{"id":6765,"date":"2021-01-13T09:21:47","date_gmt":"2021-01-13T09:21:47","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6765"},"modified":"2021-06-09T08:03:57","modified_gmt":"2021-06-09T08:03:57","slug":"cinryze","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/cinryze\/","title":{"rendered":"Cinryze &#8211; C1 inhibitor uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n500 IU&nbsp;powder and solvent for&nbsp;injection&nbsp;, solution&nbsp;<br>C1 inhibitor (&nbsp;human&nbsp;)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Cinryze is and what it is used for<\/h2>\n\n\n\n<p>Cinryze contains the human&nbsp;protein&nbsp;called &#8220;C1 inhibitor&#8221; as the active substance.<br><\/p>\n\n\n\n<p>C1 inhibitor is a naturally occurring&nbsp;protein&nbsp;that is normally found in the blood.&nbsp;If you have a low amount of C1 inhibitors in your blood or if the C1 inhibitor does not work normally, this can lead to swelling attacks (called&nbsp;angioedema&nbsp;).&nbsp;Symptoms may include abdominal pain and swelling of:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>hands and feet<\/li><li>face, eyelids, lips, or tongue<\/li><li>the voice box (&nbsp;larynx&nbsp;), which may make it difficult to breathe<\/li><li>genitals.<\/li><\/ul>\n\n\n\n<p>In adults and children, Cinryze can increase the amount of C1 inhibitors in the blood and either prevent (before medical or dental procedures) the swelling attacks from occurring or stop the swelling attacks once they have started.<\/p>\n\n\n\n<p>In adults, adolescents and children (6 years of age and older), Cinryze may increase the amount of C1 inhibitors in the blood and regularly prevent the onset of swelling attacks.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you use Cinryze<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Cinryze<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are allergic to C1 inhibitors or any of the other ingredients of this medicine (listed in section 6).&nbsp;It is important that you tell your doctor if you think you have ever had an&nbsp;allergic reaction&nbsp;to any of the ingredients in Cinryze.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Before starting treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with&nbsp;your&nbsp;blood coagulation (&nbsp;thrombosis&nbsp;).&nbsp;In that case, you will be checked carefully.<\/li><li>If you start to get a rash, tightness in your chest, wheezing or rapid heartbeat after taking Cinryze, you should&nbsp;tell your doctor&nbsp;<strong>immediately<\/strong>&nbsp;.&nbsp;See section 4.<\/li><li>When medicines are made from human blood or&nbsp;plasma,&nbsp;special measures are taken to prevent the&nbsp;transmission of&nbsp;infection&nbsp;to patients.&nbsp;The measures include carefully selecting blood and plasma donors to ensure that donors who can carry the&nbsp;infection&nbsp;are excluded, and that all donations and plasma pools are analyzed for signs of viruses \/ infections.&nbsp;The manufacturers of these products also take steps in the processing of blood or plasma that can inactivate or remove&nbsp;viruses&nbsp;.&nbsp;Despite these measures, the risk of transmitting an&nbsp;infection&nbsp;can not be completely ruled out when medicinal products made from human blood or&nbsp;plasma administered.&nbsp;This also applies to any unknown or newly developed&nbsp;viruses&nbsp;or other types of&nbsp;infections.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>The measures taken are considered to be effective in the case of enveloped&nbsp;viruses&nbsp;such as&nbsp;human immunodeficiency virus (&nbsp;HIV&nbsp;),&nbsp;hepatitis&nbsp;B and&nbsp;hepatitis&nbsp;C&nbsp;viruses&nbsp;, and non-enveloped&nbsp;hepatitis&nbsp;A&nbsp;virus&nbsp;and parvovirus B19.<br><\/li><li>Your doctor may recommend that you get vaccinations against&nbsp;hepatitis&nbsp;A and B if you are regularly or repeatedly receiving C1 inhibitor products made from&nbsp;human plasma&nbsp;.<\/li><li>To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented by the nurse or doctor.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<p>Cinryze should not be used in children under 6 years of age for routine&nbsp;prevention&nbsp;of angioedema attacks.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Cinryze<\/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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.&nbsp;There is only limited information on the safety of Cinryze use during pregnancy and lactation.&nbsp;Your doctor will discuss with you the risks and benefits of taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Cinryze has less influence on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Cinryze contains sodium<\/h2>\n\n\n\n<p>This medicine contains 11.5 mg&nbsp;sodium&nbsp;(the main ingredient in table salt\/table salt) per&nbsp;vial.&nbsp;This corresponds to 0.5% of the maximum recommended daily&nbsp;sodium intake&nbsp;for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Cinryze<\/h2>\n\n\n\n<p>Treatment will be initiated and supervised by a physician experienced in the management of patients with hereditary&nbsp;angioedema&nbsp;(HAE).<br><\/p>\n\n\n\n<p>A doctor or nurse can prepare and inject Cinryze for you.&nbsp;If your doctor thinks you can inject the medicine yourself, a doctor or nurse will instruct you or a family member on how to prepare and inject Cinryze.&nbsp;The doctor will regularly agree with you or a relative \/ carer on how preparations and&nbsp;administration&nbsp;are going&nbsp;.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Cinryze for adults, adolescents, children, the elderly or patients suffering from kidney or liver problems is as follows:<br><\/p>\n\n\n\n<p><em><strong>Use in adults and adolescents (12 years and older)<\/strong><\/em><br><\/p>\n\n\n\n<p><strong>Treatment of swelling attacks<\/strong><br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A&nbsp;dose&nbsp;of 1,000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.<\/li><li>An additional&nbsp;1,000 IU&nbsp;injections&nbsp;may be given if symptoms do not subside after 60 minutes.<\/li><li>If you get a severe attack, particularly if the voice box (&nbsp;larynx&nbsp;), swelling, or insertion of the drug is delayed, the second&nbsp;dose&nbsp;one of 1000 IU given earlier than 60 minutes after the first&nbsp;dose&nbsp;one, depending on how you react.<\/li><li>Cinryze should be injected&nbsp;intravenously&nbsp;(into a vein).<\/li><\/ul>\n\n\n\n<p><strong>Routine&nbsp;prevention&nbsp;of swelling attacks<\/strong><br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A&nbsp;dose&nbsp;of 1,000 IU (two vials) of Cinryze is injected at 3 or 4 day intervals for routine&nbsp;prevention&nbsp;of swelling attacks.<\/li><li>The dosing interval can be adjusted by your doctor depending on how you respond to Cinryze.<\/li><li>Cinryze should be injected&nbsp;intravenously&nbsp;(into a vein).<\/li><\/ul>\n\n\n\n<p><strong>Prevention&nbsp;of swelling attacks before surgery<\/strong><br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A&nbsp;dose&nbsp;of 1,000 IU (two vials) of Cinryze is injected up to 24 hours before a medical, dental or surgical procedure.<\/li><li>Cinryze should be injected&nbsp;intravenously&nbsp;(into a vein).<br><\/li><\/ul>\n\n\n\n<p><strong><em>Use for children<\/em><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Treatment of angioedema attacks<\/strong><\/td><td><strong>Prevention&nbsp;of angioedema attacks before surgery<\/strong><\/td><td><strong>Routine&nbsp;prevention&nbsp;of angioedema attacks<\/strong><\/td><\/tr><tr><td><em>2 to 11 years,&gt; 25 kg:<\/em>A&nbsp;dose&nbsp;of 1,000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.<br>Another&nbsp;injection&nbsp;on1,000 IU can be given if your symptoms do not improve after 60 minutes.<br><em>2 to 11 years, 10\u201325 kg:<\/em>A&nbsp;dose&nbsp;of 500 IU (one&nbsp;vial) of Cinryze should be injected at the first sign of a swelling attack.<br>An additional&nbsp;500 IU&nbsp;injection&nbsp;may be given if your symptoms have not improved after 60 minutes.<\/td><td><em>2 to 11 years,&gt; 25 kg:<\/em>A&nbsp;dose&nbsp;of 1,000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental or surgical procedure.<br><em>2 to 11 years, 10\u201325 kg:<\/em>&nbsp;A&nbsp;dose&nbsp;of 500 IU (one&nbsp;vial&nbsp;) of Cinryze should be injected up to 24 hours before a medical, dental or surgical procedure.<\/td><td><em>6 to 11 years:<\/em>A&nbsp;dose&nbsp;of 500 IU (one&nbsp;vial) of Cinryze should be injected at 3 or 4 day intervals for routine&nbsp;prevention&nbsp;of swelling attacks.<br>Your doctor may need to adjust the dosing interval depending on how you respond to treatment with Cinryze.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Preparation&nbsp;and&nbsp;method of&nbsp;administration<\/strong><br><\/p>\n\n\n\n<p>Cinryze is usually injected into a vein (&nbsp;intravenously&nbsp;) by your doctor or nurse.&nbsp;You or your carer can also give Cinryze as an&nbsp;injection&nbsp;, but only after getting enough exercise.&nbsp;If you inject Cinryze yourself, always do as your doctor advised.&nbsp;Consult a doctor if you are unsure.&nbsp;If your doctor thinks you may be suitable for such treatment at home, you will receive detailed instructions from him \/ her.&nbsp;You must keep a diary to document each treatment you take \/ receive at home and bring the diary to all your visits to the doctor.&nbsp;Your \/ your caregiver&#8217;s injection technique will be checked regularly to ensure continued appropriate handling.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor 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&nbsp;, although not everybody gets them.<br><\/p>\n\n\n\n<p>This may include allergic reactions.<br><\/p>\n\n\n\n<p>Tell&nbsp;your doctor&nbsp;<strong>immediately<\/strong>&nbsp;if you get any of the following symptoms after taking this medicine.&nbsp;Although the symptoms are rare, they can be severe.<br><\/p>\n\n\n\n<p>Sudden wheezing, difficulty breathing, swelling of eyelids, face or lips, rash or&nbsp;itching(especially if the rash or itching affects the whole body).<br><\/p>\n\n\n\n<p><strong>Very common&nbsp;side effect&nbsp;are<\/strong>&nbsp;(can occur in more than 1 in 10): headache, nausea.<br><\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 10): hypersensitivity, dizziness, vomiting, rashes,&nbsp;itching&nbsp;or&nbsp;redness&nbsp;, rash or pain at the injection site, fever.<br><\/p>\n\n\n\n<p><strong>Less common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 100): high blood sugar, blood clots, pain in the veins, hot flush, cough, abdominal pain, diarrhea, flaky skin, joint swelling and joint pain, muscle pain, and chest discomfort.<br><\/p>\n\n\n\n<p>Side effects&nbsp;in children and adolescents are expected to be similar to those in adults.<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 Cinryze<\/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 vials after EXP.<\/p>\n\n\n\n<p>Do not store above 25 \u00b0 C.&nbsp;Do not freeze.&nbsp;Store in the original package.&nbsp;Sensitive to light.<br><\/p>\n\n\n\n<p>When the Cinryze solution is ready, it should be used immediately.<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<p>The active substance is a C1 inhibitor made from&nbsp;plasma&nbsp;from human donors.&nbsp;Each&nbsp;vial&nbsp;of powder contains 500 IU C1 inhibitors.&nbsp;After&nbsp;reconstitution&nbsp;, one&nbsp;vial&nbsp;contains&nbsp;500 IU C1 inhibitor (&nbsp;human&nbsp;) per 5 ml, corresponding to a concentration of 100 IU \/ ml.&nbsp;Two vials of reconstituted Cinryze contain 1,000 IU C1 inhibitor (&nbsp;human&nbsp;) per 10 ml, corresponding to a concentration of 100 IU \/ ml.<br><\/p>\n\n\n\n<p>The total protein content of the reconstituted solution is 15 \u00b1 5 mg\/ml.<br><\/p>\n\n\n\n<p>An international unit (IU) corresponds to the amount of C1 inhibitors present in 1 ml of normal&nbsp;human&nbsp;plasma&nbsp;.<br><\/p>\n\n\n\n<p>The other ingredients are sodium chloride, sucrose, sodium citrate, L-&nbsp;valine&nbsp;, L-alanine, L-threonine.&nbsp;(See section 2).<br><\/p>\n\n\n\n<p>Liquid: water for&nbsp;injection.<\/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>Powder and solvent for&nbsp;solution&nbsp;for&nbsp;injection.<\/p>\n\n\n\n<p>Cinryze is a white powder enclosed in a&nbsp;vial&nbsp;.<\/p>\n\n\n\n<p>When the powder is dissolved in the water for&nbsp;injection&nbsp;, the solution is clear and colorless to bluish.<br><\/p>\n\n\n\n<p><em>Each package contains:<\/em><br><\/p>\n\n\n\n<p>2 vials of Cinryze 500 IU powder for&nbsp;injection&nbsp;solution<br><\/p>\n\n\n\n<p>2 vials of water for&nbsp;injections&nbsp;(5 ml each)<\/p>\n\n\n\n<p>2 transfer units with filters<\/p>\n\n\n\n<p>2 disposable syringes of 10 ml<\/p>\n\n\n\n<p>2 sets for venipuncture<\/p>\n\n\n\n<p>2 protective pads<br><\/p>\n\n\n\n<p>Use only a silicone-free&nbsp;syringe&nbsp;(included in the package) to&nbsp;administer the&nbsp;product.<\/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><br><\/p>\n\n\n\n<p>Shire Services BVBA<\/p>\n\n\n\n<p>Rue Montoyer 47<\/p>\n\n\n\n<p>1000 Brussels<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p>medinfoEMEA@shire.com<\/p>\n\n\n\n<p>Tel: +800 66838470<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><br><\/p>\n\n\n\n<p>Takeda Manufacturing Austria AG<\/p>\n\n\n\n<p>Industriestrasse 67<\/p>\n\n\n\n<p>1221 Vienna<\/p>\n\n\n\n<p>Austria<br><\/p>\n\n\n\n<p>Baxter AG<\/p>\n\n\n\n<p>Industriestrasse 67<\/p>\n\n\n\n<p>1221 Vienna<\/p>\n\n\n\n<p>Austria<br><\/p>\n\n\n\n<p>Shire International Licensing BV<\/p>\n\n\n\n<p>Strawinskylaan 481<\/p>\n\n\n\n<p>1077 XX Amsterdam<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cinryze contains the human protein called &#8220;C1 inhibitor&#8221; as the active substance.<\/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":[2203,2200],"tags":[7326,7328,7329,7330,7331,7334,7333,2215,2212,7327,7332],"class_list":["post-6765","post","type-post","status-publish","format-standard","hentry","category-c","category-medicines","tag-c1-inhibitor","tag-c1-inhibitor-injection","tag-c1-inhibitor-side-effects","tag-c1-inhibitor-uses","tag-cinryze","tag-cinryze-injection","tag-cinryze-side-effects","tag-injection","tag-medicine","tag-what-is-c1-inhibitor","tag-what-is-cinryze"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6765","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=6765"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6765\/revisions"}],"predecessor-version":[{"id":11482,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6765\/revisions\/11482"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}