Oct 01, 2018
  Oct 01, 2018

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
a kind of cancer called classical Hodgkin Lymphoma
a kind of cancer called urothelial carcinoma, including bladder cancer
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.
KEYTRUDA may be given in combination with chemotherapy medicines called pemetrexed and either carboplatin or cisplatin. It is important that you also read the Consumer Medicine Information for these medicines. If you have any questions about pemetrexed, carboplatin, or cisplatin please ask your doctor.
This medicine is available only with a doctor's prescription.

Before you are given KEYTRUDA

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) 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 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.

Side Effects

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.
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
chest pain
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
dark urine
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
weight loss
increased sweating
weight gain
hair loss
feeling cold
your voice gets deeper
muscle aches
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
weight loss
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)
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 a transplant
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)
diarrhoea, nausea
itching, rash
joint pain
back pain
feeling tired
patches of skin which have lost colour
stomach pain
decreased sodium levels in the blood
infections of the upper respiratory tract
The following side effects have been reported in more than 1 in 5 people when KEYTRUDA was given in combination with chemotherapy:
feeling tired
nausea, vomiting, diarrhoea
shortness of breath
rash, itching
hair loss
infections of the upper respiratory tract
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.

Product Description

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.


Active ingredient:
Inactive ingredients:
Histidine hydrochloride monohydrate
Water for Injections