{"id":6146,"date":"2021-01-02T15:02:44","date_gmt":"2021-01-02T15:02:44","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6146"},"modified":"2021-06-29T07:26:36","modified_gmt":"2021-06-29T07:26:36","slug":"bivalirudin-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/bivalirudin-accord\/","title":{"rendered":"Bivalirudin Accord &#8211; Bivalirudin uses, dose and side effects"},"content":{"rendered":"\n<p>250 mg&nbsp;powder for concentrate for solution for injection \/ infusion&nbsp;<br>bivalirudin<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Bivalirudin Accord is and what it is used for<\/h2>\n\n\n\n<p>Bivalirudin Accord contains a substance called bivalirudin, which is an antithrombotic agent.&nbsp;Antithrombotic agents are drugs that prevent the formation of blood clots (&nbsp;thrombosis&nbsp;).<br><\/p>\n\n\n\n<p>Bivalirudin Accord is used to treat patients:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>with chest pain due to heart disease (&nbsp;acute&nbsp;coronary syndrome &#8211; AKS)<\/li><li>undergoing surgery to treat narrowed blood vessels (vascular surgery and\/or&nbsp;percutaneous&nbsp;coronary&nbsp;intervention&nbsp;&#8211; PCI).<\/li><\/ul>\n\n\n\n<p>Bivalirudin contained in Bivalirudin Accord may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Bivalirudin Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Bivalirudin Accord<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinners).<\/li><li>if you have or have recently had, bleeding from the stomach, intestines,&nbsp;bladder, or other organs, eg if you have detected abnormal blood in the stool or urine (with the exception of menstrual bleeding).<\/li><li>if you have or have had, problems with blood coagulation (low&nbsp;platelet count&nbsp;).<\/li><li>if you have high&nbsp;blood pressure.<\/li><li>if you have an&nbsp;infection&nbsp;of the heart tissue.<\/li><li>if you have severe kidney problems or if you need kidney dialysis.<\/li><\/ul>\n\n\n\n<p>Check with your doctor if you are unsure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using Bivalirudin Accord.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if bleeding occurs (if this happens, treatment with Bivalirudin Accord will be stopped).&nbsp;Your doctor will monitor you throughout the treatment period for signs of bleeding.<\/li><li>if you have previously been treated with medicines similar to Bivalirudin Accord (eg lepirudin).<\/li><li>Before&nbsp;starting&nbsp;an&nbsp;injection&nbsp;or&nbsp;infusion, your doctor will inform you about the signs of an&nbsp;allergic reaction.&nbsp;Such a reaction is less common (may affect 1 in 100 people).<\/li><li>if you receive radiation therapy to the blood vessels that supply the heart with blood (a procedure called beta- or gamma-brachytherapy).<\/li><\/ul>\n\n\n\n<p>After treatment with Bivalirudin Accord for heart problems, you should stay in the hospital for at least 24 hours.&nbsp;There, you should be monitored for symptoms or signs similar to those you experienced when you had heart problems that resulted in you being hospitalized.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are a child (under 18 years) this medicine is not suitable for you.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Bivalirudin Accord<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are taking, have recently taken, or might take any other medicines.<\/li><li>if you are taking blood thinners or medicines that prevent blood clots (anticoagulants or antithrombotic agents, such as&nbsp;warfarin&nbsp;, dabigatran, apixaban, rivaroxaban,&nbsp;acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor).<\/li><\/ul>\n\n\n\n<p>These drugs can increase the risk of&nbsp;side effects&nbsp;such as&nbsp;bleeding when co-administered with Bivalirudin Accord.&nbsp;The results of blood tests taken during warfarin treatment (INR test) may be affected by Bivalirudin Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/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 or pharmacist for advice before taking this medicine.<br><\/p>\n\n\n\n<p>Bivalirudin Accord should not be used during pregnancy unless it is very important that you get it.&nbsp;Your doctor will decide if the treatment is right for you or not.&nbsp;If you are breast-feeding, your doctor will decide if you should use Bivalirudin Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>The effect of this drug is short-lived.&nbsp;Bivalirudin Accord is only given to patients in hospitals.&nbsp;It is therefore unlikely that your ability to drive or use machines will be affected.<\/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 increased 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.<br><\/p>\n\n\n\n<p><em>Bivalirudin Accord contains&nbsp;sodium<\/em><\/p>\n\n\n\n<p>This medicine contains less than 23 mg&nbsp;sodium&nbsp;per&nbsp;vial, ie is essential &#8216;sodium-free&#8217;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Bivalirudin Accord<\/h2>\n\n\n\n<p>Your treatment with Bivalirudin Accord will be monitored by a doctor.&nbsp;Your doctor will decide how much Bivalirudin Accord you are taking and prepare the medicine.<br><\/p>\n\n\n\n<p>The&nbsp;dose&nbsp;one is given depends on your body weight and the type of treatment you are receiving.<br><\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p><strong>For patients with&nbsp;the acute&nbsp;coronary syndrome (ACS) who are receiving medical treatment,<\/strong>&nbsp;the recommended&nbsp;<strong>starting dose is:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>0.1 mg\/kg body weight as an&nbsp;intravenous&nbsp;injection&nbsp;followed by an&nbsp;infusion&nbsp;(drip) into a vein at 0.25 mg\/kg body weight per hour for up to 72 hours.<\/li><\/ul>\n\n\n\n<p>If you&nbsp;<strong>subsequently<\/strong>&nbsp;need to undergo&nbsp;percutaneous&nbsp;coronary intervention therapy,&nbsp;dose&nbsp;one will be increased to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>0.5 mg\/kg body weight as an&nbsp;intravenous&nbsp;injection&nbsp;followed by an&nbsp;infusion&nbsp;into a vein of 1.75 mg\/kg body weight per hour during the PCI<\/li><li>Once this treatment has been completed, you may return to an&nbsp;infusion&nbsp;of&nbsp;<strong>0.25 mg\/kg<\/strong>&nbsp;body weight per hour for a further 4 to 12 hours.<\/li><\/ul>\n\n\n\n<p>If you need to undergo bypass surgery on the coronary arteries of the heart, bivalirudin treatment will either be stopped 1 hour before the operation or an additional&nbsp;dose&nbsp;of 0.5 mg\/kg body weight&nbsp;will be given&nbsp;as an&nbsp;injection&nbsp;followed by&nbsp;an infusion&nbsp;of 1.75 mg\/kg body weight per hour.<\/p>\n\n\n\n<p><strong>For patients starting&nbsp;percutaneous&nbsp;coronary intervention (PCI)<\/strong>, the recommended dose is:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>0.75 mg\/kg<\/strong>&nbsp;body weight as an&nbsp;intravenous&nbsp;injection&nbsp;immediately followed by an&nbsp;infusion&nbsp;(drip) of&nbsp;<strong>1.75 mg\/kg<\/strong>&nbsp;body weight per hour for at least the duration of the PCI.&nbsp;The intravenous&nbsp;infusion&nbsp;can be continued for up to 4 hours after PCI and for STEMI patients (those with a severe type of myocardial infarction) it should be continued at this&nbsp;dose&nbsp;for up to 4 hours.&nbsp;Infusion&nbsp;one can be followed by an&nbsp;infusion&nbsp;with a lower&nbsp;dose&nbsp;of 0.25 mg\/kg body weight for a further 4 to 12 hours.<\/li><\/ul>\n\n\n\n<p>If you have kidney problems, the&nbsp;dose of&nbsp;Bivalirudin Accord may need to be reduced.<br><\/p>\n\n\n\n<p>In the elderly, the&nbsp;dose&nbsp;may&nbsp;need to be reduced if renal function is impaired.<br><\/p>\n\n\n\n<p>Your doctor will decide how long you should be treated.<br><\/p>\n\n\n\n<p>Bivalirudin Accord is given by&nbsp;injection&nbsp;followed by an&nbsp;infusion&nbsp;(drip) into a vein (never into a muscle).&nbsp;An injection&nbsp;is given and supervised by a physician experienced in the management of patients with heart disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Bivalirudin Accord than you should<\/h2>\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;If you get any of the following, possibly serious, side effects:<br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>while you are in hospital: Tell your doctor or nurse immediately<\/strong><\/li><li><strong>after you leave the hospital: contact a doctor immediately or see the emergency department at the nearest hospital.<\/strong><\/li><\/ul>\n\n\n\n<p>The most common (may affect up to 1 in 10 people)&nbsp;side effect&nbsp;of treatment with bivalirudin is major bleeding which may occur in the body (eg stomach, digestive system [including blood in vomit or feces], abdomen, lungs, groin,&nbsp;bladder, heart, eyes, ear, nose or brain)<strong>.&nbsp;<\/strong>They can&nbsp;<strong>rarely<\/strong>&nbsp;result in&nbsp;stroke&nbsp;or be fatal.&nbsp;Swelling or pain in the groin or arm, back pain, bruising, headache, blood in the cough, pink or red urine, sweating, fainting, nausea, or dizziness due to low&nbsp;blood pressure may be a sign of internal bleeding.&nbsp;Bleeding is more likely to occur when bivalirudin is used in combination with other anticoagulants or antithrombotic agents (see section 2 \u201cOther medicines and Bivalirudin Accord\u201d).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bleeding and bruising at the injection site (after PCI) can be painful.&nbsp;In rare cases,&nbsp;surgery&nbsp;may be needed to repair the blood vessel in the groin (&nbsp;fistula, pseudoaneurysm) (may affect up to 1 in 1,000 users).&nbsp;A less common&nbsp;side effect(which may affect up to 1 in 100 people) is a low&nbsp;platelet count, which may aggravate any bleeding.&nbsp;Bleeding in the gums (less common, may affect up to 1 in 100 people) is usually not serious.<\/li><li>Allergic reactions are uncommon (may affect up to 1 in 100 people) and usually not serious but can in some cases be severe and in rare cases fatal due to low&nbsp;blood pressure&nbsp;(&nbsp;shock&nbsp;).&nbsp;They can start with limited symptoms such as&nbsp;itching, redness of the skin, rash, or small lumps on the skin.&nbsp;Sometimes the reactions can be more severe with&nbsp;itching&nbsp;in the throat, feeling of tightness in the throat, swelling of the tongue, face, eyes, or lips, wheezing during inhalation, difficulty breathing or exhaling (wheezing).<\/li><li>Thrombosis&nbsp;(blood clot) is a less common&nbsp;side effect&nbsp;(may affect up to 1 in 100 people) that can lead to serious or fatal complications such as a heart attack.&nbsp;Thrombosis&nbsp;includes&nbsp;thrombosis&nbsp;in the coronary artery (blood clot in the coronary&nbsp;artery&nbsp;s or in a&nbsp;stent&nbsp;which feels like a heart attack and can even be fatal) and\/or&nbsp;thrombosis&nbsp;in the catheter.&nbsp;Both of these are rare (may affect up to 1 in 1,000 people).<\/li><\/ul>\n\n\n\n<p>If you get any of the following&nbsp;side effects&nbsp;(which may be less serious):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>while you are in hospital: Tell your doctor or nurse immediately<\/strong><\/li><li><strong>after leaving the hospital: first consult a doctor.&nbsp;If you cannot reach the doctor, you should immediately go to the emergency department at the nearest hospital.<\/strong><\/li><\/ul>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 user in 10):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Minor bleeding<\/li><\/ul>\n\n\n\n<p>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Anemia&nbsp;(low&nbsp;blood cell count&nbsp;)<\/li><li>Hematoma (bruising)<\/li><\/ul>\n\n\n\n<p>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nausea and\/or vomiting<\/li><\/ul>\n\n\n\n<p>Rare&nbsp;side effects&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>INR test (results from blood tests taken during warfarin treatment) increased (see section 2 \u201cOther medicines and Bivalirudin Accord\u201d)<\/li><li>Angina or chest pain<\/li><li>Slow heartbeat<\/li><li>Fast heartbeat<\/li><li>Respiratory distress<\/li><li>Reperfusion injury (no or slow reflow): impaired flow in the coronary&nbsp;artery&#8217;s when they have been reopened<\/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 Bivalirudin Accord<\/h2>\n\n\n\n<p>Because Bivalirudin Accord is a hospital-only medicine, healthcare professionals are responsible for storing Bivalirudin Accord.<br><\/p>\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 and EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Prepared solution: Store in a refrigerator (2-8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>Diluted solution: Do not store above 25 \u00b0 C.&nbsp;Store in a cold place.&nbsp;Do not freeze.<br><\/p>\n\n\n\n<p>The solution should be a clear to slightly opalescent, colorless to light yellow solution.<\/p>\n\n\n\n<p>The doctor will inspect the solution and discard it if it contains particles or is discolored.<\/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 bivalirudin.<\/li><li>One&nbsp;vial&nbsp;contains 250 mg of bivalirudin.<\/li><li>After&nbsp;reconstitution&nbsp;(5 ml of water for injections added to the vial to dissolve the powder) 1 ml contains 50 mg of bivalirudin.<\/li><li>After dilution (a&nbsp;mixture&nbsp;of 5 ml of the reconstituted solution in an&nbsp;infusion bag[total volume 50 ml] glucose solution or sodium chloride solution) 1 ml contains 5 mg of bivalirudin.<\/li><\/ul>\n\n\n\n<p>The other ingredients are mannitol (E421) and sodium hydroxide (for&nbsp;pH&nbsp;adjustment).<\/p>\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>Bivalirudin Accord is a powder for concentrate for solution for injection or infusion (powder for concentrate).<\/p>\n\n\n\n<p>Bivalirudin Accord is a sterile white to off-white powder in a&nbsp;glass&nbsp;vial.<\/p>\n\n\n\n<p>Bivalirudin Accord is supplied in cartons containing 1&nbsp;vial, 5 vials, or 10 vials.<\/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><strong>Marketing Authorisation Holder:<\/strong><\/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<br><\/p>\n\n\n\n<p><strong>Manufacturer:<\/strong><\/p>\n\n\n\n<p>Laboratory Reig Jofr\u00e9 SA<\/p>\n\n\n\n<p>C \/ Gran Capit\u00e1n, 10, Sant Joan Desp\u00ed,<\/p>\n\n\n\n<p>08970 Barcelona<\/p>\n\n\n\n<p>Spain<br><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House, 319 Pinner Road,<\/p>\n\n\n\n<p>North Harrow, Middlesex, HA1 4HF,<\/p>\n\n\n\n<p>UK<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bivalirudin Accord contains a substance called bivalirudin, which is an antithrombotic agent. Antithrombotic agents are drugs that prevent the formation of blood clots ( thrombosis ).<\/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":[8661,8673,8675,8677,8664,8672,8676,8663,8662,8674],"class_list":["post-6146","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bivalirudin","tag-bivalirudin-accord","tag-bivalirudin-accord-injection","tag-bivalirudin-accord-side-effects","tag-bivalirudin-injection","tag-bivalirudin-side-effects","tag-what-bivalirudin-accord-is-used-for","tag-what-bivalirudin-is-used-for","tag-what-is-bivalirudin","tag-what-is-bivalirudin-accord"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6146","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=6146"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6146\/revisions"}],"predecessor-version":[{"id":11925,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6146\/revisions\/11925"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}