Keytruda

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Pembrolizumab

MAH:

Merck Sharp & Dohme B.V.

ATC_code:

L01FF02

INN:

pembrolizumab

therapeutic_group:

Antineoplastic agents

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 5.1).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. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving 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 5.1).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:

Authorised

authorization_date:

2015-07-17

PIL

133
B. PACKAGE LEAFLET
134
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KEYTRUDA
25 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
pembrolizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
It is important that you keep the
c
ard with you during treatment.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effec
ts not listed
in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
What KEYTRUDA is and what it is used for
2.
What you need to know before you are given KEYTRUDA
3.
How you are given KEYTRUDA
4.
Possible side effects
5.
How to store KEYTRUDA
6.
Contents of the pack and other information
1.
WHAT KEYTRUDA IS AND WHAT IT IS USED FOR
KEYTRUDA contains the active substance pembrolizumab,
which is
a monoclonal antibody
.
KEYTRUDA
works by helping your immune system fight your cancer.
KEYTRUDA is used in adults to treat:
•
a kind of skin cancer called melanoma
•
a kind of lung cancer called non
-
small cell lung cancer
•
a kind of cancer called classical Hodgkin lymphoma
•
a kind of cancer
called bladder cancer (urothelial carcinoma)
•
a kind of head and neck cancer called head and neck squamous cell
carcinoma.
•
a kind of kidney cancer called renal cell carcinoma
•
a kind of cancer that is determined to be microsatellite instability
-high (MSI-H)
or mismatch
repair deficient (dMMR) in the colon or rectum (called colorectal
cancer), uterus (called
endometrial cancer), stomach (called gastric cancer), small bowel
(called small intestine cancer),
or
bile duct or gallbladder (called biliary tract cance
r)
•
a kind of cancer called oesophageal carcinoma
•
a kind of breast cancer called triple
-
negative breast cancer
•
a kind of uterine cancer called endometrial carcinoma
•
a kind of cancer called cervical cancer
•
a kind
of stomach cancer called gastric or gastro
-oe
sophage

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
KEYTRUDA 25
mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 4
mL of
concentrate contains 100
mg of pembrolizumab.
Each
mL of concentrate contains 25
mg of
pembrolizumab
.
Pembrolizumab is a humanised monoclonal anti
-
programmed cell death
-1 (PD-1) antibody
(IgG4/kappa isotype with a stabilising sequence alteration in the Fc
region) produced in Chinese
hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to slightly yell
ow solution,
pH 5.2
–
5.8.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
KEYTRUDA 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
III melanoma and who have undergone complete resection
(see section 5.1).
Non-small cell lung c
arcinoma (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
5.1).
KEYTRUD
A 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