{"id":28539,"date":"2022-10-29T13:19:08","date_gmt":"2022-10-29T13:19:08","guid":{"rendered":"https:\/\/zeepedia.com\/?p=28539"},"modified":"2022-11-01T10:27:52","modified_gmt":"2022-11-01T10:27:52","slug":"vidaza","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/vidaza\/","title":{"rendered":"Vidaza &#8211; Azacitidine uses, dose and side effects"},"content":{"rendered":"\n<p>25 mg\/ml\u00a0powder for\u00a0injection,\u00a0suspension<br>azacitidine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Vidaza is and what it is used for<\/h2>\n\n\n\n<p><strong>What Vidaza is<\/strong><\/p>\n\n\n\n<p>Vidaza is an anti-cancer agent that belongs to a group of medicines called &#8216;antimetabolites&#8217;.&nbsp;Vidaza contains the active substance &#8220;azacytidine&#8221;.<\/p>\n\n\n\n<p><strong>What Vidaza is used for<\/strong><\/p>\n\n\n\n<p>Vidaza is used in adults who cannot be treated with a&nbsp;stem cell transplant&nbsp;to treat:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>myelodysplastic syndrome&nbsp;(MDS) at higher risk.<\/li><li>chronic&nbsp;myelomonocytic&nbsp;leukemia&nbsp;(CMML).<\/li><li>acute&nbsp;myeloid&nbsp;leukemia&nbsp;(AML).<\/li><\/ul>\n\n\n\n<p>These are diseases that affect the&nbsp;bone marrow&nbsp;and can cause problems with normal blood cell production.<\/p>\n\n\n\n<p><strong>How Vidaza works<\/strong><\/p>\n\n\n\n<p>Vidaza works by stopping cancer cells from growing.\u00a0Azacitidine is incorporated into the cell&#8217;s genetic material (\u00a0ribonucleic acid\u00a0(\u00a0RNA\u00a0) and deoxyribonucleic acid (\u00a0DNA\u00a0)).\u00a0It is thought to work by changing the way cells activate and deactivate genes, and also by interfering with the production of new\u00a0RNA\u00a0and\u00a0DNA.\u00a0These measures are considered to correct problems with the maturation and growth of new blood cells in the\u00a0bone marrow\u00a0that cause\u00a0myelodysplastic syndromes, as well as dead cancer cells in\u00a0leukemia.<\/p>\n\n\n\n<p>Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use Vidaza<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Vidaza<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you have advanced liver cancer.<\/li><li>if you are breastfeeding.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Vidaza:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have a reduced number of\u00a0platelets, red or\u00a0white blood cells.<\/li><li>If you have kidney disease.<\/li><li>If you have liver disease.<\/li><li>If you have ever had heart disease or heart attack or have had lung disease<\/li><\/ul>\n\n\n\n<p>Vidaza can cause a serious immune reaction called &#8216;differentiation syndrome&#8217; (see section 4).<\/p>\n\n\n\n<p>Blood sample<\/p>\n\n\n\n<p>You will be given blood tests before you start treatment with Vidaza and at the start of each treatment period (called a &#8216;cycle&#8217;).&nbsp;The intention is to check that you have enough&nbsp;blood cells&nbsp;and that the liver and kidneys are working as they should.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Vidaza is not recommended for children and adolescents under 18 years of age.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Vidaza<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0This is because Vidaza can affect the way other medicines work.\u00a0Some other medicines can also affect the way Vidaza works.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Pregnancy<\/p>\n\n\n\n<p>You should not use Vidaza during pregnancy as it may harm the baby.&nbsp;If you are a woman of childbearing potential, you must use effective contraception while taking Vidaza and for 6 months after stopping treatment with Vidaza.&nbsp;Tell your doctor immediately if you become pregnant during treatment.<\/p>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n<p>Breast-feeding<\/p>\n\n\n\n<p>You must not use Vidaza if you are breastfeeding.\u00a0It is not known whether Vidaza passes into breast milk.<\/p>\n\n\n\n<p>Fertility<\/p>\n\n\n\n<p>Men should not father children while being treated with Vidaza.&nbsp;Men should use an effective method of contraception while taking Vidaza and for 3 months after stopping treatment with Vidaza.<\/p>\n\n\n\n<p>Talk to your doctor if you want to save sperm before undergoing this treatment.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Do not drive a car and do not use tools or machines if you experience&nbsp;side effects&nbsp;such as&nbsp;fatigue.<a><\/a><br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Vidaza<\/h2>\n\n\n\n<p>Before your doctor gives you Vidaza, he\/she will give you another medicine to prevent you from feeling sick and vomiting at the start of each treatment cycle.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The recommended\u00a0dose\u00a0is 75 mg per m\u00a0<sup>2<\/sup>\u00a0body surface.\u00a0Your doctor determines the\u00a0amount\u00a0of this medicine depending on your general condition and your height and weight.\u00a0Your doctor will examine how your condition develops and may change the\u00a0amount\u00a0if necessary.<\/li><li>Vidaza is given every day for a week, followed by a rest period of 3 weeks.\u00a0This \u201ctreatment cycle\u201d will be repeated every 4 weeks.\u00a0You normally receive at least 6 treatment cycles.<\/li><\/ul>\n\n\n\n<p>This medicine will be given to you as an\u00a0injection\u00a0under the skin (\u00a0subcutaneously\u00a0) by a doctor or nurse.\u00a0It can be given under the skin of the thigh, abdomen, or upper arm.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, 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><strong>Tell your doctor immediately if you notice any of the following side effects:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Drowsiness, tremors, jaundice, swollen abdomen,<\/strong> and frequent bruising.\u00a0These can be symptoms of liver failure and can be life-threatening.<\/li><li>Swelling of the legs and feet, back pain, decreased urination, increased thirst, rapid\u00a0pulse, dizziness and nausea, vomiting or decreased appetite, and feeling confused, restlessness or fatigue.\u00a0These can be symptoms of\u00a0kidney failure\u00a0and can be life-threatening.<\/li><li>Fever.\u00a0Fever can be due to an\u00a0infection\u00a0due to low levels of\u00a0white blood cells, which can be life-threatening.<\/li><li>Chest pain or shortness of breath may be accompanied by fever.\u00a0This can be due to\u00a0pneumonia\u00a0and can be life-threatening.<\/li><li>Bleeding.\u00a0Like blood in the stool due to bleeding in the stomach or intestines, or bleeding inside the head.\u00a0These may be symptoms of low levels of\u00a0platelets\u00a0in the blood.<\/li><li>Difficulty breathing, swelling of the lips,\u00a0itching,<strong>\u00a0or rash.\u00a0<\/strong>This may be due to an allergic (hypersensitivity) reaction.<\/li><\/ul>\n\n\n\n<p>Other&nbsp;side effects&nbsp;include:<\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Decreased number of\u00a0red blood cells\u00a0(\u00a0anemia\u00a0).\u00a0You may feel tired and pale.<\/li><li>Decreased number of\u00a0white blood cells.\u00a0This may be accompanied by fever.\u00a0You are also at greater risk of getting an\u00a0infection.<\/li><li>Low\u00a0platelet count\u00a0(\u00a0thrombocytopenia\u00a0).\u00a0You are more likely to bleed and bruise.<\/li><li>Constipation, diarrhea, nausea, vomiting.<\/li><li>Pneumonia.<\/li><li>Chest pain, shortness of breath.<\/li><li>Fatigue.<\/li><li>A reaction at the injection site in the form of\u00a0redness, pain, or a skin reaction.<\/li><li>Loss of appetite.<\/li><li>Joint pain.<\/li><li>Bruises.<\/li><li>Rash.<\/li><li>Red or blue-red spots under the skin.<\/li><li>Stomachache (abdominal pain).<\/li><li>Itching.<\/li><li>Fever.<\/li><li>Sore nose and throat.<\/li><li>Dizziness.<\/li><li>Headache.<\/li><li>Difficulty sleeping (insomnia).<\/li><li>Epistaxis (\u00a0epistaxis\u00a0).<\/li><li>Muscle pain.<\/li><li>Weakness (\u00a0asthenia\u00a0).<\/li><li>Weight loss.<\/li><li>Low levels of\u00a0potassium\u00a0in the blood.<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bleeding inside the head.<\/li><li>A blood infection caused by bacteria (\u00a0sepsis\u00a0).\u00a0This may be due to reduced levels of\u00a0white blood cells\u00a0in the blood.<\/li><li>Bone marrow failure.\u00a0This can cause low levels of red and\u00a0white blood cells\u00a0and\u00a0platelets.<\/li><li>A type of\u00a0anemia\u00a0with reduced numbers of red and\u00a0white blood cells\u00a0and\u00a0platelets.<\/li><li>Urine infection.<\/li><li>A viral infection that causes cold sores (\u00a0herpes\u00a0).<\/li><li>Bleeding gums, bleeding in the stomach or intestines, bleeding from the anal opening due to\u00a0hemorrhoids\u00a0(hemorrhoidal bleeding), bleeding in the eyes, bleeding under the skin or in the skin (hematoma).<\/li><li>Blood in the urine.<\/li><li>Sores in the mouth or on the tongue.<\/li><li>Changes in the skin at the injection site in the form of swelling, a hard lump, bruising, bleeding in the skin (hematoma), rash,\u00a0itching,\u00a0and discoloration of the skin.<\/li><li>Skin redness.<\/li><li>Skin infection (\u00a0cellulitis\u00a0).<\/li><li>An\u00a0infection\u00a0in the nose and throat or a sore throat.<\/li><li>Sore or runny nose or sinuses (\u00a0sinusitis\u00a0).<\/li><li>High or low\u00a0blood pressure\u00a0(\u00a0hypertension\u00a0or\u00a0hypotension\u00a0).<\/li><li>Shortness of breath on exertion.<\/li><li>Pain in the throat and vocal cords.<\/li><li>Indigestion.<\/li><li>Lethargy.<\/li><li>General malaise.<\/li><li>Anxiety.<\/li><li>State of confusion.<\/li><li>Hair loss.<\/li><li>Kidney failure.<\/li><li>Dehydration.<\/li><li>White coating on the tongue, the inside of the cheeks, and sometimes in the palate, on the gums and tonsils (\u00a0oral\u00a0fungal infection).<\/li><li>Fainting.<\/li><li>Drop in blood pressure when standing up (\u00a0orthostatic\u00a0hypotension\u00a0) leading to dizziness when standing up or sitting up.<\/li><li>Sleepiness, drowsiness (\u00a0somnolence\u00a0).<\/li><li>Bleeding due to a\u00a0catheter.<\/li><li>A disease that affects the intestine and can lead to fever, vomiting, and stomach pain (\u00a0diverticulitis\u00a0).<\/li><li>Fluid around the lungs (pleural effusion).<\/li><li>Tremors (chills).<\/li><li>Muscle spasms.<\/li><li>Raised itchy rashes on the skin (\u00a0urticaria\u00a0)<\/li><li>Accumulation of fluid around the heart (pericardial effusion).<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic (hypersensitivity) reaction.<\/li><li>Tremors.<\/li><li>Liver failure.<\/li><li>Large dark purple raised painful spots on the skin and fever.<\/li><li>Painful skin ulcer (pyoderma gangrenosum).<\/li><li>Inflammation\u00a0of the pericardium (pericarditis).<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 1,000 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dry cough.<\/li><li>Painless swelling of the fingertips.<\/li><li>Tumor lysis syndrome \u2013 metabolic complications that can occur during cancer treatment and sometimes even without treatment.\u00a0These complications are caused by the products of dying cancer cells and can include the following: changes in blood chemistry, such as high levels of\u00a0potassium, phosphorus, and\u00a0uric acid, and low levels of\u00a0calcium, which can lead to changes in kidney function and heart rhythm, seizures and sometimes death.<\/li><\/ul>\n\n\n\n<p><strong>Frequency not known<\/strong>&nbsp;(cannot be estimated from available data)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infection\u00a0in the deeper skin layers spreads quickly and damages the skin and\u00a0tissue, which can be life-threatening (\u00a0necrotizing\u00a0fasciitis).<\/li><li>Severe immune reaction (differentiation syndrome) which may cause fever, cough, difficulty breathing,\u00a0itching, decreased urine, low\u00a0blood pressure\u00a0(\u00a0hypotension\u00a0), swollen arms or legs, and rapid weight gain.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Vidaza<\/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 vial label and carton.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Your doctor, pharmacist, or nurse is responsible for storing Vidaza.\u00a0They are also responsible for\u00a0the preparation\u00a0and proper disposal of leftover Vidaza.<\/p>\n\n\n\n<p>For unopened vials of this medicine &#8211; no special storage conditions.<\/p>\n\n\n\n<p><em>For immediate use<\/em><\/p>\n\n\n\n<p>After\u00a0preparation, the\u00a0suspension\u00a0should be\u00a0administered within 45 minutes.<\/p>\n\n\n\n<p><em>For later use<\/em><\/p>\n\n\n\n<p>If Vidaza&nbsp;suspension&nbsp;is prepared with water for&nbsp;injection that is not chilled, the&nbsp;suspension&nbsp;must be&nbsp;placed in the refrigerator (2-8 \u00b0C) immediately after&nbsp;preparation&nbsp;and refrigerated for up to 8 hours.<\/p>\n\n\n\n<p>If Vidaza&nbsp;suspension&nbsp;is prepared with water for&nbsp;injection&nbsp;that is cooled (2-8\u00b0C), the&nbsp;suspension&nbsp;must be placed in the refrigerator (2-8\u00b0C) immediately after&nbsp;preparation&nbsp;and refrigerated for up to a maximum of 22 hours.<\/p>\n\n\n\n<p>Suspension&nbsp;should be allowed to stand for up to 30 minutes before&nbsp;administration&nbsp;to reach room temperature (20\u201325 \u00b0C).<\/p>\n\n\n\n<p>If there are large particles in\u00a0the suspension, they should be discarded.<\/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 azacitidine.\u00a0One\u00a0vial\u00a0contains 100 mg of azacitidine.\u00a0After\u00a0reconstitution\u00a0with 4 ml water for\u00a0injection, the prepared\u00a0suspension\u00a0contains 25 mg\/ml azacitidine.<\/li><li>The other ingredient is mannitol (E421).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Vidaza is a white powder for&nbsp;suspension&nbsp;for&nbsp;injection&nbsp;and is supplied in a glass&nbsp;vial&nbsp;containing 100 mg of azacitidine.&nbsp;Each pack contains one&nbsp;vial&nbsp;of Vidaza.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Bristol-Myers Squibb Pharma EEIG<\/p>\n\n\n\n<p>Plaza 254<\/p>\n\n\n\n<p>Blanchardstown Corporate Park 2<\/p>\n\n\n\n<p>Dublin 15, D15 T867<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Celgene Distribution BV<\/p>\n\n\n\n<p>Orteliuslaan 1000<\/p>\n\n\n\n<p>3528 BD<\/p>\n\n\n\n<p>Utrecht<\/p>\n\n\n\n<p>Netherlands<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vidaza is an anti-cancer agent that belongs to a group of medicines called &#8216;antimetabolites&#8217;.\u00a0Vidaza contains the active substance &#8220;azacytidine&#8221;.<\/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":[2200,22502],"tags":[9531,20198,20199,27395,27391,27394,9533,9532,27392,27393],"class_list":["post-28539","post","type-post","status-publish","format-standard","hentry","category-medicines","category-v","tag-azacitidine","tag-azacitidine-side-effects","tag-benefits-of-azacitidine","tag-benefits-of-vidaza","tag-vidaza","tag-vidaza-side-effects","tag-what-azacitidine-is-used-for","tag-what-is-azacitidine","tag-what-is-vidaza","tag-what-vidaza-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28539","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=28539"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28539\/revisions"}],"predecessor-version":[{"id":28569,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/28539\/revisions\/28569"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=28539"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=28539"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=28539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}