{"id":31528,"date":"2022-11-10T12:39:24","date_gmt":"2022-11-10T12:39:24","guid":{"rendered":"https:\/\/zeepedia.com\/?p=31528"},"modified":"2022-11-11T10:25:30","modified_gmt":"2022-11-11T10:25:30","slug":"waylivra","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/waylivra\/","title":{"rendered":"Waylivra &#8211; Volanesorsen uses, dose and side effects"},"content":{"rendered":"\n<p>285 mg\u00a0solution for injection\u00a0in a pre-filled\u00a0syringe<br>volanesorsen<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Waylivra is and what it is used for<\/h2>\n\n\n\n<p>Waylivra contains the active substance volanesorsen, which is used to treat the condition of familial chylomicronemia (FCS\u00a0).\u00a0FCS is a genetic disorder that causes abnormally high levels of blood fats called\u00a0triglycerides.\u00a0This can lead to inflammation of the pancreas, which causes severe pain.\u00a0Along with a controlled low-fat diet, Waylivra helps lower the triglyceride levels in your blood.<\/p>\n\n\n\n<p>You can receive Waylivra after you have already received other medicines used to lower the levels of&nbsp;triglycerides&nbsp;in your blood without any particular effect.<\/p>\n\n\n\n<p>You will only receive Waylivra if it has been confirmed by genetic testing that you have FCS and your risk of pancreatitis is considered very high.<\/p>\n\n\n\n<p>During treatment with Waylivra, you must continue with the low-fat diet prescribed by the doctor.<\/p>\n\n\n\n<p>This medicine is intended for patients who are 18 years of age and older.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Waylivra<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Waylivra:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to volanesorsen or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you have\u00a0thrombocytopenia, which means you have a very low number of\u00a0platelets\u00a0(less than 140 x 10\u00a0<sup>9<\/sup>\u00a0\/l).\u00a0This can be noticed if you get an injury that causes bleeding and it takes a long time for it to stop (more than 5-6 minutes for a scratch on the skin).\u00a0The doctor will take samples for this before starting treatment with this medicine.\u00a0You may not know beforehand that you have this condition or what may have caused it.<\/li><\/ul>\n\n\n\n<p>If any of the above apply to you, or if you are not sure, talk to your doctor, pharmacist, or nurse before using Waylivra.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Waylivra if you have or have had any of the following medical problems:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>very high triglyceride levels that are not due to FCS.<\/li><li>a low number of\u00a0platelets, a type of cell in the blood that clumps together so the blood can clot (\u00a0thrombocytopenia\u00a0).\u00a0The doctor will take a blood test before you start using this medicine to check the number of\u00a0platelets\u00a0in your blood.<\/li><li>liver or kidney problems.<\/li><\/ul>\n\n\n\n<p>Blood samples<\/p>\n\n\n\n<p>Your doctor will take a blood test before you start taking this medicine to check your\u00a0platelet count\u00a0and then at regular intervals after you start using Waylivra to check your\u00a0platelet count.<\/p>\n\n\n\n<p>See a doctor immediately if you have signs or symptoms of a low\u00a0platelet count, e.g.\u00a0unusual or prolonged bleeding, red spots on the skin (called\u00a0petechiae\u00a0), unexplained bruising, bleeding that does not stop or nosebleeds, or if you have a stiff neck or severe headache.<\/p>\n\n\n\n<p>The doctor may also take a blood test every three months to check for signs of liver damage.\u00a0See a doctor immediately if you have signs or symptoms of liver damage, e.g.\u00a0yellowing of the skin and whites of the eyes, pain or swelling in the abdomen, nausea or vomiting, confusion, or feeling generally unwell.<\/p>\n\n\n\n<p>If necessary, the doctor may decide to change how often you use this medicine or decide on a treatment break.&nbsp;It may be necessary to consult with a doctor who specializes in blood disorders to decide whether or not to continue treatment with Waylivra.<\/p>\n\n\n\n<p>Urine sample<\/p>\n\n\n\n<p>The doctor may take a urine and or blood test every three months to check for signs of kidney damage.\u00a0See a doctor immediately if you have signs or symptoms of kidney damage, e.g.\u00a0swelling of the ankles, legs, and feet, passing less urine than usual, shortness of breath, nausea, confusion, or if you feel very tired or drowsy.<\/p>\n\n\n\n<p>Diet<\/p>\n\n\n\n<p>Before starting treatment with this medicine, you should eat a diet designed to lower blood triglyceride levels.\u00a0You must continue to eat the triglyceride-lowering diet during treatment with Waylivra.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Do not use Waylivra if you are under 18 years of age.&nbsp;Waylivra has not been studied in patients under 18 years of age.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Waylivra<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0You must tell the doctor if you are already being treated with any of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>medicines that inhibit blood coagulation, e.g.\u00a0aspirin, dipyridamole, or\u00a0warfarin.<\/li><li>other medicines that can affect blood\u00a0clotting, include non-steroidal anti-inflammatory medicines such as\u00a0ibuprofen, medicines used to prevent heart attack and\u00a0strokes\u00a0such as clopidogrel, ticagrelor, and prasugrel,\u00a0antibiotics\u00a0such as\u00a0penicillin, medicines such as ranitidine (used to reduce the amount of stomach acid) and quinine (used to treat\u00a0malaria\u00a0).<\/li><li>medicines that can cause problems with the liver, e.g.\u00a0paracetamol.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Waylivra with alcohol<\/h2>\n\n\n\n<p>The effect of using Waylivra with alcohol is unknown.&nbsp;You should avoid drinking alcohol during treatment with this medicine because of the risk of liver problems.<a><\/a><\/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 or pharmacist for advice before using this medicine.\u00a0Use of Waylivra during pregnancy should preferably be avoided.<\/p>\n\n\n\n<p>It is unknown whether Waylivra is excreted in breast milk.&nbsp;You should discuss breastfeeding with your doctor to find out what is best for you and your baby.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Waylivra is unlikely to affect the ability to drive or use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Waylivra contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg) of\u00a0sodium\u00a0per\u00a0dose, i.e. it is almost &#8220;sodium-free&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Waylivra<\/h2>\n\n\n\n<p>Always use this medicine as directed by your doctor.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p>Before you receive this medicine, other causes of high triglyceride levels, such as\u00a0diabetes\u00a0or problems with the thyroid gland, are to be ruled out by the doctor.<\/p>\n\n\n\n<p>The doctor will tell you how often to take this medicine.\u00a0Depending on your blood and urine test results or possible\u00a0side effects, the doctor may decide to change how often you use this medicine, decide on a treatment break or stop the medicine altogether.<\/p>\n\n\n\n<p>You or your healthcare provider will be shown how to use Waylivra according to the instructions for use in this leaflet.&nbsp;Waylivra should be injected under the skin (&nbsp;subcutaneous&nbsp;or sc&nbsp;administration&nbsp;) in the same way as the doctor, nurse or pharmacist has shown you and you should make sure that you inject all the liquid in the syringe.&nbsp;Each single-use pre-filled&nbsp;syringe&nbsp;of this medicine gives you a&nbsp;dose&nbsp;of 285 mg in 1.5 ml.<\/p>\n\n\n\n<p>Before using this medicine, you must read, understood, and carefully follow the instructions for use.<\/p>\n\n\n\n<p>Instructions for use can be found at the end of this leaflet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use too much Waylivra&nbsp;<\/h2>\n\n\n\n<p>If you inject too much Waylivra, contact your doctor or pharmacist, or go to an emergency department even if you have no symptoms.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Waylivra<\/h2>\n\n\n\n<p>If you forget a\u00a0dose, contact the doctor and ask when you should take the next\u00a0dose.\u00a0If a\u00a0dose\u00a0is missed and less than 48 hours have passed before it is discovered, the missed\u00a0dose\u00a0should be given as soon as possible.\u00a0If more than 48 hours have passed before it is detected, the missed\u00a0dose\u00a0should be skipped and the next\u00a0injection\u00a0given as usual.\u00a0Do not inject more than one\u00a0dose\u00a0within 2 days.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Waylivra<\/h2>\n\n\n\n<p>Do not stop using Waylivra unless you have discussed stopping treatment with your doctor.<\/p>\n\n\n\n<p>If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.<\/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.<\/p>\n\n\n\n<p><strong>Serious&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p>Contact your doctor immediately if you experience any of the following side effects:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Symptoms that may indicate a low number of\u00a0blood platelets\u00a0(\u00a0platelets\u00a0play an important role in blood\u00a0clotting\u00a0).\u00a0See a doctor immediately if you have signs or symptoms of a low\u00a0platelet count, e.g.\u00a0unusual or prolonged bleeding, red spots on the skin (called\u00a0petechiae\u00a0), unexplained bruising, bleeding that does not stop or nosebleeds, or if you have a stiff neck or severe headache.<\/li><\/ul>\n\n\n\n<p><strong>Other\u00a0side effects\u00a0ar<\/strong><\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>injection site reactions (rash, pain,\u00a0redness, heat, dryness, swelling,\u00a0itching, tingling, induration,\u00a0hives, blistering, swelling, bruising, bleeding, numbness, pallor, discoloration, or burning at the injection site).\u00a0You can reduce the risk of injection site reactions by waiting until Waylivra has reached room temperature before\u00a0injection\u00a0and by applying ice after\u00a0injection.<\/li><li>headache<\/li><li>muscle pain<\/li><li>overindulge.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect more than 1 in 10 users)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>blood tests that show unusually high levels of\u00a0white blood cells<\/li><li>blood tests showing unusually low levels of\u00a0white blood cells\u00a0(lymphopenia)<\/li><li>easy bruising, large bruises, or bruising for no apparent reason<\/li><li>bleeding under the skin that appears as a rash, bleeding gums or bleeding in the mouth, blood in the urine or stool, nosebleeds, or heavy menstrual bleeding<\/li><li>an\u00a0allergic reaction\u00a0with symptoms including rash, joint stiffness, or fever<\/li><li>blood or\u00a0protein\u00a0in the urine<\/li><li>changed results for certain blood tests, including:<ul><li>an increased level of certain constituents in the blood:\u00a0creatinine,\u00a0urea,\u00a0transaminases, liver enzymes<\/li><li>an increased blood clotting time (the time it takes for the blood to clot)<\/li><li>a reduced amount of\u00a0hemoglobin\u00a0in the blood<\/li><li>a lower flow rate of blood passing through the kidneys<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>diabetes\u00a0with symptoms including thirst, frequent urination (especially at night), extreme hunger, severe fatigue, and unexplained weight loss<\/li><li>sleep difficulties<\/li><li>numbness, tingling, tingling, fainting or fainting, dizziness or shaking<\/li><li>visual disturbances, e.g.\u00a0flashes of light or short-term, temporary blindness in one eye, bleeding under the surface of the eye, or blurred vision<\/li><li>high\u00a0blood pressure<\/li><li>hot flashes increased sweating, night sweats, feeling hot, pain,\u00a0flu-like symptoms,\u00a0or feeling generally unwell<\/li><li>cough, difficulty breathing, nasal congestion, swelling of the throat, wheezing<\/li><li>nausea or vomiting,\u00a0dry mouth, diarrhea, swelling of the throat, face, or gums, abdominal pain or bloating, indigestion<\/li><li>skin redness, rash, pimples, thickening or scarring of the skin, or\u00a0hives<\/li><li>pain in the hands or feet, pain in the large joints of the arms and legs, e.g.\u00a0elbows, wrists, knees, and ankles, other joint pain or stiffness, back pain, neck pain, jaw pain, muscle cramps, or other body aches<\/li><li>severe fatigue, weakness or lack of energy, fluid retention, and chest pain unrelated to the heart.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Waylivra<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date which is stated on the carton and syringe after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2\u00b0C\u20118\u00b0C).<\/p>\n\n\n\n<p>Store in the original packaging.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>Waylivra can be stored at room temperature (up to 30 \u00b0C) in the original packaging for up to 6 weeks after removal from the refrigerator.\u00a0During this time, the medicine can be stored either at room temperature or put back in the refrigerator as needed.\u00a0Record the date you first took the package out of the refrigerator on the outer carton in the area provided.\u00a0If the medicine is not used within 6 weeks after the first time it was taken out of the refrigerator, it should be thrown away.\u00a0If the expiration date on the syringe label has passed during the 6 weeks at room temperature, the syringe should not be used and should be discarded.<\/p>\n\n\n\n<p>Do not use this medicine if the solution is cloudy or contains particles.&nbsp;The solution should be clear and colorless to slightly yellow.<\/p>\n\n\n\n<p>Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is volanesorsen.\u00a0Each ml contains 200 mg of volanesorsen sodium, which corresponds to 190 mg of volanesorsen.\u00a0Each pre-filled single-dose syringe\u00a0contains 285 mg of volanesorsen in 1.5 ml of solution.<\/li><li>The other ingredients are water for injections, sodium hydroxide, and\u00a0hydrochloric acid\u00a0(to adjust the acidity, see section 2 under Waylivra contains\u00a0sodium\u00a0).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Waylivra is supplied in a carton as a\u00a0single-dose syringe\u00a0with a needle and needle guard, pre-filled with a clear, colorless slightly yellow solution.\u00a0It is filled to give 1.5 ml of the solution when the syringe plunger is fully depressed.<\/p>\n\n\n\n<p>It is supplied either in a carton containing 1 pre-filled&nbsp;syringe&nbsp;or as a multipack of 4 pre-filled syringes (4 packs of 1&nbsp;syringe&nbsp;).<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Akcea Therapeutics Ireland Ltd.<\/p>\n\n\n\n<p>St.&nbsp;James House<\/p>\n\n\n\n<p>72 Adelaide Road, Dublin 2<\/p>\n\n\n\n<p>D02 Y017<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Almac Pharma Services Ireland Ltd.<\/p>\n\n\n\n<p>Finnabair Industrial Estate<\/p>\n\n\n\n<p>Dundalk<\/p>\n\n\n\n<p>Co.&nbsp;Louth<\/p>\n\n\n\n<p>Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Waylivra contains the active substance volanesorsen, which is used to treat the condition familial chylomicronemia (FCS\u00a0)\u00a0.\u00a0FCS is a genetic disorder that causes abnormally high levels of blood fats called\u00a0triglycerides\u00a0.\u00a0This can lead to inflammation of the pancreas, which causes severe pain.\u00a0Along with a controlled low-fat diet, Waylivra helps lower the triglyceride levels in your blood.<\/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":[2200,22503],"tags":[27819,27824,27816,27818,27820,27825,27817,27822,27821,27823],"class_list":["post-31528","post","type-post","status-publish","format-standard","hentry","category-medicines","category-w","tag-benefits-of-volanesorsen","tag-benefits-of-waylivra","tag-volanesorsen","tag-volanesorsen-side-effects","tag-waylivra","tag-waylivra-side-effects","tag-what-is-volanesorsen","tag-what-is-waylivra","tag-what-volanesorsen-is-used-for","tag-what-waylivra-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31528","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=31528"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31528\/revisions"}],"predecessor-version":[{"id":31557,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31528\/revisions\/31557"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=31528"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=31528"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=31528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}