{"id":34175,"date":"2022-11-18T09:43:23","date_gmt":"2022-11-18T09:43:23","guid":{"rendered":"https:\/\/zeepedia.com\/?p=34175"},"modified":"2022-11-19T09:18:52","modified_gmt":"2022-11-19T09:18:52","slug":"yervoy","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/yervoy\/","title":{"rendered":"YERVOY &#8211; Ipilimumab uses, dose and side effects"},"content":{"rendered":"\n<p>5 mg\/ml&nbsp;concentrate for&nbsp;infusion&nbsp;solution<br>ipilimumab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What YERVOY is and what it is used for<\/h2>\n\n\n\n<p>YERVOY contains the active substance ipilimumab, a&nbsp;protein&nbsp;that, through your immune cells, helps your immune system attack and destroy cancer cells.<\/p>\n\n\n\n<p>Ipilimumab alone is used to treat advanced&nbsp;melanoma&nbsp;(a type of skin cancer) in adults and adolescents 12 years of age and older.<\/p>\n\n\n\n<p>Ipilimumab in combination with nivolumab is used to treat<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>advanced&nbsp;melanoma&nbsp;(a type of skin cancer) in adults.<\/li><li>advanced renal cell carcinoma (advanced kidney cancer) in adults<\/li><li>pleural cancer (malignant pleural mesothelioma, a type of cancer that affects the&nbsp;tissue&nbsp;surrounding the lungs) in adults<\/li><li>advanced colorectal cancer (colon or rectal cancer) in adults<\/li><li>advanced esophageal cancer (esophageal cancer) in adults.<\/li><\/ul>\n\n\n\n<p>Ipilimumab in combination with nivolumab and\u00a0chemotherapy\u00a0is used to treat advanced non-small cell lung cancer\u00a0(a type of lung cancer) in adults.<\/p>\n\n\n\n<p>YERVOY can be given in combination with other cancer medicines.&nbsp;It is important that you also read the leaflet for these medicines.&nbsp;Discuss with your doctor if you have questions about these medicines.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using YERVOY<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You should not be given YERVOY<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are\u00a0<strong>allergic<\/strong>\u00a0to ipilimumab or any of the other ingredients of this medicine (listed in section 6).\u00a0<strong>Talk to your doctor<\/strong>\u00a0if you are unsure.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor before using YERVOY as it may cause:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>problems\u00a0<\/strong><strong>with your heart<\/strong>\u00a0such as changes in heart rhythm, heart rate, or abnormal heart rhythm.<\/li><li>I\u00a0inflammation in the intestines (\u00a0colitis\u00a0)\u00a0which can worsen into bleeding or holes in the intestinal wall.\u00a0Signs and symptoms of\u00a0colitis\u00a0may 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.<\/li><li>problems with your lungs\u00a0such as difficulty breathing or coughing.\u00a0This may be a sign of\u00a0inflammation\u00a0in the lungs (\u00a0pneumonitis\u00a0or interstitial lung disease).<\/li><li>inflammation\u00a0of the liver (\u00a0hepatitis\u00a0)\u00a0which can lead to liver failure.\u00a0Signs and symptoms of\u00a0hepatitis\u00a0may include yellowing of the eyes or skin (jaundice), pain on the right side of the stomach, and tiredness.<\/li><li>inflammation\u00a0of the skin\u00a0that can lead to severe skin reactions (\u00a0toxic epidermal necrolysis,\u00a0Stevens-Johnson\u00a0syndrome, and drug-induced reaction with\u00a0eosinophilia\u00a0and systemic symptoms (DRESS)).\u00a0Signs and symptoms of severe skin reactions may include rash with or without\u00a0itching, flaky skin, dry skin, fever, tiredness, swelling of the face or lymph nodes, increased number of\u00a0eosinophils\u00a0(a type of\u00a0white blood cell\u00a0), and effects on the liver, kidneys or lungs.\u00a0Note that the reaction called DRESS can develop weeks or months after the last\u00a0dose.<\/li><li>inflammation\u00a0of the nerves\u00a0that can lead to paralysis.\u00a0Symptoms of nerve damage may include muscle weakness, numbness or tingling in the hands or feet, loss of consciousness, or difficulty waking up.<\/li><li>inflammation\u00a0or problems with the kidneys.\u00a0Signs and symptoms may include abnormal kidney function values \u200b\u200bor decreased urine output.<\/li><li>inflammation\u00a0of hormone-producing\u00a0glands\u00a0(especially the\u00a0pituitary, adrenal, and thyroid glands) which can affect how these\u00a0glands\u00a0work.\u00a0Signs and symptoms of gland dysfunction may include headaches, blurred or double vision, fatigue, decreased sex drive, and behavioral changes.<\/li><li>type 1\u00a0diabetes, including diabetic\u00a0ketoacidosis\u00a0(acid in the blood that comes from\u00a0diabetes).<\/li><li>inflammation\u00a0of the muscles\u00a0such as\u00a0myocarditis\u00a0(\u00a0inflammation\u00a0of the heart muscle), myositis (\u00a0inflammation\u00a0of the muscles), and\u00a0rhabdomyolysis\u00a0(stiffness of the muscles and joints, muscle cramps).\u00a0Signs and symptoms of it can manifest as muscle pain, stiffness, weakness, chest pain, or severe fatigue.<\/li><li>inflammation\u00a0of the eyes.\u00a0Signs and symptoms may include red eyes, eye pain, vision problems, blurred vision, or temporary vision loss.<\/li><li>hemophagocytic lymphohistiocytosis.\u00a0An unusual disease in which our immune system produces too many of the otherwise normal infection-fighting cells called histiocytes and\u00a0lymphocytes.\u00a0Symptoms may include enlarged liver and\/or\u00a0spleen, skin rash, enlarged lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.<\/li><li>rejection of the transplanted organs<strong>.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor right away<\/strong>&nbsp;if you have any of these signs or symptoms, or if they get worse.&nbsp;<strong>Do not try to treat your symptoms with other medicines.&nbsp;<\/strong>Your doctor may give you other medicines to prevent more serious complications and reduce symptoms, delay the next&nbsp;dose&nbsp;of YERVOY or stop treatment with YERVOY altogether.<\/p>\n\n\n\n<p>Note that these symptoms\u00a0<strong>may appear later<\/strong>, sometimes weeks or months after your last\u00a0dose.\u00a0Before treatment, your doctor will review your general state of health.\u00a0<strong>Blood samples<\/strong>\u00a0will also be taken during the treatment.<\/p>\n\n\n\n<p><strong>Check with your doctor or nurse before receiving YERVOY<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have an\u00a0<strong>autoimmune\u00a0disease<\/strong>\u00a0(a condition where the body attacks its cells)<\/li><li>if you have or have had,\u00a0a chronic\u00a0viral infection of the liver, including\u00a0hepatitis\u00a0B (HBV) or\u00a0hepatitis\u00a0C (\u00a0HCV\u00a0)<\/li><li>if you have\u00a0human immunodeficiency virus\u00a0(\u00a0HIV\u00a0) or acquired immunodeficiency syndrome (\u00a0AIDS\u00a0)<\/li><li>if you have previously had a serious skin side effect during previous cancer treatment.<\/li><li>if you have previously had\u00a0inflammation\u00a0of the lungs<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>YERVOY should not be used by children under 12 years of age.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and YERVOY<\/h2>\n\n\n\n<p><strong>Before receiving YERVOY, tell your doctor<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are taking any medicines that suppress the immune system, such as\u00a0corticosteroids.\u00a0Such medicines may affect the effect of YERVOY.\u00a0However, your doctor may give you\u00a0corticosteroids\u00a0after you start treatment with YERVOY to reduce the\u00a0side effects\u00a0that may occur with YERVOY.<\/li><li>if you are taking any medicines that prevent the blood from clotting (\u00a0anticoagulants\u00a0).\u00a0Such medicines may increase the likelihood of bleeding in the stomach or intestines, which is a\u00a0side effect\u00a0of YERVOY.<\/li><li>if you have recently received Zelboraf (vemurafenib, another medicine used to treat\u00a0melanoma\u00a0).\u00a0When YERVOY is given after vemurafenib, there may be an increased risk of skin side effects.<\/li><\/ul>\n\n\n\n<p><strong>Also, tell your doctor if you are taking or have recently taken any other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Do not take any other medicines<\/strong>&nbsp;during your treatment without first talking to your doctor.&nbsp;Based on current information, YERVOY (ipilimumab) should not be given in combination with vemurafenib, due to increased hepatotoxicity.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p><strong>Tell your doctor<\/strong>\u00a0if you are pregnant, planning to become pregnant or if you are breastfeeding.<\/p>\n\n\n\n<p><strong>You must not use YERVOY if you are pregnant<\/strong>&nbsp;unless your doctor specifically recommends it.&nbsp;The effects of&nbsp;YERVOY&nbsp;on pregnant women are not known, but it is possible that the active substance, ipilimumab, could harm an unborn child.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are a woman of\u00a0childbearing potential, you must use\u00a0<strong>effective contraception<\/strong>\u00a0while you are being treated with YERVOY.<\/li><li><strong>Tell your doctor<\/strong>\u00a0if you become pregnant during treatment with YERVOY.<\/li><\/ul>\n\n\n\n<p>It is not known whether ipilimumab is excreted in human milk.&nbsp;Infants are not expected to have significant exposure to ipilimumab via breast milk and no effects are expected on breastfed infants.&nbsp;Ask your doctor if you can breastfeed during or after treatment with YERVOY.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p><strong>Do not drive or cycle or operate machinery<\/strong>\u00a0after receiving YERVOY, unless you are sure you are well.\u00a0Feeling tired or weak is a very common\u00a0side effect\u00a0of YERVOY.\u00a0This may affect your ability to drive, cycle or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">YERVOY contains sodium<\/h2>\n\n\n\n<p><strong>Tell your doctor<\/strong>&nbsp;if you have been prescribed a low salt (low sodium) diet before being treated with YERVOY.&nbsp;The product contains 2.3 mg&nbsp;of sodium&nbsp;per ml of concentrate.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use YERVOY<\/h2>\n\n\n\n<p><strong>How YERVOY is given<\/strong><\/p>\n\n\n\n<p>YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.<\/p>\n\n\n\n<p>When YERVOY is used alone in the treatment of\u00a0melanoma, YERVOY will be given to you as an\u00a0infusion\u00a0(a drip) into a vein (\u00a0intravenously\u00a0) during<\/p>\n\n\n\n<p>30 minutes.<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab in the treatment of\u00a0melanoma, you will receive an\u00a0infusion\u00a0over 30 minutes every 3 weeks for the first 4\u00a0doses\u00a0(the combination phase).\u00a0After that, nivolumab is given as an\u00a0infusion\u00a0over 30 or 60 minutes, every two weeks, or every four weeks, depending on the\u00a0dose\u00a0you receive (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, you will receive an\u00a0infusion\u00a0over 30 minutes every 3 weeks for the first 4\u00a0doses\u00a0(the combination phase).\u00a0After that, nivolumab is given as an\u00a0infusion\u00a0over 30 or 60 minutes, every two weeks, or every four weeks, depending on the\u00a0dose\u00a0you receive (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer in adults, you will receive an\u00a0infusion\u00a0over 30 minutes every 3 weeks for the first 4\u00a0doses\u00a0(the combination phase).\u00a0Afterward, nivolumab is given as an\u00a0infusion\u00a0over 30 minutes, every two weeks (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced esophageal cancer, you will receive an&nbsp;infusion&nbsp;over 30 minutes every 6 weeks.<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab and\u00a0chemotherapy\u00a0to treat advanced non-small cell lung cancer, you will receive an\u00a0infusion\u00a0over 30 minutes every 6 weeks.\u00a0After 2 cycles of\u00a0chemotherapy, ipilimumab in combination with nivolumab alone is given as an\u00a0infusion\u00a0over 30 minutes every 6 weeks.<\/p>\n\n\n\n<p><strong>How much YERVOY is given<\/strong><\/p>\n\n\n\n<p>When YERVOY is used alone in the treatment of\u00a0melanoma, the recommended\u00a0dose\u00a0is 3 mg of ipilimumab per kilogram of body weight.<\/p>\n\n\n\n<p>The amount of YERVOY you will receive is calculated based on your body weight.\u00a0Depending on your\u00a0dose, some or all of the contents of the YERVOY vial will be diluted with sodium chloride 9 mg\/ml (0.9%)\u00a0solution for injection\u00a0or\u00a0glucose\u00a050 mg\/ml (5%)\u00a0solution for injection\u00a0before use.\u00a0More than one\u00a0vial\u00a0may be needed to achieve the correct\u00a0dose.<\/p>\n\n\n\n<p>You will be treated with YERVOY once every 3 weeks, in total<\/p>\n\n\n\n<p>4 dosing rounds.\u00a0You may notice new skin changes or growth of current skin changes.\u00a0This is to be expected with treatment with YERVOY.\u00a0Your doctor will continue to give you YERVOY up to a total of 4\u00a0doses, depending on how you tolerate the treatment.<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of\u00a0melanoma, the recommended\u00a0dose\u00a0is one of YERVOY 3 mg ipilimumab per kg body weight every 3 weeks for the first 4\u00a0doses\u00a0(combination phase).\u00a0Thereafter, the recommended\u00a0dose\u00a0of nivolumab 240 mg will be given every two weeks or 480 mg will be given every four weeks (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended&nbsp;dose&nbsp;is one of YERVOY 1 mg ipilimumab per kg body weight every 3 weeks for the first 4&nbsp;doses&nbsp;(combination phase).<\/p>\n\n\n\n<p>Thereafter, the recommended&nbsp;dose&nbsp;of nivolumab 240 mg will be given every two weeks or 480 mg will be given every four weeks (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of advanced colon or rectal cancer, the recommended\u00a0dose\u00a0is one of YERVOY 1 mg ipilimumab per kg body weight every 3 weeks for the first 4\u00a0doses\u00a0(combination phase).\u00a0Thereafter, the recommended\u00a0dose\u00a0of nivolumab 240 mg will be given every other week (the monotherapy phase).<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab for the treatment of malignant pleural mesothelioma or advanced esophageal cancer, the recommended&nbsp;dose&nbsp;is one of YERVOY 1 mg ipilimumab per kg body weight every 6 weeks.<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab and\u00a0chemotherapy\u00a0for the treatment of advanced non-small cell lung cancer, the recommended\u00a0dose\u00a0is one of YERVOY 1 mg ipilimumab per kg body weight.\u00a0You will receive an\u00a0infusion\u00a0for over 30 minutes every 6 weeks.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you miss a dose of YERVOY<\/h2>\n\n\n\n<p>You need to attend your scheduled doctor&#8217;s appointments when you are to receive your YERVOY treatment.\u00a0If you miss an appointment, ask your doctor when you can book a new appointment for the next\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using YERVOY<\/h2>\n\n\n\n<p>Termination of treatment may lead to the drug&#8217;s effect disappearing.&nbsp;Do not stop treatment with YERVOY without first talking to your doctor.<\/p>\n\n\n\n<p>If you have further questions about the treatment or use of this medicine, contact your doctor.<\/p>\n\n\n\n<p>When YERVOY is given in combination with nivolumab or combination with nivolumab and\u00a0chemotherapy, you will receive nivolumab first and then YERVOY, and then\u00a0chemotherapy.<\/p>\n\n\n\n<p>See the package insert for the other anticancer drugs to understand how these drugs should be used.&nbsp;If you have any questions about these medicines, ask your doctor.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Your doctor will discuss this with you and will explain the risks and benefits of treatment.<\/p>\n\n\n\n<p><strong>Pay attention to important symptoms of&nbsp;inflammation<\/strong><\/p>\n\n\n\n<p>YERVOY affects your immune system and can cause&nbsp;<strong>inflammation<\/strong>&nbsp;in parts of your body.&nbsp;Inflammation&nbsp;can cause serious damage to your body and some inflammatory conditions can be life-threatening.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been reported in patients receiving 3 mg of ipilimumab alone per kilogram of body weight:<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>loss of appetite<\/li><li>diarrhea (watery, loose or soft stools), vomiting or nausea<\/li><li>skin rash,&nbsp;itching<\/li><li>feeling tired or weak, injection site reaction, fever<\/li><\/ul>\n\n\n\n<p><strong>\u2192 Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>tumor pain<\/li><li>impaired thyroid function which may cause fatigue or weight gain, impaired function (\u00a0hypopituitarism\u00a0), or\u00a0inflammation\u00a0(hypophysitis) of the\u00a0pituitary gland, which sits on the underside of the brain<\/li><li>dehydration<\/li><li>confusion<\/li><li>nerve damage (leading to pain, weakness, and cramps), dizziness, headache<\/li><li>blurred vision, eye pain<\/li><li>low\u00a0blood pressure, temporary\u00a0redness\u00a0of the face and neck, feeling of intense heat with sweating, and rapid heartbeat<\/li><li>shortness of breath (\u00a0dyspnea\u00a0), cough<\/li><li>bleeding in the stomach or intestines,\u00a0inflammation\u00a0of the intestines (\u00a0colitis\u00a0), constipation, heartburn, stomach pain<\/li><li>abnormal liver function<\/li><li>inflammation\u00a0of the inner surface surrounding a specific organ<\/li><li>skin inflammation and\u00a0redness, patchy discoloration of the skin (vitiligo),\u00a0hives\u00a0(itchy, bumpy rash), hair loss or thinning, heavy night sweats, dry skin<\/li><li>pain in muscles and joints (\u00a0arthralgia\u00a0), spasms in the muscles<\/li><li>chills, weakness,\u00a0edema\u00a0(swelling), pain<\/li><li>flu-like illness<\/li><li>weight loss<\/li><\/ul>\n\n\n\n<p><strong>\u2192\u00a0<\/strong><strong>Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>serious bacterial\u00a0infection\u00a0in the blood (blood poisoning,\u00a0septic\u00a0shock\u00a0),\u00a0inflammation\u00a0around the brain or spinal cord, intestinal and stomach inflammation,\u00a0inflammation\u00a0of the intestinal wall (causing fever, vomiting, and stomach pain), urinary tract infection, respiratory tract infection,\u00a0lung inflammation\u00a0(\u00a0pneumonia\u00a0)<\/li><li>a group of symptoms caused by cancer in the body such as high levels of\u00a0calcium\u00a0and\u00a0cholesterol\u00a0in the blood and low blood sugar levels (paraneoplastic syndrome)<\/li><li>allergic reaction<\/li><li>reduced secretion of\u00a0hormones\u00a0produced by the adrenal glands (\u00a0glands\u00a0located above the kidneys), overactive thyroid function that can cause rapid heart rate, sweating, and weight loss,\u00a0defects\u00a0in the glands that produce sex hormones<\/li><li>reduced adrenal gland function caused by\u00a0the hypothalamus\u00a0(part of the brain) interactivity<\/li><li>a group of metabolic complications that occur after cancer treatment and are characterized by high levels of\u00a0potassium\u00a0and\u00a0phosphate\u00a0in the blood, and low levels of\u00a0calcium\u00a0in the blood (tumor lysis syndrome)<\/li><li>changes in mental health, depression, decreased sex drive<\/li><li>inflammation\u00a0of the nerves, which is severe and possibly fatal and causes pain, weakness, or paralysis in the arms and legs (Guillain Barr\u00e9 syndrome), fainting,\u00a0inflammation\u00a0of the nerves in the brain, abnormal accumulation of fluid in the brain, difficulty coordinating movements (\u00a0ataxia\u00a0), tremors, short-term involuntary muscle contractions, difficulty speaking<\/li><li>inflammation of the eye (conjunctivitis), bleeding in the eye,\u00a0inflammation\u00a0of the colored part of the eye, reduced vision, the sensation of a foreign object in the eye, swollen watery eyes, swollen eyes, eyelid inflammation<\/li><li>irregular or abnormal heartbeats<\/li><li>inflammation\u00a0of the blood vessels, blood vessel disease, the limited blood supply to the arms and legs, low\u00a0blood pressure\u00a0when standing up<\/li><li>extreme breathing difficulties, fluid accumulation in the lungs,\u00a0inflammation\u00a0of the lungs, hay fever<\/li><li>hole in the intestinal wall,\u00a0inflammation\u00a0of the\u00a0membrane\u00a0et al in the stomach wall,\u00a0inflammation\u00a0of the small intestine,\u00a0inflammation\u00a0of the intestine or pancreas (\u00a0pancreatitis\u00a0),\u00a0stomach ulcers, ulcers in the mouth and on the lips (\u00a0stomatitis\u00a0),\u00a0inflammation\u00a0of the esophagus, blocked intestine<\/li><li>liver failure, inflammation of the liver, enlarged liver, yellowing of the skin and eyes (jaundice)<\/li><li>peeling skin (\u00a0toxic epidermal necrolysis\u00a0) which is severe and possibly fatal<\/li><li>muscle inflammation that causes pain or stiffness in the hip and shoulder, joint pain (\u00a0arthralgia\u00a0)<\/li><li>swelling of the thyroid gland,\u00a0inflammation\u00a0of the kidney or\u00a0central nervous system<\/li><li>inflammation\u00a0in multiple organs<\/li><li>inflammation\u00a0of skeletal muscles<\/li><li>muscle weakness<\/li><li>kidney failure, kidney disease<\/li><li>missed menstruation<\/li><li>multiorgan failure, a reaction linked to the actual\u00a0infusion\u00a0of one of the drugs<\/li><li>changed hair color<\/li><li>inflammation\u00a0of the bladder.\u00a0Signs and symptoms may include frequent and\/or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen<\/li><\/ul>\n\n\n\n<p><strong>\u2192 Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Rare (may affect up to 1 in 1,000 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>inflammatory\u00a0disease of blood vessels (mainly in\u00a0arteries\u00a0in the head)<\/li><li>inflammation\u00a0of the anus and rectal wall (characterized by blood in the stool and frequent bowel movements)<\/li><li>a skin disease characterized by dry, red patches covered in scales (\u00a0psoriasis\u00a0)<\/li><li>inflammation\u00a0and\u00a0redness\u00a0of the skin (erythema multiforme)<\/li><li>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\u00a0eosinophils\u00a0(a type of\u00a0white blood cell\u00a0), effects on the liver, kidneys or lungs (a reaction that called DRESS).<\/li><li>membrane detachment from the back of the eye (serous retinal detachment)<\/li><li>symptoms of type 1\u00a0diabetes\u00a0or diabetic\u00a0ketoacidosis\u00a0include 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<\/li><\/ul>\n\n\n\n<p><strong>\u2192 Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Very rare (may affect up to 1 in 10,000 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>serious, possibly life-threatening,&nbsp;allergic reaction<\/li><\/ul>\n\n\n\n<p><strong>\u2192 Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p>In addition, the following less common\u00a0side effects\u00a0(which may affect up to 1 in 100 people) have been reported in patients receiving\u00a0doses\u00a0other than 3 mg\/kg of YERVOY in clinical trials:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>three linked symptoms: neck stiffness, intolerance to bright light, and headaches which together are called meningism,\u00a0flu-like symptoms<\/li><li>myocarditis, weakness of the heart muscle, fluid around the heart<\/li><li>inflammation\u00a0of the liver or pancreas, nodules of inflammatory cells in various organs of the body<\/li><li>infection\u00a0in the abdomen<\/li><li>painful sores on arms, legs, and face (erythema nodosum)<\/li><li>overactive\u00a0pituitary gland<\/li><li>decreased parathyroid function<\/li><li>eye inflammation, eye muscle inflammation<\/li><li>impaired hearing<\/li><li>poor blood circulation causes numb and pale toes and fingers<\/li><li>tissue damage in the hands and feet resulting in\u00a0redness, swelling, and blisters<\/li><\/ul>\n\n\n\n<p><strong>\u2192 Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;that have been reported (frequency not known) include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rejection of transplanted organ<\/li><li>a type of skin blistering disease (so-called\u00a0pemphigoid\u00a0)<\/li><li>A condition where our immune system produces too many infection-fighting cells, called histiocytes and\u00a0lymphocytes, which can cause various symptoms (so-called hemophagocytic lymphohistiocytosis).\u00a0Symptoms include enlarged liver and\u00a0spleen, skin rash, enlarged\u00a0lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.<\/li><li>pain, numbness, tingling, or weakness in arms or legs,\u00a0bladder\u00a0or bowel problems including needing to urinate more often, urinary incontinence, difficulty urinating, and constipation (due to\u00a0inflammation\u00a0of the spinal cord called\u00a0myelitis\u00a0)<\/li><\/ul>\n\n\n\n<p>\u2192\u00a0<strong>Tell your doctor immediately if<\/strong>\u00a0you get any of these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Do not try to treat your symptoms with other medicines.<\/strong><\/p>\n\n\n\n<p><strong>Changes in test answers<\/strong><\/p>\n\n\n\n<p>YERVOY may cause altered test results in the tests your doctor performs.&nbsp;These include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a change in the number of\u00a0red blood cells\u00a0(which carry oxygen),\u00a0white blood cells\u00a0(which are important for fighting\u00a0infection\u00a0), or\u00a0platelets\u00a0(cells that help the blood to clot)<\/li><li>an abnormal variation in\u00a0hormone\u00a0and liver enzyme levels in the blood<\/li><li>abnormal liver values<\/li><li>abnormal levels of\u00a0calcium,\u00a0sodium,\u00a0phosphate,\u00a0or\u00a0potassium\u00a0in the blood<\/li><li>presence of blood or\u00a0protein\u00a0in the urine<\/li><li>an abnormally high level of basicity (alkalinity) in the blood or body tissues<\/li><li>the kidneys are unable to remove acids from the blood in a normal way<\/li><li>presence of\u00a0antibodies\u00a0in the blood directed against some of your own body&#8217;s cells<\/li><\/ul>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been reported when&nbsp;<strong>ipilimumab was used in combination<\/strong>&nbsp;(the frequency and severity of&nbsp;side effects&nbsp;may vary with the combination of anticancer drugs you receive):<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>upper respiratory tract infection,\u00a0lung inflammation\u00a0(\u00a0pneumonia\u00a0)<\/li><li>impaired thyroid function (may cause fatigue or weight gain), overactive\u00a0thyroid\u00a0(which may cause palpitations, sweating, and weight loss)<\/li><li>reduced number of\u00a0red blood cells\u00a0(which carry oxygen),\u00a0white blood cells\u00a0(which are important in defense against\u00a0infection\u00a0), or\u00a0platelets\u00a0(cells that help the blood to clot)<\/li><li>loss of appetite, high (hyperglycemia) or low (hypoglycemia) sugar levels in the blood<\/li><li>headache, dizziness<\/li><li>high\u00a0blood pressure\u00a0(\u00a0hypertension\u00a0)<\/li><li>shortness of breath (\u00a0dyspnoea\u00a0), cough<\/li><li>inflammation\u00a0of the intestines (\u00a0colitis\u00a0), diarrhea (watery, loose or soft stools), vomiting or nausea, stomach pain, constipation<\/li><li>skin rash sometimes with blisters,\u00a0itching, dry skin<\/li><li>pain in the muscles and bones (musculoskeletal pain), pain in the joints (\u00a0arthralgia\u00a0)<\/li><li>feeling tired or weak, fever,\u00a0edema\u00a0(swelling)<br>\u2192 Tell your doctor immediately if\u00a0you get any of these\u00a0side effects.\u00a0<strong>Do not try to treat your symptoms with other medicines.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bronchitis, eye inflammation (\u00a0conjunctivitis\u00a0)<\/li><li>increase in\u00a0eosinophils\u00a0(type of\u00a0white blood cells\u00a0) decrease in\u00a0neutrophils\u00a0with fever<\/li><li>allergic reactions, reactions associated with\u00a0the infusion\u00a0of one of the drugs<\/li><li>decreased secretion of\u00a0hormones\u00a0produced by the adrenal glands (\u00a0glands\u00a0located above the kidneys), underactive function (hypopituitarism) of or\u00a0inflammation\u00a0(hypophysitis) of the\u00a0pituitary gland, located in the lower part of the brain, swelling of the thyroid gland,\u00a0diabetes<\/li><li>dehydration decreased levels of albumin and\u00a0phosphate\u00a0in the blood<\/li><li>inflammation\u00a0of the nerves (causes numbness, weakness, tingling, or burning pain in the arms and legs)<\/li><li>eye inflammation causing redness or pain, blurred vision, dry eyes<\/li><li>increased\u00a0heart rate<\/li><li>inflammation\u00a0of the lungs (\u00a0pneumonitis, characterized by coughing and difficulty breathing), blood clots, fluid in the lungs<\/li><li>ulcers in the mouth and lips (\u00a0stomatitis\u00a0),\u00a0inflammation\u00a0of the pancreas (\u00a0pancreatitis\u00a0), constipation,\u00a0dry mouth,\u00a0inflammation\u00a0of the stomach (\u00a0gastritis\u00a0)<\/li><li>liver inflammation<\/li><li>patches of skin discoloration (vitiligo),\u00a0redness\u00a0of the skin, unusual hair loss or thinning,\u00a0hives\u00a0(itchy, raised rash)<\/li><li>inflammation\u00a0of the joints (\u00a0arthritis\u00a0), muscle twitching, muscle weakness<\/li><li>kidney failure\u00a0(including sudden loss of kidney function)<\/li><li>pain, chest pain, chills<\/li><li>weight loss<br><br>\u00a0\u2192 Tell your doctor immediately if\u00a0you get any of these\u00a0side effects.\u00a0<strong>Do not try to treat your symptoms with other medicines.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>temporary and\u00a0reversible\u00a0non-infectious\u00a0inflammation\u00a0of protective membranes surrounding the brain and spinal cord (aseptic\u00a0meningitis\u00a0)<\/li><li>chronic\u00a0disease associated with an increase in inflammatory cells in various organs and\u00a0tissues, most often in the lungs (\u00a0sarcoid\u00a0)<\/li><li>the acid in the blood caused by\u00a0diabetes\u00a0(diabetic\u00a0ketoacidosis\u00a0)<\/li><li>reduced function of the parathyroid gland<\/li><li>increased level of acid in the blood<\/li><li>a temporary\u00a0inflammation\u00a0of the nerves causing pain, weakness, and paralysis of the arms and legs (\u00a0Guillain-Barr\u00e9 syndrome\u00a0);\u00a0damage to nerves causing numbness and weakness (\u00a0polyneuropathy\u00a0);\u00a0inflammation\u00a0of the nerves;\u00a0drop foot (peroneus paresis);\u00a0inflammation\u00a0of the nerves caused by the body attacking itself and causing numbness, weakness, tingling or burning pain (\u00a0autoimmune\u00a0neuropathy\u00a0);\u00a0muscle weakness and fatigue without wasting (\u00a0myasthenia gravis\u00a0)<\/li><li>encephalitis<\/li><li>changes in the heart rhythm or speed of the heartbeat, irregular or abnormal\u00a0pulse,\u00a0inflammation\u00a0of the heart muscle, slow heart rate<\/li><li>ulcers in the intestines,\u00a0inflammation\u00a0of the\u00a0duodenum\u00a0a<\/li><li>skin disease with thickened patches of red skin, often with silvery scales (\u00a0psoriasis\u00a0), 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)<\/li><li>severe and possibly fatal skin rash (\u00a0Stevens-Johnson syndrome\u00a0)<\/li><li>chronic\u00a0joint disease (spondylitis);\u00a0a disease that causes the immune system to attack the glands in the body that produce fluids, such as tears and saliva (Sj\u00f6gren&#8217;s syndrome), pain, tenderness, or weakness in the muscles, not caused by exercise (\u00a0myopathy\u00a0),\u00a0inflammation\u00a0of the muscles (myositis), muscle stiffness and joints, muscle spasm (\u00a0rhabdomyolysis\u00a0),\u00a0inflammation\u00a0of the muscles causing pain or stiffness (muscular rheumatism)<\/li><li>inflammation\u00a0of the kidneys<\/li><li>inflammation\u00a0of the bladder.\u00a0Signs and symptoms may include frequent and\/or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen<br>\u2192 Tell your doctor immediately if\u00a0you get any of these\u00a0side effects.\u00a0<strong>Do not try to treat your symptoms with other medicines.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Rare (may affect up to 1 in 1,000 users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>severe skin shedding (\u00a0toxic epidermal necrolysis\u00a0) which can be fatal<\/li><li>membrane detachment from the back of the eye (serous retinal detachment)<\/li><li>pain, numbness, tingling, or weakness in arms or legs,\u00a0bladder\u00a0or bowel problems including needing to urinate more often, urinary incontinence, difficulty urinating, and constipation (\u00a0myelitis\u00a0)<br><br>\u2192 Tell your doctor immediately if\u00a0you get any of these\u00a0side effects.\u00a0<strong>Do not try to treat your symptoms with other medicines.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;that have been reported (frequency not known) with ipilimumab in combination include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rejection of transplanted organ<\/li><li>a group of metabolic complications that occur after cancer treatment and are characterized by high levels of\u00a0potassium\u00a0and\u00a0phosphate\u00a0in the blood, and low levels of\u00a0calcium\u00a0in the blood (tumor lysis syndrome)<\/li><li>an\u00a0inflammatory\u00a0condition (most likely of\u00a0autoimmune\u00a0origin) affecting the eyes, skin, and\u00a0membranes\u00a0in the ears, brain, and spinal cord (Vogt Koyanagi Harada syndrome)<\/li><li>Inflammation\u00a0and effusion in the pericardium (pericardial disorders)<\/li><li>a condition where the immune system produces too many infection-fighting cells, called histiocytes and\u00a0lymphocytes, which can cause various symptoms (so-called hemophagocytic lymphohistiocytosis).\u00a0Symptoms include enlarged liver and\u00a0spleen, skin rash, enlarged\u00a0lymph nodes, difficulty breathing, easy bruising, kidney damage, and heart problems.<\/li><\/ul>\n\n\n\n<p><strong>Changes in blood tests<\/strong><\/p>\n\n\n\n<p>YERVOY in combination can cause altered test results in the tests your doctor performs.&nbsp;These include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>abnormal liver function values \u200b\u200b(increased amount of the liver enzymes\u00a0aspartate aminotransferase\u00a0(\u00a0AST\u00a0),\u00a0alanine aminotransferase\u00a0(\u00a0ALT\u00a0), gamma-glutamyltransferase or alkaline phosphatase in the blood, increased amount of the waste product\u00a0bilirubin\u00a0in the blood)<\/li><li>abnormal kidney function values \u200b\u200b(increased amounts of\u00a0creatinine\u00a0in the blood)<\/li><li>increased level of an\u00a0enzyme\u00a0that breaks down fats and of an\u00a0enzyme\u00a0that breaks down\u00a0starch<\/li><li>increased or decreased level of\u00a0calcium\u00a0or\u00a0potassium<\/li><li>increased or decreased levels of\u00a0magnesium\u00a0or\u00a0sodium\u00a0in the blood<\/li><li>increased level of thyroid-stimulating hormone<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store YERVOY<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date stated on the carton and label after EXP or EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00baC-8 \u00baC).<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>Store in the original packaging.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>Do not save unused&nbsp;infusion fluid&nbsp;for reuse.&nbsp;Unused medicines and waste must be disposed of according to current regulations.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is ipilimumab.Each ml of concentrate contains 5 mg of ipilimumab.One 10 ml\u00a0vial\u00a0contains 50 mg of ipilimumab.One 40 ml\u00a0vial\u00a0contains 200 mg of ipilimumab.<\/li><li>The other ingredients are tris hydrochloride, sodium chloride (see section 2), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide,\u00a0hydrochloric acid,\u00a0and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>YERVOY concentrate for\u00a0infusion, the solution is clear to slightly opalescent, colorless to pale yellow, and may contain light particles (few).<\/p>\n\n\n\n<p>YERVOY is available in packs of either 1&nbsp;vial&nbsp;of 10 ml or 1&nbsp;vial&nbsp;of 40 ml.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Bristol\u2011Myers Squibb Pharma EEIG<br>Plaza 254<br>Blanchardstown Corporate Park 2<br>Dublin 15, D15 T867<br>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>CATALENT ANAGNI SRL<br>Loc.&nbsp;Fontana del Ceraso snc<br>Strada Provinciale 12 Casilina, 41<br>03012 Anagni (FR)<br>Italy<\/p>\n\n\n\n<p>Swords Laboratories Unlimited Company T\/A Bristol-Myers Squibb Cruiserath Biologics<br>Cruiserath Road, Mulhuddart<br>Dublin 15, D15 H6EF<br>Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>YERVOY contains the active substance ipilimumab, a\u00a0protein\u00a0that, through your immune cells, helps your immune system attack and destroy cancer cells.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200],"tags":[28203,28209,28200,28201,28202,28205,28207,28206,28204,28208],"class_list":["post-34175","post","type-post","status-publish","format-standard","hentry","category-medicines","tag-benefits-of-ipilimumab","tag-benefits-of-yervoy","tag-ipilimumab","tag-ipilimumab-side-effects","tag-what-ipilimumab-is-used-for","tag-what-is-ipilimumab","tag-what-is-yervoy","tag-what-yervoy-is-used-for","tag-yervoy","tag-yervoy-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34175","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=34175"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34175\/revisions"}],"predecessor-version":[{"id":34483,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34175\/revisions\/34483"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=34175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=34175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=34175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}