{"id":18121,"date":"2022-02-11T09:21:34","date_gmt":"2022-02-11T09:21:34","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18121"},"modified":"2022-02-12T11:22:10","modified_gmt":"2022-02-12T11:22:10","slug":"mitoxantrone-ebewe","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/mitoxantrone-ebewe\/","title":{"rendered":"Mitoxantrone Ebewe &#8211; Mitoxantrone uses, dose and side effects"},"content":{"rendered":"\n<p>2 mg \/ ml&nbsp;concentrate for&nbsp;solution for&nbsp;infusion<br>mitoxantrone (as hydrochloride)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Mitoxantron Ebewe is and what it is used for<\/h2>\n\n\n\n<p>Mitoxantrone Ebewe contains the active substance mitoxantrone.\u00a0Mitoxantrone Ebewe belongs to a group of medicines called\u00a0chemotherapy drugs\u00a0or cancer medicines.\u00a0It is also part of a subgroup of cancer drugs called\u00a0anthracyclines.\u00a0Mitoxantrone Ebewe prevents cancer cells from growing, causing them to eventually die.\u00a0The drug also inhibits the immune system and is used for this reason to treat a specific form of\u00a0multiple sclerosis\u00a0in cases where there are no other treatment options.<\/p>\n\n\n\n<p>Mitoxantrone Ebewe is used to treat:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>advanced (metastatic) breast cancer<\/li><li>a form of lymph node cancer (&nbsp;non-Hodgkin&#8217;s lymphoma&nbsp;)<\/li><li>a form of blood cancer in which a&nbsp;bone marrow&nbsp;(the fungal&nbsp;tissue&nbsp;inside the large skeletal bones) produces too many&nbsp;white blood cells&nbsp;(&nbsp;acute myeloid leukemia&nbsp;)<\/li><li>a type of cancer of the white&nbsp;blood cells&nbsp;(&nbsp;chronic myeloid leukemia&nbsp;) at a stage where it is difficult to keep the number of&nbsp;white blood cells&nbsp;under control (&nbsp;blast crisis&nbsp;).&nbsp;Mitoxantron Ebewe is used in combination with other medicines for this use<\/li><li>pain caused by prostate cancer in an advanced stage and then in combination with&nbsp;corticosteroids&nbsp;(&nbsp;cortisone&nbsp;)<\/li><li>multiple sclerosis&nbsp;(MS) with very active relapses associated with rapid development of disability in cases where there are no other treatment options (see sections 2 and 3).<\/li><\/ul>\n\n\n\n<p>Mitoxantrone contained in Mitoxantron Ebewe may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use Mitoxantron Ebewe<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Mitoxantron Ebewe<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to mitoxantrone or any of the other ingredients of this medicine (listed in section 6)<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to sulphite<\/li><li>if you have a form of&nbsp;asthma&nbsp;(&nbsp;bronchial asthma&nbsp;) with a sulphite allergy<\/li><li>if you are breast-feeding (see section \u201cPregnancy and breast-feeding\u201d).<\/li><\/ul>\n\n\n\n<p><strong>For use in the treatment of&nbsp;multiple sclerosis&nbsp;(MS):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are pregnant.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Mitoxantrone Ebewe should be given under the supervision of a specialist physician experienced in the use of chemotherapy or cancer drugs (&nbsp;cytotoxic&nbsp;chemotherapy&nbsp;).<\/p>\n\n\n\n<p>Mitoxantrone Ebewe should be given as a slow, free-flowing&nbsp;infusion&nbsp;(drip) into a vein.<\/p>\n\n\n\n<p>Mitoxantrone Ebewe must not be given under the skin (\u00a0subcutaneously\u00a0), in a muscle (\u00a0intramuscularly\u00a0), or an\u00a0artery\u00a0(intraarterial).\u00a0Severe local tissue damage can occur if Mitoxantron Ebewe leaks into the surrounding\u00a0tissue\u00a0(so-called extravasation) when given.<\/p>\n\n\n\n<p>Mitoxantrone Ebewe must also not be injected into the spinal fluid (\u00a0intrathecal\u00a0injection\u00a0), as this can lead to severe injuries with a permanent disability.<\/p>\n\n\n\n<p><strong>Talk to your doctor, pharmacist,<\/strong> or nurse before taking Mitoxantrone<strong> Ebewe if you:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>have liver problems<\/li><li>have kidney problems<\/li><li>have used Mitoxantron Ebewe before<\/li><li>have heart problems<\/li><li>previously received radiation treatment of the chest<\/li><li>use drugs that affect the heart<\/li><li>have been previously treated with&nbsp;anthracyclines&nbsp;or anthracenediones, such as daunorubicin or doxorubicin<\/li><li>have problems with&nbsp;bone marrow&nbsp;one or if you have poor general condition<\/li><li>have an&nbsp;infection&nbsp;.&nbsp;Any&nbsp;infection&nbsp;should be treated before using Mitoxantron Ebewe<\/li><li>should be vaccinated or immunized during treatment.&nbsp;Vaccinations and immunizations may not have the intended effect during treatment with Mitoxantron Ebewe and for 3 months after stopping treatment<\/li><li>is pregnant or if you and your partner are trying to conceive<\/li><li>ammar.&nbsp;You should stop breast-feeding before taking Mitoxantron Ebewe<\/li><\/ul>\n\n\n\n<p>If you get any of the following signs or symptoms during treatment with Mitoxantrone Ebewe, tell your doctor, pharmacist, or nurse immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fever,&nbsp;infection&nbsp;, unexplained bleeding or bruising, feeling weak or if you get tired easily<\/li><li>shortness of breath (even at night), cough, fluid retention (swelling) in the ankles or legs, palpitations (irregular heartbeat).&nbsp;This can occur either during treatment or months to years after stopping treatment with Mitoxantron Ebewe.<\/li><\/ul>\n\n\n\n<p>Your doctor may need to adjust or stop the treatment, either temporarily or for good.<\/p>\n\n\n\n<p><strong>Blood tests before and during treatment with Mitoxantrone Ebewe<\/strong><\/p>\n\n\n\n<p>Mitoxantrone Ebewe can affect the number of\u00a0blood cells.\u00a0Before starting and during treatment with Mitoxantrone Ebewe, you will be given blood samples to check your\u00a0blood cells.\u00a0In the following conditions, the doctor will\u00a0prescribe\u00a0more frequent blood test checks to count in particular the number of\u00a0white blood cells\u00a0(neutrophilic\u00a0leukocytes\u00a0) in the blood:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have a low number of a particular type of&nbsp;white blood cell&nbsp;(&nbsp;neutrophils&nbsp;) (less than 1,500 cells \/ mm&nbsp;<sup>3<\/sup>&nbsp;)<\/li><li>if you are taking high&nbsp;doses&nbsp;of Mitoxantron Ebewe (more than 14 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;per day for 3 days).<\/li><\/ul>\n\n\n\n<p><strong>Cardiac function is monitored before and during treatment with Mitoxantrone Ebewe<\/strong><\/p>\n\n\n\n<p>Mitoxantrone Ebewe can damage the heart and cause impaired heart function or, in more severe cases,\u00a0heart failure.\u00a0You are more likely to suffer from these\u00a0side effects\u00a0if you take higher\u00a0doses\u00a0of Mitoxantrone Ebewe or:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have heart problems<\/li><li>if you have previously received radiation therapy to your chest<\/li><li>if they are already taking other medicines that affect the heart<\/li><li>if you have been previously treated with&nbsp;anthracyclines&nbsp;or anthracenediones, such as daunorubicin or doxorubicin.<\/li><\/ul>\n\n\n\n<p>Your doctor will check your heart function before you start Mitoxantron Ebewe and regularly during treatment.\u00a0If you are receiving Mitoxantron Ebewe to treat\u00a0multiple sclerosis, your doctor will check your heart function before starting treatment, before each subsequent\u00a0dose,\u00a0and annually for up to 5 years after stopping treatment.<\/p>\n\n\n\n<p><strong>Acute myeloid leukemia&nbsp;(AML) and&nbsp;myelodysplastic syndrome<\/strong><\/p>\n\n\n\n<p>A group of cancer drugs (\u00a0topoisomerase\u00a0II inhibitors), including Mitoxantron Ebewe, can cause the following diseases when used separately but in particular in combination with other\u00a0chemotherapy drugs, cancer drugs, and\/or radiation therapy:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>cancer of the&nbsp;white blood cells&nbsp;(&nbsp;acute myeloid leukemia&nbsp;, AML)<\/li><li>bone marrow disorders that cause abnormally shaped&nbsp;blood cells&nbsp;and lead to&nbsp;leukemia&nbsp;(&nbsp;myelodysplastic syndrome&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Discoloration of urine and&nbsp;tissue&nbsp;er<\/strong><\/p>\n\n\n\n<p>Mitoxantrone may cause a blue-green discoloration of the urine for 24 hours after\u00a0infusion.\u00a0Bluish discoloration of the whites of the eyes, skin, and nails can also occur.<\/p>\n\n\n\n<p><strong>Pregnancy protection in men and women<\/strong><\/p>\n\n\n\n<p>Men must not make their female partners pregnant and must use contraception during treatment and for at least 6 months after the end of treatment.\u00a0Women who can have children should show a negative pregnancy test before each\u00a0dose\u00a0and use an effective contraceptive during treatment and for at least 4 months after stopping treatment.\u00a0If you are taking this medicine during pregnancy or if you become pregnant while taking this medicine, tell your doctor, as it may pose a risk to the fetus.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>This medicine may increase the risk of the temporary or permanent absence of menstruation (\u00a0amenorrhea\u00a0) in women who may have children.<\/p>\n\n\n\n<p><strong>Children and young people<\/strong>&nbsp;<\/p>\n\n\n\n<p>There is little experience of use in children and adolescents.<\/p>\n\n\n\n<p>Do not give this medicine to children and adolescents from birth to 18 years of age, as the safety and efficacy in children and adolescents have not been established.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Mitoxantron Ebewe<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0It is especially important that you indicate if you are taking any of the following medicines:<\/p>\n\n\n\n<p>Medicines that may increase the risk of\u00a0side effects\u00a0with Mitoxantrone Ebewe:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Medicines that can harm the heart (eg&nbsp;anthracyclines&nbsp;)<\/li><li>Drugs that inhibit the bone marrow production of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;(myelosuppressive substances)<\/li><li>Drugs that inhibit the immune system (immunosuppressive substances)<\/li><li>Antivitamin K, especially if you are taking Mitoxantron Ebewe as a treatment for cancer<\/li><li>Topoisomerase&nbsp;II inhibitors (a group of cancer drugs, including mitoxantrone) in combination with other&nbsp;chemotherapy drugs&nbsp;, cancer drugs and \/ or radiation therapy.&nbsp;These can cause:&nbsp;<ul><li>cancer of the&nbsp;white blood cells&nbsp;(&nbsp;acute myeloid leukemia&nbsp;, AML)<\/li><li>bone marrow disorders that cause abnormally shaped&nbsp;blood cells&nbsp;and lead to&nbsp;leukemia&nbsp;(&nbsp;myelodysplastic syndrome&nbsp;).<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>Ask your doctor or pharmacist if you are not sure if any of your medicines are listed in the list above.<\/p>\n\n\n\n<p>These medicines should be used with caution or may need to be avoided during treatment with Mitoxantrone Ebewe.\u00a0If you are taking any of these, your doctor may need to\u00a0prescribe\u00a0an alternative medicine for you.<\/p>\n\n\n\n<p>You should also tell your doctor if you are already taking Mitoxantrone Ebewe and you are receiving a new medicine that you have not already used with Mitoxantrone Ebewe.<\/p>\n\n\n\n<p>Vaccinations and immunizations (protection against vaccines) may not work during treatment with Mitoxantrone Ebewe and for three months after stopping treatment.<\/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><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>Mitoxantrone Ebewe can harm your unborn baby.\u00a0Therefore, you should avoid getting pregnant during treatment.\u00a0Mitoxantrone Ebewe must not be used as a treatment for\u00a0multiple sclerosis\u00a0if you are pregnant (especially not during the first three months of pregnancy).\u00a0<\/p>\n\n\n\n<p>If you become pregnant while taking Mitoxantrone Ebewe, tell your doctor immediately and stop taking Mitoxantrone.<\/p>\n\n\n\n<p>Ebewe.<\/p>\n\n\n\n<p>You should avoid getting pregnant.&nbsp;Men must use an effective contraceptive during treatment and for at least 6 months after stopping treatment.&nbsp;Women who can have children should show a negative pregnancy test before each&nbsp;dose&nbsp;and use an effective contraceptive during treatment and for at least 4 months after stopping treatment.<\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>Mitoxantrone Ebewe is excreted in breast milk and may cause serious\u00a0side effects\u00a0in your baby.\u00a0You must not breastfeed while using mitoxantrone and for up to one month after the last\u00a0infusion.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Mitoxantrone Ebewe may increase the risk of the temporary or permanent absence of menstruation (\u00a0amenorrhea\u00a0) in women who may have children.\u00a0You should therefore talk to your doctor if you plan to have children in the future.\u00a0You may then need to freeze eggs.\u00a0For men, there is no data.\u00a0In male animals, however, damage to the testicles and a reduced number of sperm have been observed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Mitoxantrone Ebewe has a minor effect on the ability to drive and use machines.\u00a0This is due to possible\u00a0side effects, such as confusion and fatigue (see section 4).<\/p>\n\n\n\n<p>Do not drive or use any machines if you experience any of these\u00a0side effects.<\/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.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Mitoxantrone Ebewe contains sodium<\/h2>\n\n\n\n<p><em>For 5 ml vial:<\/em><\/p>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0vial, ie essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<p><em>For 10 ml vial:<\/em><\/p>\n\n\n\n<p>This medicine contains 34.14 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 1.7% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Mitoxantron Ebewe<\/h2>\n\n\n\n<p>You will receive Mitoxantron Ebewe under the supervision of a specialist doctor with experience in&nbsp;chemotherapy&nbsp;or cancer drugs.&nbsp;It should always be given as an&nbsp;intravenous&nbsp;infusion&nbsp;(into a vein) and should always be diluted before use.&nbsp;The infusion fluid may leak from the vein into the surrounding&nbsp;tissue&nbsp;(extravasation).&nbsp;If this happens, one&nbsp;infusion&nbsp;must be stopped and started in another vein.<\/p>\n\n\n\n<p>Avoid direct contact with Mitoxantrone Ebewe, especially through the skin, mucous membranes, and eyes.<\/p>\n\n\n\n<p>Dose\u00a0one of Mitoxantrone Ebewe is adjusted individually by your doctor.<\/p>\n\n\n\n<p>Dose&nbsp;one is based on your body surface area measured in square meters (m&nbsp;<sup>2<\/sup>&nbsp;) and which is calculated using length and weight.&nbsp;Blood samples will also be taken regularly during treatment.&nbsp;Dosage&nbsp;one of the drug will be adjusted depending on the result of these blood tests.<\/p>\n\n\n\n<p>The usual\u00a0dose\u00a0is:<\/p>\n\n\n\n<p><em>Metastatic breast cancer,&nbsp;<\/em><em>non-Hodgkin&#8217;s&nbsp;<\/em><em>lymphoma<\/em><em>&nbsp;<\/em>&nbsp;<\/p>\n\n\n\n<p>When only Mitoxantron Ebewe is used:<\/p>\n\n\n\n<p>The recommended starting dose is 14 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;body surface area, given as a single&nbsp;intravenous&nbsp;dose.&nbsp;This can be repeated at 21-day intervals if your blood levels have returned to acceptable levels.<\/p>\n\n\n\n<p>If you have bone marrow problems, for example, due to previous\u00a0chemotherapy drugs, cancer drugs, or a bad general condition, you should receive a lower\u00a0dose\u00a0the first time, 12 mg \/ m\u00a0<sup>2<\/sup>\u00a0or less.<\/p>\n\n\n\n<p>Your doctor will decide on the\u00a0next dose.<\/p>\n\n\n\n<p>For subsequent treatments, the previous&nbsp;dose&nbsp;can usually be repeated if the number of&nbsp;white blood cells&nbsp;and&nbsp;platelets&nbsp;has returned to normal levels after 21 days.<\/p>\n\n\n\n<p>In combination therapy (if used with other drugs):<\/p>\n\n\n\n<p>Mitoxantrone Ebewe has been given as part of combination therapies.\u00a0In metastatic breast cancer, combinations with other\u00a0chemotherapy drugs\u00a0such as cyclophosphamide and 5-fluorouracil, or methotrexate and mitomycin C are effective.<\/p>\n\n\n\n<p>Mitoxantrone Ebewe has also been used in various combinations for\u00a0non-Hodgkin&#8217;s lymphoma, but knowledge of this is currently limited and there is no specific recommendation for treatment.<\/p>\n\n\n\n<p>As a guide, the starting dose of Mitoxantrone Ebewe, when used in\u00a0combination therapy\u00a0with other\u00a0chemotherapy drugs, should be 2 to 4 mg \/ m\u00a0<sup>2<\/sup>\u00a0lower than when Mitoxantron Ebewe alone is used.<\/p>\n\n\n\n<p><em>Acute&nbsp;<\/em><em>myeloid&nbsp;<\/em><em>leukemia<\/em><em>&nbsp;<\/em>&nbsp;<\/p>\n\n\n\n<p>For single use in case of relapse (when your cancer has returned):&nbsp;<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for initial treatment is 12 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;body surface area, given as a single&nbsp;intravenous&nbsp;dose for five consecutive days (total 60 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;body surface area over five days).&nbsp;<\/p>\n\n\n\n<p>When used in combination with other chemotherapy drugs:<\/p>\n\n\n\n<p>Your doctor will decide exactly what&nbsp;dose&nbsp;you should receive.&nbsp;Your&nbsp;dosage&nbsp;may need to be adjusted if:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>the combination of the drugs reduces the bone marrow&#8217;s production of both white and&nbsp;red blood cells&nbsp;and&nbsp;platelets&nbsp;to a greater degree than just Mitoxantron Ebewe.<\/li><li>you have severe liver or kidney problems.<\/li><\/ul>\n\n\n\n<p><em>Treatment of&nbsp;blast crisis&nbsp;in (&nbsp;chronic&nbsp;)&nbsp;myeloid&nbsp;leukemia<\/em><\/p>\n\n\n\n<p>For single use in case of relapse<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for relapse is 10 to 12 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;body surface area, given as a single&nbsp;intravenous&nbsp;dose for five consecutive days (total 50 to 60 mg \/ m&nbsp;<sup>2<\/sup>&nbsp;).<\/p>\n\n\n\n<p><em>Advanced&nbsp;<\/em><em>castration-resistant&nbsp;<\/em><em>prostate cancer<\/em><\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0is 12 to 14 mg \/ m\u00a0<sup>2<\/sup>, given as a short-term\u00a0intravenous\u00a0infusion at 21-day intervals, in combination with low oral\u00a0doses of\u00a0corticosteroids\u00a0(\u00a0cortisone\u00a0that\u00a0inhibits the immune system).\u00a0<\/p>\n\n\n\n<p><em>Multiple sclerosis<\/em><\/p>\n\n\n\n<p>You will receive Mitoxantron Ebewe under the supervision of a specialist doctor with experience in\u00a0chemotherapy\u00a0for the treatment of\u00a0multiple sclerosis.<\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0of mitoxantrone is normally 12 mg \/ m\u00a0<sup>2<\/sup>\u00a0body surface area, given as a short-term\u00a0intravenous\u00a0infusion (approximately 5 to 15 minutes) that can be repeated every three months.\u00a0The total\u00a0dose\u00a0over a lifetime must not exceed 72 mg \/ m\u00a0<sup>2<\/sup>.<\/p>\n\n\n\n<p>If mitoxantrone is given repeatedly, dose adjustments should be made depending on the size of the white and red&nbsp;blood cells&nbsp;and platelets and how long they last.&nbsp;<\/p>\n\n\n\n<p><strong>Elderly patients<\/strong><\/p>\n\n\n\n<p>Elderly patients should receive the lowest recommended starting doses due to the risk of hepatic, renal, or cardiac impairment and any other diseases or treatment with other drugs.<\/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>The most serious&nbsp;side effects&nbsp;are damage to the heart (cardiac toxicity) and myelosuppression (decreased formation of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;in the&nbsp;bone marrow&nbsp;).<\/p>\n\n\n\n<p><strong>Some&nbsp;side effects&nbsp;can be serious<\/strong><\/p>\n\n\n\n<p><em>If any of the following happens, tell your doctor immediately:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you become pale and feel weak or suffer from sudden shortness of breath, this may be a sign of decreased&nbsp;red blood cell count&nbsp;.<\/li><li>Abnormal bruising or bleeding, such as bloody cough, vomiting or urine, or black stools (which may indicate a decrease in the number of&nbsp;platelets&nbsp;).<\/li><li>New or worsening breathing difficulties.<\/li><li>Chest pain, shortness of breath, altered heart rate (fast or slow), fluid retention (swelling) in the ankles or legs (which may indicate heart problems).<\/li><li>Severe, itchy&nbsp;hives&nbsp;or swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), or if you feel you are about to faint, these may be signs of a severe&nbsp;allergic reaction reaction&nbsp;.<\/li><li>Fever or&nbsp;infection&nbsp;is.<\/li><\/ul>\n\n\n\n<p><strong>For patients being treated for cancer:<\/strong><\/p>\n\n\n\n<p><strong>Very common&nbsp;<\/strong><strong>(may affect more than 1 user in 10):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infection&nbsp;is<\/li><li>Low number of&nbsp;red blood cells&nbsp;, which can cause feelings of fatigue and shortness of breath (&nbsp;anemia&nbsp;).&nbsp;You may need a&nbsp;blood transfusion&nbsp;.<\/li><li>Low number of certain types of&nbsp;white blood cells&nbsp;(&nbsp;neutrophils&nbsp;and&nbsp;leukocytes&nbsp;)<\/li><li>Nausea<\/li><li>Vomiting<\/li><li>Hair loss<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;<\/strong><strong>(may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;platelet count&nbsp;, which may cause bleeding and bruising<\/li><li>Low number of a certain type of&nbsp;white blood cell&nbsp;(&nbsp;granulocytes&nbsp;)<\/li><li>Fatigue, feeling of weakness and lack of energy<\/li><li>Loss of appetite<\/li><li>Myocardial infarction<\/li><li>Shortness of breath<\/li><li>Constipation<\/li><li>Diarrhea<\/li><li>Inflammation&nbsp;of the mouth and lips<\/li><li>Fever<\/li><li>Congestive&nbsp;heart failure&nbsp;(a serious condition in which the heart cannot pump enough blood)<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;<\/strong><strong>(may affect up to 1 in 100 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Decreased formation of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;in the&nbsp;bone marrow&nbsp;.&nbsp;The inhibition of&nbsp;bone marrow&nbsp;can be stronger or more prolonged if you have previously been treated with&nbsp;chemotherapy&nbsp;, cancer drugs or undergone radiation therapy.<\/li><li>Insufficient formation of&nbsp;blood cells&nbsp;in&nbsp;bone marrow&nbsp;(bone marrow failure)<\/li><li>Abnormal&nbsp;white blood cell count<\/li><li>Severe&nbsp;allergic reaction&nbsp;(&nbsp;anaphylactic reaction&nbsp;, including anaphylactic&nbsp;shock&nbsp;).&nbsp;You may experience sudden itchy&nbsp;hives&nbsp;, swollen hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing and you may feel dizzy.<\/li><li>Upper respiratory tract infection<\/li><li>Urinary tract infection<\/li><li>Blood poisoning (&nbsp;sepsis&nbsp;)<\/li><li>Infections&nbsp;caused by&nbsp;microorganisms&nbsp;that do not normally cause diseases when the immune system is good (opportunistic&nbsp;infections&nbsp;)<\/li><li>Cancer of the white&nbsp;blood cells&nbsp;(&nbsp;acute myeloid leukemia&nbsp;[AML])<\/li><li>Abnormal&nbsp;bone marrow&nbsp;, which causes the formation of abnormal&nbsp;blood cells&nbsp;and leads to&nbsp;leukemia&nbsp;(&nbsp;myelodysplastic syndrome&nbsp;[MDS])<\/li><li>Weight changes<\/li><li>Metabolic disorders (effects on heart rhythm and kidney problems caused by substances from the breakdown of cancer cells, so-called tumor lysis syndrome)<\/li><li>Anxiety<\/li><li>Confusion<\/li><li>Headache<\/li><li>Knitting<\/li><li>Irregular heartbeat or slow heartbeat<\/li><li>Abnormal&nbsp;ECG<\/li><li>Reduction in the amount of blood that the left ventricle of the heart can pump, without causing any symptoms<\/li><li>Bruises<\/li><li>Heavy bleeding<\/li><li>Low&nbsp;blood pressure<\/li><li>Abdominal pain<\/li><li>Bleeding in the stomach or intestines, this may manifest as blood in vomit and stool, or black, tar-like stool<\/li><li>Mucositis<\/li><li>Pancreatitis<\/li><li>Abnormal liver values<\/li><li>Skin inflammations (&nbsp;erythema&nbsp;)<\/li><li>Nail disorders (eg detachment of the nail from the&nbsp;nail bed&nbsp;, altered nail surface and structure)<\/li><li>Rash<\/li><li>Discolored whites of the eyes<\/li><li>Skin discolorations<\/li><li>Leakage of fluid to surrounding&nbsp;tissue&nbsp;(extravasation):<ul><li>Redness&nbsp;(&nbsp;erythema&nbsp;)<\/li><li>Swelling<\/li><li>Pain<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Abnormal liver and kidney values \u200b\u200bin blood samples (elevated levels of&nbsp;aspartate aminotransferase&nbsp;,&nbsp;creatinine&nbsp;and urea-bound nitrogen in the blood)&nbsp;<\/li><li>Kidney damage, which causes swelling and feeling of weakness (&nbsp;nephropathy&nbsp;)<\/li><li>Discolored urine<\/li><li>Swelling (&nbsp;edema&nbsp;)<\/li><li>Taste disorders.<\/li><li>Abnormal missed periods (&nbsp;amenorrhea&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;<\/strong><strong>(may affect up to 1 in 1,000 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Damage to the heart muscle, which prevents it from functioning properly (&nbsp;cardiomyopathy&nbsp;).<\/li><li>Pneumonia<\/li><\/ul>\n\n\n\n<p><strong>For patients treated for multiple sclerosis:<\/strong><\/p>\n\n\n\n<p><strong>Very&nbsp;<\/strong><strong>common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Infection&nbsp;er, including upper respiratory tract infections and urinary tract infections<\/li><li>Nausea<\/li><li>Hair loss<\/li><li>Abnormal missed periods (&nbsp;amenorrhea&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;<\/strong><strong>(may affect up to 1 in 10&nbsp;<\/strong>&nbsp;<strong>people):<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low number of&nbsp;red blood cells&nbsp;, which can cause feelings of fatigue and shortness of breath (&nbsp;anemia&nbsp;).&nbsp;You may need a&nbsp;blood transfusion&nbsp;.<\/li><li>Low number of certain types of&nbsp;white blood cells&nbsp;(&nbsp;granulocytes&nbsp;and&nbsp;leukocytes&nbsp;)<\/li><li>Constipation<\/li><li>Vomiting<\/li><li>Diarrhea<\/li><li>Inflammation&nbsp;of the mouth and lips<\/li><li>Low&nbsp;white blood cell count<\/li><li>Headache<\/li><li>Irregular heartbeat<\/li><li>Abnormal&nbsp;ECG<\/li><li>Reduction in the amount of blood that the left ventricle of the heart can pump, without causing any symptoms<\/li><li>Abnormal liver values \u200b\u200bin blood tests (elevated levels of&nbsp;aspartate aminotransferase&nbsp;)<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pneumonia<\/li><li>Blood poisoning (&nbsp;sepsis&nbsp;)<\/li><li>Infections&nbsp;caused by&nbsp;microorganisms&nbsp;that do not normally cause diseases when the immune system is normal (opportunistic&nbsp;infections&nbsp;).<\/li><li>Cancer of the white&nbsp;blood cells&nbsp;(&nbsp;acute myeloid leukemia&nbsp;[AML])<\/li><li>Abnormal&nbsp;bone marrow&nbsp;, which causes the formation of abnormal&nbsp;blood cells&nbsp;and leads to&nbsp;leukemia&nbsp;(&nbsp;myelodysplastic syndrome&nbsp;[MDS])<\/li><li>Insufficient formation of&nbsp;blood cells&nbsp;in&nbsp;bone marrow&nbsp;(bone marrow failure)<\/li><li>Decreased formation of&nbsp;blood cells&nbsp;and&nbsp;platelets&nbsp;in the&nbsp;bone marrow&nbsp;.&nbsp;The inhibition of&nbsp;bone marrow&nbsp;can be stronger or more prolonged if you have previously been treated with&nbsp;chemotherapy&nbsp;or undergone radiation therapy.<\/li><li>Low&nbsp;platelet count&nbsp;, which may cause bleeding and bruising<\/li><li>Low number of a certain type of&nbsp;white blood cell&nbsp;(&nbsp;neutrophils&nbsp;)<\/li><li>Severe&nbsp;allergic reaction&nbsp;(&nbsp;anaphylactic reaction&nbsp;, including anaphylactic&nbsp;shock&nbsp;).&nbsp;You may experience sudden itchy&nbsp;hives&nbsp;, swollen hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing and you may feel dizzy.<\/li><li>Loss of appetite<\/li><li>Weight changes<\/li><li>Anxiety<\/li><li>Confusion<\/li><li>Knitting<\/li><li>Fatigue, feeling of weakness and lack of energy<\/li><li>Congestive&nbsp;heart failure&nbsp;(a serious condition in which the heart cannot pump enough blood)<\/li><li>Damage to the heart muscle, which prevents it from functioning properly (&nbsp;cardiomyopathy&nbsp;).<\/li><li>Slow heartbeat<\/li><li>Myocardial infarction<\/li><li>Unusual bruises<\/li><li>Heavy bleeding<\/li><li>Low&nbsp;blood pressure<\/li><li>Shortness of breath<\/li><li>Abdominal pain<\/li><li>Bleeding in the stomach or intestines, this may manifest as blood in vomit and stool, or black, tar-like stool<\/li><li>Mucositis<\/li><li>Pancreatitis<\/li><li>Abnormal liver values<\/li><li>Nail disorders (eg detachment of the nail from the&nbsp;nail bed&nbsp;, altered nail surface and structure)<\/li><li>Rash<\/li><li>Discolored whites of the eyes<\/li><li>Skin discolorations<\/li><li>Leakage of fluid to surrounding&nbsp;tissue&nbsp;(extravasation):<ul><li>Redness&nbsp;(&nbsp;erythema&nbsp;)<\/li><li>Swelling<\/li><li>Pain<\/li><li>Burning and \/ or discoloration of the skin<\/li><li>Cell death, which can lead to the removal of dead&nbsp;tissue&nbsp;and the transplantation of new skin<\/li><\/ul><\/li><li>Abnormal liver and kidney values \u200b\u200bin blood samples (elevated levels of&nbsp;creatinine&nbsp;and urea-bound nitrogen in the blood)<\/li><li>Kidney damage, which causes swelling and feeling of weakness (&nbsp;nephropathy&nbsp;)<\/li><li>Discolored urine<\/li><li>Swelling (&nbsp;edema&nbsp;)<\/li><li>Fever<\/li><li>Sudden death<\/li><\/ul>\n\n\n\n<p><strong>Rare (may affect up to 1 in 1,000 people):<\/strong><\/p>\n\n\n\n<p>No.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Mitoxantron Ebewe<\/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 after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>No special storage instructions.<\/p>\n\n\n\n<p>The concentrate should be diluted immediately after the first opening.<\/p>\n\n\n\n<p>Diluted solution is stable for 24 hours at room temperature and a maximum of 3 days at 2\u20138 \u00b0 C.<\/p>\n\n\n\n<p>From\u00a0a microbiological\u00a0point of view, the diluted product should be used immediately.\u00a0If the product is not used immediately, the storage time and storage conditions before use are the user&#8217;s responsibility.\u00a0The storage time should not normally exceed 24 hours at 2 to 8 \u00b0 C unless dilution has taken place under controlled, validated aseptic conditions.<\/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\">Contents of the pack 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 mitoxantrone (as hydrochloride).&nbsp;Each ml contains 2 mg mitoxantrone (as hydrochloride).<\/li><li>The other ingredients are sodium chloride, sodium acetate, concentrated acetic acid, sodium sulphate,&nbsp;hydrochloric acid&nbsp;(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>The clear, blue solution, is free from particles.\u00a0Packed in colorless glass vials, in outer carton.\u00a01, 5, or 10 identical vials containing 10 mg mitoxantrone per 5 ml or 20 mg mitoxantrone per 10 ml are packaged in a carton.<\/p>\n\n\n\n<p>Pack sizes: 1 x 5 ml, 5 x 5 ml, 10 x 5 ml, 1 x 10 ml, 5 x 10 ml and 10 x 10 ml.<\/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>EBEWE Pharma Ges.&nbsp;Mb H Nfg.&nbsp;KG, Mondseestrasse 11, 4866 Unterach, Austria<\/p>\n\n\n\n<p><em>Manufacturer<\/em><\/p>\n\n\n\n<p>EBEWE Pharma Ges.&nbsp;Mb H Nfg.&nbsp;KG, Mondseestrasse 11, 4866 Unterach, Austria<\/p>\n\n\n\n<p>or<\/p>\n\n\n\n<p>Fareva Unterach GmbH, Mondseestrasse 11, 4866 Unterach, Austria<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder if you would like to know more about this medicine.<\/p>\n\n\n\n<p><strong>Local representative<\/strong><\/p>\n\n\n\n<p>Sandoz A \/ S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mitoxantrone Ebewe contains the active substance mitoxantrone. Mitoxantron Ebewe belongs to a group of medicines called chemotherapy drugs or cancer medicines. It is also part of a subgroup of cancer drugs called anthracyclines . Mitoxantrone Ebewe prevents cancer cells from growing, causing them to eventually die. The drug also inhibits the immune system and is used for this reason to treat a specific form of multiple sclerosis in cases where there are no other treatment options.<\/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":[2200,15580],"tags":[17768,17773,17764,17769,17772,17767,17765,17770,17771,17766],"class_list":["post-18121","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-benefits-of-mitoxantrone","tag-benefits-of-mitoxantrone-ebewe","tag-mitoxantrone","tag-mitoxantrone-ebewe","tag-mitoxantrone-ebewe-side-effects","tag-mitoxantrone-side-effects","tag-what-is-mitoxantrone","tag-what-is-mitoxantrone-ebewe","tag-what-mitoxantrone-ebewe-is-used-for","tag-what-mitoxantrone-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18121","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=18121"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18121\/revisions"}],"predecessor-version":[{"id":18166,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18121\/revisions\/18166"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}