Keytruda 100mg Solution for Infusion

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

pembrolizumab

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

pembrolizumab

Unit dalam pakej:

1vial Vials

Dikeluarkan oleh:

SCHERING-PLOUGH LABO N.V.

Risalah maklumat

KEYTRUDA
®
P
embrolizumab
(100mg/4ml Solution for injection in Vial)
1
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
WHAT IS IN THIS LEAFLET
1.
What Keytruda is used for
2.
How Keytruda works
3.
Before you use
Keytruda
4.
How to use Keytruda
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Keytruda
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT KEYTRUDA IS USED FOR?
Keytruda is used to treat:

A kind of skin cancer called
melanoma in adults

A kind of lung cancer called non
-
small cell lung cancer
in adults

A
kind of head and neck cancer
called
head and neck squamous cell
carcinoma in adults

A kind of cancer calle
d classical
Hodgkin lymphoma in adults and
children

A kind of cancer called urothelial
carcinoma, including bladder cancer
,
in adults

A kind of cancer called colon or
rectal cancer in adults that is shown
by a laboratory test t
o be
microsatellite instability-high (MSI-
H) or mismatch repair
deficient
(dMMR)

A
kind of cancer called cervical
cancer in adult women

A kind of kidney
cancer called renal
cell carcinoma in adults

A kin
d of uterine cancer called
endometrial carcinoma in a
dult
women

A kind of cancer called eso
phageal
cancer in adults

A kind of cancer called triple-
negative breast cancer in adults
People get Keytruda wh
en their cancer
has spread or cannot be tak
en out by
surgery.
People get Keytruda after they had
surgery
to remove melanoma
or renal
cell carcinoma
to help prevent their
cancer from coming back.
People get Keytruda
before surgery to
treat triple negative breast cancer and
then continued after surgery to help
prevent their cancer from coming back.
Keytruda
may be given in combination
with other anti-cancer medicines. It is
important that you also rea
d the package
leaflets for these other
medicines. If you
hav
e any questions about
these
medicines
, please ask your doctor.
HOW KEYTRUDA WO
RKS
Keytruda contains
the active substance
pembrolizumab, which is a monoc

Ciri produk

LOCAL
PRODUCT CIRCULA
R
LPC-MK3475-IV-072022a_KN091
KEYTRUDA
® (
PEMBROLIZUMAB
)
INJECTION
I. THERAPEUTIC CLASS
KEYTRUDA (pembrolizumab) is an antineoplastic agent, monoclonal
antibody
.
II. COMPOSITION
IIA. ACTIVE INGREDIENTS
Pembrolizumab
IIB. INACTIVE INGREDIENTS
L-histidine
L-
histidine hydrochloride monohydrate
Sucrose
Polysorbate 80
Water for injection
III. CLINICAL PHARMACOLOGY
IIIA. MECHANISM OF ACTION
PD-1 is an immune-
checkpoint receptor
that limits the activity of T
lymphocytes in peripheral tissues. The
PD-
1 pathway is an immune control checkpoint that may be engaged by tumor
cells to inhibit active T
-cell
immune surveillance. KEYTRUDA is a high affinity antibody against
PD-1, which exerts dual ligand
blockade of the PD-1 pathway, including PD-L1 and PD-L2, on antigen
presenting or tumor cells. By
inhibiting the PD-1 receptor from binding to its ligands,
KEYTRUDA reactivates
tumor-specific cytotoxic T
lymphocyte
s in the tumor microenvironment and reactivates anti
-
tumor immunity.
IIIB. PHARMACOKINETICS
The
pharmacokinetics
of pembrolizumab was studied in 2993 patients with various cancers who
received
doses in the range of 1 to 10
mg/kg every 2
weeks, 2 to 10m
g/kg every 3 weeks
, or 200mg every 3 weeks
.
The
re are no clinically meaningful differences in
pharmacokinetics of pembrolizumab across indications.
IIIB-1. ABSORPTION
KEYTRUDA is dosed via the IV route and therefore is immediately and
completely bioava
ilable.
IIIB-2. DISTRIBUTION
Consistent with a limited extravascular distribution, the volume of
distribution
of pembrolizumab
at steady
state is small (6.0 L; c
oefficient of variation [CV]:
20
%). As expected for an antibody, pembrolizumab does
not
bind to plasma proteins in a specific manner.
IIIB-3. METABOLISM
KEYTRUDA
®
(PEMBROLIZUMAB)
LPC-MK3475-IV-072022a_KN091
INJECTION
Pembrolizumab
is catabolized through non-specific pathways; metabolism does not
contribute to its
clearance.
IIIB-4. ELIMINATION
Pembrolizumab
clearance (CV%) is
approximately
23% lower [geometric mean, 195 mL/day