BEFORE YOU ARE GIVEN YERVOY
You should not be given YERVOY
if you are allergic (hypersensitive) to ipilimumab or any of the other ingredients of YERVOY. If you are not sure, talk to your doctor.
Check with your doctor or nurse before you are given YERVOY
if you take corticosteroids or immunosuppressive therapy. These are medicines which reduce the functioning of your immune system, and may make you more likely to develop infections and some cancers
if you have an autoimmune disease (a condition where the body attacks its own cells).
if you have, or have ever had, chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV)
if you have a human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
if you take anticoagulant therapy. These are medicines which increase the risk of bleeding in the stomach and gut
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Ask your doctor for advice before taking any medicine.
Children
It is not recommended to use this medicine in children or adolescents (below 18 years) until further data become available.
Take special care with YERVOY
YERVOY is a medicine that influences your immune system and may cause inflammation in parts of your body. Inflammation can cause serious damage to your body and some inflammatory conditions may be irreversible or life-threatening. Tell your doctor immediately if you have any of the symptoms of inflammation. The signs and symptoms of potential inflammatory side effects of Yervoy are described under "Possible Side Effects" in this leaflet
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning 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.
Driving and using machines
Do not drive or use machines after you have been given YERVOY unless you are sure that you are not affected.
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.
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.
POSSIBLE SIDE EFFECTS
Like all medicines, YERVOY 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.
It is important that you tell your doctor immediately if you have, or develop, any of the symptoms listed below.
Your doctor can then give you treatment to prevent more severe complications. Your doctor may decide to prescribe other medicines in order to reduce your symptoms, withhold the next dose of YERVOY, or stop your treatment with YERVOY altogether.
SIGNS AND SYMPTOMS OF INFLAMMATION
Bowel and stomach inflammation which can worsen to bleedings or bowel perforation
diarrhoea (watery, loose or soft stools)
an increased number of bowel movements (an increase by two or more per day)
constipation
blood in your stools, or darker-coloured stools
pain or tenderness in your stomach area
Liver damage or hepatitis
yellowing of your skin or the whites of your eyes (jaundice)
pain in your stomach area
excessive sleepiness
Skin rash or itching
red or itchy rash
peeling skin
dry skin
Nerve damage
muscle weakness or decreased strength
numbness or tingling in your hands or feet
loss of consciousness or difficulty waking up
Damage or inflammation of hormone producing glands
headaches
blurry or double vision
fatigue
decreased sexual drive
behavioural changes
Eye inflammation
redness in the eye
pain in the eye
vision changes or blurry vision
These 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 have blood tests during treatment.
Tell your doctor immediately if you have any symptoms or your symptoms get worse. Do not try to treat your symptoms with other medicines.
The following side effects have been reported in clinical trials:
Very common side effects (affects more than 1 user in 10)
loss of appetite
diarrhoea
feeling sick (nausea) or being sick (vomiting)
stomach pain
itching, skin rash
feeling tired or weak
cough
headache
fever
insomnia
Tell your doctor immediately if you get any of these side effects. Do not try to treat your symptoms with other medicines.
Common side effects (affects 1 to 10 users in 100)
serious bacterial infection of the blood (sepsis)
tumour pain
underactive function of pituitary gland (hypopituitarism), the adrenal glands, or underactive function of the thyroid gland (hypothyroidism) which can cause tiredness or weight gain
overactive function of the thyroid gland (hyperthyroidism), which can cause rapid heart rate, sweating and weight loss
dehydration
inflammation of the eye which causes pain and redness, blurred vision
low blood pressure, temporary redness of the face and neck
shortness of breath, bleeding in the stomach or intestine (gut), inflammation of the colon (large bowel), constipation
weight loss
abnormal function of the liver
inflammation and redness of the skin, skin colour change in patches (vitiligo), hair loss or thinning,
excessive sweating at night
pain in muscles and joints
kidney function failure
fever, shivering, lack of energy,
swelling, pain, reaction at site of injection,
confusion
increase in alkaline phosphatase (an enzyme released by the liver)
influenza like illness
Tell your doctor immediately if you get any of these side effects. Do not try to treat your symptoms with other medicines.
Uncommon side effects (affects 1 to 10 users in 1,000)
serious bacterial infection of the blood (sepsis, septic shock)
urinary tract infection, kidney disease, kidney function failure
inflammation of the stomach and intestines
depression, lowered sex drive,
inflammation of blood vessels in the skin, hives (itchy, bumpy rash), painful skin lesions of the arms, legs and face
muscle spasms, painful joints, muscle inflammation
change or absence of menstrual periods
pain in the eye, reduced vision, bleeding in the eye, a foreign body sensation in the eyes, inflammation of the eye muscle, swollen runny eyes
irregular or abnormal heart beat
extreme difficulty breathing, inflammation of the lungs, fluid in the lungs, hay fever
disease of blood vessels, low blood pressure, feeling of intense heat with sweating and rapid heartbeat, weakness of the heart muscle, fluid around the heart
damage to the nerves (causing pain, weakness and cramps), dizziness, brief involuntary muscle contraction, shaking, excessive accumulation of water in the brain, disease of nerves in the head, difficulty in speaking, difficulty in coordinating movements (ataxia)
bowel perforation, stomach wall membrane inflammation, inflammation of the duodenum, of the bowel or of the pancreas, heartburn
a group of metabolic complications occurring after cancer treatment
liver failure, enlarged liver, inflammation of the liver, thyroid gland, kidney, pancreas or central nervous system, nodules of inflammatory cells in various organs of your body, immune-related effects of the inner surface lining of a particular organ, yellowing of the skin or eyes (jaundice)
reaction related to infusion, multi-organ failure
reduction of red blood cells
multi organ inflammation
decreased hearing
change in hair colour
mucosal inflammation
infusion related reaction
Tell your doctor immediately if you get any of these side effects.
Do not try to treat your symptoms with other medicines.
Rare side effects (affects 1 to 10 users in 10,000)
infection of the airways or of the upper respiratory tract
infection around the brain or spinal cord
allergic reaction (shock)
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 glands producing sex hormones
antibodies against some of your own body cells causing damage to the thyroid gland or inflammation of the kidney or brain
changes in mental health
inflammation of the nerves (causing pain, weakness or paralysis in the extremities), drowsiness or lack of energy
triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache
inflammation of the eye, swollen runny eyes, inflammation of the coloured part of the eye, swelling of the eye
inflammation of the heart muscle, disease of the heart muscle, irregular heart beat
restriction in blood supply of the extremities, inflammatory destruction of blood vessels, inflammatory disease of blood vessels (most commonly head arteries), poor blood circulation which makes toes and fingers numb or pale
breathing failure caused by fluid in the lungs
inflammatory disease of the intestines (causing abdominal pain, diarrhoea which may be bloody, vomiting or weight loss)
peeling skin
inflammation of muscles, causing pain or stiffness in hip and shoulder
hearing disorder
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), of white blood cells (which are important in fighting infection) or of platelets (cells which help the blood to clot)
an abnormal variation of hormones and liver enzyme levels in the blood
a low blood level of sodium, of phosphate or of potassium
blood or proteins in the urine
an increased level of rheumatoid factor
kidneys unable to remove acids from blood normally
an abnormally high alkalinity of the blood and other body tissues
presence of antibodies in the blood against some of your own cells
If any of the side effects listed in this leaflet appear or worsen, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Do not be alarmed by possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.
FURTHER INFORMATION
What YERVOY contains
The active substance is ipilimumab.
Each vial contains either 50 mg or 200 mg of ipilimumab.
Before dilution, each one mL of concentrate contains 5 mg of ipilimumab.
The other ingredients are trometamol hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injection.
What YERVOY looks like and contents of the pack
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.
Not all pack sizes may be marketed.
HOW TO STORE YERVOY
It is unlikely that you will be asked to store YERVOY yourself. It will be stored in the hospital or clinic where it is given to you.
Keep YERVOY out of the reach and sight of children.
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.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original package in order to protect from light.
From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately. The chemical and physical in use stability of the undiluted or diluted infusion solution has been demonstrated for 24 hours at room temperature (20°C to 25°C) or when refrigerated (2°C to 8°C). Other in-use storage time and conditions are the responsibility of the user.
