται σε κύτταρα
ωοθήκης Κινεζικού
κρικητού (
Chinese hamster
) με τεχνολογία ανασυνδυασμένου
DNA.
Για τον πλήρη κατάλογο των εκδόχων, βλ.
παράγραφο
6.1.
3.
ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ
Πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση.
Διαυγές έως ελαφρώς ιριδίζον, άχρωμο
έως ελαφρώς κίτρινο διάλυμα, με
pH 5,2
–
5,8.
4.
ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ
4.1
Θεραπευτικές ενδείξεις
Μελάνωμα
Το
KEYTRUDA
,
ως μονοθεραπεία, ενδείκνυται ως αγωγή
σε ενήλικες και εφήβους ηλικίας 12
ετών
και άνω
με προχωρημένο (ανεγχείρητο ή
μεταστατικό) μελάνωμα
.
Το
KEYTRUDA
ως μονοθεραπεία, ενδείκνυται ως
επικουρική θεραπεία ενηλίκων κ�