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.
a kind of lung cancer called non-small cell lung cancer.
a kind of head and neck cancer called head and neck squamous cell carcinoma
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.
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 you.
This medicine is available only with a doctor's prescription.
Before you are given KEYTRUDA
You should not be given KEYTRUDA
If you are allergic to pembrolizumab or to any of the other ingredients listed at the end of this leaflet
KEYTRUDA should not be used in children below 18 years of age until more information becomes available.
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)
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 your doctor.
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 become pregnant.
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 your treatment.
When you get KEYTRUDA, you can have some serious side effects.
You may experience more than one side effect at the same time. These side effects can occur after treatment.
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 adrenal glands)
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)
shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
Signs and symptoms of infusion (IV) reactions
shortness of breath
itching or rash
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
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 your doctor.
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 in March 2017
Australian Register Numbers:
AUST R 226597
AUST R 263932