KEYTRUDA POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PEMBROLIZUMAB

Boleh didapati daripada:

MERCK CANADA INC

Kod ATC:

L01FF02

INN (Nama Antarabangsa):

PEMBROLIZUMAB

Dos:

50MG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

PEMBROLIZUMAB 50MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

2.3ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0156910001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-12-04

Ciri produk

_KEYTRUDA® (pembrolizumab) _
_Page 1 of 248_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
KEYTRUDA®
pembrolizumab
solution for infusion 100 mg/4 mL vial
Antineoplastic agent, monoclonal antibody
KEYTRUDA®, indicated for:
•
Adult and pediatric patients with refractory or relapsed classical
Hodgkin Lymphoma
(cHL), as monotherapy, who have failed autologous stem cell transplant
(ASCT) or who
are not candidates for multi-agent salvage chemotherapy and ASCT.
•
Adult and pediatric patients with refractory Primary Mediastinal
B-cell Lymphoma
(PMBCL) or who have relapsed after 2 or more lines of therapy, as
monotherapy.
•
Adult patients with locally advanced unresectable or metastatic
urothelial carcinoma, as
monotherapy, who are not eligible for any platinum-containing
chemotherapy.
•
Adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive,
high-risk, non-muscle
invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or
without papillary
tumours who are ineligible for or have elected not to undergo
cystectomy.
•
Adult patients with unresectable or metastatic microsatellite
instability-high (MSI-H) or
mismatch repair deficient (dMMR)
o
colorectal cancer whose tumours have progressed following treatment
with a
fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy, or
o
endometrial cancer whose tumours have progressed following prior
therapy and
who have no satisfactory alternative treatment options, as
monotherapy.
•
Adult patients in combination with lenvatinib with advanced
endometrial carcinoma that
is not microsatellite instability high (MSI-H) or mismatch repair
deficient (dMMR), who
have disease progression following prior platinum-based systemic
therapy, and are not
candidates for curative surgery or radiation.
has been issued market authorization WITH CONDITIONS, pending the
results of trials to verify its
clinical benefit. Patients should be advised of the nature of the
authorization. For further
information for KEYTRUDA® please refer to Health Canada’s No