{"id":34178,"date":"2022-11-18T09:45:15","date_gmt":"2022-11-18T09:45:15","guid":{"rendered":"https:\/\/zeepedia.com\/?p=34178"},"modified":"2022-11-19T09:18:36","modified_gmt":"2022-11-19T09:18:36","slug":"yescarta","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/yescarta\/","title":{"rendered":"Yescarta &#8211; Axikabtagencilloleucel uses, dose and side effects"},"content":{"rendered":"\n<p>0.4\u20132 x 10\u00a0<sup>8<\/sup>\u00a0cells\u00a0infusion fluid,\u00a0dispersion<br>axikabtagencilloleucel (CAR+ viable\u00a0T-cells\u00a0)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Yescarta is and what it is used for<\/h2>\n\n\n\n<p>Yescarta is a gene therapy medicine for the treatment of adults with aggressive diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular\u00a0lymphoma\u00a0(FL) that affect your lymph tissue (part of the immune system), which in turn affects a type of\u00a0white blood cell\u00a0called\u00a0B-lymphocyte\u00a0er, as well as other organs in the body.\u00a0Too many of these abnormal\u00a0white blood cells\u00a0accumulate in your\u00a0tissues\u00a0and cause the symptoms you may have.<\/p>\n\n\n\n<p>The medicine is specially prepared for you as a one-time treatment with your own modified\u00a0white blood cells.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you receive Yescarta<\/h2>\n\n\n\n<p><strong>You should not receive Yescarta<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to axicabtagenciloleucel or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you cannot receive treatment with so-called lymphocyte-depleting chemotherapy, which reduces the number of\u00a0white blood cells\u00a0in the blood (see also section 3, &#8220;How Yescarta is given&#8221;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Yescarta is made from your white blood cells\u00a0and must only be given to you<\/p>\n\n\n\n<p><em>(&nbsp;autologous&nbsp;use).<\/em><\/p>\n\n\n\n<p><strong>Before you are treated with Yescarta, you must tell your doctor if you:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>have problems with the nervous system (eg seizures,\u00a0stroke,\u00a0or memory loss).<\/li><li>have kidney problems.<\/li><li>have a low number of\u00a0blood cells\u00a0(blood cell count).<\/li><li>have had a\u00a0stem cell transplant\u00a0in the last 4 months.<\/li><li>have any problems with the lungs, heart, or\u00a0blood pressure\u00a0(low or high).<\/li><li>have signs or symptoms of\u00a0graft-versus-host disease.\u00a0This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhea, and bloody stools.<\/li><li>notice that the symptoms of your cancer are getting worse.\u00a0If you have\u00a0lymphoma, this may include fever, feeling weak, night sweats, and sudden weight loss.<\/li><li>have an\u00a0infection.\u00a0The infection\u00a0will be treated before you receive the Yescarta\u00a0infusion.<\/li><li>have had an\u00a0infection\u00a0with\u00a0hepatitis\u00a0B,\u00a0hepatitis\u00a0C or human immunodeficiency virus (\u00a0HIV\u00a0).<\/li><\/ul>\n\n\n\n<p>If any of the above apply to you (or if you are not sure), talk to your doctor before being treated with Yescarta.<\/p>\n\n\n\n<p><strong>Tests and checks<\/strong><\/p>\n\n\n\n<p><strong>Before you are given Yescarta, your doctor will:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>check lungs, heart, and\u00a0blood pressure.<\/li><li>look for signs of infection;\u00a0any\u00a0infection\u00a0will be treated before you are treated with Yescarta.<\/li><li>check your cancer to see if it has worsened.<\/li><li>look for signs of\u00a0graft-versus-host disease, which can occur after a transplant.<\/li><li>check your blood for\u00a0uric acid\u00a0and how many cancer cells are in your blood.\u00a0This shows whether you are likely to develop a condition called tumor lysis syndrome.\u00a0You may be given medication to help prevent this condition.<\/li><li>check if you have\u00a0hepatitis\u00a0B,\u00a0hepatitis\u00a0C\u00a0or\u00a0HIV\u00a0infection.<\/li><li>check if you have received a vaccination in the previous 6 weeks or if you are scheduled to receive one in the coming months.<\/li><\/ul>\n\n\n\n<p><strong>After you have been treated with Yescarta<\/strong><\/p>\n\n\n\n<p><strong>Tell your doctor or nurse immediately if you have any of the following:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or palpitations, may be symptoms of a condition known as cytokine release syndrome.\u00a0Measure your temperature twice a day for 3-4 weeks after treatment with Yescarta.\u00a0If your temperature is elevated, see your doctor immediately.<\/li><li>Seizures, tremors or difficulty speaking or slurred speech, unconsciousness or reduced level of consciousness, confusion and disorientation, impaired balance or coordination<\/li><li>Fever, can be a symptom of an\u00a0infection.<\/li><li>Extreme tiredness, weakness, and shortness of breath, can be symptoms of a lack of\u00a0red blood cells.<\/li><li>Bleeding or bruising easily, which can be symptoms of low levels of\u00a0blood cells\u00a0called\u00a0platelets.<\/li><\/ul>\n\n\n\n<p>Your doctor will regularly check your blood cell count as the number of&nbsp;blood cells&nbsp;and other blood components may decrease.<\/p>\n\n\n\n<p>You must not donate blood, organs,\u00a0tissues,\u00a0or cells for transplantation.<\/p>\n\n\n\n<p>If any of the above applies to you (or if you are not sure), talk to your doctor or nurse before being treated with Yescarta.&nbsp;Your doctor may need to give you special care during your treatment with Yescarta.<\/p>\n\n\n\n<p>In some cases, it may not be possible to proceed with the planned treatment with Yescarta.&nbsp;For example:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If the\u00a0infusion\u00a0of Yescarta is delayed more than 2 weeks after you have received preparatory\u00a0chemotherapy, you may need to receive more preparatory\u00a0chemotherapy.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Yescarta must not be used by children and adolescents under 18 years of age as Yescarta has not been studied in this age group.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Yescarta<\/h2>\n\n\n\n<p>Tell the doctor or nurse if you are taking, have recently taken, or might take other medicines.<\/p>\n\n\n\n<p>Before receiving Yescarta, tell your doctor or nurse if you are taking any medicines that weaken the immune system, such as\u00a0cortisone, as these medicines may interfere with the effect of Yescarta.<\/p>\n\n\n\n<p>In particular, you must not be given certain vaccines called live vaccines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>in the 6 weeks before you are given a short course of\u00a0chemotherapy\u00a0(called lymphocyte-depleting chemotherapy\u00a0) to prepare your body for the Yescarta cells.<\/li><li>during Yescarta treatment.<\/li><li>after treatment while the immune system recovers.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor if you need to be vaccinated.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine.\u00a0This is because the effects of Yescarta on pregnant or breastfeeding women are unknown, and it may harm your unborn baby or your breastfed baby.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are pregnant or think you may be pregnant after treatment with Yescarta, talk to your doctor immediately.<\/li><li>You will be given a pregnancy test before the treatment starts.&nbsp;Yescarta can only be given if the result shows that you are not pregnant.<\/li><\/ul>\n\n\n\n<p>Discuss pregnancy with your doctor if you have received Yescarta.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Some people may feel tired, dizzy, or shaky after receiving Yescarta.\u00a0If this happens to you, you should not drive or use heavy machinery for at least 8 weeks after\u00a0infusion\u00a0one, or until your doctor says you are fully recovered.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Yescarta contains sodium, dimethyl sulfoxide (DMSO), and traces of gentamicin<\/h2>\n\n\n\n<p>This medicine contains 300 mg of\u00a0sodium\u00a0(the main component of table salt) in each\u00a0infusion.\u00a0This corresponds to 15% of the recommended maximum daily intake of\u00a0sodium\u00a0for an adult.<\/p>\n\n\n\n<p>This medicine contains DMSO and residues of gentamicin which can cause serious allergic reactions.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Yescarta is given<\/h2>\n\n\n\n<p>Yescarta is always given by healthcare professionals.&nbsp;It is given as a drip (&nbsp;infusion&nbsp;) into a vein (&nbsp;intravenously&nbsp;).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Because Yescarta is made from your white blood cells, your\u00a0blood cells\u00a0will be collected from you to make your medicine.\u00a0Your doctor will collect some of your blood via a\u00a0catheter\u00a0placed in a vein (a procedure called leukapheresis).\u00a0Some of your\u00a0white blood cells\u00a0are separated from your blood and the rest of the blood is returned to your vein.\u00a0This may take 3 to 6 hours and may need to be repeated.\u00a0Your\u00a0white blood cells\u00a0are sent off to make Yescarta.\u00a0It usually takes around 3 to 4 weeks to receive your Yescarta treatment but the time can vary.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Medicines are given before Yescarta treatment<\/h2>\n\n\n\n<p>In the 30 to 60 minutes before you are given Yescarta, you may be given other medicines.&nbsp;This is done to prevent infusion reactions and fever.&nbsp;These other medicines may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>paracetamol.<\/li><li>an\u00a0antihistamine\u00a0such as diphenhydramine.<\/li><\/ul>\n\n\n\n<p>Before you receive Yescarta, you will receive other medicines such as preparatory\u00a0chemotherapy, which causes your modified\u00a0white blood cells\u00a0in Yescarta to multiply in your body while you receive the medicine.<\/p>\n\n\n\n<p>Your doctor or nurse will check carefully that this medicine is yours.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How you are given Yescarta<\/h2>\n\n\n\n<p>Yescarta is always given by a doctor in a qualified treatment unit.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Yescarta is given as a single dose.<\/li><li>Your doctor or nurse will give you a single&nbsp;infusion&nbsp;of Yescarta through a&nbsp;catheter inserted&nbsp;into a vein (&nbsp;intravenous&nbsp;infusion&nbsp;) over about 30 minutes.<\/li><\/ul>\n\n\n\n<p>You must receive the Yescarta&nbsp;infusion&nbsp;at a qualified clinic, and will only be prescribed when your doctor thinks it is safe for you to go home.<\/p>\n\n\n\n<p>Your doctor may take blood tests to check if you have\u00a0any side effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">After you have received Yescarta<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Plan to stay near the hospital where you were treated for at least 4 weeks after you are treated with Yescarta.\u00a0Your doctor will recommend that you return to the hospital every day for at least 10 days and will consider whether you need to remain in the hospital as an inpatient for the first 10 days after the\u00a0infusion.\u00a0This is done so that the doctor can check whether your treatment is working and help you if you experience\u00a0side effects.<\/li><\/ul>\n\n\n\n<p>If you miss an appointment, call your doctor or qualified clinic as soon as possible to reschedule your appointment.<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.<\/p>\n\n\n\n<p>Yescarta can cause\u00a0side effects\u00a0on the immune system, which can be serious or life-threatening and can lead to death.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been reported with Yescarta.<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 patients)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fever, chills, and low\u00a0blood pressure, can cause symptoms such as dizziness, vertigo, and fluid in the lungs, which can be serious and fatal (all of these are symptoms of a condition called cytokine release syndrome).<\/li><li>Abnormally low\u00a0white blood cell count, can increase your risk of\u00a0infection.<\/li><li>Unconsciousness or reduced level of consciousness, confusion, or memory loss due to disturbances in brain function, involuntary shaking (\u00a0tremor\u00a0), sudden confusion with\u00a0agitation, disorientation, hallucinations, or irritability (\u00a0delirium\u00a0).<\/li><li>Decreased number of\u00a0red blood cells\u00a0(cells that carry oxygen): symptoms may include extreme tiredness with loss of energy.<\/li><li>Extreme fatigue.<\/li><li>A low number of cells that help the blood clot (\u00a0thrombocytopenia\u00a0): symptoms may include excessive or prolonged bleeding or bruising.<\/li><li>Muscle and joint pain, back pain.<\/li><li>Fever or chills may be signs of an\u00a0infection.<\/li><li>Headache.<\/li><li>High uric acid\u00a0or sugar (\u00a0glucose\u00a0) levels show up in blood tests.\u00a0Low levels of\u00a0sodium\u00a0or\u00a0phosphate, show up in blood tests.<\/li><li>Nausea, constipation, diarrhea, abdominal pain, vomiting.<\/li><li>Decreased appetite.<\/li><li>Low\u00a0blood pressure, dizziness.<\/li><li>Shortness of breath, cough.<\/li><li>Rapid heartbeat.<\/li><li>Irregular heart rhythm (\u00a0arrhythmia\u00a0).<\/li><li>Low levels of immunoglobulins, which show up in blood tests, can lead to\u00a0infection.<\/li><li>Accumulation of fluids in\u00a0tissue\u00a0(\u00a0edema\u00a0) can lead to swelling, weight gain, difficulty breathing, and reduced urine output.<\/li><li>Lack of energy or strength, muscle weakness, difficulty moving, muscle spasms.<\/li><li>Skin rash or skin problems.<\/li><li>Difficulty sleeping.<\/li><li>High\u00a0blood pressure.<\/li><li>Elevated levels of liver enzymes, show up in blood tests.<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dry mouth, dehydration, difficulty swallowing.<\/li><li>Pain in hands or feet.<\/li><li>High levels of\u00a0bilirubin, which shows up in blood tests.\u00a0Low levels of albumin,\u00a0potassium,\u00a0or\u00a0calcium, show up in blood tests.<\/li><li>Low oxygen level in the blood.<\/li><li>Kidney failure causes fluid to build up in the body, which can be serious or life-threatening.<\/li><li>Swelling in the\u00a0extremities, fluid around the lungs (pleural effusion).<\/li><li>Alteration of the blood&#8217;s ability to form blood clots (\u00a0coagulopathy\u00a0): symptoms may include excessive or prolonged bleeding or bruising.<\/li><li>Vision changes make it difficult to see things (vision impairment).<\/li><li>Pain.<\/li><li>Sudden unexpected cardiac arrest (cardiac arrest): this is serious and life-threatening.<\/li><li>Heart failure.<\/li><li>Blood clots: symptoms may include pain in the chest or upper back, difficulty breathing, coughing up blood or cramping pain, swelling in a single leg, and warm and dark skin around the painful area.<\/li><li>Convulsions (seizures, including seizures that can be prolonged and life-threatening).<\/li><li>Inability to move one side of the body.<\/li><li>Hypersensitivity: symptoms such as skin rash,\u00a0itching, swelling, and\u00a0anaphylaxis.<\/li><li>Mood disorders.<\/li><li>Nasal inflammation.<\/li><li>Weakness or inability to move one side of the body, making it difficult to carry out daily activities such as eating or dressing.<\/li><li>Loss of control over body movements.<\/li><li>Loss of movement of facial muscles.<\/li><li>Anxiety.<\/li><li>Inability to breathe on your own (respiratory failure).<\/li><li>Weight loss.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Difficulty understanding numbers.<\/li><li>Breakdown of muscle tissue leads to the\u00a0release\u00a0of muscle fibers into the blood.<\/li><li>At least two organs that are not functioning properly (eg, liver, lungs, and kidneys), require medical treatment and\/or procedures that restore normal organ function.<\/li><li>Swelling of the spinal cord, can cause\u00a0partial\u00a0or total paralysis of the\u00a0limbs\u00a0and trunk.<\/li><li>Paralysis of all four\u00a0limbs.<\/li><li>State of severe systemic\u00a0inflammation.<\/li><\/ul>\n\n\n\n<p>Tell your doctor immediately if you get any of the&nbsp;side effects&nbsp;listed above.&nbsp;Do not try to treat your symptoms yourself with other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Yescarta<\/h2>\n\n\n\n<p><strong>The following information is intended for medical use only.<\/strong><\/p>\n\n\n\n<p>Use before the expiry date stated on the container label and the infusion bag.<\/p>\n\n\n\n<p>Store in liquid nitrogen gas phase freezer \u2264 -150 \u00b0C until thawed for use.&nbsp;The medicine should not be refrozen.<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\">What Yescarta contains<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is axicabtagencilloleucel.\u00a0Each patient-specific single-use infusion bag contains a\u00a0dispersion\u00a0of anti-CD19 CAR\u00a0T-cells\u00a0in approximately 68 mL for a target dose of 2 x 10\u00a0<sup>6<\/sup>\u00a0anti-CD19 CAR-positive viable T cells\/kg.<\/li><li>Other ingredients are Cryostor CS10 (contains DMSO), sodium chloride, and human albumin.\u00a0See section 2 &#8220;Yescarta contains\u00a0sodium, dimethyl sulfoxide (DMSO), and traces of gentamicin&#8221;.<\/li><\/ul>\n\n\n\n<p>This medicine contains genetically modified human\u00a0blood cells.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and packaging of the medicine<\/h2>\n\n\n\n<p>Yescarta is a clear to opaque, white-to-red\u00a0dispersion\u00a0for\u00a0infusion, supplied in an infusion bag individually wrapped in a metal cassette.\u00a0A single-use infusion bag contains approximately 68 ml of cell dispersion.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p>Kite Pharma EU BV<\/p>\n\n\n\n<p>Tufstone 1<\/p>\n\n\n\n<p>2132 NT Hoofddorp<\/p>\n\n\n\n<p>Netherlands<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yescarta is a gene therapy medicine for the treatment of adults with aggressive diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular\u00a0lymphoma\u00a0(FL) that affect your lymph tissue (part of the immune system), which in turn affects a type of\u00a0white blood cell\u00a0called\u00a0B-lymphocyte\u00a0er, as well as other organs in the body.\u00a0Too many of these abnormal\u00a0white blood cells\u00a0accumulate in your\u00a0tissues\u00a0and cause the symptoms you may have.<\/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":[2200,22505],"tags":[28195,28196,28199,28198,28197],"class_list":["post-34178","post","type-post","status-publish","format-standard","hentry","category-medicines","category-y","tag-axikabtagencilloleucel","tag-axikabtagencilloleucel-side-effects","tag-benefits-of-axikabtagencilloleucel","tag-what-axikabtagencilloleucel-is-used-for","tag-what-is-axikabtagencilloleucel"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34178","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=34178"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34178\/revisions"}],"predecessor-version":[{"id":34481,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/34178\/revisions\/34481"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=34178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=34178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=34178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}