{"id":23368,"date":"2022-07-28T06:10:00","date_gmt":"2022-07-28T06:10:00","guid":{"rendered":"https:\/\/zeepedia.com\/?p=23368"},"modified":"2022-07-29T11:10:38","modified_gmt":"2022-07-29T11:10:38","slug":"soliris","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/soliris\/","title":{"rendered":"Soliris &#8211; Eculizumab uses, dose and side effects"},"content":{"rendered":"\n<p>300 mg&nbsp;concentrate for&nbsp;infusion&nbsp;solution<br>eculizumab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Soliris is and what it is used for<\/h2>\n\n\n\n<p><strong>What is Soliris?<\/strong><\/p>\n\n\n\n<p>Soliris contains the active ingredient eculizumab and it belongs to a class of medicines called monoclonal\u00a0antibodies.\u00a0Eculizumab binds to and inhibits a certain\u00a0protein\u00a0in the body that causes\u00a0inflammation\u00a0and thus prevents the body from attacking and destroying sensitive\u00a0blood cells, kidneys, muscle, and\u00a0optic nerves\u00a0as well as the spinal cord.<\/p>\n\n\n\n<p><strong>What Soliris is used for<\/strong><\/p>\n\n\n\n<p><strong>Paroxysmal&nbsp;nocturnal hemoglobinuria<\/strong><\/p>\n\n\n\n<p>Soliris is used to treat adults and children with a certain type of disease affecting the blood system called\u00a0paroxysmal\u00a0nocturnal hemoglobinuria (PNH).\u00a0In patients with PNH, the red\u00a0blood cells\u00a0can be destroyed, which can lead to low blood counts (\u00a0anemia\u00a0), fatigue, functional difficulties, pain, dark-colored urine, shortness of breath, and blood clots.\u00a0Eculizumab can block the body&#8217;s inflammatory response, and thus the body&#8217;s ability to attack and destroy its own sensitive PNH\u00a0blood cells.<\/p>\n\n\n\n<p><strong>Atypical&nbsp;hemolytic uremic syndrome<\/strong><\/p>\n\n\n\n<p>Soliris is also used to treat adults and children with a certain type of disease that affects the blood system and kidneys, called atypical\u00a0Haemolytic Uremic Syndrome\u00a0(aHUS).\u00a0In patients with aHUS, the kidneys and\u00a0blood cells, including\u00a0platelets, can become inflamed, which can lead to low blood values \u200b\u200b(\u00a0thrombocytopenia\u00a0and\u00a0anemia\u00a0), reduced or lost kidney function, blood clots, fatigue, and functional difficulties.\u00a0Eculizumab can block the body&#8217;s inflammatory response and its ability to attack and destroy its sensitive\u00a0blood cells\u00a0and kidney cells.<\/p>\n\n\n\n<p><strong>Refractory generalized&nbsp;myasthenia gravis<\/strong><\/p>\n\n\n\n<p>Soliris is also used in adult patients with a certain type of disease that affects the muscles and is called generalized&nbsp;myasthenia gravis&nbsp;(gMG).&nbsp;In patients with gMG, the muscles are attacked and damaged by the immune system, which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk of aspiration, and marked impairment of activities of daily living.&nbsp;Soliris can block the body&#8217;s inflammatory response and its ability to attack and destroy the muscle&#8217;s ability to improve muscle contraction, reducing the symptoms of the disease and the impact of the disease on activities of daily living.&nbsp;Soliris is specifically intended for patients who still have symptoms despite treatment with other existing MG treatments.<\/p>\n\n\n\n<p><strong>Neuromyelitis Optica spectrum condition<\/strong><\/p>\n\n\n\n<p>Soliris is also used to treat adults with a certain type of disease that primarily affects\u00a0the optic nerves\u00a0and spinal cord and is called neuromyelitis optica spectrum disorder (NMOSD).\u00a0In patients with NMOSD,\u00a0the optic nerve\u00a0and spinal cord are attacked and damaged by the immune system, which can lead to blindness in one or both eyes, weakness or paralysis in the arms or legs, painful seizures, loss of sensation, and marked impairment in the ability to perform activities in the daily life.\u00a0Soliris can block the body&#8217;s inflammatory response and its ability to attack and destroy its optic nerves\u00a0and spinal cord, reducing the symptoms of the disease and the disease&#8217;s impact on activities of daily living.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Soliris<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Soliris<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to eculizumab, mouse proteins, other monoclonal\u00a0antibodies\u00a0or any other ingredient in this medicine listed in section 6)<\/li><li>if you have not been vaccinated against meningococcal infection unless you take\u00a0antibiotics\u00a02 weeks after the vaccination to reduce the risk of\u00a0infection.<\/li><li>if you have a meningococcal infection.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p><strong>Warning&nbsp;regarding&nbsp;meningococcal&nbsp;and&nbsp;other&nbsp;<em>Neisseria<\/em>&nbsp;infections<\/strong><\/p>\n\n\n\n<p>Soliris treatment may impair your natural resistance to\u00a0infection, especially to certain\u00a0organisms\u00a0that cause meningococcal infection (severe\u00a0meningitis\u00a0and\u00a0sepsis\u00a0) and other\u00a0Neisseria\u00a0infections,\u00a0including disseminated\u00a0gonorrhea.<\/p>\n\n\n\n<p>Contact your doctor before taking Soliris to make sure you are vaccinated against\u00a0<em>Neisseria meningitides<\/em>, an\u00a0organism\u00a0that causes meningococcal infection, at least 2 weeks before starting treatment, or that you take\u00a0antibiotics\u00a0to reduce the risk of\u00a0infection\u00a0until 2 weeks have passed after vaccination.\u00a0Make sure your recent meningococcal vaccination still protects against\u00a0infection.\u00a0You should also be aware that vaccination does not always prevent this type of\u00a0infection.\u00a0By national recommendations, your doctor can consider whether in your case additional measures are needed to prevent\u00a0infection.<\/p>\n\n\n\n<p>If you are at risk of\u00a0gonorrhea, consult your doctor or pharmacist before using this medicine.<\/p>\n\n\n\n<p><em>Symptoms of meningococcal infection<\/em><\/p>\n\n\n\n<p>As it is important to quickly identify and treat certain types of&nbsp;infection&nbsp;in patients receiving Soliris, you will be given a card to carry with you, with a list of particularly important symptoms.&nbsp;This card is marked &#8220;Patient safety card&#8221;.<\/p>\n\n\n\n<p>If you experience any of the following symptoms, you should inform your doctor immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>headache with nausea and vomiting<\/li><li>headache along with neck or back stiffness<\/li><li>fever<\/li><li>rash<\/li><li>confusion<\/li><li>severe muscle pain combined with&nbsp;flu-like symptoms<\/li><li>light sensitivity<\/li><\/ul>\n\n\n\n<p><em>Treatment of meningococcal infection in connection with travel:<\/em><\/p>\n\n\n\n<p>If you are traveling in inaccessible areas where you cannot contact a doctor or where you cannot get prompt medical treatment, as a preventive measure, your doctor can write a prescription for an antibiotic preparation against\u00a0<em>Neisseria meningitides<\/em>\u00a0that you can carry with you.\u00a0If you experience any of the symptoms listed above, take the antibiotic medication as directed.\u00a0You should consider contacting a doctor as soon as possible, even if you feel better after taking\u00a0antibiotics.<\/p>\n\n\n\n<p><strong>Infection&nbsp;you<\/strong><\/p>\n\n\n\n<p>Before taking Soliris, inform your doctor if you suffer from any\u00a0infection.<\/p>\n\n\n\n<p><strong>Allergic reactions<\/strong><\/p>\n\n\n\n<p>Soliris contains a\u00a0protein, and\u00a0proteins\u00a0can cause allergic reactions in some people.<\/p>\n\n\n\n<p><strong>Children and young people<\/strong><\/p>\n\n\n\n<p>Patients younger than 18 years must be vaccinated against\u00a0<em>Haemophilus influenza<\/em>\u00a0and pneumococcal infections.<\/p>\n\n\n\n<p><strong>Older<\/strong><\/p>\n\n\n\n<p>No special precautions are needed for the treatment of patients aged 65 years and older.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Soliris<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are using, have recently used or might be using other medicines.<a><\/a><\/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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n<p><em>Women who can become pregnant<\/em><\/p>\n\n\n\n<p>Use of safe contraception during treatment and up to 5 months after treatment should be considered in women of childbearing potential.<\/p>\n\n\n\n<p><em>Pregnancy\/breastfeeding<\/em><\/p>\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 using this medicine.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Soliris has no or negligible effect on the ability to drive and use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Soliris contains sodium<\/h2>\n\n\n\n<p>Soliris contains 115 mg&nbsp;sodium&nbsp;per&nbsp;vial&nbsp;.&nbsp;This should be taken into account if you have been prescribed a low-salt diet.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Soliris<\/h2>\n\n\n\n<p>At least 2 weeks before you start treatment with Soliris, your doctor will vaccinate you against meningococcal infection if you have not been vaccinated before or if the vaccine is no longer protective.&nbsp;If your child is under the age limit for vaccination or if you have not been vaccinated at least 2 weeks before starting treatment with Soliris, your doctor will prescribe&nbsp;antibiotics&nbsp;to reduce the risk of&nbsp;infection&nbsp;until 2 weeks after you have been vaccinated.<\/p>\n\n\n\n<p>Your doctor will vaccinate children under 18 against&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;and&nbsp;pneumococcus&nbsp;according to national recommendations for each age group.<\/p>\n\n\n\n<p><strong>Instructions for proper use<\/strong><\/p>\n\n\n\n<p>A doctor or other healthcare professional will treat you with Soliris.&nbsp;Soliris is given as an&nbsp;intravenous&nbsp;infusion&nbsp;(drip).&nbsp;According to the recommendation, the initial phase of the treatment, the so-called initial phase, should last for 4 weeks and then be followed by a maintenance phase.<\/p>\n\n\n\n<p><em>In the treatment of PNH<\/em><\/p>\n\n\n\n<p>For adults:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Initial phase:<ul><li>Every week for the first four weeks, you will receive an&nbsp;intravenous&nbsp;infusion&nbsp;of diluted Soliris.&nbsp;Each&nbsp;infusion&nbsp;consists of a&nbsp;dose&nbsp;of 600 mg (2 bottles of 30 ml) and takes approximately 25-45 minutes (35 minutes \u00b1 10 minutes).<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Maintenance Phase:<ul><li>In the fifth week, you will receive an\u00a0intravenous\u00a0infusion\u00a0of diluted Soliris at a\u00a0dose\u00a0of 900 mg (3 vials of 30 ml) over 25-45 minutes (35 minutes \u00b1 10 minutes).<\/li><li>After the fifth week, you will receive 900 mg of diluted Soliris every two weeks as a long-term treatment.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><em>In treatment against aHUS, refractory gMG&nbsp;<\/em><em>or NMOSD<\/em><\/p>\n\n\n\n<p>For adults:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Initial phase:<ul><li>Every week for the first four weeks, you will receive an&nbsp;intravenous&nbsp;infusion&nbsp;of diluted Soliris.&nbsp;Each&nbsp;infusion&nbsp;consists of a&nbsp;dose&nbsp;of 900 mg (3 bottles of 30 ml) and takes approximately 25-45 minutes (35 minutes \u00b1 10 minutes).<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Maintenance Phase:<ul><li>In the fifth week, you will receive an\u00a0intravenous\u00a0infusion\u00a0of diluted Soliris at a\u00a0dose\u00a0of 1200 mg (4 bottles of 30 ml) over 25-45 minutes (35 minutes \u00b1 10 minutes).<\/li><li>After the fifth week, you will receive up to 1,200 mg of diluted Soliris every two weeks as a long-term treatment.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>Children and adolescents with PNH or aHUS who weigh 40 kg or more receive the same&nbsp;dose&nbsp;as adults.<\/p>\n\n\n\n<p>Children and adolescents with PNH or aHUS who weigh less than 40 kg need a lower&nbsp;dose&nbsp;based on their body weight.&nbsp;Your doctor will calculate it.<\/p>\n\n\n\n<p>For children and adolescents with PNH or aHUS who are under 18 years of age:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20061202000018#\" rel=\"noopener\">View larger<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th scope=\"col\">Body weight<\/th><th scope=\"col\">Initial phase<\/th><th scope=\"col\">Maintenance phase<\/th><\/tr><\/thead><tbody><tr><td>30 to &lt;40 kg<\/td><td>600 mg per week x 2<\/td><td>900 mg week 3;&nbsp;thereafter 900 mg every two weeks<\/td><\/tr><tr><td>20 to &lt;30 kg<\/td><td>600 mg per week x 2<\/td><td>600 mg week 3;&nbsp;thereafter 600 mg every two weeks<\/td><\/tr><tr><td>10 to &lt;20 kg<\/td><td>600 mg per week x 1<\/td><td>300 mg week 2;&nbsp;thereafter 300 mg every two weeks<\/td><\/tr><tr><td>5 to &lt;10 kg<\/td><td>300 mg per week x 1<\/td><td>300 mg week 2;&nbsp;thereafter 300 mg<br>every three weeks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>People undergoing plasma exchange may receive an additional&nbsp;dose&nbsp;of Soliris.<\/p>\n\n\n\n<p>After each\u00a0infusion, you will be monitored for about an hour.\u00a0Follow your doctor&#8217;s instructions carefully.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you have been given too much Soliris<\/h2>\n\n\n\n<p>If you suspect that you have accidentally received a higher&nbsp;dose of&nbsp;Soliris than recommended, contact your doctor for advice.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget a time when you should receive Soliris<\/h2>\n\n\n\n<p>If you miss an appointment, contact your doctor immediately for advice and read the section below \u201cIf you stop using Soliris\u201d.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Soliris in the treatment of PNH<\/h2>\n\n\n\n<p>If you stop or stop Soliris treatment, your PNH symptoms may come back and be more severe.&nbsp;Your doctor will discuss possible&nbsp;side effects&nbsp;with you and explain the risks.&nbsp;The doctor will want to follow you closely for at least 8 weeks.<\/p>\n\n\n\n<p>The risks of stopping Soliris include an increased breakdown of your\u00a0red blood cells, which can cause the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A significant decrease in the number of&nbsp;red blood cells&nbsp;(&nbsp;anemia&nbsp;).<\/li><li>Confusion or altered attention<\/li><li>Chest pain or angina<\/li><li>An increase in&nbsp;serum&nbsp;creatinine level (kidney problems)<\/li><li>Thrombosis&nbsp;(blood clot)<\/li><\/ul>\n\n\n\n<p>If you experience any of these symptoms, contact your doctor.<\/p>\n\n\n\n<p><strong>If you stop using Soliris in the treatment of aHUS<\/strong><\/p>\n\n\n\n<p>If you stop or stop Soliris treatment, your aHUS symptoms may come back.&nbsp;Your doctor will discuss possible&nbsp;side effects&nbsp;with you and explain the risks.&nbsp;The doctor will want to monitor you closely.<\/p>\n\n\n\n<p>The risks of stopping Soliris include an increased risk of\u00a0inflammation\u00a0in your\u00a0blood platelets, which can cause the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A significant decrease in the number of&nbsp;platelets&nbsp;(&nbsp;thrombocytopenia&nbsp;)<\/li><li>A significant increase in the destruction of&nbsp;red blood cells<\/li><li>Decreased urine output (problems with the kidneys)<\/li><li>An increase in the serum creatinine level (kidney problems)<\/li><li>Confusion or altered attention<\/li><li>Chest pain or angina<\/li><li>Shortness of breath or<\/li><li>Thrombosis&nbsp;(blood clot)<\/li><\/ul>\n\n\n\n<p>If you experience any of these symptoms, contact your doctor.<\/p>\n\n\n\n<p><strong>If you stop using Soliris in the treatment of refractory gMG<\/strong><\/p>\n\n\n\n<p>If you stop or stop Soliris treatment, your gMG symptoms may come back.&nbsp;Talk to your doctor before you stop using Soliris.&nbsp;Your doctor will discuss possible&nbsp;side effects&nbsp;with you and explain the risks.&nbsp;The doctor will want to monitor you closely.<\/p>\n\n\n\n<p><strong>If you stop using Soliris in the treatment of NMOSD<\/strong><\/p>\n\n\n\n<p>If you stop or stop Soliris treatment, your NMOSD may get worse and you may relapse.&nbsp;Talk to your doctor before you stop using Soliris.&nbsp;Your doctor will discuss possible&nbsp;side effects&nbsp;with you and explain the risks.&nbsp;The doctor will want to monitor you closely.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.<br><\/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\u00a0side effects\u00a0caused by Soliris are usually mild or moderate.\u00a0Your doctor will discuss possible\u00a0side effects\u00a0with you and explain the risks and benefits of Soliris before you start treatment.<\/p>\n\n\n\n<p>The most serious\u00a0side\u00a0effect\u00a0was\u00a0meningococcal\u00a0sepsis.<\/p>\n\n\n\n<p>Contact a doctor immediately if you experience any symptoms of meningococcal infection (see section 2, Warning regarding&nbsp;meningococcal&nbsp;and&nbsp;other&nbsp;<em>Neisseria<\/em>&nbsp;infections&nbsp;).<\/p>\n\n\n\n<p>If you are unsure of what the&nbsp;side effects&nbsp;below mean, ask your doctor to explain.<\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 in 10 people): headache.<\/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>pneumonia\u00a0(\u00a0pneumonia\u00a0), cold (\u00a0nasopharyngitis\u00a0), urinary tract infection<\/li><li>low\u00a0white blood cell count\u00a0(\u00a0leukopenia\u00a0), decrease in\u00a0red blood cells\u00a0which can make the skin pale and cause weakness and shortness of breath<\/li><li>inability to sleep<\/li><li>dizziness, taste disturbances, high\u00a0blood pressure<\/li><li>upper respiratory\u00a0tract infection, cough, sore throat,\u00a0bronchitis, mouth ulcers (\u00a0herpes\u00a0simplex)<\/li><li>diarrhea, vomiting, nausea, abdominal pain, rash, hair loss,\u00a0itching<\/li><li>pain in the joints (arms and legs)<\/li><li>fever, feeling tired, flu-like illness.<\/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>serious\u00a0infection\u00a0(meningococcal infection),\u00a0sepsis,\u00a0septic\u00a0shock, viral infection, lower respiratory tract infection, stomach flu (intestinal infection),\u00a0cystitis<\/li><li>infection, fungal infection, accumulation of var (abscess), skin infection (\u00a0cellulitis\u00a0),\u00a0flu, sinusitis, tooth infection (\u00a0abscess\u00a0)<\/li><li>skin cancer (\u00a0melanoma\u00a0), bone marrow disease<\/li><li>relatively few\u00a0platelets\u00a0in the blood (\u00a0thrombocytopenia\u00a0), low levels of\u00a0lymphocytes\u00a0(a certain type of\u00a0white blood cells, lymphopenia), palpitations<\/li><li>severe\u00a0allergic reaction\u00a0causing difficulty in breathing or dizziness (\u00a0anaphylactic reaction\u00a0), hypersensitivity<\/li><li>loss of appetite<\/li><li>depression, anxiety, mood swings<\/li><li>tingling in parts of the body, tremors<\/li><li>blurred vision<\/li><li>tinnitus, dizziness<\/li><li>the sudden and rapid development of extremely high\u00a0blood pressure, low\u00a0blood pressure, hot flashes, vascular diseases<\/li><li>dyspnoea\u00a0(difficulty breathing), nosebleed, nasal congestion, throat irritation, runny nose (\u00a0rhinorrhea\u00a0)<\/li><li>peritonitis (\u00a0peritonitis\u00a0), constipation, discomfort in the stomach after a meal (\u00a0dyspepsia\u00a0) distended abdomen<\/li><li>hives,\u00a0redness, dry skin, red or purple spots under the skin, increased sweating<\/li><li>muscle cramps, muscle pain, back and neck pain, bone pain, joint swelling, pain in arms and legs<\/li><li>kidney disease, difficulty or pain when urinating, blood in the urine<\/li><li>spontaneous\u00a0erection<\/li><li>swelling (\u00a0edema\u00a0), chest discomfort, weakness (\u00a0asthenia\u00a0), chest pain, infusion site pain, chills<\/li><li>increase in liver enzyme values, low proportion of\u00a0red blood cells\u00a0in the total blood volume, decrease in oxygen-transporting\u00a0protein\u00a0in red\u00a0blood\u00a0cells<\/li><li>infusion-related reaction.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(may affect up to 1 in 1,000 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fungal infection (Aspergillus\u00a0infection\u00a0),\u00a0joint infection\u00a0(bacterial\u00a0arthritis\u00a0),\u00a0<em>Haemophilus influenzae<\/em>\u00a0infection, gum\u00a0infection,\u00a0swine pox, bacterial sexually transmitted disease (\u00a0gonorrhea\u00a0)<\/li><li>skin tumor (\u00a0melanoma\u00a0), bone marrow disease<\/li><li>decrease in the number of\u00a0red blood cells, cell accumulation, abnormal blood clotting factor, abnormal blood clotting<\/li><li>disease caused by overproduction of the thyroid gland (Basedow&#8217;s disease)<\/li><li>sleep disturbance, abnormal dreams<\/li><li>fainting<\/li><li>eye irritation<\/li><li>bruises<\/li><li>acid reflux, pain in the gums<\/li><li>yellowing of the skin and\/or eyes (jaundice)<\/li><li>skin inflammation, skin discoloration<\/li><li>spasm in the muscles of the face<\/li><li>menstrual disorders<\/li><li>abnormal leakage of infusion medicine from the vein, an abnormal sensation at the infusion site, feeling of warmth<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Soliris<\/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 stated on the carton after &#8220;EXP&#8221;.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00baC\u20138 \u00baC).<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>Bottles of Soliris in original packaging can be taken out of refrigerator storage\u00a0<strong>on a single occasion that lasts a maximum of 3 days<\/strong>.\u00a0At the end of this period, you can put the product back in the refrigerator.<\/p>\n\n\n\n<p>Store in the original packaging.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>After dilution, the product must be used within 24 hours.<\/p>\n\n\n\n<p>Medicines should not be thrown down the drain.&nbsp;Ask the pharmacist how to dispose of medicines that are no longer used.&nbsp;These measures will help to protect the environment.<a><\/a><\/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<p>&#8211; The active substance is eculizumab 10 mg\/ml (300 mg\/30 ml in a bottle).<\/p>\n\n\n\n<p>&#8211; Other ingredients are<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>monobasic sodium phosphate,<\/li><li>dibasic sodium phosphate,<\/li><li>sodium chloride,<\/li><li>polysorbate 80 (vegetable origin)<\/li><\/ul>\n\n\n\n<p>Diluent: water for injections<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Soliris is a concentrate solution for\u00a0injection\u00a0(30 ml in a bottle &#8211; pack size is 1 bottle).<\/p>\n\n\n\n<p>Soliris is a clear and colorless solution.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Alexion Europe SAS<\/p>\n\n\n\n<p>103-105 rue Anatole France<\/p>\n\n\n\n<p>92300 Levallois-Perret<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Almac Pharma Services<\/p>\n\n\n\n<p>22 Seagoe Industrial Estate<\/p>\n\n\n\n<p>Craigavon \u200b\u200bBT63 5QD<\/p>\n\n\n\n<p>UK<\/p>\n\n\n\n<p>Patheon Italia SpA<\/p>\n\n\n\n<p>Viale GB Stucchi, 110<\/p>\n\n\n\n<p>20900 Monza (MB)<\/p>\n\n\n\n<p>Italy<\/p>\n\n\n\n<p>Alexion Pharma International<\/p>\n\n\n\n<p>Operations Unlimited Company<\/p>\n\n\n\n<p>College Business and Technology Park<\/p>\n\n\n\n<p>Blanchardstown<\/p>\n\n\n\n<p>Dublin 15<\/p>\n\n\n\n<p>Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Soliris contains the active ingredient eculizumab and it belongs to a class of medicines called monoclonal\u00a0antibodies\u00a0.\u00a0Eculizumab binds to and inhibits a certain\u00a0protein\u00a0in the body that causes\u00a0inflammation\u00a0and thus prevents the body from attacking and destroying sensitive\u00a0blood cells\u00a0, kidneys, muscle and\u00a0optic nerves\u00a0as well as the spinal cord.<\/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":[2200,18530],"tags":[24448,24444,24447,24449,24446,24445,24450,24451],"class_list":["post-23368","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-eculizumab","tag-eculizumab","tag-eculizumab-side-effects","tag-soliris","tag-what-eculizumab-is-used-for","tag-what-is-eculizumab","tag-what-is-soliris","tag-what-soliris-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23368","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=23368"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23368\/revisions"}],"predecessor-version":[{"id":23405,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23368\/revisions\/23405"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=23368"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=23368"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=23368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}