KEYTRUDA 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEMBROLIZUMAB

Available from:

MERCK SHARP & DOHME ISRAEL LTD

ATC code:

L01XC18

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

PEMBROLIZUMAB 50 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME CORP., USA

Therapeutic area:

PEMBROLIZUMAB

Therapeutic indications:

- Melanoma:Keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.- Non-Small Cell Lung Cancer:• KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) negative for EGFR or ALK genomic tumor aberrations.• KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. • Keytruda, as a single agent, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as determined by a validated test. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving Keytruda.• Keytruda, as a single agent, is indic

Authorization date:

2015-02-12

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be supplied upon physician’s prescription only
KEYTRUDA
® 50 MG
POWDER FOR SOLUTION FOR
INTRAVENOUS INFUSION
Each vial contains:
Pembrolizumab 50 mg
KEYTRUDA
® 100
MG/4 ML
CONCENTRATE FOR SOLUTION FOR
INTRAVENOUS INFUSION
Each vial contains:
Pembrolizumab 100 mg
For a list of inactive ingredients see section 6.1 "What KEYTRUDA
contains".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

This leaflet contains concise information about KEYTRUDA. If you have
any further questions, refer to
your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
1. WHAT KEYTRUDA IS AND WHAT IT IS USED FOR?
KEYTRUDA is a prescription medicine used to treat:

skin cancer called melanoma. KEYTRUDA may be used when your melanoma
has spread or cannot
be removed by surgery (advanced melanoma).

lung cancer called non-small cell lung cancer (NSCLC). KEYTRUDA may be
used when your lung
cancer:
o
has spread (advanced NSCLC) AND,
o
tests positive for “PD-L1” AND,

you have not received chemotherapy to treat your advanced NSCLC and
your tumor does not
have an abnormal “EGFR” or “ALK” gene, OR

you have received chemotherapy that contains platinum to treat your
advanced NSCLC, and it
did not work or it is no longer working, AND

if your tumor has an abnormal “EGFR” or “ALK” gene, you have
also received an EGFR or ALK
inhibitor medicine and it did not work or is no longer working.

head and neck squamous cells cancer (HNSCC). KEYTRUDA may be used when
your HNSCC:
o
has returned or spread (advanced HNSCC) AND
o
you have received chemotherapy that contains platinum to treat your
advanced HNSCC, and it did
not work or is no longer working.

cancer called classical Hodgkin lymphoma (cHL) in adults and children
when:
o
you have tried a treatment and it did

Summary of Product characteristics

KEYTRUDA
® 50 MG (PEMBROLIZUMAB) KEYTRUDA
®
100 MG/4 ML (PEMBROLIZUMAB)
POWDER FOR SOLUTION FOR INTRAVENOUS INFUSION CONCENTRATE FOR SOLUTION
FOR INTRAVENOUS INFUSION
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
1.1
MELANOMA
KEYTRUDA (pembrolizumab) is indicated for the treatment of patients
with unresectable or metastatic
melanoma
_[see Clinical Studies (14.1)]_.
1.2
NON-SMALL CELL LUNG CANCER
KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated
for the first-line treatment of
patients with metastatic nonsquamous non-small cell lung cancer
(NSCLC) negative for EGFR or ALK
genomic tumor aberrations _[see Clinical Studies (14.2)]_.
KEYTRUDA, in combination with carboplatin and either paclitaxel or
nab-paclitaxel, is indicated for the first-
line treatment of patients with metastatic squamous NSCLC _[see
Clinical Studies (14.2)]_.
KEYTRUDA, as a single agent, is indicated for the treatment of
patients with metastatic NSCLC whose
tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as
determined by
a validated test. Patients
with EGFR or ALK genomic tumor aberrations
should have disease progression on or after platinum-
containing chemotherapy and an approved therapy for these aberrations
prior to receiving KEYTRUDA
_[see Clinical Studies (14.2)]_.
_ _
KEYTRUDA, as a single agent, is indicated for the treatment of
patients with advanced NSCLC whose
tumors express PD-L1 as determined by a validated test, with disease
progression on or after platinum
containing chemotherapy. Patients with EGFR or ALK genomic tumor
aberrations should have disease
progression on approved therapy for these aberrations prior to
receiving KEYTRUDA _[see Clinical Studies _
_(14.2)]_.
1.3
HEAD AND NECK CANCER
KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic head and neck squamous
cell carcinoma (HNSCC) with disease progression on or after
platinum-containing chemotherapy _[see _
_Clinical Studies (14.3)]_.
1.4 CLASSICAL HODGKIN LYMPHOMA
KEYTRUDA is indicated for the treatment