{"id":6347,"date":"2021-01-05T09:50:02","date_gmt":"2021-01-05T09:50:02","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6347"},"modified":"2021-06-22T19:04:31","modified_gmt":"2021-06-22T19:04:31","slug":"busilvex","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/busilvex\/","title":{"rendered":"Busilvex &#8211; Busulfan uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n6 mg \/ ml&nbsp;concentrate for solution for&nbsp;infusion&nbsp;solution&nbsp;<br>busulfan<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Busilvex is and what it is used for<\/h2>\n\n\n\n<p>Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.&nbsp;Busilvex destroys the original&nbsp;bone marrow before transplantation.<br><\/p>\n\n\n\n<p>Busilvex is used in adults, newborns, children, and adolescents as a&nbsp;<strong>pre-transplant treatment<\/strong>.<\/p>\n\n\n\n<p>Busilvex is used in adults in combination with cyclophosphamide or fludarabine.<\/p>\n\n\n\n<p>For newborns, infants, and young people, Busilvex is used in combination with cyclophosphamide or melphalan.<br><\/p>\n\n\n\n<p>You will receive this preparatory medicine before receiving a&nbsp;transplant&nbsp;of either&nbsp;bone marrow&nbsp;or hematopoietic&nbsp;stem cells.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you use Busilvex<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Busilvex<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to busulfan or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are pregnant or suspect you may be pregnant.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Busilvex is a powerful antitumor drug that greatly reduces the number of&nbsp;blood cells.&nbsp;This is the desired effect at the recommended&nbsp;dose.&nbsp;Close monitoring and follow-up will therefore be done.&nbsp;It is possible that the use of Busilvex may increase the risk of another tumor disease in the future.<\/p>\n\n\n\n<p>Tell your doctor:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have liver, kidney, heart, or lung problems<\/li><li>if you have had seizures before<\/li><li>if you are currently taking other medicines.<\/li><\/ul>\n\n\n\n<p>Blood clots can form in the small blood vessels after&nbsp;hematopoietic&nbsp;cell transplantation (HCT) if a high&nbsp;dose&nbsp;of your treatment is given with other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Busilvex<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.&nbsp;Busilvex can affect or be affected by other medicines.<br><\/p>\n\n\n\n<p>Take special care with itraconazole and metronidazole (used for certain types of&nbsp;infections&nbsp;) or ketobemidone (used to treat pain) as these may increase the&nbsp;side effects.<br><\/p>\n\n\n\n<p>Use of&nbsp;paracetamol&nbsp;within 72 hours before or during Busilvex treatment should be done.<\/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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.&nbsp;Women must not be pregnant during treatment with Busilvex and for up to 6 months after treatment.&nbsp;Women must stop breast-feeding before starting treatment with Busilvex.<br><\/p>\n\n\n\n<p>Appropriate contraception should be used when either partner is being treated with Busilvex.<br><\/p>\n\n\n\n<p>There is a risk that you can no longer become pregnant after treatment with busulfan (&nbsp;infertility&nbsp;).<\/p>\n\n\n\n<p>If you are worried about not being able to have children, you should discuss this with your doctor before treatment.<\/p>\n\n\n\n<p>Busilvex can also cause menopausal-like symptoms and can prevent young girls from entering puberty.<br><\/p>\n\n\n\n<p>Men treated with Busilvex are advised not to have children during and up to 6 months after treatment.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Busilvex<\/h2>\n\n\n\n<p><strong>Dosage&nbsp;and administration:<\/strong><\/p>\n\n\n\n<p>Dose&nbsp;a Busilvex will be calculated according to your body weight.<br><\/p>\n\n\n\n<p><strong><em>Adults:<\/em><\/strong><\/p>\n\n\n\n<p><em>Busilvex in combination with cyclophosphamide:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The recommended&nbsp;dose of&nbsp;Busilvex is 0.8 mg\/kg<\/li><li>Each&nbsp;infusion&nbsp;will last for 2 hours<\/li><li>Busilvex will be given every 6 hours for 4 consecutive days before transplantation.<\/li><\/ul>\n\n\n\n<p><em>Busilvex in combination with fludarabine:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The recommended&nbsp;dose of&nbsp;Busilvex is 3.2 mg\/kg<\/li><li>Each&nbsp;infusion&nbsp;will last for 3 hours<\/li><li>Busilvex will be given once daily for 2 to 3 consecutive days before transplantation.<\/li><\/ul>\n\n\n\n<p><strong><em>Newborns, children, and adolescents (0-17 years):<\/em><\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose of&nbsp;Busilvex in combination with cyclophosphamide or melphalan is calculated according to your body weight and varies between 0.8 and 1.2 mg\/kg.<br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Each&nbsp;infusion&nbsp;will last for 2 hours.<\/li><li>Busilvex will be given every 6 hours for 4 consecutive days before transplantation.<\/li><\/ul>\n\n\n\n<p><strong>Medications before you receive Busilvex:<\/strong><\/p>\n\n\n\n<p>Before you receive Busilvex you will receive<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>anticonvulsants to prevent seizures (&nbsp;phenytoin&nbsp;or benzodiazepines) and<\/li><li>medicines to prevent vomiting.<\/li><\/ul>\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>Serious side effects:<\/strong><\/p>\n\n\n\n<p>The most serious&nbsp;side effects&nbsp;of Busilvex treatment or transplantation are a decrease in the number of circulating&nbsp;blood cells&nbsp;(which is the intended effect of the medicine to prepare you for your transplant infusion),&nbsp;infection&nbsp;, liver disease including stoppage of a hepatic vein,&nbsp;transplant-&nbsp;versus-host-disease (&nbsp;transplant&nbsp;et attacks your body) and lung complications.&nbsp;Your doctor will monitor your blood levels and liver enzymes regularly to detect and treat these&nbsp;side effects.<br><\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;that may occur:<\/strong><\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 user in 10):<\/strong><\/p>\n\n\n\n<p><em>Blood:<\/em>&nbsp;reduction in the number of circulating&nbsp;blood cells&nbsp;(red and white) and&nbsp;platelets.&nbsp;<em>Infection&nbsp;is.&nbsp;Nervous system:<\/em>&nbsp;insomnia, anxiety, dizziness, and depression.&nbsp;<em>Nutrition:<\/em>&nbsp;loss of appetite, decreased&nbsp;ma<strong>gnesium<\/strong>,&nbsp;calcium,&nbsp;potassium&nbsp;,&nbsp;phosphate, albumin in the blood, and increased blood sugar.&nbsp;<em>Heart:<\/em>&nbsp;increased heart rate, increase or decrease in&nbsp;blood pressure&nbsp;,&nbsp;vasodilation&nbsp;(a condition of dilation of blood vessels), and blood clots.&nbsp;<em>Lungs:<\/em>&nbsp;shortness of breath, runny&nbsp;nose), sore throat, cough, hiccups, nosebleeds, abnormal breathing sounds.&nbsp;<em>Gastrointestinal disorders:<\/em>&nbsp;nausea,&nbsp;inflammation&nbsp;of the oral mucosa, vomiting, abdominal pain, diarrhea, constipation, heartburn, anal discomfort, fluid in the abdomen.&nbsp;<em>Liver:<\/em>&nbsp;enlarged liver, jaundice, blockage of a hepatic vein.&nbsp;<em>Skin:<\/em>&nbsp;rash,&nbsp;itching, hair loss.&nbsp;<em>Muscles and bones:<\/em>&nbsp;back, muscle, and joint pain.&nbsp;<em>Kidneys:<\/em>&nbsp;increased excretion of&nbsp;creatinine, discomfort when urinating, decreased amounts of urine, and blood in the urine.&nbsp;<em>General:<\/em>&nbsp;fever, headache, weakness, chills, pain,&nbsp;allergic reaction,&nbsp;edema, general pain inflammation&nbsp;at the injection site, chest pain,&nbsp;inflammation&nbsp;of the mucous membrane.&nbsp;<em>Examinations:<\/em>&nbsp;elevated liver enzymes and weight gain.<br><\/p>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n<p><em>Nervous system:<\/em>&nbsp;confusion, diseases of the nervous system.&nbsp;<em>Nutrition:<\/em>&nbsp;low&nbsp;sodium&nbsp;in the blood.&nbsp;<em>Heart:<\/em>&nbsp;altered and abnormal heart rhythm, fluid or&nbsp;inflammation&nbsp;around the heart, decreased flow from the heart.&nbsp;<em>Lungs:<\/em>&nbsp;increase in respiratory rhythm, respiratory failure, alveolar hemorrhage,&nbsp;asthma, collapse of small parts of the lung, fluid around the lung.&nbsp;Gastrointestinal<em>:&nbsp;<\/em>inflammation&nbsp;of the esophageal&nbsp;mucosa, intestinal paralysis, vomiting of blood.&nbsp;<em>Skin:<\/em>&nbsp;changes in skin color, skin redness, peeling.&nbsp;<em>Kidneys:<\/em>&nbsp;increase in the number of nitrogen components in the blood, moderate renal impairment, kidney disease.<br><\/p>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people):<\/strong><\/p>\n\n\n\n<p><em>Nervous system:&nbsp;<\/em>delirium, nervousness, hallucinations,&nbsp;agitation, abnormal brain function, cerebral hemorrhage, and seizures.&nbsp;<em>Heart:<\/em>&nbsp;thrombosis of the femoral artery, extra heartbeat, decreased heart rate, diffuse leakage of fluid from the&nbsp;capillaries&nbsp;(small blood vessels).&nbsp;<em>Lungs:<\/em>&nbsp;decreased oxygen content in the blood.&nbsp;Gastrointestinal:&nbsp;bleeding in the stomach and\/or intestines.<br><\/p>\n\n\n\n<p><strong>No known frequency (cannot be calculated from the available data)<\/strong><\/p>\n\n\n\n<p>Impaired function in the gonads.<\/p>\n\n\n\n<p>Visual disturbances including cloudiness of the lens of the eye (&nbsp;cataracts&nbsp;) and blurred vision (thinning of the&nbsp;cornea&nbsp;of the eye&nbsp;).<\/p>\n\n\n\n<p>Symptoms such as menopause and&nbsp;infertility&nbsp;in women.<\/p>\n\n\n\n<p>Brain abscess, dermatitis, the spread of&nbsp;infection.<\/p>\n\n\n\n<p>Liver disease.<\/p>\n\n\n\n<p>An increased amount of&nbsp;lactate dehydrogenase&nbsp;in the blood.<\/p>\n\n\n\n<p>The increased amount of&nbsp;uric acid&nbsp;and&nbsp;urea&nbsp;in the blood.<\/p>\n\n\n\n<p>Incomplete development of teeth.<br><\/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 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 Busilvex<\/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 and carton after EXP.<br><\/p>\n\n\n\n<p><em>Unopened vial:<\/em><\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).<br><\/p>\n\n\n\n<p><em>Diluted solution:<\/em><\/p>\n\n\n\n<p>Chemical and physical in-use stability after dilution with 5%&nbsp;glucose&nbsp;or 9 mg\/ml (0.9%) sodium chloride&nbsp;solution for injection&nbsp;has been demonstrated for 8 hours (including infusion time) after dilution when stored at 20 \u00b0 C \u00b1 5 \u00b0 C or 12 hours after dilution when stored at 2 \u00b0 C \u2013 8 \u00b0 C followed by 3 hours at 20 \u00b0 C \u00b1 5 \u00b0 C (including infusion time).<br><\/p>\n\n\n\n<p>Do not freeze.<br><\/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 busulfan.&nbsp;One ml of concentrate contains 6 mg of busulfan (60 mg in the vial).&nbsp;After dilution: One ml of solution contains about 0.5 mg of busulfan.<\/li><li>The other ingredients are dimethylacetamide and macrogol 400.<\/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>Busilvex consists of an infusion concentrate and is supplied in colorless glass vials, each containing 60 mg of busulfan.<\/p>\n\n\n\n<p>Busilvex is supplied in a multiple packs consisting of two cartons, each containing four vials.<\/p>\n\n\n\n<p>After dilution, Busilvex is a clear, colorless solution.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder:<\/h2>\n\n\n\n<p>Pierre Fabre Medicament<\/p>\n\n\n\n<p>45, Place Abel Gance<\/p>\n\n\n\n<p>F-92654 Boulogne-Billancourt Cedex<\/p>\n\n\n\n<p>France<br><\/p>\n\n\n\n<p><strong>Manufacturer:<\/strong><\/p>\n\n\n\n<p>Pierre Fabre Medicament Production, Aquitaine Pharm International<\/p>\n\n\n\n<p>Avenue du B\u00e9arn<\/p>\n\n\n\n<p>F-64320 Idron<\/p>\n\n\n\n<p>France<br><\/p>\n\n\n\n<p>For further information on this medicine, please contact the Marketing Authorization Holder.<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents. Busilvex destroys the original bone marrow before transplantation.<\/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":[2202,2200],"tags":[8144,8148,8147,8139,8141,8143,8146,8142,8145,8140],"class_list":["post-6347","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-busilvex","tag-busilvex-dose","tag-busilvex-side-effects","tag-busulfan","tag-busulfan-side-effects","tag-busulfan-uses","tag-what-busilvex-is-used-for","tag-what-busulfan-is-used-for","tag-what-is-busilvex","tag-what-is-busulfan"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6347","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=6347"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6347\/revisions"}],"predecessor-version":[{"id":11720,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6347\/revisions\/11720"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6347"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6347"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6347"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}