{"id":7311,"date":"2021-02-21T08:13:31","date_gmt":"2021-02-21T08:13:31","guid":{"rendered":"https:\/\/zeepedia.com\/?p=7311"},"modified":"2021-05-27T06:33:27","modified_gmt":"2021-05-27T06:33:27","slug":"defitelio","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/defitelio\/","title":{"rendered":"Defitelio &#8211; Defibrotide uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n80 mg \/ mL&nbsp;concentrate for&nbsp;infusion&nbsp;solution&nbsp;<br>defibrotide<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Defitelio is and what it is used for<\/h2>\n\n\n\n<p>Defitelio is a medicine that contains the active substance defibrotide.<br><\/p>\n\n\n\n<p>It is used to treat a disease called&nbsp;hepatic&nbsp;venous-occlusive disease, which causes the blood vessels in the liver to be damaged and clogged by blood clots.&nbsp;This can be caused by drugs that are given before a&nbsp;stem cell transplant.<\/p>\n\n\n\n<p>Defibrotide works by protecting the cells of the blood vessels, preventing the formation of blood clots, or breaking down clots that have formed.<br><\/p>\n\n\n\n<p>It can be used in adults and adolescents, children and infants from 1 month of age.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you take Defitelio<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Defitelio<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are taking other medicines that break down blood clots, e.g.&nbsp;tissue plasminogen activator.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using Defitelio<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are taking medicines that increase the risk of bleeding<\/li><li>if you have major bleeding and need a&nbsp;blood transfusion<\/li><li>if you are going to have surgery<\/li><li>if you have problems with blood circulation due to your body not being able to maintain constant&nbsp;blood pressure.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Defitelio is not recommended for children under 1 month.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Defitelio<\/h2>\n\n\n\n<p>Tell your doctor if you are taking medicines to prevent blood clots, e.g.&nbsp;acetylsalicylic acid heparins,&nbsp;warfarin, dabigatran, rivaroxaban, or apixaban and if you are taking anti-inflammatory drugs (eg&nbsp;ibuprofen,&nbsp;naproxen,&nbsp;diclofenac,&nbsp;and other non-steroidal anti-inflammatory drugs).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Do not use Defitelio if you are pregnant unless your illness requires treatment with Defitelio.<br><\/p>\n\n\n\n<p>If you are sexually active and you or your partner may become pregnant, you must both use an effective contraceptive during treatment with Defitelio and for 1 week after stopping treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Defitelio is not expected to affect your ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Defitelio contains sodium<\/h2>\n\n\n\n<p>This medicine contains 20.4 mg&nbsp;sodium&nbsp;(the main ingredient in table salt\/table salt) per&nbsp;vial.&nbsp;This corresponds to 1.02% of the highest recommended daily intake of&nbsp;sodium&nbsp;for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to get Defitelio<\/h2>\n\n\n\n<p>Treatment with Defitelio should only be started and continuously monitored by an experienced doctor in a hospital or at a specialist center for&nbsp;stem cell transplants.<br><\/p>\n\n\n\n<p>The drug is injected slowly (over 2 hours) into a vein.&nbsp;This is called an &#8220;intravenous infusion&#8221; or &#8220;drip&#8221;.<br><\/p>\n\n\n\n<p>You will receive treatment four times a day for at least 21 days or until your symptoms have disappeared.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for children between 1 month and 18 years is the same as for adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to give you a dose of Defitelio<\/h2>\n\n\n\n<p>Because you are receiving this medicine from a doctor or nurse, it is unlikely that a&nbsp;dose will be&nbsp;missed.&nbsp;However, tell your doctor or healthcare professional if you think a&nbsp;dose&nbsp;has been missed.&nbsp;You should not receive a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, nurse, 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.&nbsp;The following&nbsp;side effects&nbsp;have been reported in patients treated with Defitelio.<br><\/p>\n\n\n\n<p>If you get any of these&nbsp;side effects,&nbsp;talk to your&nbsp;<strong>doctor immediately<\/strong>.<br><\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low&nbsp;blood pressure<br><\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bleeding, general<\/li><li>bleeding from the nose<\/li><li>bleeding in the brain<\/li><li>bleeding in the intestine<\/li><li>bloody vomiting<\/li><li>bleeding in the lungs<\/li><li>bleeding from the infusion line<\/li><li>blood in the urine<\/li><li>bleeding from the mouth<\/li><li>bleeding in the skin<\/li><li>coagulopathy&nbsp;(disturbed blood coagulation)<\/li><li>nausea<\/li><li>vomiting<\/li><li>diarrhea<\/li><li>rash<\/li><li>itching<\/li><li>fever.<\/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>bleeding from the eyes<\/li><li>blood in the stool<\/li><li>bleeding at the injection site<\/li><li>local blood collection outside the&nbsp;vessel&nbsp;(hematoma) in the brain<\/li><li>hemothorax&nbsp;(accumulation of blood between the heart and lungs)<\/li><li>bruises<\/li><li>severe&nbsp;allergic reaction&nbsp;(may manifest as swelling of the hands, face, lips, tongue, or throat, as well as difficulty breathing).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Adverse reactions&nbsp;in children (1 month to 18 years) are expected to be the same in terms of type, severity, and frequency, and no special precautions are needed.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Defitelio<\/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 carton and vial label after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Do not freeze.<br><\/p>\n\n\n\n<p>After dilution, the infusion solution may be stored for a maximum of 24 hours at 2 \u00b0 C-8 \u00b0 C unless dilution has taken place under controlled and approved aseptic conditions.<br><\/p>\n\n\n\n<p>Defitelio should not be used if the solution is cloudy or contains particles.<br><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater.&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 defibrotide.&nbsp;A&nbsp;vial&nbsp;of 2.5 ml contains 200 mg of defibrotide and each mL of solution contains 80 mg of defibrotide.<\/li><li>The other ingredients are sodium citrate (dihydrate),&nbsp;hydrochloric acid,&nbsp;and sodium hydroxide (both used to adjust the&nbsp;pH&nbsp;value), and water for&nbsp;injections&nbsp;(see section 2 \u201cDefitelio contains sodium\u201d).<\/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>Defitelio is a clear light yellow to brown concentrate for infusion solution, without solid particles or turbidity.<br><\/p>\n\n\n\n<p>One carton contains 10 glass vials with 2.5 ml of concentrate each.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Gentium Srl<\/p>\n\n\n\n<p>Piazza XX Settembre, 2<\/p>\n\n\n\n<p>Villa Guardia<\/p>\n\n\n\n<p>22079 Italy<\/p>\n\n\n\n<p>Phone +39 031 5373200<\/p>\n\n\n\n<p>Fax +39 031 5373784<\/p>\n\n\n\n<p>info@gentium.it<br><\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>AT&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>BE&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>DE&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>DK&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>EE&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>ES&nbsp;<\/strong><strong>&#8211;<\/strong><strong>FI&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>FR &#8211;&nbsp;<\/strong><strong>IE&nbsp;<\/strong>&nbsp;<strong>&#8211;&nbsp;<\/strong>&nbsp;<strong>IS&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong>&nbsp;<strong>IT&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong>&nbsp;<strong>LT&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong>&nbsp;<strong>LU&nbsp;<\/strong><strong>&#8211;<\/strong><strong>LV&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>MT&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>NL&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>NO&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>PT&nbsp;<\/strong><strong>&#8211;<\/strong><strong>SE&nbsp;<\/strong><strong>&#8211;&nbsp;<\/strong><strong>UK<\/strong>Jazz Pharmaceuticals Ireland LimitedTel: + 353 1 634 7800<\/td><td><strong>Poland<\/strong>Valeant Pharma Poland sp.&nbsp;z ooTel .: +48 17 865 5100ICN_Polfa@valeant.com<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Pharmaceuticals LODGTel .: + 359 2 895 21 10Bulgaria.Info@bauschhealth.com<\/td><td><strong>Romania<\/strong>Valeant Pharma SRLTel .: +40 374 102 600Romania.info@valeant.com<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>17000 Prague 7Tel .: + 420-234 719 600czech.info@bauschhealth.com<\/td><td><strong>Slovenia<\/strong>PharmaSwiss dooTel: +386 1 236 47 00slovenia.inforegulatory@bauschhealth.com<\/td><\/tr><tr><td><strong>Greece,&nbsp;<\/strong><strong>.\u03c0\u03c1\u03bf\u03c2<\/strong>Pharmaswiss Hellas AE.:\u0397\u03bb .: + 30-2108108460<\/td><td><strong>Slovak Republic<\/strong>Valeant Slovakia sroTel: + 421 2 3233 4900<\/td><\/tr><tr><td><strong>Croatia<\/strong>PharmaSwiss dooTel: +385 1 6311 833croatia.info@bauschhealth.com<\/td><td><br><\/td><\/tr><tr><td><strong>Hungary<\/strong>Valeant Pharma Magyarorsz\u00e1g Kft.Tel: + 36-1-345-5900<\/td><td><br><\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>It is used to treat a disease called hepatic venous-occlusive disease, which causes the blood vessels in the liver to be damaged and clogged by blood clots. This can be caused by drugs that are given before a stem cell transplant.<\/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":[2204,2200],"tags":[5993,5995,5997,5998,6002,6000,5996,6001,5994,5999],"class_list":["post-7311","post","type-post","status-publish","format-standard","hentry","category-d","category-medicines","tag-defibrotide","tag-defibrotide-side-effects","tag-defibrotide-uses","tag-defitelio","tag-defitelio-dose","tag-defitelio-side-effects","tag-side-effects-of-defibrotide","tag-side-effects-of-defitelio","tag-what-is-defibrotide","tag-what-is-defitelio"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7311","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=7311"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7311\/revisions"}],"predecessor-version":[{"id":11120,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7311\/revisions\/11120"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=7311"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=7311"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=7311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}