KEYTRUDA pembrolizumab (rch) 50 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pembrolizumab

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

pembrolizumab

Authorization status:

REPI

Patient Information leaflet

THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING DUE TO PROVISIONAL
APPROVAL OF AN EXTENSION OF INDICATION. THIS
WILL ALLOW QUICK IDENTIFICATION OF NEW SAFETY INFORMATION. YOU CAN
HELP BY REPORTING ANY SIDE EFFECTS YOU MAY GET.
YOU CAN REPORT SIDE EFFECTS TO YOUR DOCTOR, OR DIRECTLY AT
WWW.TGA.GOV.AU/REPORTING-PROBLEMS.
KEYTRUDA
®
THIS MEDICINE HAS PROVISIONAL REGISTRATION IN AUSTRALIA FOR
UNRESECTABLE OR METASTATIC, MICROSATELLITE INSTABILITY-HIGH
(MSI-H) OR MISMATCH REPAIR DEFICIENT (DMMR) CANCER AND ENDOMETRIAL
CARCINOMA. THE DECISION TO PROVISIONALLY
REGISTER THESE NEW USES OF THE MEDICINE HAS BEEN MADE ON THE BASIS OF
PROMISING RESULTS FROM PRELIMINARY STUDIES. MORE
EVIDENCE IS REQUIRED TO BE SUBMITTED WHEN AVAILABLE TO SUBSTANTIATE
THE BENEFIT OF THE MEDICINE FOR THESE USES.
_POWDER FOR INJECTION AND CONCENTRATED INJECTION_
_pembrolizumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KEYTRUDA. It
does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using KEYTRUDA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
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 called classical
Hodgkin Lymphoma in adults.
•
a kind of cancer called primary
mediastinal B-cell lymphoma in
adults and children.
•
a kind of cancer called urothelial
carcinoma, including bladder
cancer in adults.
•
a kind of cancer in adults and
children that can occur in any part
of the body and is shown by
laboratory tests to be
microsatellite instability-high
(MSI-H) or mismatch repair
defic

Summary of Product characteristics

1
This medicinal product is subject to additional monitoring in
Australia due to provisional
approval of an extension of indication. This will allow quick
identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – KEYTRUDA
®
(PEMBROLIZUMAB (RCH))
1 NAME OF THE MEDICINE
pembrolizumab (rch)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
KEYTRUDA
® 50 MG POWDER FOR INJECTION
One vial contains 50 mg of pembrolizumab.
After reconstitution, 1 mL of solution contains 25 mg of
pembrolizumab.
KEYTRUDA
® 100 MG/4 ML CONCENTRATED INJECTION
One vial contains 100 mg of pembrolizumab in 4 mL of solution.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
KEYTRUDA
® 50 MG POWDER FOR INJECTION
KEYTRUDA 50 mg powder for injection is a sterile, preservative-free,
white to off-white
lyophilised powder.
Not
for
direct
infusion
or
injection
(see
Section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION).
KEYTRUDA
® 100 MG/4 ML CONCENTRATED INJECTION
KEYTRUDA 100 mg/4 mL concentrated injection is a sterile,
preservative-free, clear to slightly
opalescent, colourless to slightly yellow solution.
Not
for
direct
infusion
or
injection
(see
Section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Melanoma
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the treatment of
unresectable
or metastatic melanoma in adults.
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the adjuvant treatment
of
patients with melanoma with lymph node involvement who have undergone
complete
▼

2
resection.
Non-small cell lung cancer (NSCLC)
KEYTRUDA
®
(pembrolizumab), in combination with pemetrexed and platinum
chemotherapy,
is indicated for the first-line treatment of patients with metastatic
non-squamous NSCLC, with
no EGFR or ALK genomic tumour aberrations.
KEYTRUDA
®
(pembrolizumab), in combination with carboplatin and either paclita