5 mg/ml concentrate for infusion solution
ipilimumab
What YERVOY is and what it is used for
YERVOY contains the active substance ipilimumab, a protein that, through your immune cells, helps your immune system attack and destroy cancer 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.
- advanced renal cell carcinoma (advanced kidney cancer) in adults
- pleural cancer (malignant pleural mesothelioma, a type of cancer that affects the tissue surrounding the lungs) in adults
- advanced colorectal cancer (colon or rectal cancer) in adults
- advanced esophageal cancer (esophageal 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 adults.
YERVOY can be given in combination with other cancer medicines. It is important that you also read the leaflet for these medicines. Discuss with your doctor if you have questions about these medicines.
2. What you need to know before using 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). Talk to your doctor if you are unsure.
Warnings and precautions
Talk to your doctor before using YERVOY as it may cause:
- problems with your heart such as changes in heart rhythm, heart rate, or abnormal heart rhythm.
- I inflammation in the intestines ( colitis ) which can worsen into bleeding or holes in the intestinal wall. Signs and symptoms of colitis may include diarrhea (watery, loose, or soft stools), more frequent bowel movements than normal, blood in the stool or dark-colored stools, and pain or tenderness in the gastrointestinal tract.
- problems with your lungs such as difficulty breathing or coughing. This may be a sign of inflammation in the lungs ( pneumonitis or interstitial lung disease).
- inflammation of the liver ( hepatitis ) which can lead to liver failure. Signs and symptoms of hepatitis may include yellowing of the eyes or skin (jaundice), pain on the right side of the stomach, and tiredness.
- inflammation of the skin that can lead to severe skin reactions ( toxic epidermal necrolysis, Stevens-Johnson syndrome, and drug-induced reaction with eosinophilia and systemic symptoms (DRESS)). Signs and symptoms of severe skin reactions may include rash with or without itching, flaky skin, dry skin, fever, tiredness, swelling of the face or lymph nodes, increased number of eosinophils (a type of white blood cell ), and effects on the liver, kidneys or lungs. Note that the reaction called DRESS can develop weeks or months after the last dose.
- inflammation of the nerves that can lead to paralysis. Symptoms of nerve damage may include muscle weakness, numbness or tingling in the hands or feet, loss of consciousness, or difficulty waking up.
- inflammation or problems with the kidneys. Signs and symptoms may include abnormal kidney function values or decreased urine output.
- inflammation of hormone-producing glands (especially the pituitary, adrenal, and thyroid glands) which can affect how these glands work. Signs and symptoms of gland dysfunction may include headaches, blurred or double vision, fatigue, decreased sex drive, and behavioral changes.
- type 1 diabetes, including diabetic ketoacidosis (acid in the blood that comes from diabetes).
- inflammation of the muscles such as myocarditis ( inflammation of the heart muscle), myositis ( inflammation of the muscles), and rhabdomyolysis (stiffness of the muscles and joints, muscle cramps). Signs and symptoms of it can manifest as muscle pain, stiffness, weakness, chest pain, or severe fatigue.
- inflammation of the eyes. Signs and symptoms may include red eyes, eye pain, vision problems, blurred vision, or temporary vision loss.
- hemophagocytic lymphohistiocytosis. An unusual disease in which our immune system produces too many of the otherwise normal infection-fighting cells called histiocytes and lymphocytes. Symptoms may include enlarged liver and/or spleen, skin rash, enlarged lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.
- rejection of the transplanted organs.
Tell your doctor right away if you have any of these signs or symptoms, or if they get worse. Do not try to treat your symptoms with other medicines. Your doctor may give you other medicines to prevent more serious complications and reduce symptoms, delay the next dose of YERVOY or stop treatment with YERVOY altogether.
Note that these symptoms may appear later, sometimes weeks or months after your last dose. Before treatment, your doctor will review your general state of health. Blood samples will also be taken during the treatment.
Check with your doctor or nurse before receiving YERVOY
- if you have an autoimmune disease (a condition where the body attacks its cells)
- if you have or have had, a chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C ( HCV )
- if you have human immunodeficiency virus ( HIV ) or acquired immunodeficiency syndrome ( AIDS )
- if you have previously had a serious skin side effect during previous cancer treatment.
- if you have previously had inflammation of the lungs
Children and young people
YERVOY should not be used by children under 12 years of age.
Other medicines and YERVOY
Before receiving YERVOY, tell your doctor
- if you are taking any medicines that suppress the immune system, such as corticosteroids. Such medicines may affect the effect of YERVOY. However, your doctor may give you corticosteroids after you start treatment with YERVOY to reduce the side effects that may occur with YERVOY.
- if you are taking any medicines that prevent the blood from clotting ( anticoagulants ). Such medicines may increase the likelihood of bleeding in the stomach or intestines, which is a side effect of YERVOY.
- if you have recently received Zelboraf (vemurafenib, another medicine used to treat melanoma ). When YERVOY is given after vemurafenib, there may be an increased risk of skin side effects.
Also, tell your doctor if you are taking or have recently taken any other medicines.
Do not take any other medicines during your treatment without first talking to your doctor. Based on current information, YERVOY (ipilimumab) should not be given in combination with vemurafenib, due to increased hepatotoxicity.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, planning to become pregnant or if you are breastfeeding.
You must not use YERVOY if you are pregnant unless your doctor specifically recommends it. The effects of YERVOY on pregnant women are not known, but it is possible that the active substance, ipilimumab, could harm an unborn child.
- If you are a woman of childbearing potential, you must use effective contraception while you are being treated with YERVOY.
- Tell your doctor if you become pregnant during treatment with YERVOY.
It is not known whether ipilimumab is excreted in human milk. Infants are not expected to have significant exposure to ipilimumab via breast milk and no effects are expected on breastfed infants. Ask your doctor if you can breastfeed during or after treatment with YERVOY.
Driving ability and use of machinery
Do not drive or cycle or operate machinery after receiving YERVOY, unless you are sure you are well. Feeling tired or weak is a very common side effect of YERVOY. This may affect your ability to drive, cycle or use machines.
YERVOY contains sodium
Tell your doctor if you have been prescribed a low salt (low sodium) diet before being treated with YERVOY. The product contains 2.3 mg of sodium per ml of concentrate.
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 used alone in the treatment of melanoma, YERVOY will be given to you as an infusion (a drip) into a vein ( intravenously ) during
30 minutes.
When YERVOY is given in combination with nivolumab in the treatment of melanoma, you will receive an infusion over 30 minutes every 3 weeks for the first 4 doses (the combination phase). After that, nivolumab is given as an infusion over 30 or 60 minutes, every two weeks, or every four weeks, depending on the dose you receive (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, you will receive an infusion over 30 minutes every 3 weeks for the first 4 doses (the combination phase). After that, nivolumab is given as an infusion over 30 or 60 minutes, every two weeks, or every four weeks, depending on the dose you receive (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer in adults, you will receive an infusion over 30 minutes every 3 weeks for the first 4 doses (the combination phase). Afterward, nivolumab is given as an infusion over 30 minutes, every two weeks (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced esophageal cancer, you will receive an infusion over 30 minutes every 6 weeks.
When YERVOY is given in combination with nivolumab and chemotherapy to treat advanced non-small cell lung cancer, you will receive an infusion over 30 minutes every 6 weeks. After 2 cycles of chemotherapy, ipilimumab in combination with nivolumab alone is given as an infusion over 30 minutes every 6 weeks.
How much YERVOY is given
When YERVOY is used alone in the treatment of melanoma, the recommended dose is 3 mg of ipilimumab per kilogram of body weight.
The amount of YERVOY you will receive is calculated based on your body weight. Depending on your dose, some or all of the contents of the YERVOY vial will be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection before use. More than one vial may be needed to achieve the correct dose.
You will be treated with YERVOY once every 3 weeks, in total
4 dosing rounds. You may notice new skin changes or growth of current skin changes. This is to be expected with treatment with YERVOY. Your doctor will continue to give you YERVOY up to a total of 4 doses, depending on how you tolerate the treatment.
When YERVOY is given in combination with nivolumab for the treatment of melanoma, the recommended dose is one of YERVOY 3 mg ipilimumab per kg body weight every 3 weeks for the first 4 doses (combination phase). Thereafter, the recommended dose of nivolumab 240 mg will be given every two weeks or 480 mg will be given every four weeks (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended dose is one of YERVOY 1 mg ipilimumab per kg body weight every 3 weeks for the first 4 doses (combination phase).
Thereafter, the recommended dose of nivolumab 240 mg will be given every two weeks or 480 mg will be given every four weeks (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer, the recommended dose is one of YERVOY 1 mg ipilimumab per kg body weight every 3 weeks for the first 4 doses (combination phase). Thereafter, the recommended dose of nivolumab 240 mg will be given every other week (the monotherapy phase).
When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced esophageal cancer, the recommended dose is one of YERVOY 1 mg ipilimumab per kg body weight every 6 weeks.
When YERVOY is given in combination with nivolumab and chemotherapy for the treatment of advanced non-small cell lung cancer, the recommended dose is one of YERVOY 1 mg ipilimumab per kg body weight. You will receive an infusion for over 30 minutes every 6 weeks.
If you miss a dose of YERVOY
You need to attend your scheduled doctor’s appointments when you are to receive your YERVOY treatment. If you miss an appointment, ask your doctor when you can book a new appointment for the next dose.
If you stop using YERVOY
Termination of treatment may lead to the drug’s effect disappearing. Do not stop treatment with YERVOY without first talking to your doctor.
If you have further questions about the treatment or use of this medicine, contact your doctor.
When YERVOY is given in combination with nivolumab or combination with nivolumab and chemotherapy, you will receive nivolumab first and then YERVOY, and then chemotherapy.
See the package insert for the other anticancer drugs to understand how these drugs should be used. If you have any questions about these medicines, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss this with you and will explain the risks and benefits of treatment.
Pay attention to important symptoms of inflammation
YERVOY affects your immune system and can cause inflammation in parts of your body. Inflammation can cause serious damage to your body and some inflammatory conditions can be life-threatening.
The following side effects have been reported in patients receiving 3 mg of ipilimumab alone per kilogram of body weight:
Very common (may affect more than 1 in 10 users)
- loss of appetite
- diarrhea (watery, loose or soft stools), vomiting or nausea
- skin rash, itching
- feeling tired or weak, injection site reaction, fever
→ 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 users)
- tumor pain
- impaired thyroid function which may cause fatigue or weight gain, impaired function ( hypopituitarism ), or inflammation (hypophysitis) of the pituitary gland, which sits on the underside of the brain
- dehydration
- confusion
- nerve damage (leading to pain, weakness, and cramps), dizziness, headache
- blurred vision, eye pain
- low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating, and rapid heartbeat
- shortness of breath ( dyspnea ), cough
- bleeding in the stomach or intestines, inflammation of the intestines ( colitis ), constipation, heartburn, stomach pain
- abnormal liver function
- inflammation of the inner surface surrounding a specific organ
- skin inflammation and redness, patchy discoloration of the skin (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, heavy night sweats, dry skin
- pain in muscles and joints ( arthralgia ), spasms in the muscles
- chills, weakness, edema (swelling), pain
- flu-like illness
- weight loss
→ 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 users)
- serious bacterial infection in the blood (blood poisoning, septic shock ), inflammation around the brain or spinal cord, intestinal and stomach inflammation, inflammation of the intestinal wall (causing fever, vomiting, and stomach pain), urinary tract infection, respiratory tract infection, lung inflammation ( pneumonia )
- a group of symptoms caused by cancer in the body such as high levels of calcium and cholesterol in the blood and low blood sugar levels (paraneoplastic syndrome)
- allergic reaction
- reduced secretion of hormones produced by the adrenal glands ( glands located above the kidneys), overactive thyroid function that can cause rapid heart rate, sweating, and weight loss, defects in the glands that produce sex hormones
- reduced adrenal gland function caused by the hypothalamus (part of the brain) interactivity
- a group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate in the blood, and low levels of calcium in the blood (tumor lysis syndrome)
- changes in mental health, depression, decreased sex drive
- inflammation of the nerves, which is severe and possibly fatal and causes pain, weakness, or paralysis in the arms and legs (Guillain Barré syndrome), fainting, inflammation of the nerves in the brain, abnormal accumulation of fluid in the brain, difficulty coordinating movements ( ataxia ), tremors, short-term involuntary muscle contractions, difficulty speaking
- inflammation of the eye (conjunctivitis), bleeding in the eye, inflammation of the colored part of the eye, reduced vision, the sensation of a foreign object in the eye, swollen watery eyes, swollen eyes, eyelid inflammation
- irregular or abnormal heartbeats
- inflammation of the blood vessels, blood vessel disease, the limited blood supply to the arms and legs, low blood pressure when standing up
- extreme breathing difficulties, fluid accumulation in the lungs, inflammation of the lungs, hay fever
- hole in the intestinal wall, inflammation of the membrane et al in the stomach wall, inflammation of the small intestine, inflammation of the intestine or pancreas ( pancreatitis ), stomach ulcers, ulcers in the mouth and on the lips ( stomatitis ), inflammation of the esophagus, blocked intestine
- liver failure, inflammation of the liver, enlarged liver, yellowing of the skin and eyes (jaundice)
- peeling skin ( toxic epidermal necrolysis ) which is severe and possibly fatal
- muscle inflammation that causes pain or stiffness in the hip and shoulder, joint pain ( arthralgia )
- swelling of the thyroid gland, inflammation of the kidney or central nervous system
- inflammation in multiple organs
- inflammation of skeletal muscles
- muscle weakness
- kidney failure, kidney disease
- missed menstruation
- multiorgan failure, a reaction linked to the actual infusion of one of the drugs
- changed hair color
- inflammation of the bladder. Signs and symptoms may include frequent and/or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen
→ 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 1,000 users)
- inflammatory disease of blood vessels (mainly in arteries in the head)
- inflammation of the anus and rectal wall (characterized by blood in the stool and frequent bowel movements)
- a skin disease characterized by dry, red patches covered in scales ( psoriasis )
- inflammation and redness of the skin (erythema multiforme)
- a type of serious skin reaction characterized by a rash accompanied by one or more of the following signs: fever, swelling of the face or lymph nodes, increased number of eosinophils (a type of white blood cell ), effects on the liver, kidneys or lungs (a reaction that called DRESS).
- membrane detachment from 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, tiredness, nausea, stomach pain, fast and deep breathing, confusion, unusual sleepiness, a sweet smell on the breath, a sweet or metallic taste in the mouth or a different smell of urine or sweat
→ 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 users)
- serious, possibly life-threatening, allergic reaction
→ 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 less common side effects (which may affect up to 1 in 100 people) have been reported in patients receiving doses other than 3 mg/kg of YERVOY in clinical trials:
- three linked symptoms: neck stiffness, intolerance to bright light, and headaches which together are called meningism, flu-like symptoms
- myocarditis, weakness of the heart muscle, fluid around the heart
- inflammation of the liver or pancreas, nodules of inflammatory cells in various organs of the body
- infection in the abdomen
- painful sores on arms, legs, and face (erythema nodosum)
- overactive pituitary gland
- decreased parathyroid function
- eye inflammation, eye muscle inflammation
- impaired hearing
- poor blood circulation causes numb and pale toes and fingers
- tissue damage in the hands and feet resulting in redness, swelling, and blisters
→ 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 (frequency not known) include:
- rejection of transplanted organ
- a type of skin blistering disease (so-called pemphigoid )
- A condition where our immune system produces too many infection-fighting cells, called histiocytes and lymphocytes, which can cause various symptoms (so-called hemophagocytic lymphohistiocytosis). Symptoms include enlarged liver and spleen, skin rash, enlarged lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.
- pain, numbness, tingling, or weakness in arms or legs, bladder or bowel problems including needing to urinate more often, urinary incontinence, difficulty urinating, and constipation (due to inflammation of the spinal cord called myelitis )
→ 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 answers
YERVOY may cause altered test results in the tests your doctor performs. These include:
- a change in the number of red blood cells (which carry oxygen), white blood cells (which are important for fighting infection ), or platelets (cells that help the blood to clot)
- an abnormal variation in hormone and liver enzyme levels in the blood
- abnormal liver values
- abnormal levels of calcium, sodium, phosphate, or potassium in the blood
- presence of blood or protein in the urine
- an abnormally high level of basicity (alkalinity) in the blood or body tissues
- the kidneys are unable to remove acids from the blood in a normal way
- presence of antibodies in the blood directed against some of your own body’s cells
The following side effects have been reported when ipilimumab was used in combination (the frequency and severity of side effects may vary with the combination of anticancer drugs you receive):
Very common (may affect more than 1 in 10 users)
- upper respiratory tract infection, lung inflammation ( pneumonia )
- impaired thyroid function (may cause fatigue or weight gain), overactive thyroid (which may cause palpitations, sweating, and weight loss)
- reduced number of red blood cells (which carry oxygen), white blood cells (which are important in defense against infection ), or platelets (cells that help the blood to clot)
- loss of appetite, high (hyperglycemia) or low (hypoglycemia) sugar levels in the blood
- headache, dizziness
- high blood pressure ( hypertension )
- shortness of breath ( dyspnoea ), cough
- inflammation of the intestines ( colitis ), diarrhea (watery, loose or soft stools), vomiting or nausea, stomach pain, constipation
- skin rash sometimes with blisters, itching, dry skin
- pain in the muscles and bones (musculoskeletal pain), pain in the joints ( arthralgia )
- feeling tired or weak, fever, edema (swelling)
→ 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 users)
- bronchitis, eye inflammation ( conjunctivitis )
- increase in eosinophils (type of white blood cells ) decrease in neutrophils with fever
- allergic reactions, reactions associated with the infusion of one of the drugs
- decreased secretion of hormones produced by the adrenal glands ( glands located above the kidneys), underactive function (hypopituitarism) of or inflammation (hypophysitis) of the pituitary gland, located in the lower part of the brain, swelling of the thyroid gland, diabetes
- dehydration decreased levels of albumin and phosphate in the blood
- inflammation of the nerves (causes numbness, weakness, tingling, or burning pain in the arms and legs)
- eye inflammation causing redness or pain, blurred vision, dry eyes
- increased heart rate
- inflammation of the lungs ( pneumonitis, characterized by coughing and difficulty breathing), blood clots, fluid in the lungs
- ulcers in the mouth and lips ( stomatitis ), inflammation of the pancreas ( pancreatitis ), constipation, dry mouth, inflammation of the stomach ( gastritis )
- liver inflammation
- patches of skin discoloration (vitiligo), redness of the skin, unusual hair loss or thinning, hives (itchy, raised rash)
- inflammation of the joints ( arthritis ), muscle twitching, muscle weakness
- kidney failure (including sudden loss of kidney function)
- pain, chest pain, chills
- weight loss
→ 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 users)
- temporary and reversible non-infectious inflammation of protective membranes surrounding the brain and spinal cord (aseptic meningitis )
- chronic disease associated with an increase in inflammatory cells in various organs and tissues, most often in the lungs ( sarcoid )
- the acid in the blood caused by diabetes (diabetic ketoacidosis )
- reduced function of the parathyroid gland
- increased level of acid in the blood
- a temporary inflammation of the nerves causing pain, weakness, and paralysis of the arms and legs ( Guillain-Barré syndrome ); damage to nerves causing numbness and weakness ( polyneuropathy ); inflammation of the nerves; drop foot (peroneus paresis); inflammation of the nerves caused by the body attacking itself and causing numbness, weakness, tingling or burning pain ( autoimmune neuropathy ); muscle weakness and fatigue without wasting ( myasthenia gravis )
- encephalitis
- changes in the heart rhythm or speed of the heartbeat, irregular or abnormal pulse, inflammation of the heart muscle, slow heart rate
- ulcers in the intestines, inflammation of the duodenum a
- skin disease with thickened patches of red skin, often with silvery scales ( psoriasis ), a serious condition of the skin that causes red, often itchy spots, similar to a measles rash, that starts on the arms and legs and sometimes on the face and the rest of the body (erythema multiforme)
- severe and possibly fatal skin rash ( Stevens-Johnson syndrome )
- chronic joint disease (spondylitis); a disease that causes the immune system to attack the glands in the body that produce fluids, such as tears and saliva (Sjögren’s syndrome), pain, tenderness, or weakness in the muscles, not caused by exercise ( myopathy ), inflammation of the muscles (myositis), muscle stiffness and joints, muscle spasm ( rhabdomyolysis ), inflammation of the muscles causing pain or stiffness (muscular rheumatism)
- inflammation of the kidneys
- inflammation of the bladder. Signs and symptoms may include frequent and/or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen
→ 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 1,000 users)
- severe skin shedding ( toxic epidermal necrolysis ) which can be fatal
- membrane detachment from the back of the eye (serous retinal detachment)
- pain, numbness, tingling, or weakness in arms or legs, bladder or bowel problems including needing to urinate more often, urinary incontinence, difficulty urinating, and constipation ( myelitis )
→ 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 (frequency not known) with ipilimumab in combination include:
- rejection of transplanted organ
- a group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate in the blood, and low levels of calcium in the blood (tumor lysis syndrome)
- an inflammatory condition (most likely of autoimmune origin) affecting the eyes, skin, and membranes in the ears, brain, and spinal cord (Vogt Koyanagi Harada syndrome)
- Inflammation and effusion in the pericardium (pericardial disorders)
- a condition where the immune system produces too many infection-fighting cells, called histiocytes and lymphocytes, which can cause various symptoms (so-called hemophagocytic lymphohistiocytosis). Symptoms include enlarged liver and spleen, skin rash, enlarged lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.
Changes in blood tests
YERVOY in combination can cause altered test results in the tests your doctor performs. These include:
- abnormal liver function values (increased amount of the liver enzymes aspartate aminotransferase ( AST ), alanine aminotransferase ( ALT ), gamma-glutamyltransferase or alkaline phosphatase in the blood, increased amount of the waste product bilirubin in the blood)
- abnormal kidney function values (increased amounts of creatinine in the blood)
- increased level of an enzyme that breaks down fats and of an enzyme that breaks down starch
- increased or decreased level of calcium or potassium
- increased or decreased levels of magnesium or sodium in the blood
- increased level of thyroid-stimulating hormone
How to store YERVOY
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and label after EXP or EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ºC-8 ºC).
Do not freeze.
Store in the original packaging. Light sensitive.
Do not save unused infusion fluid for reuse. Unused medicines and waste must be disposed of according to current regulations.
Contents of the packaging and other information
Contents declaration
- The active substance is ipilimumab.Each ml of concentrate contains 5 mg of ipilimumab.One 10 ml vial contains 50 mg of ipilimumab.One 40 ml vial contains 200 mg of ipilimumab.
- The other ingredients are tris hydrochloride, sodium chloride (see section 2), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
Appearance and package sizes of the medicine
YERVOY concentrate for infusion, the solution is clear to slightly opalescent, colorless to pale yellow, and may contain light particles (few).
YERVOY is available in packs of either 1 vial of 10 ml or 1 vial of 40 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol‑Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI SRL
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland