{"id":14069,"date":"2021-09-24T06:22:28","date_gmt":"2021-09-24T06:22:28","guid":{"rendered":"https:\/\/zeepedia.com\/?p=14069"},"modified":"2021-10-26T07:09:35","modified_gmt":"2021-10-26T07:09:35","slug":"idarubicin-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/idarubicin-accord\/","title":{"rendered":"Idarubicin Accord &#8211; Idarubicin hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p>1 mg \/ ml solution for injection<br>idarubicin hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Idarubicin Accord is and what it is used for<\/h2>\n\n\n\n<p>Idarubicin Accord belongs to a group of medicines called&nbsp;anthracyclines&nbsp;and affects how the cells in the body grow and increase in number.<\/p>\n\n\n\n<p>Idarubicin Accord is a medicine used to treat:<\/p>\n\n\n\n<p><em>Adults<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Acute&nbsp;non-&nbsp;lymphatic&nbsp;leukemia&nbsp;in adults to induce&nbsp;remission&nbsp;(improvement) in untreated patients and to induce&nbsp;remission&nbsp;in patients with relapse or treatment-resistant patients (who do not respond to treatment).<\/li><li>Acute&nbsp;lymphocytic&nbsp;leukemia&nbsp;as secondary treatment.<\/li><\/ul>\n\n\n\n<p><em>Children<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Acute&nbsp;non-&nbsp;lymphatic&nbsp;leukemia&nbsp;, in combination with cytarabine to induce&nbsp;remission&nbsp;(improvement) in untreated patients<\/li><li>Acute&nbsp;lymphocytic&nbsp;leukemia&nbsp;as secondary treatment.<\/li><\/ul>\n\n\n\n<p>Idarubicin Accord can also be used in combination with other anticancer medicines.<\/p>\n\n\n\n<p>Idarubicin hydrochloride contained in Idarubicin Accord may also be approved for the treatment of other conditions not mentioned in this leaflet.&nbsp;Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Idarubicin Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Idarubicin Accord<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to idarubicin or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are allergic to other&nbsp;anthracyclines&nbsp;or anthracenediones<\/li><li>if you have severe liver problems<\/li><li>if you have severe kidney problems<\/li><li>if you have heart problems<\/li><li>if you have low production of&nbsp;blood cells&nbsp;and&nbsp;platelets<\/li><li>if you have previously been treated with idarubicin and \/ or other&nbsp;anthracyclines&nbsp;or anthracenediones<\/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<ul class=\"wp-block-list\"><li>If you have heart problems.&nbsp;Cardiac function must be assessed before initiating idarubicin therapy and monitored throughout treatment to minimize the risk of severe&nbsp;heart failure&nbsp;.<\/li><li>If you have a decreased number of&nbsp;blood cells&nbsp;in the&nbsp;bone marrow&nbsp;and a decreased number of&nbsp;platelets&nbsp;.<\/li><li>If you have a clear and persistent increase in abnormal&nbsp;white blood cells&nbsp;in your blood You may develop&nbsp;leukemia&nbsp;.<\/li><li>If you have problems with the gastrointestinal tract.<\/li><li>If you have liver problems.<\/li><li>If you have kidney problems.<\/li><li>This medicine may cause vomiting,&nbsp;inflammation&nbsp;of the oral mucosa or&nbsp;inflammation&nbsp;of the lining of the gastrointestinal tract.<\/li><li>You may experience reactions at the injection site.<\/li><li>If extravasation (leakage of drugs to surrounding&nbsp;tissue&nbsp;) occurs during&nbsp;injection&nbsp;, you may feel pain.&nbsp;Extravasation can cause severe tissue damage.&nbsp;If extravasation occurs,&nbsp;injection of&nbsp;one of the drugs&nbsp;must be&nbsp;stopped&nbsp;immediately.<\/li><li>As with other cytotoxic agents,&nbsp;inflammation&nbsp;of a vein wall can occur, with the formation of blood clots.<\/li><li>If you have recently received a vaccine or are considering getting vaccinated.<\/li><li>If you are a man, idarubicin can cause permanent&nbsp;infertility&nbsp;(infertility).<\/li><\/ul>\n\n\n\n<p>Idarubicin should only be given under the supervision of a physician experienced in&nbsp;cytotoxic&nbsp;chemotherapy.<\/p>\n\n\n\n<p>This medicine may cause redness of the urine for one or two days after&nbsp;administration.<\/p>\n\n\n\n<p>Before and during treatment with Idarubicin Accord, regular examinations of blood, liver, kidneys, and heart should be performed.&nbsp;Infants and children appear to be more sensitive to the effects of anthracyclines on the heart.&nbsp;Thus, in these patients, it is necessary for a long time to perform regular examinations of the heart.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Idarubicin Accord<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>Idarubicin is mainly used with other medicines to treat cancer (cytotoxic drugs) and there is an increased risk of damage, especially to the&nbsp;bone marrow, blood, and gastrointestinal tract.&nbsp;The risk of damage to the heart may increase in patients who at the same time have received other drugs that affect the heart.<\/p>\n\n\n\n<p>Because idarubicin is largely broken down by the liver, hepatic impairment caused by other medicines may affect the way idarubicin works.<\/p>\n\n\n\n<p>Anthracyclines, including idarubicin, must not be given with other substances that can damage the heart unless the cardiac function is closely monitored.<\/p>\n\n\n\n<p>In combination with oral anticoagulants (blood thinners) and&nbsp;chemotherapy, closer monitoring of INR (International Normalized Ratio) is recommended.<\/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, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<p>Men receiving idarubicin treatment must use effective contraception for up to 3 months after stopping treatment.<\/p>\n\n\n\n<p>There are no adequate and controlled studies on pregnant women.&nbsp;Idarubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<\/p>\n\n\n\n<p><em>Breast-feeding<\/em><\/p>\n\n\n\n<p>It is unknown whether idarubicin is excreted in human milk.&nbsp;Because many drugs do this, mothers must stop breastfeeding before starting treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>The effect of idarubicin on the ability to drive and use machines has not been evaluated.<\/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\">3. How to use Idarubicin Accord<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p>Dose&nbsp;one is normally calculated based on body surface area (mg \/ m&nbsp;<sup>2<\/sup>&nbsp;).&nbsp;The drug is usually given&nbsp;intravenously.<\/p>\n\n\n\n<p><em>Acute&nbsp;non-&nbsp;lymphatic&nbsp;leukemia<\/em><\/p>\n\n\n\n<p>Adults: In&nbsp;acute&nbsp;non-lymphocytic&nbsp;leukemia, the recommended&nbsp;dose is&nbsp;12 mg \/ m&nbsp;<sup>2&nbsp;<\/sup>intravenously&nbsp;daily for 3 days in combination with cytarabine.&nbsp;Alternatively, 8 mg \/ m&nbsp;<sup>2 can<\/sup>&nbsp;be given&nbsp;intravenously&nbsp;daily for 5 days, as a single treatment or as a combination treatment.<\/p>\n\n\n\n<p>Children: The recommended dose range is 10\u201112 mg \/ m&nbsp;<sup>2&nbsp;<\/sup>intravenously&nbsp;daily for 3 days in combination with cytarabine.<\/p>\n\n\n\n<p><em>Acute&nbsp;lymphocytic&nbsp;leukemia<\/em><\/p>\n\n\n\n<p>Adults: As the sole drug for&nbsp;acute&nbsp;lymphocytic&nbsp;leukemia, the recommended&nbsp;dose is&nbsp;12 mg \/ m&nbsp;<sup>2&nbsp;<\/sup>intravenously&nbsp;daily for 3 days.<\/p>\n\n\n\n<p>Children: As the sole drug for&nbsp;acute&nbsp;lymphocytic&nbsp;leukemia, the recommended&nbsp;dose is&nbsp;10 mg \/ m&nbsp;<sup>2&nbsp;<\/sup>intravenously&nbsp;daily for 3 days.<\/p>\n\n\n\n<p>All of these dosing schedules must take into account the patient&#8217;s blood status and the&nbsp;doses&nbsp;of other cytotoxic agents during combination therapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Idarubicin Accord than you should &nbsp;<\/h2>\n\n\n\n<p>Very high&nbsp;doses&nbsp;of idarubicin can cause&nbsp;acute&nbsp;damage to the heart muscle during the first 24 hours and severe inhibition of&nbsp;bone marrow&nbsp;production&nbsp;within one or two weeks.<\/p>\n\n\n\n<p>The occurrence of delayed&nbsp;heart failure&nbsp;during treatment with&nbsp;anthracyclines&nbsp;has been observed, up to several months after an overdose.<\/p>\n\n\n\n<p>If you have ingested too much medicine or if e.g.&nbsp;If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Idarubicin Accord<\/h2>\n\n\n\n<p>Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/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.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;are very common: infections;&nbsp;decreased number of&nbsp;red blood cells,&nbsp;white blood cells,&nbsp;and&nbsp;platelets&nbsp;in the blood;&nbsp;markedly reduced appetite or loss of appetite;&nbsp;nausea, vomiting, diarrhea, abdominal pain, burning in the abdomen,&nbsp;inflammation&nbsp;of the oral mucosa;&nbsp;hair loss;&nbsp;red urine 1-2 days after receiving the medicine;&nbsp;fever, headache, and chills.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;are common: increased or decreased heart rate, irregular heartbeat, decreased heart function;&nbsp;inflammation&nbsp;of the vein,&nbsp;inflammation&nbsp;of the vein associated with blood clots (&nbsp;thrombosis&nbsp;), bleeding;&nbsp;gastrointestinal bleeding, stomach pain;&nbsp;elevated levels of liver enzymes and bilirubin;&nbsp;skin rash,&nbsp;itching, hypersensitivity of radiation-damaged skin.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;are less common: general infection;&nbsp;secondary leukemia;&nbsp;increased concentration of&nbsp;uric acid&nbsp;in the blood;&nbsp;abnormal ECG;&nbsp;shock;&nbsp;inflammation&nbsp;of the esophagus (esophagus),&nbsp;inflammation&nbsp;of the colon (&nbsp;colon&nbsp;), brown spots (&nbsp;hyperpigmentation&nbsp;) on skin and nails, skin infection (&nbsp;cellulite&nbsp;) and dead&nbsp;tissue&nbsp;(&nbsp;necrosis&nbsp;).<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;are rare: cerebral haemorrhage.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;are very rare: general severe allergic reaction;&nbsp;myocarditis and other heart diseases;&nbsp;blockage (&nbsp;occlusion&nbsp;) in a blood vessel,&nbsp;redness,&nbsp;stomach ulcers, skin redness, especially on the arms and legs.<\/p>\n\n\n\n<p>Cases of pancytopenia (lack of all types of&nbsp;blood cells&nbsp;in the blood), tumor lysis syndrome (rapid degradation of cancer cells), and local reaction in the skin have also been reported.<\/p>\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 also applies to any side effects not mentioned in this information.&nbsp;You can also report side effects directly to the Medical Products Agency.&nbsp;By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Idarubicin Accord<\/h2>\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 label or carton after EXP.&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 to 8 \u00b0 C).&nbsp;Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/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 idarubicin hydrochloride.<\/li><li>1 ml solution contains 1 mg idarubicin hydrochloride.<\/li><li>One&nbsp;vial&nbsp;of 5 ml contains 5 mg of idarubicin hydrochloride.<\/li><li>A&nbsp;vial&nbsp;with 10 ml contains 10 mg idarubicin hydrochloride.<\/li><li>One&nbsp;vial&nbsp;of 20 ml contains 20 mg of idarubicin hydrochloride.<\/li><li>The other ingredients are&nbsp;glycerol&nbsp;, concentrated&nbsp;hydrochloric acid&nbsp;, sodium hydroxide (for&nbsp;pH&nbsp;adjustment) and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Solution for&nbsp;injection<\/p>\n\n\n\n<p>The clear, orange-red solution, free from visible particles.&nbsp;A&nbsp;vial&nbsp;of clear type I glass containing use solution with 5 mg, 10 mg, or 20 mg of idarubicin hydrochloride&nbsp;injection&nbsp;solution.<\/p>\n\n\n\n<p>Vials with 5 ml, 10 ml, or 20 ml solution.&nbsp;Carton with 1&nbsp;vial.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><em>Marketing Authorisation Holder<\/em><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 KV Utrecht<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><em>Manufacturer<\/em><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House<\/p>\n\n\n\n<p>319 Pinner Road<\/p>\n\n\n\n<p>North Harrow<\/p>\n\n\n\n<p>Middlesex HA1 4HF<\/p>\n\n\n\n<p>UK<\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50,95-200 Pabianice, Poland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Idarubicin Accord belongs to a group of medicines called anthracyclines and affects how the cells in the body grow and increase in number.<\/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":[2200,12116],"tags":[13320,13314,13316,13319,13321,13310,13313,13315,13318,13312,13317,13311],"class_list":["post-14069","post","type-post","status-publish","format-standard","hentry","category-medicines","category-i","tag-benefits-of-idarubicin-accord","tag-benefits-of-idarubicin-hydrochloride","tag-idarubicin-accord","tag-idarubicin-accord-injection","tag-idarubicin-accord-side-effects","tag-idarubicin-hydrochloride","tag-idarubicin-hydrochloride-injection","tag-idarubicin-hydrochloride-side-effects","tag-what-idarubicin-accord-is-used-for","tag-what-idarubicin-hydrochloride-is-used-for","tag-what-is-idarubicin-accord","tag-what-is-idarubicin-hydrochloride"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14069","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=14069"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14069\/revisions"}],"predecessor-version":[{"id":15106,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14069\/revisions\/15106"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=14069"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=14069"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=14069"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}