KEYTRUDA 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:

25MG

Borang farmaseutikal:

SOLUTION

Komposisi:

PEMBROLIZUMAB 25MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

4ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0156910003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2016-08-09

Ciri produk

_KEYTRUDA® (pembrolizumab) _
_Page 1 of 282_
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.
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 Notice of
Compliance with conditions -
drug products web site:
https://www.canada.ca/en/health-canada/services/drugs-health-
products/drug-products/notice-compliance/conditions.html.
Keytruda, indicated for the:
•
Treatment of adult patients with unresectable or metastatic melanoma
who have not
received prior treatment with ipilimumab. Subjects with BRAF V600
mutant melanoma
may have received prior BRAF inhibitor therapy.
•
Treatment of adult patients with unresectable or metastatic melanoma
and disease
progression following ipilimumab therapy and, if BRAF V600 mutation
positive, following
a BRAF or MEK inhibitor.
•
Adjuvant treatment of adult and pediatric (12 years and older)
patients with Stage IIB or
IIC melanoma follo