KEYTRUDA SOLUTION FOR INFUSION 25MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Pembrolizumab

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

L01FF02

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Pembrolizumab 25.0 mg/mL

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

MSD International GmbH T/A MSD Ireland (Carlow)

Authorization status:

ACTIVE

Authorization date:

2015-10-27

Patient Information leaflet

1
Your Guide to KEYTRUDA®
(pembrolizumab)
25 mg/mL
Solution for Infusion
Important safety information to minimise the risk of immune-related
adverse reactions
Information for Patients
If you experience any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this brochure.
2
Introduction
Your doctor has prescribed KEYTRUDA (pembrolizumab) to treat your
cancer.
KEYTRUDA may be given in combination with chemotherapy medicines. It
is important that you
also read the package leaflets for the specific chemotherapy
medicines. If you have any questions
these medicines, please ask your doctor.
This brochure will serve as a guide to your treatment, including what
to expect while you are
taking this medicine.
This guide will explain some of the side effects that might occur
while you undergo treatment with
KEYTRUDA, and how to check for them. You will also learn why it is
important to report any
symptoms to your doctor right away.
3
About KEYTRUDA (pembrolizumab)
KEYTRUDA is a type of therapy that works by helping your immune system
fight your cancer.
This treatment may have side effects.
Before you start KEYTRUDA
Tell your doctor about any medicines that you are taking, have
recently taken, or might take.
Make sure your doctor knows if you:
•
Have an autoimmune disease (a condition where the body attacks its own
cells)
•
Have pneumonia or inflammation of the lungs (called pneumonitis)
•
Were previously given ipilimumab, another medicine for treating a
selected type of cancer,
and experienced serious side effects because of that medicine
•
Had an allergic reaction to other monoclonal antibody therapies
•
Have or have had chronic viral infection of the liver, including
hepatitis B (HBV) or hepatitis
C (HCV)
•
Have human immunodeficiency virus (HIV) infection or acquired immune
deficiency
syndrome (AIDS)
•
Have liver damage
•
Have kidney damage
•
Are taking other medicines that make your immune system weak. Examples
of these
include corticosteroids s

Summary of Product characteristics

S-CCDS-MK3475-IV-112023
KEYTRUDA® (pembrolizumab)
Solution for Infusion
25
mg/mL
1.
INDICATIONS AND USAGE
Melanoma
KEYTRUDA
(pembrolizumab)
is
indicated
for
the
treatment
of
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 who have undergone complete
resection.
Non-Small Cell Lung Carcinoma
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is
indicated for the first-
line treatment of patients with metastatic non-squamous non-small cell
lung carcinoma (NSCLC), with
no 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 monotherapy is indicated for the first-line treatment of
patients with metastatic
NSCLC whose tumors express PD-L1 with a ≥ 50% tumor proportion score
(TPS) as determined by a
validated test, with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA as monotherapy is indicated for the treatment of patients
with locally advanced or
metastatic NSCLC whose tumors express PD-L1 with a ≥ 1% TPS as
determined by a validated test
and who have received platinum-containing chemotherapy. Patients with
EGFR or ALK genomic
tumor
aberrations
should
have
received
prior
therapy
for
these
aberrations
prior
to
receiving
KEYTRUDA.
KEYTRUDA, as monotherapy, is indicated as adjuvant treatment following
resection and platinum-
based chemotherapy for adults patients with Stage IB (T2a ≥ 4 cm),
II, or IIIA NSCLC.
Head and Neck Cancer
KEYTRUDA, as monotherapy or in combination with platinum and
5-fluorouracil (5-FU) chemotherapy,
is indicated for the first line treatment of patients with metastatic
or unresectable recurrent head and
neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 with
a CPS ≥ 1.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pedi