KEYTRUDA 100 MG4 ML

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

PEMBROLIZUMAB

Հասանելի է:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC կոդը:

L01FF02

Դեղագործական ձեւ:

CONCENTRATE FOR SOLUTION FOR INFUSION

Կազմը:

PEMBROLIZUMAB 25 MG/ML

Կառավարման երթուղին:

I.V

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

MERCK SHARP & DOHME LLC, USA

Թերապեւտիկ տարածք:

PEMBROLIZUMAB

Թերապեւտիկ ցուցումներ:

Melanoma• KEYTRUDA is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.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 paclitaxel protein-bound , 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 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 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 .• KEYTRUDA , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.Head and Neck Cancer• KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).• KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test .• KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy..Classical Hodgkin Lymphoma• KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).• KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapyPrimary Mediastinal large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.Limitation of Use: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.Urothelial Carcinoma• KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS ≥10) ] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. • KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.Microsatellite Instability-High CancerKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Limitation of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with MSI H central nervous system cancers have not been established. Gastric Cancer• KEYTRUDA, 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 (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a CPS ≥ 1.• KEYTRUDA ,as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or GEJ whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu targeted therapy.Cervical Cancer• KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test. • KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by a validated test.Biliary Tract CarcinomaKEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).Merkel Cell CarcinomaKEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).Renal Cell Carcinoma• KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).• KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.• KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.Non-Muscle Invasive Bladder Cancer (NMIBC)KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.Esophageal Cancer• KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (Siewert type I) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.Cutaneous Squamous Cell CarcinomaKEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiationMicrosatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).Tumor Mutational Burden-High CancerKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.Triple Negative Breast Cancer• KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by a validated test• KEYTRUDA is indicated for the treatment of patients with high risk early stage triple negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.Endometrial carcinomaKeytruda, 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 and who are not candidates for curative surgery or radiation.

Հաստատման ամսաթիվը:

2020-08-31

Տեղեկատվական թերթիկ

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) - 1986
This medicine is marketed upon physician’s prescription only
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.
In addition to the leaflet, KEYTRUDA has a ‘Patient Alert Card’
and a ‘Patient information Guide’. The card
and guide include important safety information, that you need to know
before starting and during the
treatment with KEYTRUDA and act accordingly. Read the Patient Alert
Card, Patient Information Guide
and the patient leaflet before you start using this medicine. Keep the
Patient Alert Card and Patient
Information Guide for further reference if needed.
1. WHAT KEYTRUDA IS INTENDED FOR?
KEYTRUDA is a prescription medicine used to treat:
•
skin cancer called melanoma. KEYTRUDA may be used in adults and
children 12 years of age and
older:
o
when your melanoma has spread or cannot be removed by surgery
(advanced melanoma), or
o
with Stage IIB, Stage IIC, or Stage III melanoma,
to help prevent melanoma from coming back after
it and lymph nodes that contain cancer have been removed by surgery.
•
lung cancer called non-small cell lung cancer (NSCLC).
o
KEYTRUDA may be used with the chemotherapy medicines pemetrexed and
carboplatin as your
first treatment when your lung cancer:

has spread (advanced NSCLC), and

is a type of lung cancer called “nonsquamous”, and

your tumor does not have an abnormal “EGFR” or “ALK” gene.
o
KEYTRUDA may be used with the chemotherapy medicines carboplatin and
eith

Ապրանքի հատկությունները

KEYTRUDA
®
100 MG/4 ML (
PEMBROLIZUMAB)
CONCENTRATE FOR S
OLUTION FOR INTRAVENO
US INFUSION
PATIENT ALERT CARD AND PATIENT INFOR
MATION GUIDE
The marketing of K
EYTRUDA
is subject to a risk management plan (RMP) including a 'Patient Alert
Card'
and a ‘Pati
ent
Information Guide’. The
'Patient Alert Card’ and 'Patient Information Guide’,
emphasize
important safety informa
tion that the patient shoul
d be aware of before and during treatment.
Please explain to the patient the need to review the card and guide b
efor
e starting treatment
.
1
THERAPEUTIC INDICATION
S
1.1
MELANOMA
KEYTRUDA (pembrolizumab) is indicated for the treatment of adult and
pediatric (12 years and older)
patients with unresectable or metastatic
melanoma.
KEYTRUDA is i
ndicated for the adj
uvant treatment of adult a
nd pediatric (12 years and older)
patients with
Stage IIB, IIC, or III melanoma
following complet
e resection.
1.2
NON-SMALL CELL LUNG CANCER
KEYTRUDA, in combi
na
tion with pemetrexed and carboplatin, is indicated f
or the first-line treatment of
patients with metastati
c nonsquamous non-small cell lung cancer (NSCLC) negative fo
r EGFR or ALK
genomic tumor aberrations
KEYTRUDA, in c
om
bination with carboplatin and
ei
ther paclitaxel or
paclitaxel protein
-bound, is indicated for
the first-line t
reatment of patients with metastatic sq
uamous NSCLC
KEYTRUDA, as a single agent, is indicated for the treatment of
patients with metastatic NSCLC whose
tumors express PD-L1 [Tu
mor Proportion Score (TPS) ≥5
0%)]
as determined by
a validated test
. Patients
with
EGFR or ALK genomic tumor aberrati
ons
shoul
d have disease progression on or after platinum
-
containing chemoth
erapy and an approved therapy for these aberrations prior to
rec
eiving KEYTRUDA
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 progres
sion on or after platinum
containing chemotherapy.
Patients with
EGFR or ALK genomic tumor aberrations