{"id":15911,"date":"2021-11-24T07:10:28","date_gmt":"2021-11-24T07:10:28","guid":{"rendered":"https:\/\/zeepedia.com\/?p=15911"},"modified":"2021-11-25T11:46:42","modified_gmt":"2021-11-25T11:46:42","slug":"kovaltry","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/kovaltry\/","title":{"rendered":"Kovaltry | Octocog alfa recombinant human coagulation factor VIII uses, dose and side effects"},"content":{"rendered":"\n<p>powder and solvent for solution for injection<br>octocog alfa&nbsp;recombinant&nbsp;human&nbsp;coagulation factor&nbsp;VIII<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Kovaltry is and what it is used for<\/h2>\n\n\n\n<p>Kovaltry contains the active substance\u00a0recombinant\u00a0human\u00a0factor VIII\u00a0(octocog alfa).\u00a0Kovaltry is produced by\u00a0recombinant DNA\u00a0technology without the addition of any human or animal components in the manufacturing process.\u00a0Factor VIII\u00a0is a\u00a0protein\u00a0found naturally in the blood that helps it to coagulate.<\/p>\n\n\n\n<p>Kovaltry is used to treat and prevent bleeding in adults, adolescents, and children of all ages with\u00a0type hemophilia\u00a0(hereditary\u00a0factor VIII\u00a0deficiency\u00a0).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Kovaltry<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Kovaltry<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to octocog alfa 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 mouse or hamster.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p><strong>Talk to your doctor or pharmacist if you have:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pressure over the chest, feeling dizzy (when you get up from a sitting or lying position), itchy&nbsp;hives&nbsp;, wheezing, feeling nauseous or fainting.&nbsp;This may be a sign of a rare, severe, sudden&nbsp;allergic reaction&nbsp;to Kovaltry.&nbsp;<strong>A&nbsp;<\/strong><strong>vbryt administering the product immediately<\/strong>&nbsp;and see your doctor immediately if this occurs.<\/li><li>a bleeding that can not be controlled using your usual&nbsp;dose&nbsp;of Kovaltry.&nbsp;Development of inhibitors (&nbsp;antibodies&nbsp;) is a known complication that can occur during treatment with any&nbsp;factor VIII&nbsp;drug.&nbsp;The inhibitors prevent, especially at high levels, that the treatment works properly.&nbsp;Patients receiving Kovaltry will be closely monitored for the development of such inhibitors.&nbsp;If you or your child has a haemorrhage that cannot be controlled with Kovaltry, tell your doctor immediately.<\/li><li>developed&nbsp;factor VIII&nbsp;inhibitor previously when using another drug.&nbsp;There is a risk that the inhibitor will come back if you switch between different&nbsp;factor VIII&nbsp;drugs.<\/li><li>confirmed heart disease or are at risk of heart disease<\/li><li>a central venous catheter to deliver Kovaltry.&nbsp;You may be at risk for catheter-related complications where the catheter is inserted in the form of:local&nbsp;infection&nbsp;is- bacteria in the bloodformation of a blood clot in that blood vessel<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>The stated warnings apply to patients of all ages, adults, and children.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Kovaltry<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/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 for advice before using this medicine.<\/p>\n\n\n\n<p>Kovaltry is unlikely to affect the&nbsp;fertility&nbsp;of male or female patients as the active substance is found naturally in the body.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>If you experience dizziness or other symptoms that affect your ability to concentrate and react, do not drive or use machines until the symptoms subside.<\/p>\n\n\n\n<p><strong>Kovaltry contains&nbsp;sodium<\/strong><\/p>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0dose, ie essentially &#8216;sodium-free.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Kovaltry<\/h2>\n\n\n\n<p>Treatment with Kovaltry is started by a doctor who has experience in the treatment of patients with\u00a0hemophilia.\u00a0Always use this medicine exactly as your doctor has told you.\u00a0Consult a doctor if you are unsure.<\/p>\n\n\n\n<p>Dose&nbsp;one of&nbsp;factor VIII&nbsp;units is measured in international units (IU).<\/p>\n\n\n\n<p><em>Treatment of bleeding<\/em><\/p>\n\n\n\n<p>To treat bleeding, the doctor calculates and adjusts the&nbsp;dose&nbsp;and how often it should be given based on factors such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>your weight<\/li><li>severity of&nbsp;hemophilia&nbsp;A<\/li><li>where it is bleeding and how severe the bleeding is<\/li><li>if you have inhibitors and how high their level is<\/li><li>the&nbsp;factor VIII&nbsp;level required<\/li><\/ul>\n\n\n\n<p><em>Prevent bleeding<\/em><\/p>\n\n\n\n<p>If you are being given Kovaltry to prevent bleeding, your doctor will calculate a\u00a0dose\u00a0for you.\u00a0Dose\u00a0one is usually 20 &#8211; 40 IU octocog alfa per kg body weight and is injected two or three times a week.\u00a0In some cases, especially younger patients, however, may need to be dosed more often or at higher\u00a0doses.<\/p>\n\n\n\n<p><em>Laboratory tests<\/em><\/p>\n\n\n\n<p>Laboratory tests at appropriate intervals will help ensure that you have adequate&nbsp;factor VIII&nbsp;levels.&nbsp;Particularly in the case of major surgical procedures, the&nbsp;coagulation capacity of the&nbsp;blood must be&nbsp;closely monitored.<\/p>\n\n\n\n<p><em>Use for children and adolescents<\/em><\/p>\n\n\n\n<p>Kovaltry can be used for children of all ages.&nbsp;Children under the age of 12 may need higher&nbsp;doses&nbsp;or be injected more often than prescribed for adults.<\/p>\n\n\n\n<p><em>Patients with inhibitors<\/em><\/p>\n\n\n\n<p>If you have developed&nbsp;factor VIII&nbsp;inhibitors, you may need to use a higher&nbsp;dose&nbsp;to achieve bleeding control.&nbsp;If the increased&nbsp;dose&nbsp;does not&nbsp;reduce the bleeding, your doctor may consider giving you another medicine.<\/p>\n\n\n\n<p>Talk to your doctor for more information.<\/p>\n\n\n\n<p>Do not&nbsp;increase the&nbsp;dose of&nbsp;a Kovaltry to be able to control the bleeding without consulting your doctor.<\/p>\n\n\n\n<p><em>Duration of treatment<\/em><\/p>\n\n\n\n<p>Most often, treatment with Kovaltry for&nbsp;hemophilia is&nbsp;a lifelong treatment.<\/p>\n\n\n\n<p><strong>How to use Kovaltry<\/strong><\/p>\n\n\n\n<p>Kovaltry is injected into a vein (2 to 5 minutes) depending on the total volume and taking into account what feels comfortable for you.\u00a0The drug should be used within 3 hours after\u00a0reconstitution.<\/p>\n\n\n\n<p><em>How Kovaltry is prepared for&nbsp;administration<\/em><\/p>\n\n\n\n<p>Use only the components (vial adapter, pre-filled\u00a0syringe\u00a0containing\u00a0diluent,\u00a0and infusion set) that come with each pack of this medicine.\u00a0Contact a doctor if these components cannot be used.<\/p>\n\n\n\n<p>Do not use if any of the supplied components in the package have been opened or damaged.<\/p>\n\n\n\n<p>The reconstituted product must be\u00a0<strong>filtered using the vial adapter <\/strong>before\u00a0administration\u00a0so that any particles in the solution are removed.<\/p>\n\n\n\n<p>Do not use the supplied infusion set to draw blood as it contains a built-in filter.<\/p>\n\n\n\n<p>This medicine must\u00a0<strong>not<\/strong>\u00a0be mixed with other infusion fluids.\u00a0Do not use solutions with visible particles or that are cloudy.\u00a0Carefully follow the doctor&#8217;s instructions for use and the instructions\u00a0<strong>for<\/strong>\u00a0use\u00a0<strong>at the end of this leaflet<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Kovaltry than you should&nbsp;<\/h2>\n\n\n\n<p>Talk to your doctor if this happens.&nbsp;No overdose symptoms have been reported.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Kovaltry<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Take the next&nbsp;dose&nbsp;immediately and continue at regular intervals according to your doctor&#8217;s prescription.<\/li><li>Do&nbsp;<strong>not<\/strong>&nbsp;use&nbsp;<strong>a<\/strong>&nbsp;double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose&nbsp;.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you want to stop using Kovaltry<\/h2>\n\n\n\n<p><strong>Do not stop<\/strong>&nbsp;using this medicine 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\">What you need to know before using Kovaltry<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects5.<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects,&nbsp;although not everybody gets them.<\/p>\n\n\n\n<p>The\u00a0<strong>most serious\u00a0<\/strong>side effects\u00a0are\u00a0<strong>allergic reactions<\/strong>\u00a0which can be severe allergic reactions.\u00a0<strong>Discontinue\u00a0injection\u00a0of Kovaltry immediately and contact a doctor immediately if such reactions occur.<\/strong><\/p>\n\n\n\n<p>The following symptoms&nbsp;<strong>&nbsp;may<\/strong>&nbsp;be an early warning for these reactions:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pressure over the chest \/ general malaise<\/li><li>dizziness<\/li><li>feeling dizzy when standing up indicating a drop in blood pressure<\/li><li>nausea<\/li><\/ul>\n\n\n\n<p>In children who have not previously been treated with\u00a0factor VIII, it is very common for inhibitor antibodies (see section 2) to form (may occur in more than 1 in 10 patients).\u00a0In patients who have previously been treated with\u00a0factor VIII\u00a0(more than 150 days of treatment), inhibitor antibodies may be formed (see section 2).\u00a0This complication is classified as uncommon (affects less than 1 user in 100).\u00a0If this happens, your medication may stop working properly and you may experience persistent bleeding.\u00a0If this happens, consult a doctor immediately.<\/p>\n\n\n\n<p><strong>Other possible side effects:<\/strong><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swollen&nbsp;lymph nodes&nbsp;(swelling under the skin of the neck, armpits or groin)<\/li><li>palpitation&nbsp;er (you feel your heart beating hard, fast or irregularly)<\/li><li>fast&nbsp;pulse<\/li><li>abdominal pain or stomach upset<\/li><li>indigestion<\/li><li>fever<\/li><li>local reaction at the injection site (eg subcutaneous bleeding, intense&nbsp;itching&nbsp;, swelling, burning sensation, transient redness of the skin)<\/li><li>headache<\/li><li>difficulty sleeping<\/li><li>rash \/ itchy rash.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (<\/strong>&nbsp;may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>dysgeusi&nbsp;(taste disturbances)<\/li><li>urticaria&nbsp;(itchy rash)<\/li><li>hemorrhage (&nbsp;redness&nbsp;of the face)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Kovaltry<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p><strong>Do not use this medicine after the<\/strong>&nbsp;expiry date which is stated on the labels and cartons.&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>Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>This medicinal product can be stored at room temperature (at a maximum of 25 \u00b0 C) for up to 12 months, provided it is stored in the outer carton.&nbsp;If you store it at room temperature, it will expire 12 months after the first room storage date or at the expiry date on the packaging if this occurs first.&nbsp;The new expiry date must be stated on the outer carton when the medicine is taken out of the refrigerator.<\/p>\n\n\n\n<p><strong>Do not refrigerate the<\/strong>\u00a0solution after\u00a0reconstitution.\u00a0The reconstituted solution must be used within 3 hours.\u00a0This medicine is for single use only.\u00a0Any unused product should be discarded.<\/p>\n\n\n\n<p><strong>Do not use<\/strong>&nbsp;this medicine if the solution contains particles or if the solution is cloudy.<\/p>\n\n\n\n<p>Medicines&nbsp;<strong>should not<\/strong>&nbsp;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<p>The&nbsp;<strong>active<\/strong>&nbsp;substance is octocog alfa (&nbsp;human&nbsp;coagulation factor&nbsp;VIII).<\/p>\n\n\n\n<p>Each\u00a0vial\u00a0of Kovaltry nominally contains 250, 500, 1,000, 2,000, or 3,000 IU octocog alfa.<\/p>\n\n\n\n<p><strong>The other<\/strong>\u00a0ingredients are sucrose, histidine,\u00a0glycine\u00a0(E 640), sodium chloride, calcium chloride dihydrate (E 509), polysorbate 80 (E 433), glacial acetic acid (E 260), and water for injections.<\/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>Kovaltry is supplied as a powder and solvent for\u00a0solution\u00a0for\u00a0injection.<\/p>\n\n\n\n<p>The powder is dry and white to off-yellow.&nbsp;The diluent is a clear liquid.<\/p>\n\n\n\n<p>Each pack of Kovaltry contains:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a&nbsp;glass&nbsp;vial&nbsp;of powder&nbsp;<\/li><li>a pre-filled&nbsp;syringe&nbsp;with&nbsp;diluent<\/li><li>a separate spray plunger<\/li><li>an adapter for the vial<\/li><li>an infusion set (to&nbsp;inject&nbsp;into a vein)<\/li><\/ul>\n\n\n\n<p>Kovaltry is available in the following pack sizes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pack<\/li><li>Multipack with 30 single packs&nbsp;<\/li><\/ul>\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>Holder of approved for sale<\/strong><\/p>\n\n\n\n<p>Bayer AG<\/p>\n\n\n\n<p>51368 Leverkusen<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Bayer AG<\/p>\n\n\n\n<p>Kaiser-Wilhelm-Allee<\/p>\n\n\n\n<p>51368 Leverkusen<\/p>\n\n\n\n<p>Germany<\/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<p><strong>Sweden<\/strong><\/p>\n\n\n\n<p>Bayer AB<\/p>\n\n\n\n<p>Tel: +46 (0) 8 580 223 00<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kovaltry contains the active substance recombinant human factor VIII (octocog alfa). Kovaltry is produced by recombinant DNA technology without the addition of any human or animal components in the manufacturing process. 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":[2200,12118],"tags":[15098,15093,15094,15097,15089,15092,15095,15090,15096,15091],"class_list":["post-15911","post","type-post","status-publish","format-standard","hentry","category-medicines","category-k","tag-benefits-of-kovaltry","tag-benefits-of-octocog-alfa-recombinant-human-coagulation-factor-viii","tag-kovaltry","tag-kovaltry-side-effects","tag-octocog-alfa-recombinant-human-coagulation-factor-viii","tag-octocog-alfa-recombinant-human-coagulation-factor-viii-side-effects","tag-what-is-kovaltry","tag-what-is-octocog-alfa-recombinant-human-coagulation-factor-viii","tag-what-kovaltry-is-used-for","tag-what-octocog-alfa-recombinant-human-coagulation-factor-viii-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15911","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=15911"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15911\/revisions"}],"predecessor-version":[{"id":15950,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/15911\/revisions\/15950"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=15911"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=15911"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=15911"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}