{"id":19228,"date":"2022-03-04T16:18:58","date_gmt":"2022-03-04T16:18:58","guid":{"rendered":"https:\/\/zeepedia.com\/?p=19228"},"modified":"2022-03-07T16:24:07","modified_gmt":"2022-03-07T16:24:07","slug":"novoeight","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/novoeight\/","title":{"rendered":"NovoEight &#8211; Turoctococcal alpha uses, dose and side effects"},"content":{"rendered":"\n<p>250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU&nbsp;powder and solvent for solution for&nbsp;injection&nbsp;turoctococcal<br>alpha (&nbsp;human&nbsp;coagulation factor&nbsp;VIII (rDNA))<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What NovoEight\u00ae is and what it is used for<\/h2>\n\n\n\n<p>NovoEight contains the active substance turoctococcal alpha,&nbsp;human&nbsp;coagulation factor&nbsp;VIII.&nbsp;Factor VIII&nbsp;is a&nbsp;protein&nbsp;found naturally in the blood that helps it to coagulate.<\/p>\n\n\n\n<p>NovoEight is used to treat and prevent bleeding in patients with\u00a0hemophilia\u00a0A (congenital\u00a0factor VIII\u00a0deficiency) and can be used for all age groups.<\/p>\n\n\n\n<p>In patients with\u00a0hemophilia A,\u00a0factor VIII\u00a0is missing or does not work\u00a0properly.\u00a0NovoEight replaces the\u00a0factor VIII\u00a0that does not work or is missing and helps the blood to form\u00a0clots\u00a0where it bleeds.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using NovoEight\u00ae<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use NovoEight\u00ae<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are allergic to&nbsp;protein&nbsp;you from hamster.<\/li><\/ul>\n\n\n\n<p>Do not use NovoEight if any of these apply to you.&nbsp;If you are not sure, talk to your doctor before using this medicine.<\/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 NovoEight.<\/p>\n\n\n\n<p>There is a risk, although rare, that you may experience an\u00a0anaphylactic reaction\u00a0(a severe sudden\u00a0allergic reaction\u00a0) to NovoEight.\u00a0Early signs of allergic reactions are skin rash,\u00a0hives, general\u00a0itching, swollen lips or tongue, difficulty breathing, wheezing, tightness of the chest, general malaise, and dizziness.<\/p>\n\n\n\n<p>If any of these symptoms occur, stop the&nbsp;injection&nbsp;immediately and consult a doctor.<\/p>\n\n\n\n<p>Talk to your doctor if you think that the bleeding is not sufficiently regulated with the&nbsp;dose&nbsp;you use, as there can be many reasons for this.&nbsp;Some people who use this medicine may develop&nbsp;antibodies&nbsp;to&nbsp;factor VIII&nbsp;(also called&nbsp;factor VIII&nbsp;inhibitors).&nbsp;These make NovoEight less effective in preventing or controlling bleeding.&nbsp;If this happens, you may need a higher&nbsp;dose&nbsp;of NovoEight or another medicine to keep your bleeding under control.&nbsp;Do not increase the total&nbsp;dose&nbsp;of NovoEight to control bleeding without talking to a doctor.&nbsp;You should tell your doctor if you have previously been treated with&nbsp;factor VIIIpreparations, especially if you have developed inhibitors, as there is an increased risk of it happening again.<\/p>\n\n\n\n<p>The development of inhibitors (\u00a0antibodies\u00a0) is a known complication that can occur during treatment with any\u00a0factor VIII\u00a0drug.\u00a0The inhibitors prevent, especially at high levels, that the treatment works properly.\u00a0You or your child will be closely monitored for the development of such inhibitors.\u00a0If you or your child suffer from bleeding that cannot be controlled with NovoEight, tell your doctor immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and NovoEight\u00ae<\/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<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/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 for advice before using this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>NovoEight does not affect the ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">NovoEight contains sodium<\/h2>\n\n\n\n<p>This medicine contains 30.5 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per reconstituted\u00a0vial.\u00a0This corresponds to 1.5% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n<p>Tell your doctor if you are on a diet with a limited salt intake.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use NovoEight\u00ae<\/h2>\n\n\n\n<p>Treatment with NovoEight is started by a doctor who has experience in the treatment of patients with\u00a0hemophilia\u00a0A. Always use this medicine exactly as your doctor has told you.\u00a0Consult a doctor if you are unsure.<\/p>\n\n\n\n<p>Your doctor will calculate your&nbsp;dose&nbsp;for you.&nbsp;It depends on your weight and what the medicine is used for.<\/p>\n\n\n\n<p><strong>Prevention of bleeding<\/strong><\/p>\n\n\n\n<p>The usual&nbsp;dose&nbsp;of NovoEight is 20 to 50 International Units (IU) per kilogram bodyweight.&nbsp;Injection&nbsp;one is taken every two or three days.&nbsp;In some cases, especially in younger patients, more frequent&nbsp;injections&nbsp;or higher&nbsp;doses&nbsp;may be needed.<\/p>\n\n\n\n<p><strong>Treatment of bleeding<\/strong><\/p>\n\n\n\n<p>The dose of NovoEight&nbsp;is calculated taking into account your body weight and the&nbsp;factor VIII&nbsp;level to be achieved.&nbsp;The level depends on how severe the bleeding is and where it is bleeding.<\/p>\n\n\n\n<p><strong>How NovoEight is given<\/strong><\/p>\n\n\n\n<p>NovoEight is given as an&nbsp;injection&nbsp;into a friend.&nbsp;See the &#8220;NovoEight User Guide&#8221; for more information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Use for children and adolescents<\/h2>\n\n\n\n<p>NovoEight can be used for children of all ages.&nbsp;For children (under 12 years of age), higher&nbsp;doses&nbsp;or more frequent&nbsp;injections&nbsp;may be needed.&nbsp;Adolescents (over 12 years of age) can use the same&nbsp;dose&nbsp;as adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more NovoEight than you should<\/h2>\n\n\n\n<p>If you inject too much NovoEight, talk to a doctor or go to a hospital straight away.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take NovoEight<\/h2>\n\n\n\n<p>Contact a doctor if you forget to take a&nbsp;dose&nbsp;and do not know how to compensate for it.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using NovoEight\u00ae<\/h2>\n\n\n\n<p>If you stop using NovoEight, you may no longer be protected against bleeding or ongoing bleeding may stop.\u00a0Do not stop using NovoEight without consulting a doctor.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor.<\/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.\u00a0The following\u00a0side effects\u00a0may occur with this medicine.<\/p>\n\n\n\n<p>If severe sudden allergic reactions (anaphylactic reactions) occur (very rare),&nbsp;injection&nbsp;must be stopped immediately.&nbsp;You must contact a doctor immediately if you get any of the following early symptoms:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>difficulty breathing, shortness of breath or wheezing<\/li><li>tightness in the chest<\/li><li>swollen lips and tongue<\/li><li>skin rash, hives or general&nbsp;itching<\/li><li>dizziness or unconsciousness<\/li><li>low&nbsp;blood pressure&nbsp;(gives pale and cold skin, palpitations).<\/li><\/ul>\n\n\n\n<p>Severe symptoms, including difficulty swallowing or breathing and red or swollen face or hands, require immediate&nbsp;urgent&nbsp;treatment.<\/p>\n\n\n\n<p>If you get a severe\u00a0allergic reaction, your doctor may change your medication.<\/p>\n\n\n\n<p>In children not previously treated with&nbsp;Factor VIII&nbsp;medicines, inhibitory&nbsp;antibodies&nbsp;(see section 2) may form.&nbsp;This complication is classified as very common (affects more than 1 patient in 10).&nbsp;In patients who have previously been treated with&nbsp;Factor VIII&nbsp;(more than 150 days of treatment), the risk is classified as unusual (occurs in less than 1 in 100 patients).&nbsp;If this happens, your or your child&#8217;s medication may stop working properly, and you \/ your child may experience persistent bleeding.&nbsp;Contact a doctor immediately if this happens.<\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(affects up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>changes in liver function that appear in blood tests<\/li><li>reactions (&nbsp;redness&nbsp;and&nbsp;itching&nbsp;) around the injection site where you injected the medicine<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(affects up to 1 in 10 people) in patients not previously treated with&nbsp;Factor<\/strong>&nbsp;VIII&nbsp;<strong>medicines<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>reddening of the skin<\/li><li>inflammation&nbsp;in the vein<\/li><li>bleeding inside the joint<\/li><li>bleeding into muscle tissue<\/li><li>cough<\/li><li>redness&nbsp;around the site where the catheter was placed<\/li><li>vomiting.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(affects up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fatigue<\/li><li>headache<\/li><li>dizziness<\/li><li>difficulty falling asleep (insomnia)<\/li><li>fast heartbeat<\/li><li>increased&nbsp;blood pressure<\/li><li>rash<\/li><li>fever<\/li><li>feeling of warmth<\/li><li>stiff muscles<\/li><li>pain in muscles<\/li><li>pain in legs and arms<\/li><li>swollen legs and feet<\/li><li>joint disease<\/li><li>bruise<\/li><li>myocardial infarction.<\/li><\/ul>\n\n\n\n<p><strong>Side&nbsp;<\/strong><strong>effects in children and adolescents<\/strong><\/p>\n\n\n\n<p>Side effects&nbsp;observed in children and adolescents are the same as in adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store NovoEight\u00ae<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use this medicine before the expiry date which is stated on the carton and label of the EXP bottle and the pre-filled syringe label.&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 &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>Keep the vial in the outer carton.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>Before diluting the NovoEight powder, it can be stored:<\/p>\n\n\n\n<p>At room temperature (\u2264 30 \u00b0 C) for a single continuous period not exceeding 9 months<br><strong>or<\/strong><\/p>\n\n\n\n<p>\u2022 above room temperature (30 \u00b0 C up to 40 \u00b0 C) for a single continuous period of not more than 3 months<\/p>\n\n\n\n<p>Once the medicine has been removed from the refrigerator, it must not be put back in the refrigerator.<\/p>\n\n\n\n<p>Make a note of the date when storage begins and the storage temperature on the outer carton.<\/p>\n\n\n\n<p>Once you have prepared the NovoEight solution, use it immediately.&nbsp;If you can not use the solution immediately, it should be used within:<\/p>\n\n\n\n<p>\u2022 24 hours when stored at 2 \u00b0 C \u2013 8 \u00b0 C<\/p>\n\n\n\n<p>\u2022 4 hours for storage at \u2264 30 \u00b0 C, for medicinal products stored for a single continuous period of not more than 9 months at room temperature (\u2264 30 \u00b0 C)<\/p>\n\n\n\n<p>\u2022 4 hours when stored up to 40 \u00b0 C, for medicines that have been stored for a single continuous period of no more than 3 months above room temperature (30 \u00b0 C up to 40 \u00b0 C).<\/p>\n\n\n\n<p>Store the reconstituted solution in the vial.&nbsp;If not used immediately, it may lose its sterility and&nbsp;infect&nbsp;you.&nbsp;Do not save a solution without consulting a doctor.<\/p>\n\n\n\n<p>The powder in the vial is white or slightly yellowish.&nbsp;Do not use the powder if the color has changed.<\/p>\n\n\n\n<p>The prepared solution is ready for something unclear.&nbsp;Do not use this medicine if it is cloudy or you see particles in the solution.<\/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 turoctococcal alpha (&nbsp;human&nbsp;coagulation factor&nbsp;VIII (rDNA)).&nbsp;Each vial of NovoEight nominally contains 250, 500, 1000, 1500, 2000 or 3000 IU turoctococcal alpha.<\/li><li>The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and&nbsp;hydrochloric acid&nbsp;.<\/li><li>The ingredients in the diluent are sodium chloride and water for injections.<\/li><\/ul>\n\n\n\n<p>After reconstitution with the&nbsp;diluent&nbsp;(9 mg \/ ml sodium chloride (0.9%)&nbsp;solution for injection&nbsp;) , the reconstituted solution contains 62.5;&nbsp;125;&nbsp;250;&nbsp;375;&nbsp;500 and 750 IU turoktokog alfa per ml respectively (based on the strength of turoktokog alfa, ie 250, 500, 1000, 1500, 2000 or 3000 IU).<\/p>\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>NovoEight is a powder and solvent for solution for\u00a0injection.<\/p>\n\n\n\n<p>Each pack of NovoEight contains a\u00a0vial\u00a0of white or slightly yellowish powder, a 4 ml pre-filled\u00a0syringe\u00a0with a clear, colorless solution, a plunger rod, and a bottle adapter.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Novo Nordisk A \/ S<\/p>\n\n\n\n<p>Novo All\u00e9<\/p>\n\n\n\n<p>DK-2880 Bagsv\u00e6rd, Denmark<\/p>\n","protected":false},"excerpt":{"rendered":"<p>NovoEight contains the active substance turoctococcal alpha, human coagulation factor VIII. Factor VIII is a protein found naturally in the blood that helps it to coagulate.<\/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":[2200,15581],"tags":[19272,19267,19268,19271,19263,19266,19269,19264,19270,19265],"class_list":["post-19228","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-novoeight","tag-benefits-of-turoctococcal-alpha","tag-novoeight","tag-novoeight-side-effects","tag-turoctococcal-alpha","tag-turoctococcal-alpha-side-effects","tag-what-is-novoeight","tag-what-is-turoctococcal-alpha","tag-what-novoeight-is-used-for","tag-what-turoctococcal-alpha-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19228","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=19228"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19228\/revisions"}],"predecessor-version":[{"id":19279,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19228\/revisions\/19279"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19228"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19228"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19228"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}