Patient leaflet - Yervoy 5 mg / ml concentrate for solution for infusion
1. What YERVOY is and what it is used for
YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells.
Ipilimumab alone is used to treat advanced melanoma (a type of skin cancer) in adults and adolescents 12 years of age and older.
Ipilimumab in combination with nivolumab is used to treat
advanced melanoma (a type of skin cancer) in
adults and adolescents 12 years of age and older
advanced renal cell carcinoma (advanced kidney
cancer) in adults
malignant pleural mesothelioma (a type of
cancer that affects the lining of the lung) in adults
advanced colorectal cancer (colon or rectal
cancer) in adults
advanced oesophageal cancer (gullet cancer)
in adults
unresectable or advanced hepatocellular
carcinoma (liver cancer) in adults.
Ipilimumab in combination with nivolumab and chemotherapy is used to treat advanced non‑small cell lung cancer (a type of lung cancer) in adult.
As YERVOY may be given in combination with other anti‑cancer medicines, it is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, please ask your doctor.
2. What you need to know before you use YERVOY
You should not be given YERVOY
if you are allergic to ipilimumab or any
of the other ingredients of this medicine (listed in Section 6 “Contents of the pack and other information”).
Talk to your doctor if you are not sure.
Warnings and precautions
Talk to your doctor before using YERVOY as it may cause:
Problems with your heart such as a change
in the rhythm or rate of the heartbeat or an abnormal heart rhythm.
Inflammation of the intestines (colitis) which
can worsen to bleedings or bowel perforation. Signs and symptoms of colitis may include diarrhoea (watery, loose or soft stools), an increased number of bowel movements than usual, blood in your stools or darker‑coloured stools, pain or tenderness in your stomach area.
Problems with your lungs such as breathing
difficulties or cough. These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease).
Inflammation of the liver (hepatitis) that can lead
to liver failure. Signs and symptoms of hepatitis may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, tiredness.
Inflammation of the skin that can lead to
severe skin reaction (known as toxic epidermal necrolysis, Stevens‑Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). Signs and symptoms of severe skin reaction may include such as 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. Please note that the reaction called DRESS may develop weeks or months after your last dose. YERVOY® 5 mg/ml
concentrate for solution for infusion
(ipilimumab)
Package leaflet: Information for the user UK61100404P99‑A2.0 The following information is intended for healthcare professionals only:
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Calculating the dose:
Ipilimumab monotherapy or ipilimumab in combination with nivolumab:
The prescribed dose for the patient is given in mg/kg. Based on this prescribed dose, calculate the total dose to be given. More than one vial of YERVOY concentrate may be needed to give the total dose for the patient.
- Each 10 ml vial of YERVOY concentrate provides 50 mg of ipilimumab; each 40 ml vial provides 200 mg of ipilimumab.
- The total ipilimumab dose in mg = the patient’s weight in kg × the prescribed dose in mg/kg.
- The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).
Preparing the infusion:
Take care to ensure aseptic handling when you prepare the infusion.
YERVOY can be used for intravenous administration either:
- without dilution, after transfer to an infusion container using an appropriate sterile syringe; or
after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate). The final concentration should range from 1 to 4 mg/ml. To dilute the YERVOY concentrate, you can use either:
sodium chloride 9 mg/ml (0.9%)
solution for injection; or
- 50 mg/ml (5%) glucose solution for injection
STEP 1
Allow the appropriate number of vials of
YERVOY to stand at room temperature for approximately 5 minutes.
- Inspect the YERVOY concentrate for particulate matter or discoloration. YERVOY concentrate is a clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates. Do not use if unusual amount of particles and signs of discoloration are present.
- Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe.
STEP 2
- Transfer the concentrate into a sterile, evacuated glass bottle or IV bag (PVC or non‑PVC).
- If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection. For ease of preparation, the concentrate can also be transferred directly into a pre-filled bag containing the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. Gently mix the infusion by manual rotation.
Administration:
The YERVOY infusion must not be administered as an intravenous push or bolus injection. Administer the YERVOY infusion intravenously over a period of 30 minutes.
The YERVOY infusion should not be infused at the same time in the same intravenous line with other agents. Use a separate infusion line for the infusion.
Use an infusion set and an in‑line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
The YERVOY infusion is compatible with: ■ PVC infusion sets
Polyethersulfone (0.2 μm to 1.2 μm)
and nylon (0.2 μm) in-line filters
Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion. ■ changes in mental health, lowered sex drive
severe and possibly fatal inflammation of the
nerves causing pain, weakness or paralysis in the extremities (Guillain-Barré syndrome), fainting, inflammation of the nerves within the brain, difficulty in coordinating movements (ataxia), shaking, brief involuntary muscle contraction, difficulty in speaking
inflammation of the eye (conjunctivitis), bleeding
in the eye, inflammation of the coloured part of the eye, reduced vision, a foreign body sensation in the eyes, swollen runny eyes, swelling of the eye, inflammation of the eyelids
inflammation of the blood vessels, disease
of the blood vessels, restriction in the blood supply to the extremities, low blood pressure when standing up
extreme difficulty in breathing, fluid accumulation
in the lungs, inflammation of the lungs
bowel perforation, inflammation of the small
intestine, inflammation of the bowel or the pancreas (pancreatitis), peptic ulcer, inflammation of the food pipe, blockage of the intestines, inflammation of the anus and the rectal wall (marked by bloody stools and a frequent urge to defecate)
liver failure, inflammation of the liver, enlarged
liver, yellowing of the skin or eyes (jaundice)
severe and possibly fatal peeling of the skin
(toxic epidermal necrolysis)
inflammation of the muscles causing pain
or stiffness in the hip and shoulder
inflammation of the kidney, or the central
nervous system
- multi organ inflammation
- inflammation of skeletal muscles
- muscle weakness
- kidney disease
- absence of menstrual periods
multi organ dysfunction, reaction related
to infusion of the medicine
- change in hair colour
inflammation of the bladder, signs and symptoms
may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Rare (may affect up to 1 in 1000 people)
inflammatory disease of blood vessels
(most commonly head arteries)
- swelling of the thyroid gland (thyroiditis)
skin disease characterised by dry red patches
covered with scales (psoriasis)
inflammation and redness of the skin
(erythema multiforme)
a type of severe skin reaction characterised
by rash accompanied by one or more of the following features: fever, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidneys or lungs (a reaction called DRESS).
an inflammatory disorder (most likely of
autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt‑ Koyanagi‑Harada syndrome), loosening of membrane at the back of the eye (serous retinal detachment)
symptoms of type 1 diabetes or diabetic
ketoacidosis include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, feeling tired, feeling sick, stomach pain, fast and deep breathing, confusion, unusual sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat
muscle weakness and tiredness without atrophy
(myasthenia gravis)
Lack or reduction of digestive enzymes made
by pancreas (pancreatic exocrine insufficiency)
Coeliac disease (characterised by symptoms
such as stomach pain, diarrhoea, and bloating after consuming gluten‑containing foods)
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Very rare (may affect up to 1 in 10,000 people)
serious, potential life‑threatening allergic reaction
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
In addition, the following uncommon (may affect up to 1 in 100 people) side effects have been reported in patients who received doses other than 3 mg/kg of YERVOY in clinical trials:
triad of symptoms (meningism): neck stiffness,
intolerance of bright light and headache, flu-like discomfort
inflammation of the heart muscle, weakness
of the heart muscle, fluid around the heart
inflammation of the liver or the pancreas,
nodules of inflammatory cells in various organs of your body
- infection within the abdomen
painful skin lesions of the arms and legs
and face (erythema nodosum)
- overactive pituitary gland
- decreased function of the parathyroid gland
- inflammation of the eye, eye muscle inflammation ■ decreased hearing
poor blood circulation which makes toes
and fingers numb or pale
damage to the tissues of the hands and feet
resulting in redness, swelling and blisters
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Other side effects that have been reported with frequency not known
(cannot be estimated from the available data):
- organ transplant rejection
a type of skin blistering disease
(called pemphigoid)
a condition where the immune system makes
too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (called haemophagocytic lymphohistiocytosis). Symptoms may include enlarged liver and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and heart problems.
pain, numbness, tingling, or weakness in
the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis)
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Changes in test results
YERVOY may cause changes in the results of tests carried out by your doctor.
These include:
a variation in the number of red blood cells
(which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
an abnormal variation of hormones and liver
enzyme levels in the blood
- abnormal liver function test
abnormal levels of calcium, sodium,
phosphate or potassium in the blood ■ presence of blood or proteins in the urine
an abnormally high alkalinity of the blood
and other body tissues
kidneys unable to remove acids from blood
normally
presence of antibodies in the blood against
some of your own cells
The following side effects have been reported with ipilimumab in combination with other anti‑cancer medicines (the frequency and severity of side effects may vary with the combination of anti‑cancer medicines received):
Very common (may affect more than 1 in 10 people)
- infections of the upper respiratory tract
underactive thyroid gland
(which can cause tiredness or weight gain)
a decreased number of red blood cells
(which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
loss of appetite, high (hyperglycaemia) or low
(hypoglycaemia) sugar levels in the blood ■ headache
- shortness of breath (dyspnoea), cough
diarrhoea (watery, loose or soft stools),
vomiting or feeling sick (nausea), stomach pain, constipation
- skin rash sometimes with blisters, itching
pain in the muscles and bones (musculoskeletal
pain), painful joints (arthralgia)
feeling tired or weak, fever, oedema (swelling)
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Common (may affect up to 1 in 10 people)
lung infection (pneumonia), bronchitis,
inflammation of the eye (conjunctivitis)
- increase of eosinophils (type of white blood cells)
allergic reaction, reactions related to the infusion
of the medicine
overactive thyroid gland (which can cause rapid
heart rate, sweating and weight loss), decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes
dehydration, decreased levels of albumin and
phosphate in the blood, decrease in body weight
inflammation of the nerves (causing numbness,
weakness, tingling or burning pain of the arms and legs), dizziness
- blurred vision, dry eye
rapid heart beat, changes in the rhythm or rate
of the heartbeat, irregular or abnormal heart beat ■ high blood pressure (hypertension)
inflammation of the lungs (pneumonitis,
characterised by coughing and difficulty breathing), fluid around the lungs
inflammation of the intestines (colitis), mouth
ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), dry mouth, inflammation of the stomach (gastritis) ■ inflammation of the liver
skin colour change in patches (vitiligo), redness
of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash), dry skin
inflammation of the joints (arthritis),
muscle spasm, muscle weakness
kidney failure (including abrupt loss
of kidney function)
pain, chest pain, chills
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Uncommon (may affect up to 1 in 100 people)
- decrease in neutrophils with fever
acid in the blood produced from diabetes
(diabetic ketoacidosis)
- increased acid levels in the blood
inflammation of the brain; damage to nerves
causing numbness and weakness
(polyneuropathy); foot drop (peroneal nerve palsy); inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy); muscle weakness and tiredness without atrophy (myasthenia gravis)
inflammation of the eye which causes redness
or pain
irregular or abnormal heart beat, inflammation
of the heart muscle, slow heart rate
- inflammation of the duodenum
skin disease with thickened patches of red skin,
often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme), severe and possibly fatal peeling of the skin (Stevens‑Johnson syndrome), changes in any area of the skin and/or genital area that are associated with drying out, thinning, itching and pain (other lichen disorders)
aching muscles, muscle tenderness of
weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica)
inflammation of the kidney
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Rare (may affect up to 1 in 1000 people)
temporary and reversible non‑infectious
inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis)
chronic diseases associated with a build‑up of
inflammatory cells in various organs and tissues, most commonly the lungs (sarcoidosis) ■ decreased function of the parathyroid gland
temporary inflammation of the nerves that
causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome), inflammation of the nerves
pain, numbness, tingling, or weakness in
the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis/transverse myelitis) ■ bowel perforation
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.
It is not known whether ipilimumab gets into breast milk. However, significant exposure of ipilimumab to the infant through breast milk is not expected and no effects on the breast-fed infant are anticipated. Ask your doctor if you can breast‑feed during or after treatment with YERVOY.
Driving and using machines
Do not drive, cycle or use machines after you have been given YERVOY unless you are sure you are feeling well. Feeling tired or weak is a very common side effect of YERVOY. This can affect your ability to drive, cycle or to use machines.
YERVOY contains sodium
Tell your doctor if you are on a low‑sodium (low‑salt) diet before you are given YERVOY.
This medicine contains 23 mg sodium
(main component of cooking/table salt) in each 10 ml vial. This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 92 mg sodium
(main component of cooking/table salt) in each 40 ml vial. This is equivalent to 4.60% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use YERVOY
How YERVOY is given
YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.
When YERVOY is given alone for the treatment of skin cancer, YERVOY will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 30 minutes.
When YERVOY is given in combination with nivolumab for the treatment of skin cancer, you will be given an infusion over a period of 30 minutes every 3 weeks for the first 4 doses (combination phase). Thereafter, nivolumab will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single‑agent phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, you will be given an infusion over a period of 30 minutes every 3 weeks for the first 4 doses (combination phase). Thereafter, nivolumab will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single‑agent phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer in adults, you will be given an infusion over a period of 30 minutes every 3 weeks for the first 4 doses (combination phase). Thereafter, nivolumab will be given as an infusion over a period of 30 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single‑agent phase).
When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced oesophageal cancer, you will be given an infusion over a period of 30 minutes every 6 weeks.
When YERVOY is given in combination with nivolumab for the treatment of unresectable or advanced liver cancer you will be given an infusion over a period of 30 minutes, every 3 weeks for up to 4 doses (combination phase) depending on your treatment. Thereafter, nivolumab will be given as an infusion over a period of 30 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single‑agent phase).
When YERVOY is given in combination with nivolumab and chemotherapy for the treatment of advanced non‑small cell lung cancer, you will be given an infusion over a period of 30 minutes every 6 weeks. After completion of 2 cycles of chemotherapy, ipilimumab will be given in combination with nivolumab as an infusion over a period of 30 minutes every 6 weeks.
How much YERVOY is given
When YERVOY is given alone for the treatment of skin cancer, the recommended dose is 3 mg of ipilimumab per kilogram of your body weight.
The amount of YERVOY you will be given will be calculated based on your body weight. Depending on your dose, some or all of the content of the YERVOY vial may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection before use. More than one vial may be necessary to obtain the required dose.
You will be treated with YERVOY once every 3 weeks, for a total of 4 doses. You may notice the appearance of new lesions or growth of existing lesions on your skin, which can be expected when you are being treated with YERVOY. Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.
When YERVOY is given in combination with nivolumab for the treatment of skin cancer in adults and adolescents 12 years of age and older, the recommended dose of YERVOY is 3 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase). Thereafter the recommended dose of nivolumab (single‑agent phase) is 240 mg given every 2 weeks or 480 mg given every 4 weeks in adults and adolescents 12 years of age and older and weighing at least 50 kg or 3 mg of nivolumab per kilogram of your body weight given every 2 weeks or 6 mg of nivolumab per kilogram of your body weight given every 4 weeks for adolescents 12 years of age and older and weighing less than 50 kg.
When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase). Thereafter, the recommended dose of nivolumab is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single‑agent phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase). Thereafter, the recommended dose of nivolumab is 240 mg given every 2 weeks or 480 mg every 4 weeks (single‑agent phase) depending on your treatment.
When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced oesophageal cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight every 6 weeks.
When YERVOY is given in combination with nivolumab for the treatment of unresectable or advanced liver cancer, the recommended dose of YERVOY is 3 mg of ipilimumab per kilogram of your body weight for up to 4 doses (combination phase) depending on your treatment. Thereafter, the recommended dose of nivolumab is 240 mg given every 2 weeks or 480 mg every 4 weeks (single agent phase) depending on your treatment.
When YERVOY is given in combination with nivolumab and chemotherapy for the treatment of advanced non‑small cell lung cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight. You will be given an infusion over a period of 30 minutes, every 6 weeks.
If you miss a dose of YERVOY
It is very important for you to keep all your appointments to receive YERVOY. If you miss an appointment, ask your doctor when to schedule your next dose.
If you stop using YERVOY
Stopping your treatment may stop the effect of the medicine. Do not stop treatment with YERVOY unless you have discussed this with your doctor.
If you have any further questions about your treatment or the use of this medicine, ask your doctor.
When YERVOY is given in combination with nivolumab or in combination with nivolumab and chemotherapy, you will first be given nivolumab followed by YERVOY and then by chemotherapy.
Please refer to the package leaflet of the other anti‑cancer medicines in order to understand the use of these other medicines. If you have questions about these medicines, please ask your doctor.
4. Possible side effects
Like all medicines, this medicine 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.
Be aware of important symptoms of inflammation
YERVOY acts 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.
The following side effects have been reported in patients receiving 3 mg/kg ipilimumab alone:
Very common
(may affect more than 1 in 10 people)
- loss of appetite
diarrhoea (watery, loose or soft stools),
vomiting or feeling sick (nausea), constipation, stomach pain
- skin rash, itching
pain in the muscles, bones, ligaments,
tendons and nerves
feeling tired or weak, reaction at site of injection,
fever, oedema (swelling), pain
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Common (may affect up to 1 in 10 people)
serious bacterial infection of the blood (sepsis),
infection of the urinary tract, infection of the respiratory tract
- tumour pain
a decreased number of red blood cells
(which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot)
underactive function of the thyroid gland which
can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain
- dehydration
- confusion, depression
excessive accumulation of fluid in the brain,
damage to the nerves (causing pain, weakness and cramps), dizziness, headache ■ blurred vision, pain in the eye
- irregular or abnormal heart beat
low blood pressure, temporary redness of
the face and neck, feeling of intense heat with sweating and rapid heart beat
- shortness of breath (dyspnoea), cough, hay fever
bleeding in the stomach or intestine,
inflammation of the intestines (colitis), heartburn, mouth ulcers and cold sores (stomatitis) ■ abnormal function of the liver
inflammation of the inner surface lining of
a particular organ
inflammation and redness of the skin, skin colour
change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin
pain in muscles and joints(arthralgia), muscle
spasms, inflammation of the joints (arthritis) ■ kidney function failure
- shivering, lack of energy
- flu-like illness
decrease in body weight
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Uncommon (may affect up to 1 in 100 people)
serious bacterial infection of the blood
(septic shock), inflammation around the brain or spinal cord, inflammation of the stomach and intestines, inflammation of bowel wall (causing fever, vomiting and stomach pain), lung infection (pneumonia)
a group of symptoms due to cancer in the
body such as high blood levels of calcium and cholesterol, and low blood levels of sugar (paraneoplastic syndrome)
- increase of eosinophils (type of white blood cells) ■ allergic reaction
decreased secretion of hormones produced
by adrenal glands (glands situated above the kidneys), overactive function of the thyroid gland, which can cause rapid heart rate, sweating and weight loss, defect of the glands producing sex hormones
decreased function of the adrenal glands caused
by an underactive hypothalamus (part of the brain)
a group of metabolic complications occurring
after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium
(tumour lysis syndrome).
severe and possibly fatal peeling of the skin
(toxic epidermal necrolysis), changes in any area of the skin and/or genital area that are associated with drying out, thinning, itching and pain (lichen sclerosus)
chronic disease of joints (spondyloarthropathy),
disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren’s syndrome), stiffness in muscles and joints, muscle spasm (rhabdomyolysis)
an inflammatory disorder (most likely
of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt‑Koyanagi‑Harada syndrome), loosening of membrane at the back of the eye (serous retinal detachment)
inflammation of the bladder, signs and symptoms
may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen
Lack or reduction of digestive enzymes made
by pancreas (pancreatic exocrine insufficiency)
Coeliac disease (characterised by symptoms
such as stomach pain, diarrhoea, and bloating after consuming gluten‑containing foods)
Î Tell your doctor immediately if you get
any of these side effects.
Do not try to treat your symptoms with other medicines.
Other side effects that have been reported with frequency not known
(cannot be estimated from the available data):
- organ transplant rejection
a group of metabolic complications occurring
after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium
(tumour lysis syndrome)
inflammation of the covering of the heart
and accumulation of fluid around the heart (pericardial disorders)
a condition where the immune system makes
too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (called haemophagocytic lymphohistiocytosis). Symptoms may include enlarged liver and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and heart problems
Changes in test results
YERVOY in combination may cause changes in the results of tests carried out by your doctor. These include:
abnormal liver function tests (increased
amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase, gamma‑ glutamyltransferase, or alkaline phosphatase in your blood, higher blood levels of the waste product bilirubin)
abnormal kidney function tests
(increased amounts of creatinine in your blood)
an increased level of the enzyme that breaks
down fats and of the enzyme that breaks down starch
increased or decreased amount of calcium
or potassium
increased or decreased blood levels
of magnesium or sodium
- increased amount of thyroid stimulating hormone
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store YERVOY
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.
If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What YERVOY contains
The active substance is ipilimumab.
Each ml of concentrate contains 5 mg of ipilimumab.
Each 10 ml vial contains 50 mg of ipilimumab. Each 40 ml vial contains 200 mg of ipilimumab.
- The other ingredients are Tris‑hydrochloride, sodium chloride (see section 2 “YERVOY contains sodium”), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
What YERVOY looks like and contents of the pack
YERVOY concentrate for solution for infusion is clear to slightly opalescent, colourless to pale yellow and may contain light (few) particulates.
It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml.
Not all pack sizes may be marketed.
Procured from within the EU and repackaged for the PL Holder: Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom
For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd. tel: +44(0)2036301244, email: MedInfo@abacusmedicine.co.uk or drugsafetyuk@abacusmedicine.co.uk
Manufacturers
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy or
Swords Laboratories Unlimited Company T/A Bristol‑Myers Squibb
Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland
YERVOY® is a registered trademark of Bristol-Myers Squibb Company
PL 45763/0844
This leaflet was last revised on 03/09/2025.
This leaflet was last revised on 19/08/2025. Blind or partially sighted? Is this leaflet hard to see or read? Call 02036301310 or write to info@ abacusmedicine.com to obtain the leaflet in a format suitable for you.
Storage conditions and shelf life:
Unopened vial
YERVOY must be stored in a refrigerator (2°C to 8°C). The vials must be kept in the original package in order to protect from light.
YERVOY should not be frozen.
Do not use YERVOY after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
YERVOY infusion
From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately. The chemical and physical in‑use stability of the undiluted or diluted infusion solution (between 1 and 4 mg/ml) has been demonstrated for 24 hours at room temperature (20°C to 25°C) or when refrigerated (2°C to 8°C). If not used immediately, the infusion solution (undiluted or diluted) must be used within 24 hours when stored either under refrigeration (2°C to 8°C) or at room temperature (20°C to 25°C). Other in‑use storage time and conditions are the responsibility of the user.
Disposal:
Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.