{"id":5783,"date":"2020-12-25T16:04:07","date_gmt":"2020-12-25T16:04:07","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5783"},"modified":"2021-07-12T06:41:20","modified_gmt":"2021-07-12T06:41:20","slug":"azacitidine-stada","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/azacitidine-stada\/","title":{"rendered":"Azacitidine STADA &#8211; Azacitidine uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n25 mg \/ ml&nbsp;powder for&nbsp;injection&nbsp;,&nbsp;suspension&nbsp;<br>azacitidine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Azazitidine STADA is and what it is used for<\/h2>\n\n\n\n<p><strong>What&nbsp;<\/strong><strong>Azacitidine Stada&nbsp;<\/strong><strong>is<\/strong><\/p>\n\n\n\n<p>Azacitidine Stada is an anticancer medicine that belongs to a group of medicines called &#8216;antimetabolites&#8217;.&nbsp;Azacitidine Stada contains the active substance &#8220;azacitidine&#8221;.<br><\/p>\n\n\n\n<p><strong>What&nbsp;<\/strong><strong>Azacitidine Stada&nbsp;<\/strong><strong>is used for<\/strong><\/p>\n\n\n\n<p>Azacitidine Stada is used in adults who cannot be treated with&nbsp;stem cell transplantation&nbsp;to treat:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><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&nbsp;<\/strong><strong>Azacitidine Stada&nbsp;<\/strong><strong>works<\/strong><\/p>\n\n\n\n<p>Azacitidine Stada 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 Stada works or why this medicine has been prescribed for you.<br><\/p>\n\n\n\n<p>Azacitidine contained in Azacitidine Stada may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use Azacitidine STADA<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Azacitidine STADA<\/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 Stada if you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>has decreased the number of&nbsp;platelets, red or&nbsp;white blood cells.<\/li><li>have kidney disease.<\/li><li>have liver disease.<\/li><li>have ever had heart disease or heart attack or have had a lung disease.<\/li><\/ul>\n\n\n\n<p><strong>Blood sample<\/strong><\/p>\n\n\n\n<p>You will be given blood tests before starting treatment with Azacitidine Stada 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 Stada 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 STADA<\/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 Stada may affect the way other medicines work.&nbsp;Some other medicines may also affect the way Azacitidine Stada works.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>You should not use this medicine 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.&nbsp;Tell your doctor immediately if you become pregnant during treatment.<\/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><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>You must not use this medicine if you are breast-feeding.&nbsp;It is not known if this medicine passes into breast milk.<br><\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Men should not have children while they are being treated with Azacitidine Stada.&nbsp;Use an effective method of contraception during and up to 3 months after treatment with this medicine.<\/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<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Azacitidine STADA<\/h2>\n\n\n\n<p>Before your doctor gives you this medicine, he\/she will give you another medicine so that you do not feel sick and vomit at the beginning of each treatment cycle.<br><\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>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.<br><\/p>\n\n\n\n<p><strong>How Azacitidine Stada is given<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Azacitidine Stada is given daily for one 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><li>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.<\/li><\/ul>\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.<\/strong><\/li><li>These can be symptoms of liver failure and can be life-threatening.<\/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.<\/strong><\/li><li>These can be symptoms of&nbsp;kidney failure&nbsp;and can be life-threatening.<\/li><li>Fever.<\/li><li>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><strong>Chest pain or shortness of breath that may be accompanied by fever.<\/strong><\/li><li>This can be due to&nbsp;pneumonia&nbsp;and can be life-threatening.<\/li><li><strong>Bleeding.<\/strong><\/li><li>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><strong>Difficulty breathing, swelling of the lips,&nbsp;itching,&nbsp;or rash.<\/strong><\/li><li>This may be due to an allergic (hypersensitivity) reaction.<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;include:<\/strong><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 number of&nbsp;red blood cells&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&nbsp;infection&nbsp;s<\/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>an injection site reaction 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>nose and throat pain<\/li><li>dizziness<\/li><li>headache<\/li><li>difficulty sleeping (insomnia)<\/li><li>nosebleeds (&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)<\/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>state of confusion<\/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>trembling (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 lysis 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 that spreads rapidly 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 STADA<\/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 label and carton after EXP.&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 Stada.&nbsp;They are also responsible for the&nbsp;preparation&nbsp;and for ensuring that the remaining Azacitidine Stada 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 45 minutes.<br><\/p>\n\n\n\n<p><em>For later use<\/em><\/p>\n\n\n\n<p>If Azacitidine Stada&nbsp;suspension is&nbsp;reconstituted&nbsp;with water for non-cooled injections,&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 8 hours.<\/p>\n\n\n\n<p>If Azacitidine Stada&nbsp;suspension is&nbsp;reconstituted&nbsp;with water for cooled injections (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 refrigerated 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 injections, the reconstituted&nbsp;suspension contains&nbsp;25 mg\/ml azacitidine<em>.<\/em><\/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 STADA is a white to off-white powder for&nbsp;injection,&nbsp;suspension&nbsp;and provided in a&nbsp;vial&nbsp;of glass containing 100 mg azacitidine.&nbsp;Each pack contains a&nbsp;vial&nbsp;of Azacitidine Stada.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>STADA Arzneimittel AG<\/p>\n\n\n\n<p>Stadastrasse 2-18<\/p>\n\n\n\n<p>61118 Bad Vilbel<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p><strong>Other manufacturers<\/strong><\/p>\n\n\n\n<p>STADApharm<\/p>\n\n\n\n<p>Feodor-Lynen-Strasse 35<\/p>\n\n\n\n<p>30625 Hanover<\/p>\n\n\n\n<p>Germany<br><\/p>\n\n\n\n<p>STADA Arzneimittel GmbH<\/p>\n\n\n\n<p>Muthgasse 36\/2<\/p>\n\n\n\n<p>1190 Vienna<\/p>\n\n\n\n<p>Austria<br><\/p>\n\n\n\n<p><strong>Local representative<\/strong><\/p>\n\n\n\n<p>STADA Nordic ApS<\/p>\n\n\n\n<p>Marielundvej 46A<\/p>\n\n\n\n<p>2730 Herlev<\/p>\n\n\n\n<p>Denmark<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Azacitidine Stada is an anticancer medicine that belongs to a group of medicines called &#8216;antimetabolites&#8217;. Azacitidine Stada contains the active substance &#8220;azacitidine&#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":[2201,2200],"tags":[9531,9534,9536,9540,9535,9539,9533,9538,9532,9537],"class_list":["post-5783","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-azacitidine","tag-azacitidine-injection","tag-azacitidine-stada","tag-azacitidine-stada-injection","tag-side-effects-of-azacitidine","tag-side-effects-of-azacitidine-stada","tag-what-azacitidine-is-used-for","tag-what-azacitidine-stada-is-used-for","tag-what-is-azacitidine","tag-what-is-azacitidine-stada"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5783","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=5783"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5783\/revisions"}],"predecessor-version":[{"id":12270,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5783\/revisions\/12270"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}