{"id":24501,"date":"2022-08-24T11:05:58","date_gmt":"2022-08-24T11:05:58","guid":{"rendered":"https:\/\/zeepedia.com\/?p=24501"},"modified":"2022-08-25T08:13:05","modified_gmt":"2022-08-25T08:13:05","slug":"tecartus","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/tecartus\/","title":{"rendered":"Tecartus &#8211; Brexucabtagen-autoleucel uses, dose and side effects"},"content":{"rendered":"\n<p>0.4\u20132 \u00d7 10\u00a0<sup>8<\/sup>\u00a0cells\u00a0Infusion fluid,\u00a0dispersion<br>brexucabtagen-auto excel (CAR-positive, viable\u00a0T cells\u00a0)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Descartes is and what it is used for<\/h2>\n\n\n\n<p>Descartes is a gene therapy medicine used to treat mantle cell lymphoma in adult patients.\u00a0It is used when other medicines no longer work for you (\u00a0relapsed\u00a0or refractory mantle cell lymphoma).\u00a0The medicine has been specially developed for you and is made from your white blood cells, which have been modified and are then called brexukabtagen-auto excel.<\/p>\n\n\n\n<p>Mantle cell lymphoma is a form of cancer that affects part of the body&#8217;s immune system.\u00a0It affects a type of\u00a0white blood cell\u00a0called\u00a0B lymphocytes.\u00a0In mantle cell lymphoma, the\u00a0B-lymphocytes\u00a0multiply in an uncontrolled manner and accumulate in the lymph tissue,\u00a0bone marrow,\u00a0and the blood.<\/p>\n\n\n\n<p><strong>How Tecartus works<\/strong><\/p>\n\n\n\n<p>The white\u00a0blood cells\u00a0are taken out of your blood and genetically modified so that they target the cancer cells in question in your body.\u00a0When Tecartus is introduced into your blood through an\u00a0infusion, the white\u00a0blood cells\u00a0will kill the cancer cells.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you receive Tecartus<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You should not receive Tecartus<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to any of the ingredients of this medicine (listed in section 6).\u00a0If you think you may be allergic, consult your doctor.<\/li><li>if you cannot receive the medicine needed to reduce the number of\u00a0white blood cells\u00a0in your blood (lymphocyte-reducing chemotherapy\u00a0) (see also section 3, &#8220;How Tecartus is given&#8221;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Descartes is made from your white blood cells\u00a0and should only be given to you.\u00a0This is called &#8221;\u00a0autologous\u00a0use&#8221;.<\/p>\n\n\n\n<p>Tests and checks<\/p>\n\n\n\n<p><strong>Before you are given Tecartus, your doctor will:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>check lungs, heart, kidneys, and\u00a0blood pressure.<\/li><li>check if you have any signs of\u00a0infection\u00a0or\u00a0inflammation\u00a0and decide if you need treatment for it before you receive Tecartus.<\/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.\u00a0This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhea, and bloody stools.<\/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\u00a0tumor 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><li>check if you have previously received treatment with a medicine that attaches to the so-called CD19\u00a0protein.<\/li><\/ul>\n\n\n\n<p>In some cases, it may not be possible to carry out the planned treatment with Tecartus.&nbsp;If the Tecartus&nbsp;infusion&nbsp;is delayed for more than two weeks after you have received the lymphocyte-depleting chemotherapy, you may need to receive additional chemotherapy (see also section 3, &#8220;How Tecartus is given&#8221;).<\/p>\n\n\n\n<p><strong>After you have been treated with Tecartus:<\/strong><\/p>\n\n\n\n<p><strong>Tell your doctor or nurse immediately or contact emergency medical services 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, fast or irregular\u00a0pulse, severe nausea, vomiting, or diarrhea, may be symptoms of a condition known as cytokine release syndrome.\u00a0Measure your temperature twice a day for 3-4 weeks after treatment with Tecartus.\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, e.g.\u00a0a temperature above 38 \u00b0C, may 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 more easily, which can be symptoms of low levels of\u00a0blood cells\u00a0called\u00a0platelets.<\/li><\/ul>\n\n\n\n<p>If any of the above applies to you, or if you are unsure, you should talk to a doctor or nurse.<\/p>\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 will be asked if you want to enroll in a study register for at least 15 years.&nbsp;The study is conducted to gain increased knowledge of Tecartu&#8217;s long-term effects.<\/p>\n\n\n\n<p>You must not donate blood, organs,\u00a0tissues,\u00a0or cells for transplantation.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Descartes should not be used by children and adolescents under the age of 18.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Tecartus<\/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 Tecartus, 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 Tecartus.<\/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 lymphocyte-depleting chemotherapy\u00a0to prepare your body for the Tecartus cells.<\/li><li>during Tecartus 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, breastfeeding, and fertility<\/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 Tecartus in pregnant or breast-feeding women are unknown, and it may harm your unborn or breast-fed 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 Tecartus, talk to your doctor immediately.<\/li><li>You will be given a pregnancy test before the treatment starts.\u00a0Descartes 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 Tecartus.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Descartes can cause problems such as altered or decreased level of consciousness, confusion, and seizures for 8 weeks after the medicine has been given.<\/p>\n\n\n\n<p>You should not drive, use machinery or take part in activities that require you to be alert until at least 8 weeks have passed after treatment with Tecartus or your doctor says you have fully recovered.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Tecartus contains sodium, dimethyl sulfoxide (DMSO), and 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.\u00a0It also contains dimethyl sulfoxide and gentamicin, which can cause severe allergic reactions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Tecartus is given<\/h2>\n\n\n\n<p>Descartes is always given by healthcare professionals.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Because Tecartus 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\u00a0leukapheresis\u00a0).\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.<\/li><li>Your\u00a0white blood cells\u00a0are sent to a Tecartus manufacturing center.\u00a0It usually takes about 2 to 3 weeks to manufacture Tecartus but the time can vary.<\/li><\/ul>\n\n\n\n<p><strong>Medicines are given before Tecartus treatment<\/strong><\/p>\n\n\n\n<p>A few days before you receive Tecartus, you will receive lymphocyte-depleting chemotherapy, which causes the modified white\u00a0blood cells\u00a0in Tecartus to multiply in your body while you receive the medicine.<\/p>\n\n\n\n<p>During the 30 to 60 minutes before you are given Tecartus, you may be given other medicines.&nbsp;This is done to prevent&nbsp;infusion&nbsp;reactions and fever.&nbsp;These other medicines may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>paracetamol<\/li><li>an&nbsp;antihistamine&nbsp;such as diphenhydramine.<\/li><\/ul>\n\n\n\n<p><strong>How you are given Tecartus<\/strong><\/p>\n\n\n\n<p>Descartes is always given by a doctor in a qualified treatment unit.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Descartes is given in a single dose.<\/li><li>Your doctor or nurse will give you a single\u00a0infusion\u00a0of Tecartus through a\u00a0catheter\u00a0inserted into a vein (this is called an\u00a0<em>intravenous\u00a0infusion<\/em>\u00a0).\u00a0Infusion\u00a0one takes about 30 minutes.<\/li><\/ul>\n\n\n\n<p><strong>After you get Tecartus<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You should remain close to the hospital where you were treated for at least 4 weeks after Tecartus treatment.\u00a0Your doctor will recommend that you return to the hospital every day for at least 10 days or that you stay in the hospital as an inpatient for the first 10 days after Tecartus treatment.\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 the doctor or the treatment unit where you received your treatment as soon as possible to reschedule your appointment.<br><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.\u00a0Do not try to treat your\u00a0side effects\u00a0yourself. Descartes can cause\u00a0side effects\u00a0that can be serious or life-threatening.\u00a0Seek\u00a0emergency\u00a0care if you experience any of the following\u00a0side effects\u00a0after the Tecartus\u00a0infusion.<\/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>Fever, chills, and low\u00a0blood pressure\u00a0can cause symptoms such as dizziness, feeling faint, and fluid in the lungs which can be serious and can cause death (these are symptoms of a condition called\u00a0cytokine release syndrome)<\/li><li>Loss of consciousness or reduced level of consciousness, confusion or memory loss due to disturbances in the functioning of the brain, difficulty speaking or slurred speech, involuntary shaking\u00a0(\u00a0tremor\u00a0), convulsive attacks\u00a0(seizures),\u00a0sudden confusion with\u00a0agitation, disorientation, hallucinations or irritability\u00a0(\u00a0delirium\u00a0).<\/li><li>Fever, and chills, which may be signs of an\u00a0infection<\/li><\/ul>\n\n\n\n<p><strong>Other possible\u00a0side effects\u00a0are<\/strong><\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;are listed below.&nbsp;If these&nbsp;side effects&nbsp;become serious, contact your doctor immediately.<\/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>The abnormally low number of\u00a0white blood cells can lead to an increased risk of\u00a0infection.<\/li><li>A low number of the\u00a0blood cells\u00a0that help to coagulate the blood\u00a0(\u00a0thrombocytopenia\u00a0),\u00a0changes the ability of the blood to clot.\u00a0Symptoms may include extensive or prolonged bleeding or large, persistent bruising.<\/li><li>High\u00a0blood pressure<\/li><li>Decreased number of\u00a0red blood cells\u00a0(the cells that transport oxygen).\u00a0Symptoms can include extreme fatigue and loss of energy<\/li><li>Extreme fatigue<\/li><li>Fast or slow heartbeats<\/li><li>Reduced amount of oxygen in the body&#8217;s\u00a0tissue.\u00a0Symptoms can include a change in skin tone, confusion, rapid breathing<\/li><li>Shortness of breath, cough<\/li><li>Nausea, constipation, diarrhea, abdominal pain, vomiting, difficulty swallowing<\/li><li>Muscle pain, joint pain, bone pain, pain in arms and legs<\/li><li>Lack of energy or strength, muscle weakness, difficulty moving, muscle spasms<\/li><li>Headache<\/li><li>Problems with the kidneys cause fluid to remain in the body and accumulate in\u00a0the\u00a0tissues\u00a0(\u00a0edema\u00a0).\u00a0This can lead to weight gain and difficulty breathing as well as decreased urine output.<\/li><li>High levels of\u00a0uric acid\u00a0that show up in blood tests<\/li><li>Low levels of\u00a0sodium,\u00a0phosphate,\u00a0potassium,\u00a0or\u00a0calcium\u00a0in blood tests<\/li><li>Decreased appetite, pain in the mouth<\/li><li>Difficulty sleeping, anxiety<\/li><li>Swelling of the arms and legs, fluid around\u00a0the lungs (alveolar effusion)<\/li><li>Rash<\/li><li>Low immunoglobulin levels.\u00a0This is shown through a blood test and can lead to\u00a0infection.<\/li><li>The increased amount of liver enzymes in blood test<\/li><li>Blood clots.\u00a0Symptoms can include pain in the chest or back of the chest, breathing difficulties, coughing up blood, cramping pain, swelling in a leg, and warm and dark skin around the painful area.<\/li><li>Nerve pain<\/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>Low levels of albumin in blood tests<\/li><li>Abnormally heavy bleeding<\/li><li>Irregular heartbeats\u00a0<em>(\u00a0arrhythmia\u00a0)<\/em>.<\/li><li>Inability to control body movements<\/li><li>Dry mouth, dehydration<\/li><li>Shortness of breath\u00a0<em>(\u00a0respiratory insufficiency\u00a0)<\/em><\/li><li>Difficulty breathing which makes you unable to utter complete sentences;\u00a0cough due to fluid in the lungs.<\/li><li>Increased pressure inside the skull<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Tecartus<\/h2>\n\n\n\n<p><strong>The following information is intended for medical use only.<\/strong><\/p>\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 which is stated on the container label and the infusion bag after EXP.<\/p>\n\n\n\n<p>Store froze in the gas phase of liquid nitrogen \u2264 -150 \u00b0C until thawed for use.<\/p>\n\n\n\n<p>Do not refreeze.<\/p>\n\n\n\n<p>This medicine contains genetically modified human blood cells.&nbsp;Local guidelines for handling human biological waste must be followed for unused medicine or waste.&nbsp;As this medicine will be given by licensed healthcare professionals, they are responsible for the correct disposal of the product.&nbsp;These measures will help to protect the environment.<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<p>The active substance is brexucabtagen-autoleucel.&nbsp;Each patient-specific single-use infusion bag contains a&nbsp;dispersion&nbsp;of anti-CD19-specific CAR&nbsp;T cells&nbsp;in approximately 68 mL for a target dose of 2 \u00d7 10&nbsp;<sup>6<\/sup>&nbsp;anti-CD19-specific CAR-positive viable T cells\/kg.<\/p>\n\n\n\n<p>Other ingredients (excipients) are Cryostor CS10, sodium chloride, and human albumin.\u00a0See section 2 &#8220;Tecartus contains sodium&#8221;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Descartes is a clear to opaque, white to red\u00a0dispersion\u00a0for\u00a0infusion, supplied in an\u00a0infusion bag\u00a0individually 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\n\n\n<p><strong>Manufacturer<\/strong><\/p>\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>0.4\u20132 \u00d7 10\u00a08\u00a0cells\u00a0Infusion fluid\u00a0,\u00a0dispersion<br \/>\nbrexucabtagen-autoleucel (CAR-positive, viable\u00a0T cells\u00a0)<\/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":[2200,22500],"tags":[25432,25442,25436,25435,25438,25439,25437,25434,25441,25440,25433],"class_list":["post-24501","post","type-post","status-publish","format-standard","hentry","category-medicines","category-t","tag-benefits-of-brexucabtagen-auttecartus","tag-benefits-of-tecartus","tag-brexucabtagen-autoleucel","tag-brexucabtagen-autoleucel-side-efforts","tag-tecartus","tag-tecartus-side-effects","tag-what-brexucabtagen-autoleucel-is-used-for","tag-what-is-brexucabtagen-autoleucel","tag-what-is-tecartus","tag-what-tecartus-is-used-for","tag-wholeucel"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24501","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=24501"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24501\/revisions"}],"predecessor-version":[{"id":24555,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24501\/revisions\/24555"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=24501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=24501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=24501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}