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Keytruda

powder for solution for infusion and solution for infusion

pembrolizumab
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Keytruda. It does not contain all the information that is known about Keytruda. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What KEYTRUDA is used for

KEYTRUDA is used to treat a kind of skin cancer called melanoma.
KEYTRUDA contains the active substance pembrolizumab.
Adults get KEYTRUDA when their skin 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

Pregnancy

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.

Breast-feeding

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.
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
chest pain
coughing
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
constipation
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 problems in other organs
Rash
Muscle pain or weakness
Changes in eyesight
Signs and symptoms of infusion (IV) reactions
Shortness of breath
itching or rash
dizziness
fever
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
feeling tired
cough
Common (may affect up to 1 in 10 people)
inflammation of the nose and throat
underactive function of the thyroid
feeling less hungry
dizziness, headache
shortness of breath
stomach pain, constipation, vomiting
redness of the skin, patches of skin which have lost colour
back pain, muscle aches, pain in arms or legs
unusual tiredness or weakness, chills, swelling of the legs or arms, fever
decrease in the number of red blood cells
KEYTRUDA may cause less common side effects such as changes in urine.
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.

Storage

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 solution for infusion comes as a white to off-white powder in a glass vial. KEYTRUDA solution for infusion comes as a clear to slightly opalescent, colourless to slightly yellow solution in a glass vial.

Ingredients

Active ingredient:
pembrolizumab
Inactive ingredients:
Histidine
Sucrose
Polysorbate-80
Water for Injection

Supplier

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 August 2016.
Australian Register Numbers:
AUST R 226597
AUST R 263932
S-CCPPI-MK3475-IV-072016