YERVOY®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
YERVOY contains the active ingredient ipilimumab. YERVOY is used to treat various
kinds of cancer.
For more information, see Section 1. Why am I using YERVOY? in the full CMI.
For more information, see Section 1. Why am I using YERVOY? in the full CMI.
Do not use if you have ever had an allergic reaction to YERVOY or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use YERVOY? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use YERVOY? in the full CMI.
Some medicines may interfere with YERVOY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
YERVOY will be given to you in hospital or clinic under the supervision of an experienced
doctor and/or nurse
It will be given to you as an infusion (a drip) into a vein (intravenously)
Your doctor will decide how many treatments you should be given
More instructions can be found in Section 4. How do I use YERVOY? in the full CMI.
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Things you should do
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Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given YERVOY
Ensure you tell your doctor if you have autoimmune disease, any history of inflammation
of the lungs, if you take anticoagulant therapy, if you have previously experienced
a severe skin reaction on prior cancer therapy or if you are taking any medicines
that suppress your immune system, such as corticosteroids
YERVOY acts on your immune system and may cause inflammation in parts of your body
which may be life threatening and need treatment or withdrawal of YERVOY
Tell your doctor immediately if you have any signs or symptoms of possible side effects
or if they get worse despite medical care or management
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Things you should not do
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Do not try to treat your symptoms with other medicines on your own without telling
your doctor. Your doctor may give you other medicines to prevent complications and
reduce your symptoms, your doctor may withhold the next dose of YERVOY, or stop your
treatment with YERVOY altogether
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Driving or using machines
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Do not drive or use machines after you have been given YERVOY unless you are sure
that you are not affected
Notify your doctor if you notice any changes to your ability to drive or use machines
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For more information, see Section 5. What should I know while receiving YERVOY? in the full CMI.
Like all medicines, YERVOY can cause side effects. Your doctor will discuss potential
side effects with you and will explain the risks and benefits of your treatment. Some
side effects can be serious and you may require medical attention. Contact your doctor
immediately or go to the Emergency Department at your nearest hospital if you have
any signs or symptoms (changes to your normal self), particularly if they are getting
worse or do not go away.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
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Both YERVOY and nivolumab act on your immune system and may cause inflammation in
parts of your body. Inflammation may cause serious damage to your body and some inflammatory
conditions may be life-threatening.
These side effects are most likely to begin during treatment, however, side effects
can show up months after your last infusion . IT
IS IMPORTANT TO TELL YOUR DOCTOR IMMEDIATELY IF YOU HAVE, OR DEVELOP, ANY OF THE SYMPTOMS
LISTED UNDER POSSIBLE SIDE EFFECTS.
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YERVOY®
(yure-voy)
Active ingredient(s):
ipilimumab (ipi-lim-u-mab)
Consumer Medicine Information (CMI)
This leaflet provides important information about using YERVOY. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using YERVOY.
Where to find information in this leaflet:
YERVOY contains the active ingredient ipilimumab. YERVOY is a protein which helps your immune system to attack and destroy cancer cells.
YERVOY as a single therapy is used to treat:
Advanced skin cancer (unresectable or metastatic melanoma)
YERVOY in combination with nivolumab is used to treat:
Advanced melanoma (unresectable or metastatic melanoma)
A type of advanced kidney cancer (renal cell carcinoma)
A type of cancer that affects the lining of the lung (Malignant pleural mesothelioma)
A type of cancer of the food pipe (oesophageal squamous cell cancer)
YERVOY in combination with nivolumab and chemotherapy is used to treat:
A type of lung cancer (non-small cell lung cancer without certain biological markers)
You should not be given YERVOY if:
you are allergic to ipilimumab, or any of the ingredients listed in Section 7. Product details
Always check the ingredients or talk to your doctor to make sure you can use this
medicine.
Check with your doctor if you:
have an autoimmune disease (a condition where the body attacks its own cells) like
Crohn's, ulcerative colitis or lupus
have any history of inflammation of the lungs
if you take anticoagulant therapy. These are medicines which increase the risk of
bleeding in the stomach and gut
if you have previously experienced a severe skin reaction on prior cancer therapy
are taking any medicines that suppress your immune system, such as corticosteroids,
since these medicines may interfere with the effect of YERVOY. However, once you are
treated with YERVOY, your doctor may give you corticosteroids to reduce any possible
side effects that you may have during your treatment and this will not impact the
effect of the medicine.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, intend to become pregnant, or if you are
breast-feeding.
You must not use YERVOY if you are pregnant unless your doctor specifically recommends
it.
The effects of YERVOY in pregnant women are not known, but it is possible that the
active substance, ipilimumab, could harm an unborn baby.
You must use effective contraception while you are being treated with YERVOY if you
are a woman who could become pregnant
If you become pregnant while using YERVOY, tell your doctor
You should stop breast-feeding if you are being treated with YERVOY.
It is not known whether ipilimumab gets into breast milk. A risk to the breast-fed
infant cannot be excluded.
Use in children or adolescents
It is not recommended to use this medicine in children or an adolescent (below 18
years) until further information becomes available
Important information about some of the ingredients of YERVOY
Tell your doctor if you are on a low-sodium (low-salt) diet before you are given YERVOY.
This medicine contains 2.3 mg sodium per mL of concentrate.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription (over the counter)
from your pharmacy, supermarket or health food shop.
Ask your doctor for advice before taking any medicine or dietary supplement/vitamin
during your treatment.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect YERVOY.
How is YERVOY given
YERVOY will be given to you in hospital or clinic under the supervision of an experienced
doctor
It will be given to you as an infusion (a drip) into a vein (intravenously)
Your doctor will decide how many treatments you should be given
Dosage and frequency of administration of YERVOY
The recommended dose (amount) and frequency (timing) of YERVOY can be different depending
on the type of cancer it is being used to treat
Some types of cancer are treated with YERVOY in combination with other prescription
anti-cancer medicines
Your doctor will advise you which treatments you will be given and will tell you about
the dose and frequency of these treatments
Please refer to the Consumer Medicine Information of the other prescription anti-cancer
medicines in order to understand the use of these other prescription anti-cancer medicines.
If you have questions about these medicines, please ask your doctor
If you miss a dose of YERVOY
It is very important for you to keep all appointments to receive YERVOY. If you miss
an appointment, ask your doctor when to schedule your next dose.
If you are given too much YERVOY
As YERVOY is given to you under the supervision of your doctor, it is unlikely that
you will be given too much. However, if you experience any side effects after being
given YERVOY, tell your doctor immediately.
Things you should do
Tell any other doctors, dentists, nurses and pharmacists who are treating you that
you are being given YERVOY.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given YERVOY.
Call your doctor straight away if you:
Have any signs or symptoms of possible side effects or if they get worse. See Section
6. Are there any side effects?
Develop symptoms of an allergic reaction. These symptoms may include shortness of
breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other
parts of the body, rash, itching or hives on the skin.
Things you should not do
Do not try to treat your symptoms with other medicines on your own without telling
your doctor.
Your doctor may:
Give you other medicines in order to prevent complications and reduce your symptoms
Withhold the next dose of YERVOY
Or stop your treatment with YERVOY altogether
Please note that these signs and symptoms are sometimes delayed, and may develop weeks
or months after your last dose. Before treatment, your doctor will check your general
health. You will also have blood tests during treatment.
Take special care with YERVOY
YERVOY is a medicine that influences your immune system and may cause inflammation
in parts of your body. Inflammation may cause serious damage to your body and some
inflammatory conditions may be life threatening and need treatment or withdrawal of
YERVOY
Tell your doctor immediately if you have any of the symptoms of inflammation listed
in Section 6. Are there any side effects?
Driving or using machines
Do not drive or use machines after you have been given YERVOY unless you are sure
that you are not affected. Notify your doctor if you notice any changes to your ability.
Feeling tired or weak is a very common side effect of YERVOY. This can affect your
ability to drive or operate any machinery. Patients should therefore be cautious after
having received YERVOY.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects
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What to do
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Lung problems:
Problems with your lungs such as breathing difficulties, shortness of breath, or cough.
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung
disease)
Stomach and Intestinal problems:
Inflammation of the intestines (colitis), stomach (gastritis) and duodenum (duodenitis)
which can worsen to bleeding or bowel perforation
Symptoms may include diarrhoea (watery, loose or soft stools), an increased number
of bowel movements (an increase by two or more per day), constipation, vomiting, nausea,
mucus and blood in your stools, or darker-coloured stools, stomach pain or tenderness
in your stomach area
Liver problems:
Inflammation of the liver (hepatitis)
Symptoms may include yellowing of the eye or skin (jaundice), pain on the right side
of your stomach area or tiredness
Kidney problems:
Inflammation in the kidney (nephritis)
Signs and symptoms may include abnormal kidney function tests, decreased volume of
urine and kidney failure (including abrupt loss of kidney function)
Hormone gland problems:
Damage or inflammation of hormone producing glands. Symptoms may include headaches,
blurry or double vision, fatigue, decreased sexual drive, behavioural changes.
Underactive function of the pituitary gland
Underactive function of the thyroid gland which can cause tiredness or weight gain
Overactive function of the thyroid which can cause rapid heart rate, sweating and
weight loss
Decreased function of the adrenal glands caused by an underactive hypothalamus part
of the brain) or an overactive pituitary gland (a small gland at the base of the brain)
Defect in gland producing sex hormones
Acid in the blood produced by diabetes (diabetic ketoacidosis)
Excessive thirst, the passing of a greatly increased amount of urine, increase in
appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable
and generally unwell (diabetes)
Skin problems:
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Signs and symptoms of severe skin reaction may include skin rash with or without itching,
peeling of the skin, dry skin, fever, fatigue, swelling of the face or lymph glands,
increase of eosinophils (type of white blood cells) and effects on liver, kidneys
or lungs
Severe condition of the skin that causes red, often itchy spots, similar to rash of
measles, which starts on the limbs and sometimes on the face and the rest of the body
(erythema multiforme), skin disease with thickened patches of red skin, often silvery
scales (psoriasis), hives (itchy, bumpy rash)
Brain and nervous system problems:
Damage to nerves causing numbness and weakness (polyneuropathy)
Inflammation of the brain (encephalitis)
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
Inflammation of the nerves caused by the body attacking itself, causing numbness,
weakness, tingling or burning pain (autoimmune neuropathy)
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain Barre syndrome)
Dizziness
Excessive accumulation of fluid on the brain,
Difficulty in speaking
Damage to the nerves (causing pain, weakness and cramps)
Difficulty in coordinating movements (ataxia), shaking, twitching, brief involuntary
muscle contraction
Inflammation of the nerves, foot drop (peroneal nerve palsy)
Triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache
Inflammation of the spinal cord (myelitis) causing back and neck pain, weakness in
the arms or legs, loss of bladder or bowel control
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT):
Complications of stem cell transplant that uses donor cells (allogeneic) may occur
after treatment with YERVOY.
These complications can be severe and can lead to death. Your healthcare provider
will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Problems in other organs:
Inflammation of the heart (myocarditis). Symptoms may include shortness of breath,
fatigue, palpitations or chest pain.
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Disease of blood vessels, low blood pressure, feeling intense heat with sweating and
rapid heartbeat, weakness of the heart muscle, fluid around the heart
Inflammation of muscles (myositis). Symptoms may include muscle pain, stiffness, weakness,
chest pain or severe fatigue
Muscle breakdown/injury (rhabdomyolysis). Symptoms may include muscle pain, weakness,
nausea or vomiting
Eye inflammation and vision changes. Symptoms may include redness in the eye, pain
in the eye, flashes of lights or tiny specs in your vision, blurry vision and short-term
vision loss.
Solid organ transplant rejection
A condition where the immune system mistakenly destroys red blood cells (oxygen carrying
cells) and results in decreased number of red blood cells (autoimmune haemolytic anaemia)
Infusion reactions:
Allergic reaction, reaction related to the infusion of the medicine
Life threatening allergic reaction
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Other side effects
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Other side effects
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What to do
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The following side effects have been reported in clinical trials when YERVOY has been
given alone:
Very Common side effects
Loss of appetite
Diarrhoea
Feeling sick (nausea) or being sick (vomiting)
Stomach pain
Itching, skin rash
Feeling tired or weak
Cough
Headache
Fever
Insomnia
Common side effects
Serious bacterial infection of the blood (sepsis)
Tumour pain
Dehydration
Inflammation of the eye which causes pain and redness, blurred vision
Low blood pressure, temporary redness of the face and neck
Weight loss
Inflammation and redness of the skin, skin colour change in patches (vitiligo)
Hair loss or thinning
Excessive sweating at night
Pain in the muscles and joints
Fever, shivering, lack of energy
Swelling, pain, reaction at site of injection
Confusion
Influenza like illness
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in clinical trials when YERVOY has been
given in combination with nivolumab:
Very Common side effects
Decreased appetite
Headache
Shortness of breath (dyspnoea)
Pain in the joints, muscles and bones
Feeling tired or weak
Fever
Common side effects
Serious lung infection (pneumonia), infections of the upper respiratory tract
Dehydration
Inflammation of the eye, which causes pain and redness, blurred vision
Fast heart rate
High blood pressure (hypertension)
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis),
constipation, dry mouth
Pain in the muscles and bones
Inflammation of the joints (arthritis)
Oedema
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Speak to your doctor if you have any of these side effects and they worry you.
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The following side effects have been reported in clinical trials when YERVOY has been
given in combination with nivolumab and chemotherapy
Very Common side effects
Decreased appetite
Diarrhoea (watery, loose or soft stools), vomiting, nausea
Skin rash sometimes with blisters, itching
Feeling tired or weak
Common side effects
Conjunctivitis
Serious lung infection (pneumonia), infections of the upper respiratory tract
Dry eyes
Headache
Shortness of breath (dyspnoea)
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis),
constipation, dry mouth
Dry skin, redness of the skin, unusual hair loss or thinning
Pain in the joints, muscles and bones, inflammation of the joints
Fever
Oedema (swelling)
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Speak to your doctor if you have any of these side effects and they worry you.
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Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What YERVOY contains
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Active ingredient
(main ingredient)
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ipilimumab
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Other ingredients
(inactive ingredients)
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trometamol hydrochloride
sodium chloride
mannitol (E421)
pentetic acid
polysorbate 80
sodium hydroxide
hydrochloric acid
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What YERVOY looks like
YERVOY concentrate for solution for infusion is a clear to slightly opalescent, colourless
to pale yellow liquid that may contain light (few) particulates and is supplied in
a glass vial with a rubber stopper sealed with aluminium.
It is available in packs containing either 1 vial of 10 mL or 1 vial of 40 mL.
YERVOY is available in the following presentations:
YERVOY (ipilimumab) concentrate solution for infusion 50mg in 10mL (5mg/mL) AUST R
174319.
YERVOY (ipilimumab) concentrate solution for infusion 200mg in 40mL (5mg/mL) AUST
R 174322.
Who distributes YERVOY
Bristol-Myers Squibb Australia Pty Ltd
Level 2, 4 Nexus Court
Mulgrave VIC 3170 Australia.
Toll free number: 1800 067 567
Email: MedInfo.Australia@bms.com
YERVOY® (ipilimumab) is a registered trademark of Bristol-Myers Squibb Company
This leaflet was prepared in October 2023.
