{"id":22697,"date":"2022-07-06T05:37:22","date_gmt":"2022-07-06T05:37:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22697"},"modified":"2022-07-06T14:22:37","modified_gmt":"2022-07-06T14:22:37","slug":"sarclisa","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/sarclisa\/","title":{"rendered":"Sarclisa &#8211; Isatuximab uses, dose and side effects"},"content":{"rendered":"\n<p>20 mg \/ ml&nbsp;concentrate for&nbsp;solution for&nbsp;infusion<br>isatuximab<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Sarclisa is and what it is used for<\/h2>\n\n\n\n<p><strong>What Sarclisa is<\/strong><\/p>\n\n\n\n<p>Sarclisa is a cancer medicine that contains the active substance isatuximab.\u00a0It belongs to a group of drugs called monoclonal\u00a0antibodies.<br>Monoclonal\u00a0antibodies, such as Sarclisa, are\u00a0proteins\u00a0that have been developed to recognize and bind specific target substances in the body.\u00a0Sarclisa has been designed to bind a surface molecule called CD38 that is found on the plasma cells (myeloma cells), a type of\u00a0bone marrow\u00a0cancer.\u00a0By binding to CD38 on myeloma cells, the drug helps the body&#8217;s natural defense system (immune system) to identify and destroy them.<\/p>\n\n\n\n<p><strong>What Sarclisa is used for<\/strong><\/p>\n\n\n\n<p>Sarclisa is used for the treatment of multiple\u00a0myeloma\u00a0in patients who have undergone previous multiple\u00a0myeloma\u00a0treatments.<br>It is used in combination with two other drug combinations<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pomalidomide and <a href=\"https:\/\/zeepedia.com\/medical\/medicines\/toflacort\/\">dexamethasone<\/a> or<\/li><li>carfilzomib and dexamethasone.<\/li><\/ul>\n\n\n\n<p>Contact your doctor if you have any questions about how Sarclisa works or your treatment with Sarclisa.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Sarclisa<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You should not be given Sarclisa<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to isatuximab or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or nurse before using Sarclisa and follow all instructions carefully.<\/p>\n\n\n\n<p><strong>Infusion-related reactions<\/strong><\/p>\n\n\n\n<p><strong>Tell your doctor or nurse immediately if you get infusion-related reactions during or after treatment with Sarclisa<\/strong>&nbsp;&#8211; see section 4 for signs of infusion-related reactions.<br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Before treatment with Sarclisa, you may be given medicines that reduce the risk of infusion-related reactions (see section 3).<\/li><li>Infusion-related reactions may occur during or after treatment with Sarclisa and may be serious.&nbsp;The reactions go back.&nbsp;The medical staff will monitor you closely during the treatment.<\/li><\/ul>\n\n\n\n<p>If you get infusion-related reactions, your doctor or nurse may give you other medicines to relieve the symptoms and prevent complications.&nbsp;They may also need to temporarily discontinue, slow down or discontinue Sarclisa&nbsp;infusion&nbsp;completely.<\/p>\n\n\n\n<p><strong>Fever and decreased&nbsp;white blood cell count<\/strong><\/p>\n\n\n\n<p>Tell your doctor or nurse immediately if you get a fever, as it may be a sign of\u00a0infection.\u00a0Sarclisa can reduce the number of\u00a0white blood cells\u00a0&#8211; which are important in fighting\u00a0infections.<br><\/p>\n\n\n\n<p><strong>Heart problems<\/strong><\/p>\n\n\n\n<p>Talk to your doctor or nurse before using Sarclisa in combination with carfilzomib and dexamethasone if you have heart problems, or if you are taking or have been taking medicines for the heart.\u00a0Contact a doctor or nurse immediately if you have difficulty breathing, coughing, or swollen legs.<br><\/p>\n\n\n\n<p><strong>Risk of new cancer<\/strong><\/p>\n\n\n\n<p>New cancers have occurred in patients treated with Sarclisa when co-administered with pomalidomide and dexamethasone or with carfilzomib and dexamethasone.&nbsp;Your doctor or nurse will follow you up due to the onset of new cancer during treatment.<\/p>\n\n\n\n<p><strong>Blood transfusion<\/strong><\/p>\n\n\n\n<p>If you need a\u00a0blood transfusion, you will first have to submit a blood sample to determine your blood type.<\/p>\n\n\n\n<p>Tell the person taking the test that you are being treated with Sarclisa.&nbsp;This is because it can affect the results of the blood test.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Sarclisa is not recommended for children and adolescents under 18 years of age.&nbsp;The reason for this is that the drug has not been tested in that age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Sarclisa<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.\u00a0This also applies to over-the-counter medicines and (traditional) herbal and herbal medicines.<br><\/p>\n\n\n\n<p>Talk to your doctor or nurse before using Sarclisa if you are taking or have been taking heart medicine.<\/p>\n\n\n\n<p>Sarclisa is given together with two other drug combinations in the treatment of multiple myeloma:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pomalidomide and dexamethasone or<\/li><li>carfilzomib and dexamethasone.<\/li><\/ul>\n\n\n\n<p>For information on the other medicines used with Sarclisa, read their package leaflets.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and contraception<\/h2>\n\n\n\n<p>Pregnancy<\/p>\n\n\n\n<p>Consult your doctor, pharmacist, or nurse before using Sarclisa.<\/p>\n\n\n\n<p>The use of Sarclisa during pregnancy is not recommended.\u00a0If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Sarclisa.<\/p>\n\n\n\n<p>For information on pregnancy for the other medicines given with Sarclisa, see the package leaflets for each medicine.<\/p>\n\n\n\n<p>Breast-feeding<\/p>\n\n\n\n<p>Consult your doctor, pharmacist, or nurse before using Sarclisa.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The reason for this is that the drug can pass into breast milk and it is not known how the drug can affect the baby.<\/li><li>You and your doctor will decide if the benefits of breastfeeding outweigh the risks to your baby.<\/li><\/ul>\n\n\n\n<p>Contraceptive<\/p>\n\n\n\n<p>Women treated with Sarclisa and of&nbsp;childbearing potential&nbsp;must use effective contraception.&nbsp;Talk to your doctor about which contraceptive to use during treatment.&nbsp;Use contraception during treatment and for 5 months after the last Sarclisa treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Sarclisa is unlikely to affect your ability to drive or use machines.&nbsp;However, Sarclisa is given with other medicines that may affect your ability to drive or use machines.&nbsp;Read the package leaflet for the other medicines you are taking with Sarclisa.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Sarclisa is given<\/h2>\n\n\n\n<p><strong>How much Sarclisa should you be given?<\/strong><\/p>\n\n\n\n<p>The amount of Sarclisa that you will receive is based on your body weight.&nbsp;The recommended&nbsp;dose&nbsp;is 10 mg Sarclisa per kg body weight.<\/p>\n\n\n\n<p><strong>How Sarclisa is given<\/strong><\/p>\n\n\n\n<p>Your doctor or nurse will give you Sarclisa as a drip via a vein (&nbsp;intravenous&nbsp;infusion&nbsp;).<\/p>\n\n\n\n<p><strong>How often is Sarclisa given?<\/strong><\/p>\n\n\n\n<p>Sarclisa is given in treatment cycles lasting 28 days (4 weeks).\u00a0It is given with two other medicines, either pomalidomide, and dexamethasone or carfilzomib and dexamethasone.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>In cycle 1: Sarclisa is given once a week on days 1, 8, 15 and 22<\/li><li>In cycle 2 and subsequent cycles: Sarclisa is given every two weeks on days 1 and 15<\/li><\/ul>\n\n\n\n<p>Your doctor will treat you with Sarclisa as long as the disease improves and the&nbsp;side effects&nbsp;are acceptable.<\/p>\n\n\n\n<p><strong>Medicines are given before Sarclisa\u00a0infusion<\/strong><\/p>\n\n\n\n<p>You will receive the following medicines before&nbsp;infusion&nbsp;one with Sarclisa.&nbsp;These medicines help reduce the risk of infusion-related reactions:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>medicines to reduce allergic reactions (&nbsp;antihistamines&nbsp;)<\/li><li>drugs to reduce&nbsp;inflammation&nbsp;(&nbsp;cortisone&nbsp;)<\/li><li>medicines to reduce pain and fever<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you miss a dose of Sarclisa<\/h2>\n\n\n\n<p>You must arrive at all booked treatment sessions at the right time for your treatment to work.\u00a0If you forget a treatment opportunity, book a new one as soon as possible.<\/p>\n\n\n\n<p>The doctor or nurse will decide how to continue the treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Sarclisa than you should<\/h2>\n\n\n\n<p>Sarclisa will be given by a doctor or nurse.\u00a0If you are unlikely to get too much (an overdose), your doctor will check and treat the\u00a0side effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Sarclisa<\/h2>\n\n\n\n<p>Do not stop treatment with Sarclisa unless you have discussed it with your doctor.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/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>Your doctor will discuss the&nbsp;side effects&nbsp;with you and will explain the risks and benefits of Sarclis treatment.<\/p>\n\n\n\n<p>The medical staff will monitor you closely during the treatment.&nbsp;Tell them right away if you get any of the&nbsp;side effects&nbsp;below.<\/p>\n\n\n\n<p><strong>Infusion-related reactions &#8211; Very common<\/strong>&nbsp;(may affect more than 1 user in 10)<\/p>\n\n\n\n<p><strong>Tell your doctor or nurse immediately if you feel unwell during or after&nbsp;an infusion&nbsp;of Sarclisa.<\/strong><\/p>\n\n\n\n<p>Serious infusion-related reactions are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>high\u00a0blood pressure\u00a0(\u00a0hypertension\u00a0)<\/li><li>breathing problems<\/li><li>severe\u00a0allergic reaction\u00a0(\u00a0anaphylactic reaction\u00a0occurring in up to 1 in 100 users) with difficulty breathing and swelling of the face, mouth, throat, lips, or tongue.<\/li><\/ul>\n\n\n\n<p>The most common infusion-related reactions are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>breathing problems<\/li><li>cough<\/li><li>overindulge<\/li><li>nausea<\/li><\/ul>\n\n\n\n<p>Other symptoms may also occur during\u00a0infusion\u00a0one.\u00a0Your doctor or nurse may consider stopping, reducing the infusion rate, or stopping Sarclisa\u00a0infusion.\u00a0They may also give you other medicines to treat the symptoms and prevent complications.<\/p>\n\n\n\n<p>Tell your doctor or nurse immediately if you feel unwell during or after&nbsp;an infusion&nbsp;of Sarclisa.<\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse immediately if you get any of the\u00a0side effects\u00a0listed below:<\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 user in 10):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low\u00a0red blood cell count\u00a0(\u00a0anemia\u00a0)<\/li><li>a low number of\u00a0white blood cells\u00a0(\u00a0neutrophils\u00a0or\u00a0lymphocytes\u00a0) that are important in fighting\u00a0infection.<\/li><li>low\u00a0platelet count\u00a0(\u00a0thrombocytopenia\u00a0) &#8211; tell your doctor or nurse if you have any abnormal bruising or bleeding.<\/li><li>lung infection\u00a0(\u00a0pneumonia\u00a0)<\/li><li>respiratory\u00a0tract infection &#8211; (eg in the nose, sinuses, or throat)<\/li><li>diarrhea<\/li><li>bronchitis\u00a0(\u00a0bronchitis\u00a0)<\/li><li>breathing problems<\/li><li>nausea<\/li><li>fever with a sharp decrease in certain\u00a0white blood cells\u00a0(febrile\u00a0neutropenia\u00a0) (see section 2 for more information)<\/li><li>vomiting<\/li><li>high\u00a0blood pressure\u00a0(\u00a0hypertension\u00a0)<\/li><li>cough<\/li><li>fatigue<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>heart problems, which may manifest as difficulty breathing, coughing, or swollen legs when Sarclisa is given with carfilzomib and dexamethasone<\/li><li>decreased appetite<\/li><li>weight loss<\/li><li>irregular heartbeat (\u00a0atrial fibrillation\u00a0)<\/li><\/ul>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse immediately if you get any of the\u00a0side effects\u00a0listed above.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Sarclisa<\/h2>\n\n\n\n<p>Sarclisa is stored in the hospital or clinic.<\/p>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and vial after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C-8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater.\u00a0Doctors, pharmacists, or nurses will discard medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/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\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is isatuximab.<\/li><li>1 ml of concentrate contains 20 mg of isatuximab.<\/li><li>Each 5 ml concentrate\u00a0vial\u00a0contains 100 mg of isatuximab and every 25 ml concentrate\u00a0vial\u00a0contains 500 mg of isatuximab.<\/li><li>The other ingredients (excipients) are sucrose, histidine hydrochloride monohydrate, histidine, polysorbate 80, and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Sarclisa is a concentrated solution for\u00a0infusion.\u00a0It is a colorless to yellowish liquid mainly free of visible particles.\u00a0Sarclisa is supplied in packs of 1 or 3 glass vials.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Holder of approval<\/h2>\n\n\n\n<p>sanofi-aventis groupe<\/p>\n\n\n\n<p>54 rue La Bo\u00e9tie<\/p>\n\n\n\n<p>75008 Paris<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Sanofi-Aventis Deutschland GmbH<\/p>\n\n\n\n<p>Industrial park Hoechst Brueningstrasse 50<\/p>\n\n\n\n<p>65926 Frankfurt am Main<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder if you want to know more about this medicine:<br><br>Sanofi AB<\/p>\n\n\n\n<p>Tel: +46 (0) 8 634 50 00<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sarclisa is a cancer medicine that contains the active substance isatuximab. It belongs to a group of drugs called monoclonal antibodies .<\/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":[2200,18530],"tags":[23774,23765,23769,23768,23770,23773,23766,23771,23767,23772],"class_list":["post-22697","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-sarclisa","tag-isatuximab","tag-isatuximab-dosage","tag-isatuximab-side-effects","tag-sarclisa","tag-sarclisa-side-effects","tag-what-is-isatuximab","tag-what-is-sarclisa","tag-what-isatuximab-is-used-for","tag-what-sarclisa-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22697","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=22697"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22697\/revisions"}],"predecessor-version":[{"id":22741,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22697\/revisions\/22741"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22697"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22697"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}