Consumer medicine information

Yervoy

Ipilimumab

BRAND INFORMATION

Brand name

Yervoy

Active ingredient

Ipilimumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Yervoy.

YERVOY®

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.

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
  • 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
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 to prevent complications and reduce your symptoms, your doctor may withhold the next dose of YERVOY, or stop your treatment with YERVOY altogether
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 to drive or use machines

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:

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 effectsWhat to do
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
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 effectsWhat to do
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
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
  • 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
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
  • 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)
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)
  • trometamol hydrochloride
  • sodium chloride
  • mannitol (E421)
  • pentetic acid
  • polysorbate 80
  • sodium hydroxide
  • hydrochloric acid
  • water for injections

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

BRAND INFORMATION

Brand name

Yervoy

Active ingredient

Ipilimumab

Schedule

S4

 

Boxed Warnings

Warning: immune-related adverse reactions. Yervoy can cause severe and life-threatening immune-related adverse reactions.
Immune-related adverse reactions are seen more frequently, and are more severe, with Yervoy and nivolumab combination therapy than with Yervoy or nivolumab monotherapy.
Immune-related adverse reactions can involve any organ system. The majority of these initially manifest during treatment; however, a minority can occur weeks to months after discontinuation. Some immune-related adverse reactions can be permanent (such as thyroid dysfunction and diabetes mellitus).
Life-threatening or fatal immune-related adverse reactions that have occurred with Yervoy monotherapy or Yervoy and nivolumab combination therapy include colitis, intestinal perforation, hepatitis, pneumonitis, hypophysitis, adrenal insufficiency, toxic epidermal necrolysis, myocarditis, encephalitis, myasthenia gravis and neuropathy (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
Early diagnosis and appropriate management are essential to minimise life-threatening complications (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). Monitoring at least prior to each dose is recommended. Advise patients of the importance of immediately reporting symptoms.
Physicians should consult the nivolumab product information prior to initiation of Yervoy in combination with nivolumab. Yervoy monotherapy and Yervoy in combination with nivolumab therapy should be administered and monitored under the supervision of physicians experienced in the treatment of cancer.

1 Name of Medicine

Ipilimumab.

2 Qualitative and Quantitative Composition

5 mg/mL concentrate solution for infusion.
Each 1 mL of concentrate contains 5 mg ipilimumab.
One 10 mL vial contains 50 mg of ipilimumab.
One 40 mL vial contains 200 mg of ipilimumab.
Yervoy (ipilimumab (rch)) is a recombinant, fully human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.
Excipient with known effect. Each 1 mL contains 5 mg of ipilimumab and 0.1 mmol sodium (or 2.30 mg sodium).
Full list of excipients, see Section 6.1.

3 Pharmaceutical Form

Concentrate solution for infusion.
Yervoy is a sterile, preservative free liquid for intravenous (IV) administration, which may contain a small amount of visible translucent-to-white, amorphous ipilimumab particulates. Yervoy has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.

4 Clinical Particulars

4.9 Overdose

The maximum tolerated dose of Yervoy has not been determined. In clinical trials, patients received up to 20 mg/kg without apparent toxic effects.
In case of overdosage, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

The effects of ipilimumab on prenatal and postnatal development were investigated in a study in cynomolgus monkeys. Pregnant monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through delivery, at exposure (AUC) levels either 3 or 7 times higher than those associated with the clinical dose of 3 mg/kg of ipilimumab. No treatment-related adverse effects on reproduction were detected during the first two trimesters of pregnancy. Beginning in the third trimester, both ipilimumab groups experienced higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birthweight), and infant mortality relative to control animals; these findings were dose-dependent. Additionally, visceral abnormalities were identified in the urogenital system of 2 infants of the 30 mg/kg group. One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal oedema. A no adverse effect level was not identified. Due to the low incidences, the relationship of these malformations to treatment is unclear.
Ipilimumab was detected in the serum of monkey infants at similar levels to their mothers' post-partum, likely through in utero exposure. Very low levels of ipilimumab were detected in milk. Human IgG1 is known to cross the placental barrier; therefore, ipilimumab has the potential to be transmitted from the mother to the developing foetus.
Genotoxicity. Studies to evaluate the genotoxic potential of ipilimumab have not been performed.
Carcinogenicity. Studies to evaluate the carcinogenic potential of ipilimumab have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

CAS number. CAS: 477202-00-9.

7 Medicine Schedule (Poisons Standard)

S4. Prescription Only Medicine.

Summary Table of Changes

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