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.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
1. Why am I given YERVOY?
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.
2. What should I know before I am given YERVOY?
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.
3. What if I am taking other medicines?
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.
4. How am I given YERVOY?
- 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.
5. What should I know while receiving YERVOY?
Things you should do |
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Things you should not do |
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Driving or using machines |
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For more information, see Section 5. What should I know while receiving YERVOY? in the full CMI.
6. Are there any side effects?
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.
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.
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:
1. Why am I given YERVOY?
2. What should I know before I am given YERVOY?
3. What if I am taking other medicines?
4. How am I given YERVOY?
5. What should I know while receiving YERVOY?
6. Are there any side effects?
7. Product details
1. Why am I given YERVOY?
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)
2. What should I know before I am given YERVOY?
Warnings
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.
3. What if I am taking other medicines?
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.
4. How am I given 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.
5. What should I know while receiving YERVOY?
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.
6. Are there any side effects?
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
Serious side effects | What to do |
Lung problems:
Stomach and Intestinal problems:
Liver problems:
Kidney problems:
Hormone gland problems:
Skin problems:
Brain and nervous system problems:
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT):
Problems in other organs:
Infusion reactions:
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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. |
Other side effects
Other side effects | What to do |
The following side effects have been reported in clinical trials when YERVOY has been given alone: Very Common side effects
Common side effects
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Speak to your doctor if you have any of these side effects and they worry you. |
The following side effects have been reported in clinical trials when YERVOY has been given in combination with nivolumab: Very Common side effects
Common side effects
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Speak to your doctor if you have any of these side effects and they worry you. |
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
Common side effects
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Speak to your doctor if you have any of these side effects and they worry you. |
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.
7. Product details
This medicine is only available with a doctor’s prescription.
What YERVOY contains
Active ingredient (main ingredient) |
ipilimumab |
Other ingredients (inactive ingredients) |
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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.
Published by MIMS January 2024