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.
This medicine has provisional registration in Australia for unresectable or metastatic,
microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer.
The decision to provisionally register this new use 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 this
powder for injection and concentrated injection
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 deficient (dMMR).
It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancers
of the brain or spinal cord (central nervous system cancers).
Note: KEYTRUDA is approved for head and neck cancer on the basis of limited, early
clinical trial results. An ongoing trial is being conducted to establish safety, survival
and quality of life outcomes.
KEYTRUDA contains the active substance pembrolizumab.
Adults get KEYTRUDA when their cancer has spread or cannot be taken out by surgery.
Adults get KEYTRUDA after they had surgery to remove melanoma to help prevent their
cancer from coming back.
KEYTRUDA works by helping your immune system fight your cancer.
Ask your doctor if you have any questions about why KEYTRUDA has been prescribed for
KEYTRUDA may be given in combination with chemotherapy medicines. It is important
that you also read the Consumer Medicine Information for these medicines. If you have
any questions about the specific chemotherapy medicines, please ask your doctor.
This medicine is available only with a doctor's prescription.
Before you are given KEYTRUDA
KEYTRUDA can be used in children with primary mediastinal B-cell lymphoma.
Before you are given KEYTRUDA
Tell your doctor if you:
have a disease of your immune system like Crohn's, ulcerative colitis or lupus
had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant
that used donor stem cells (allogeneic)
have pneumonia or swelling of your lungs (called pneumonitis)
have liver damage
If you are pregnant, think you may be pregnant or are planning to have a baby, tell
KEYTRUDA can cause harm or death to your unborn baby.
You must use effective contraception while you are being treated with KEYTRUDA and
for at least 4 months after the last dose of KEYTRUDA if you are a woman who could
If you are breastfeeding, tell your doctor.
Do not breastfeed while taking KEYTRUDA.
Taking other medicines
Tell your doctor if you
are taking any other medicines, including medicines that you buy without a prescription
from your pharmacy, supermarket or health food shop
take other medicines that make your immune system weak. Examples of these may include
steroids, such as prednisone.
How KEYTRUDA is given
Your doctor will give you KEYTRUDA through an IV for about 30 minutes.
Most people get KEYTRUDA every 3 weeks.
Your doctor will decide how many treatments you need.
If you miss a dose
Call your doctor right away to reschedule your appointment.
It is very important that you do not miss a dose of this medicine.
While you are being treated with KEYTRUDA
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given KEYTRUDA.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given KEYTRUDA.
Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and will explain the risks and benefits of
When you get KEYTRUDA, you can have some serious side effects.
These side effects can sometimes become life-threatening and can lead to death. These
side effects may happen anytime during treatment or even after your treatment has
ended. You may experience more than one side effect at the same time.
If you have any of the following symptoms, call or see your doctor right away.
Signs and symptoms of lung problems
shortness of breath
Signs and symptoms of problems with your intestines
diarrhoea or more bowel movements than usual
your stools are black, tarry, sticky or have blood or mucus
severe stomach pain or tenderness
Signs and symptoms of liver problems
nausea or vomiting
feeling less hungry
pain on the right side of your stomach
your skin looks yellow
the whites of your eyes look yellow
you bleed or bruise more easily than normal
Signs and symptoms of kidney problems
changes in the amount or colour of your urine
Signs and symptoms of hormone gland problems (especially the thyroid, pituitary, and
rapid heart beat
your voice gets deeper
dizziness or fainting
headaches that will not go away or unusual headache
Signs and symptoms of blood sugar problems
feeling more hungry or thirsty
needing to urinate more often
Signs and symptoms of skin problems
skin blistering, peeling or sores
ulcers in mouth or in lining of nose, throat, or genital area
Signs and symptoms of problems in other organs
muscle pain or weakness
changes in eyesight
stomach area pain with nausea and vomiting (pancreatitis)
confusion, fever, memory problems, or seizures (encephalitis)
swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis)
shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
inflammation of the heart muscle, which may present as shortness of breath, irregular
heartbeat, feeling tired, or chest pain (pericarditis)
inflammation of the covering of the heart and accumulation of fluid around the heart
inflammation of the nerves that may cause pain, weakness, and paralysis in the arms
and legs (peripheral neuropathy)
Signs and symptoms of infusion (IV) reactions
shortness of breath
itching or rash
There are possible side effects of treatment with KEYTRUDA in people who have received
Rejection of a transplanted organ.
People who have had an organ transplant may have an increased risk of organ transplant
rejection. Your doctor should tell you what signs and symptoms you should report and
monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host-disease (GVHD), in people with bone marrow
(stem cell) transplant that uses donor stem cells (allogeneic).
These complications can be severe and can lead to death. They may occur if you had
this kind of transplant in the past or if you get it in the future. Your doctor will
monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal
pain, and diarrhoea.
The following side effects have been reported in clinical trials:
Very common (may affect more than 1 in 10 people)
patches of skin which have lost colour
decreased sodium levels in the blood
infections of the upper respiratory tract
a decreased number of white blood cells (which are important in fighting infection)
in patients with primary mediastinal B-cell lymphoma
The following side effects have been reported in more than 1 in 5 people when KEYTRUDA
was given in combination with chemotherapy:
decrease in white blood cell count
The most common side effects when KEYTRUDA is given to children are:
Less common side effects can happen.
Also, your doctor may do blood tests to check for side effects.
KEYTRUDA may cause other side effects that are not listed. For more information, ask
If you have any side effect that bothers you or that does not go away, tell your doctor.
Ask your doctor to answer any questions you may have.
It is unlikely that you will be asked to store KEYTRUDA yourself. It will usually
be stored in the pharmacy or on the ward.
What it looks like
KEYTRUDA powder for injection comes as a white to off-white powder in a glass vial.
KEYTRUDA concentrated injection comes as a clear to slightly opalescent, colourless
to slightly yellow solution in a glass vial.
Histidine hydrochloride monohydrate
Water for Injections
KEYTRUDA is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113, AUSTRALIA
This leaflet was prepared 12 July 2019
Australian Register Numbers:
AUST R 226597 - KEYTRUDA 50mg Powder for injection
AUST R 263932 - KEYTRUDA 100mg/4mL concentrated injection