{"id":5781,"date":"2020-12-25T16:00:19","date_gmt":"2020-12-25T16:00:19","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5781"},"modified":"2021-07-12T06:41:27","modified_gmt":"2021-07-12T06:41:27","slug":"azacitidine-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/azacitidine-accord\/","title":{"rendered":"Azacitidine Accord &#8211; Azacitidine uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n25 mg \/ ml powder for suspension for injection&nbsp;<br>azacitidine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Azacitidine Accord is and what it is used for<\/h2>\n\n\n\n<p><strong>What Azacitidine Accord is<\/strong><\/p>\n\n\n\n<p>Azacitidine Accord is an anticancer medicine that belongs to a group of medicines called &#8220;antimetabolites&#8221;.&nbsp;Azacitidine Accord contains the active substance &#8216;azacitidine&#8217;.<br><\/p>\n\n\n\n<p><strong>What Azacitidine Accord is used for<\/strong><\/p>\n\n\n\n<p>Azacitidine Accord is used in adults who cannot be treated with<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>stem cell transplantation&nbsp;to treat:<\/li><li>myelodysplastic syndrome&nbsp;(MDS) with 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.<br><\/p>\n\n\n\n<p><strong>How Azacitidine Accord works<\/strong><\/p>\n\n\n\n<p>Azacitidine Accord works by preventing cancer cells from growing.&nbsp;Azacitidine is incorporated into the cells&#8217; genetic material \/ ribonucleic acid [RNA] and deoxyribonucleic acid [DNA].&nbsp;It is thought to work by altering how cells activate and deactivate genes, and also by disrupting the production of new&nbsp;RNA&nbsp;and&nbsp;DNA.&nbsp;These measures are considered to correct problems with the maturation and growth of new blood cells in the&nbsp;bone marrow&nbsp;that cause&nbsp;myelodysplastic syndromes, as well as dead cancer cells in&nbsp;leukemia.<br><\/p>\n\n\n\n<p>Talk to your doctor or nurse if you have any questions about how Azacitidine Accord works or why this medicine has been prescribed for you.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you use Azacitidine Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Azacitidine Accord<\/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 breast-feeding.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Azacitidine Accord:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have a decrease in the number of&nbsp;platelets, red or&nbsp;white 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 a lung disease<\/li><\/ul>\n\n\n\n<p><em>Blood sample<\/em><\/p>\n\n\n\n<p>You will be given a blood test before starting treatment with Azacitidine Accord and at the beginning of each treatment period (called a &#8220;cycle&#8221;).&nbsp;The intention is to check that you have enough&nbsp;blood cells&nbsp;and that the liver and kidneys are functioning properly.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Azacitidine Accord is not recommended for use in children and adolescents below 18 years.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Azacitidine Accord<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.&nbsp;The reason for this is that Azacitidine Accord may affect the way other medicines work.&nbsp;Some other medicines may also affect the way Azacitidine Accord works.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p><em>Pregnancy<\/em><\/p>\n\n\n\n<p>You should not use Azacitidine Accord during pregnancy as it may harm your baby.<\/p>\n\n\n\n<p>Use an effective method of contraception during and up to 3 months after treatment.<\/p>\n\n\n\n<p>Tell your doctor immediately if you become pregnant during treatment.<br><\/p>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<br><\/p>\n\n\n\n<p><em>Breast-feeding<\/em><\/p>\n\n\n\n<p>You must not use Azacitidine Accord if you are breast-feeding.&nbsp;It is not known if Azacitidine Accord passes into breast milk.<br><\/p>\n\n\n\n<p><em>Fertility<\/em><\/p>\n\n\n\n<p>Men should not have children while they are being treated with Azacitidine Accord.&nbsp;Use an effective method of contraception during and up to 3 months after treatment with this medicine.<br><\/p>\n\n\n\n<p>Talk to your doctor if you want to save semen before undergoing this treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Do not drive or use any tools or machines if you experience&nbsp;side effects&nbsp;such as&nbsp;fatigue.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Azacitidine Accord<\/h2>\n\n\n\n<p>Before your doctor gives you Azacitidine Accord, he\/she will give you another medicine to prevent you from feeling sick and vomiting at the beginning of each treatment cycle.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The recommended&nbsp;dose&nbsp;is 75 mg per m&nbsp;<sup>2 of<\/sup>&nbsp;body surface area.&nbsp;Your doctor will decide on the&nbsp;dose of&nbsp;one of these medicines depending on your general condition and your height and weight.&nbsp;Your doctor will examine how your condition develops and may change the&nbsp;dose&nbsp;if necessary.<\/li><li>Azacitidine Accord is given every day for a week, followed by a rest period of 3 weeks.&nbsp;This &#8220;treatment cycle&#8221; will be repeated every 4 weeks.&nbsp;You will usually receive at least 6 treatment cycles.<\/li><\/ul>\n\n\n\n<p>This medicine will be given to you as an&nbsp;injection&nbsp;under the skin (&nbsp;subcutaneously&nbsp;) by a doctor or nurse.&nbsp;It can be given under the skin of the thigh, abdomen, or upper arm.<br><\/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\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/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, shaking, jaundice, swollen abdomen, and frequent bruising.&nbsp;These can be symptoms of liver failure and can be life-threatening.<\/strong><\/li><li><strong>Swelling of the legs and feet, back pain, decreased urination, increased thirst, rapid&nbsp;heart rate, dizziness and nausea, vomiting or decreased appetite and feeling confused, restlessness, or fatigue.&nbsp;These can be symptoms of&nbsp;kidney failure&nbsp;and can be life-threatening<\/strong>.<\/li><li><strong>Fever<\/strong>.&nbsp;Fever can be due to an&nbsp;infection&nbsp;due to too low levels of&nbsp;white blood cells, which can be life-threatening.<\/li><li>Chest pain or shortness of breath that may be accompanied by fever.&nbsp;This can be due to&nbsp;pneumonia&nbsp;and can be life threatening.<\/li><li>Bleeding.&nbsp;As blood in the stool due to bleeding in the stomach or intestines, or bleeding inside the head.&nbsp;This may be a symptom that there are low levels of&nbsp;platelets&nbsp;in the blood.<\/li><li>Difficulty breathing, swelling of the lips,&nbsp;itching,<strong>&nbsp;or rash.&nbsp;<\/strong>This may be due to an allergic (hypersensitivity) reaction.<\/li><\/ul>\n\n\n\n<p>Other&nbsp;side effects&nbsp;include:<br><\/p>\n\n\n\n<p><strong>Very common&nbsp;side effect&nbsp;is<\/strong>&nbsp;(can occur in more than 1 in 10)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Decreased&nbsp;red blood cell count&nbsp;(&nbsp;anemia&nbsp;).&nbsp;You may feel tired and pale.<\/li><li>Decreased&nbsp;white blood cell count.&nbsp;This may be accompanied by fever.&nbsp;You are also at greater risk of getting an&nbsp;infection.<\/li><li>Low&nbsp;platelet count&nbsp;(&nbsp;thrombocytopenia&nbsp;).&nbsp;You are more likely to have bleeding and bruising.<\/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&nbsp;redness, pain, or a skin reaction.<\/li><li>Loss of appetite.<\/li><li>Joint pain.<\/li><li>Bruises.<\/li><li>Rash.<\/li><li>Red or bluish-red spots under the skin.<\/li><li>Stomach pain (abdominal pain).<\/li><li>Itching.<\/li><li>Fever.<\/li><li>Nasal congestion.<\/li><li>Dizziness.<\/li><li>Headache.<\/li><li>Difficulty sleeping (insomnia).<\/li><li>Nasal blood&nbsp;(&nbsp;epistaxis&nbsp;).<\/li><li>Muscle aches.<\/li><li>Weakness (&nbsp;asthenia&nbsp;).<\/li><li>Weight loss.<\/li><li>Low levels of&nbsp;potassium&nbsp;in the blood.<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;are<\/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 (&nbsp;sepsis&nbsp;).&nbsp;This may be due to decreased levels of&nbsp;white blood cells&nbsp;in the blood.<\/li><li>Bone marrow failure.&nbsp;This can cause low levels of red and&nbsp;white blood cells&nbsp;and&nbsp;platelets.<\/li><li>A type of&nbsp;anemia&nbsp;with the decreased number of red and&nbsp;white blood cells&nbsp;and&nbsp;platelets.<\/li><li>Urinary tract infection.<\/li><li>A viral infection that causes cold sores (&nbsp;herpes&nbsp;).<\/li><li>Bleeding gums, bleeding in the stomach or intestines, bleeding from the anal opening due to&nbsp;hemorrhoids&nbsp;(hemorrhoid 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,&nbsp;itching,&nbsp;and discoloration of the skin.<\/li><li>Reddening of the skin.<\/li><li>Skin infection (&nbsp;cellulite&nbsp;).<\/li><li>An&nbsp;infection&nbsp;of the nose and throat or sore throat.<\/li><li>Sore or runny nose or sinuses (&nbsp;sinusitis&nbsp;).<\/li><li>High or low&nbsp;blood pressure&nbsp;(&nbsp;hypertension&nbsp;or&nbsp;hypotension&nbsp;).<\/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>Confusion state.<\/li><li>Hair loss.<\/li><li>Kidney failure.<\/li><li>Dehydration.<\/li><li>White coating on the tongue, inside the cheeks, and sometimes in the palate, on the gums and tonsils (&nbsp;oral&nbsp;fungal infection).<\/li><li>Fainting.<\/li><li>Drop-in blood pressure when you get up (&nbsp;orthostatic&nbsp;hypotension&nbsp;) which leads to dizziness when you get up or sit up.<\/li><li>Drowsiness, drowsiness (&nbsp;somnolence&nbsp;).<\/li><li>Bleeding due to a&nbsp;catheter.<\/li><li>A disease that affects the intestines and can lead to fever, vomiting, and abdominal pain (&nbsp;diverticulitis&nbsp;).<\/li><li>Fluid around the lungs (pleural effusion).<\/li><li>Tremors (chills).<\/li><li>Muscle spasms.<\/li><li>Elevated itchy rash on the skin (&nbsp;urticaria&nbsp;).<\/li><li>Accumulation of fluid around the heart (pericardial effusion).<\/li><\/ul>\n\n\n\n<p><strong>Less common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 100)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic (hypersensitivity) reaction.<\/li><li>Shaking.<\/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&nbsp;of the pericardium (pericarditis).<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 1000 users)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dry cough.<\/li><li>Painless swelling in the fingertips.<\/li><li>Tumor light syndrome &#8211; metabolic complications that can occur during cancer treatment and sometimes even without treatment.&nbsp;These complications are caused by the products of dying cancer cells and can include the following: changes in blood chemistry, such as high levels of&nbsp;potassium, phosphorus, and&nbsp;uric acid&nbsp;and low levels of&nbsp;calcium, which can lead to changes in kidney function and heart rate, seizures and sometimes death.<\/li><\/ul>\n\n\n\n<p><strong>Has been reported<\/strong>&nbsp;(occurs in an unknown number of users)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infection&nbsp;in the deeper layers of the skin spreads quickly and damages the skin and&nbsp;tissue, which can be life-threatening (&nbsp;necrotizing&nbsp;fasciitis).<\/li><\/ul>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Azacitidine Accord<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the vial label and carton.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Your doctor, pharmacist, or nurse is responsible for storing Azacitidine Accord.&nbsp;They are also responsible for the&nbsp;preparation&nbsp;and for ensuring that the remaining Azacitidine Accord is disposed of properly.<br><\/p>\n\n\n\n<p>For unopened vials of this medicine &#8211; no special storage conditions.<br><\/p>\n\n\n\n<p><em>For immediate use<\/em><\/p>\n\n\n\n<p>After&nbsp;reconstitution,&nbsp;the suspension&nbsp;should be&nbsp;administered within 60 minutes.<br><\/p>\n\n\n\n<p><em>For later use<\/em><\/p>\n\n\n\n<p>If Azacitidine Accord\u2011&nbsp;suspension is&nbsp;reconstituted&nbsp;with water for&nbsp;non-cooled&nbsp;injections,&nbsp;suspension&nbsp;one&nbsp;must be&nbsp;placed in the refrigerator (2\u20138 \u00b0 C) immediately after&nbsp;reconstitution&nbsp;and stored refrigerated for up to a maximum of 8 hours.<\/p>\n\n\n\n<p>If Azacitidine Accord\u2011&nbsp;suspension is&nbsp;reconstituted&nbsp;with water for&nbsp;injections&nbsp;cooled (2\u20138 \u00b0 C),&nbsp;suspension&nbsp;one&nbsp;must be&nbsp;placed in the refrigerator (2\u20138 \u00b0 C) immediately after&nbsp;reconstitution&nbsp;and stored in a refrigerator for up to a maximum of 22 hours.<br><\/p>\n\n\n\n<p>The suspension&nbsp;should be allowed to stand for up to 30 minutes before&nbsp;administration&nbsp;to reach room temperature (20-25 \u00b0 C).<br><\/p>\n\n\n\n<p>If there are large particles in&nbsp;suspension&nbsp;one, it should be discarded.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. 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 azacitidine.&nbsp;One&nbsp;vial&nbsp;contains 100 mg of azacitidine.&nbsp;After&nbsp;reconstitution&nbsp;with 4 ml of water for&nbsp;injections, the reconstituted&nbsp;suspension contains&nbsp;25 mg\/ml azacitidine.<\/li><li>The other ingredient is mannitol (E421).<\/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>Azacitidine Accord is a white powder for&nbsp;injection&nbsp;,&nbsp;suspension&nbsp;and provided in a&nbsp;vial of glass containing 100 mg azacitidine.&nbsp;Each pack contains a&nbsp;vial&nbsp;of Azacitidine Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Accord Healthcare SLU<\/p>\n\n\n\n<p>World Trade Center,<\/p>\n\n\n\n<p>Moll de Barcelona, \u200b\u200bs \/ n,<\/p>\n\n\n\n<p>Edifici Est 6\u00aa planta,<\/p>\n\n\n\n<p>08039 Barcelona, \u200b\u200bSpain<br><\/p>\n\n\n\n<p><strong>Manufacturer:<\/strong><\/p>\n\n\n\n<p>Accord Healthcare Limited,<\/p>\n\n\n\n<p>Sage House, 319 Pinner Road, North Harrow,<\/p>\n\n\n\n<p>Middlesex, HA1 4HF,<\/p>\n\n\n\n<p>UK<br><\/p>\n\n\n\n<p>Or<br><\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50,<\/p>\n\n\n\n<p>95-200 Pabianice<\/p>\n\n\n\n<p>Poland<br><\/p>\n\n\n\n<p>Or<br><\/p>\n\n\n\n<p>Laboratori Fundaci\u00f3 Dau<\/p>\n\n\n\n<p>C \/ C, 12-14 Pol.&nbsp;Ind.<\/p>\n\n\n\n<p>Zona Franca, Barcelona, \u200b\u200b08040,<\/p>\n\n\n\n<p>Spain<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Azacitidine Accord is an anticancer medicine that belongs to a group of medicines called &#8220;antimetabolites&#8221;. Azacitidine Accord contains the active substance &#8216;azacitidine&#8217;.<\/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":[2201,2200],"tags":[9531,9541,9543,9534,9535,9545,9544,9533,9532,9542],"class_list":["post-5781","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-azacitidine","tag-azacitidine-accord","tag-azacitidine-accord-injection","tag-azacitidine-injection","tag-side-effects-of-azacitidine","tag-side-effects-of-azacitidine-accord","tag-what-azacitidine-accord-is-used-for","tag-what-azacitidine-is-used-for","tag-what-is-azacitidine","tag-what-is-azacitidine-accord"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5781","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=5781"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5781\/revisions"}],"predecessor-version":[{"id":12271,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5781\/revisions\/12271"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5781"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5781"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}