{"id":23134,"date":"2022-07-21T07:08:52","date_gmt":"2022-07-21T07:08:52","guid":{"rendered":"https:\/\/zeepedia.com\/?p=23134"},"modified":"2022-07-22T06:24:20","modified_gmt":"2022-07-22T06:24:20","slug":"simponi","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/simponi\/","title":{"rendered":"Simponi &#8211; Golimumab uses, dose and side effects"},"content":{"rendered":"\n<p>45 mg \/ 0.45 ml&nbsp;&nbsp;solution for injection&nbsp;in a pre-filled&nbsp;pen<br>For pediatric patients under 40 kg, golimumab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Simponi is and what it is used for<\/h2>\n\n\n\n<p>Simponi contains the active substance golimumab.<\/p>\n\n\n\n<p>Simponi belongs to a group of medicines called &#8220;TNF inhibitors&#8221;.\u00a0It is used\u00a0<strong>in\u00a0children<\/strong>\u00a02 years and older for the treatment of\u00a0polyarticular\u00a0juvenile idiopathic arthritis.<\/p>\n\n\n\n<p>Simponi works by blocking the function of a&nbsp;protein&nbsp;called &#8220;tumor necrosis factor alpha&#8221; (TNF\u03b1).&nbsp;This&nbsp;protein&nbsp;participates in inflammatory processes in the body and by blocking it,&nbsp;inflammation&nbsp;in the body can be reduced.<\/p>\n\n\n\n<p><strong>Polyarticular&nbsp;juvenile idiopathic arthritis<\/strong><\/p>\n\n\n\n<p>Polyarticular\u00a0juvenile idiopathic arthritis\u00a0is an\u00a0inflammatory\u00a0disease that causes pain and swelling in the joints in children.\u00a0If you have\u00a0polyarticular\u00a0juvenile idiopathic arthritis, you will first be given other medicines.\u00a0If you do not get enough of these medicines, you will be given Simponi in combination with methotrexate to treat the disease.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Simponi<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Simponi<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you have\u00a0tuberculosis\u00a0(TB) or any other serious\u00a0infection.<\/li><li>if you have\u00a0heart failure\u00a0that is moderate or severe.<\/li><\/ul>\n\n\n\n<p>If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Simponi.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before using Simponi.<\/p>\n\n\n\n<p>Infection&nbsp;is<\/p>\n\n\n\n<p>Tell your doctor immediately if you have or experience symptoms of\u00a0infection\u00a0during or after your Simponi treatment.\u00a0Such symptoms include fever, cough, shortness of breath, flu-like signs, diarrhea, sores, dental problems, or a burning sensation when urinating.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You can more easily get\u00a0an infection\u00a0when you use Simponi.<\/li><li>Infections\u00a0can develop faster and can be more serious.\u00a0In addition, previous\u00a0infections\u00a0may return.<br>Tuberculosis\u00a0(TBC)Tell your doctor immediately if symptoms of TB occur during or after treatment.\u00a0Symptoms of TB include persistent cough, weight loss, tiredness, fever, or night sweats.<ul><li>Cases of TB have been reported in patients treated with Simponi, in rare cases also in patients treated with anti-TB drugs.\u00a0Your doctor will check if you have TB.\u00a0Your doctor will note the examinations on your patient card.<\/li><li>You must tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.<\/li><li>If your doctor thinks you are at risk for TB, you can get TB medicine before you start using Simponi.<em>Hepatitis\u00a0B\u00a0virus\u00a0(HBV)<\/em><\/li><\/ul><ul><li>Tell your doctor if you are a carrier or if you have or have had the\u00a0hepatitis\u00a0B\u00a0virus\u00a0before receiving Simponi.<\/li><li>Tell your doctor if you think you are at risk of getting HBV.<\/li><li>Your doctor will test you for HBV.<\/li><li>Treatment with\u00a0TNF\u00a0inhibitors such as Simponi can reactivate the\u00a0hepatitis\u00a0B\u00a0virus\u00a0in patients carrying this\u00a0virus, which in some cases can be life-threatening. Invasive fungal infections tell your doctor immediately if you have lived in or traveled to areas where\u00a0the infection\u00a0is caused by a specific type of fungus that can attack the lungs or other parts of the body (\u00a0histoplasmosis,\u00a0coccidioidomycosis,\u00a0or\u00a0blastomycosis\u00a0) are common.\u00a0Ask your doctor if you do not know if these\u00a0infections\u00a0are common in areas you have lived in or traveled to.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>Cancer and&nbsp;lymphoma<\/p>\n\n\n\n<p>Tell your doctor if you have ever had&nbsp;lymphoma&nbsp;(a type of blood cancer) or any other cancer before using Simponi.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are being treated with Simponi or another\u00a0TNF\u00a0inhibitor, you may be at increased risk of developing\u00a0lymphoma\u00a0or any other cancer.<\/li><li>Patients with severe\u00a0rheumatoid arthritis\u00a0and other inflammatory diseases who have had the disease for a long time may be at a higher risk than generally developing\u00a0lymphoma.<\/li><li>There have been cases of cancer, including rare types, in children and adolescents receiving\u00a0TNF\u00a0-suppressants, which have sometimes led to death.<\/li><li>In rare cases, a specific and severe type of\u00a0lymphoma\u00a0called T-cell lymphoma in the liver and\u00a0spleen\u00a0has been observed in patients taking other\u00a0TNF\u00a0inhibitors.\u00a0Most of these patients were adolescents or younger adult men.\u00a0This type of cancer has usually led to death.\u00a0Almost all of these patients had also been given medicines called azathioprine or 6-mercaptopurine.\u00a0Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.<\/li><li>Patients with severe persistent\u00a0asthma,\u00a0chronic obstructive pulmonary disease\u00a0(COPD), or who are heavy smokers may be at increased risk of cancer when treated with Simponi.\u00a0If you have severe persistent\u00a0asthma, COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a\u00a0TNF\u00a0inhibitor is suitable for you.<\/li><li>Some patients treated with golimumab have developed certain types of skin cancer.\u00a0Tell your doctor if there are any changes in the appearance of the skin or growths on the skin during or after the treatment.<\/li><\/ul>\n\n\n\n<p>Heart failure<\/p>\n\n\n\n<p>Tell your doctor immediately if you get new or worsening signs of heart failure.&nbsp;Such symptoms include shortness of breath or swollen feet.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>New or worsening&nbsp;heart failure&nbsp;has been reported with&nbsp;TNF&nbsp;inhibitors, including Simponi.&nbsp;Some of these patients died.<\/li><li>If you have mild&nbsp;heart failure&nbsp;and are being treated with Simponi, you will be closely monitored by your doctor.<\/li><\/ul>\n\n\n\n<p>Diseases of the nervous system<\/p>\n\n\n\n<p>Tell your doctor immediately if you have ever been diagnosed with or developed symptoms of a demyelinating disease such as\u00a0multiple sclerosis.\u00a0Such symptoms may include altered vision, weakness in the arms or legs, and numbness or tingling in any part of the body.\u00a0Your doctor will decide if you should receive Simponi.<\/p>\n\n\n\n<p>Operations or dental treatments<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Tell your doctor if you are going to have any surgery or dental treatment.<\/li><li>Tell the doctor or dentist who will perform the procedure that you are being treated with Simponi by showing your patient card.<\/li><\/ul>\n\n\n\n<p>Autoimmune&nbsp;disease<\/p>\n\n\n\n<p>Tell your doctor if you develop symptoms of a disease called lupus.\u00a0Such symptoms include persistent\u00a0itching, fever, joint pain, and fatigue.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>In rare cases, people treated with&nbsp;TNF&nbsp;-antagonists have developed lupus.<\/li><\/ul>\n\n\n\n<p>Blood disease<\/p>\n\n\n\n<p>In some patients, the body may have difficulty producing enough&nbsp;blood cells&nbsp;to help fight&nbsp;infection&nbsp;or stop bleeding.&nbsp;If you get a fever that does not go away, get bruises or bleed very easily or look very pale, you should contact a doctor immediately.&nbsp;Your doctor may decide to stop treatment.<\/p>\n\n\n\n<p>If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Simponi.<\/p>\n\n\n\n<p>Vaccinations<\/p>\n\n\n\n<p>Tell your doctor if you have or are planning to get vaccinated.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You should not be given certain (live) vaccines during treatment with Simponi.<\/li><li>Some vaccinations can cause you\u00a0an infection.\u00a0If you got Simponi while you were pregnant, your baby may be at a higher risk of getting such an\u00a0infection\u00a0for up to about six months after the last\u00a0dose\u00a0you received during pregnancy.\u00a0You must tell your child&#8217;s doctor and other healthcare professionals about your use of Simponi so that they can decide when your child should receive a vaccine.<\/li><\/ul>\n\n\n\n<p>Talk to your child&#8217;s doctor regarding your child&#8217;s vaccinations.&nbsp;If possible, your child should have received all vaccinations according to the current vaccination program before using Simponi.<\/p>\n\n\n\n<p>Immunotherapy&nbsp;is<\/p>\n\n\n\n<p>Tell your doctor if you have recently received or are planning to receive\u00a0immunotherapy\u00a0(such as BCG\u00a0installation\u00a0which is used to treat cancer).<\/p>\n\n\n\n<p>Allergic reactions<\/p>\n\n\n\n<p>Tell your doctor immediately if you develop symptoms of an\u00a0allergic reaction\u00a0after using Simponi.\u00a0Symptoms of an\u00a0allergic reaction\u00a0may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet, or ankles.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Some of these reactions can be serious, or in rare cases life-threatening.<\/li><li>Some of these reactions occurred after the first use of Simponi.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<p>Simponi is not recommended for children with&nbsp;polyarticular&nbsp;juvenile idiopathic arthritis&nbsp;who are younger than 2 years as this group has not been studied.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Simponi<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines to treat\u00a0polyarticular\u00a0juvenile idiopathic arthritis.<\/li><li>You should not use Simponi with medicines containing the active substance anakinra or abatacept.\u00a0These drugs are used in the treatment of rheumatic diseases.<\/li><li>Tell your doctor or pharmacist if you are taking any medicine that affects the immune system.<\/li><li>You should not be given certain types of (life) vaccines when using Simponi<\/li><\/ul>\n\n\n\n<p>If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Talk to your doctor before using Simponi if:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You are pregnant or planning to become pregnant while using Simponi.\u00a0The effect of this drug on pregnant women is not known.\u00a0The use of Simponi during pregnancy is not recommended.\u00a0You must avoid becoming pregnant while being treated with Simponi and for at least 6 months after stopping treatment, by using appropriate contraception during this time.<\/li><li>Before starting breastfeeding, at least 6 months must have passed since the end of Simponi treatment.\u00a0You must stop breastfeeding if you receive Simponi.<\/li><li>If you got Simponi during your pregnancy, your baby may be at a higher risk of getting an\u00a0infection.\u00a0You must tell your child&#8217;s doctor and other healthcare professionals about your use of Simponi before the child receives any vaccine (for more information see the section on vaccinations).<\/li><\/ul>\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 taking this medicine.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Simponi has little effect on your ability to cycle, drive vehicles, and use tools or machines.\u00a0However, dizziness may occur after taking Simponi.\u00a0If this happens, do not cycle, drive or use any tools or machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Simponi contains latex and sorbitol<\/h2>\n\n\n\n<p>Sensitivity to latex<\/p>\n\n\n\n<p>Part of the pre-filled pen, the needle guard, contains latex.&nbsp;Because latex can cause severe allergic reactions, talk to your doctor before taking Simponi if \u200b\u200byou or your healthcare provider are allergic to latex.<\/p>\n\n\n\n<p>Hypersensitivity to sorbitol<\/p>\n\n\n\n<p>This medicine contains 18.45 mg sorbitol (E420) in each pre-filled\u00a0pen.\u00a0Every 0.05 ml of the drug contains 2.05 mg of sorbitol (E420).<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Simponi<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>Amount of Simponi given<\/strong><\/p>\n\n\n\n<p>Polyarticular&nbsp;juvenile idiopathic arthritis&nbsp;in children 2 years and older:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Children weighing\u00a0<em>less than\u00a040 kg: <\/em>The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height.\u00a0Your doctor will tell you the correct\u00a0dose\u00a0to use.\u00a0The dose should be given once a month, on the same date each month.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Children weighing\u00a0<em>at least 40 kg: <\/em>For children with a body weight of at least 40 kg, a pre-filled pen or pre-filled\u00a0syringe\u00a0with a fixed\u00a0dose\u00a0of 50 mg is available.\u00a0For a 50 mg\u00a0dose, see section 3 \u201cHow to use Simponi\u201d in the package leaflet for Simponi 50 mg pre-filled\u00a0pen\u00a0or pre-filled\u00a0syringe.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Talk to your child&#8217;s doctor before your child takes the fourth\u00a0dose.\u00a0Your child&#8217;s doctor will decide if the child should continue Simponi treatment.<\/li><\/ul>\n\n\n\n<p><strong>How Simponi is given<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Simponi is injected under the skin (&nbsp;subcutaneously&nbsp;).<\/li><li>To begin with, a doctor or nurse may&nbsp;inject&nbsp;one with Simponi.&nbsp;However, you and your doctor may decide that you can inject yourself or inject your child with Simponi.&nbsp;In that case, you will be taught how to inject Simponi yourself.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor if you have any questions about injecting Simponi yourself.&nbsp;There is a detailed &#8220;Instructions for use&#8221; in this leaflet.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Simponi than you should &nbsp;<\/h2>\n\n\n\n<p>If you have used or taken too much Simponi (either injected too much on a single occasion or used it too often) talk to a doctor or pharmacist immediately.&nbsp;Always carry the outer carton, even if it is empty, and this leaflet.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Simponi<\/h2>\n\n\n\n<p>If you forget to use Simponi on your scheduled date, take the missed&nbsp;dose&nbsp;as soon as you remember.<\/p>\n\n\n\n<p>Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n<p>Time for next dose:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are less than 2 weeks late, inject the missed\u00a0dose\u00a0as soon as you remember and stick to the original schedule.<\/li><li>If you are more than 2 weeks late, inject the missed\u00a0dose\u00a0as soon as you remember and talk to your doctor or pharmacist, and ask when to take the next\u00a0dose.<\/li><\/ul>\n\n\n\n<p>If you are not sure, talk to your doctor or pharmacist.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Simponi<\/h2>\n\n\n\n<p>If you are considering stopping Simponi, talk to your doctor or pharmacist first.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse<strong>.<\/strong><\/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.\u00a0Some patients may experience serious\u00a0side effects\u00a0that require treatment.\u00a0Side effects\u00a0can occur up to several months after the last\u00a0injection.<\/p>\n\n\n\n<p>Tell your doctor immediately if you notice any of the following serious&nbsp;side effects&nbsp;with Simponi such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>allergic reactions that can be severe, or rare, life-threatening (rare).\u00a0<\/strong>Symptoms of an\u00a0allergic reaction\u00a0may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet, or ankles.\u00a0Some of these reactions occurred after the first\u00a0administration\u00a0of Simponi.<\/li><li>severe\u00a0infections\u00a0(such as\u00a0tuberculosis, bacterial\u00a0infections\u00a0such as severe blood infections and\u00a0pneumonia, severe fungal infections, and opportunistic\u00a0infections\u00a0) (common).\u00a0Symptoms of an\u00a0infection\u00a0can include fever, fatigue, (persistent) cough, shortness of breath,\u00a0flu-like symptoms, weight loss, night sweats, diarrhea, sores, dental problems, and burning when urinating.<\/li><li>reactivation of\u00a0hepatitis\u00a0B\u00a0virus, if you are a carrier or if you have a history of\u00a0hepatitis\u00a0B (rare).\u00a0Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right part of the abdomen, fever, nausea, vomiting, and a pronounced feeling of tiredness.<\/li><li>the disease of the nervous system such as\u00a0multiple sclerosis\u00a0(rare).\u00a0Symptoms of nervous system disease can include altered vision, weakness in the arms and legs, numbness, or tingling in any part of the body.<\/li><li>lymph node cancer (\u00a0rare\u00a0).\u00a0Symptoms of\u00a0lymphoma\u00a0may include swollen\u00a0lymph nodes, weight loss, or fever.<\/li><li>heart failure\u00a0(rare).\u00a0Symptoms of\u00a0heart failure\u00a0can be shortness of breath or swollen feet.<\/li><li>signs of diseases of the immune system called:<ul><li>lupus (rare).\u00a0Symptoms may include joint pain or rash that is sensitive to light on the cheeks or arms.<\/li><li>sarcoidosis\u00a0(rare).\u00a0Symptoms may include persistent cough, shortness of breath, chest pain, fever, swelling of\u00a0lymph nodes, weight loss, rash, and blurred vision.<\/li><\/ul><\/li><li>swelling of small blood vessels (\u00a0vasculitis\u00a0) (rare).\u00a0Symptoms may include fever, headache, weight loss, night sweats, rash, and nerve problems such as numbness and tingling.<\/li><li>skin cancer (uncommon).\u00a0Symptoms of skin cancer can be changes in the appearance of the skin or growths on the skin.<\/li><li>blood disease (common).\u00a0Symptoms of blood disease can be fever that does not go away, bruising or easy bleeding, or significant pallor.<\/li><li>blood cancer (\u00a0leukemia\u00a0) (rare).\u00a0Symptoms of\u00a0leukemia\u00a0can include fever, tiredness, frequent\u00a0infections, bruising, and night sweats.<\/li><\/ul>\n\n\n\n<p>Tell your doctor immediately if you notice any of the above symptoms.<\/p>\n\n\n\n<p><strong>The following additional&nbsp;side effects&nbsp;have been observed with Simponi:<\/strong><\/p>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 user in 10):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>upper respiratory tract infection, sore throat or hoarseness, runny nose<\/li><\/ul>\n\n\n\n<p>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>abnormal liver values \u200b\u200b(increase in liver enzyme values), according to blood tests taken by a doctor<\/li><li>dizziness<\/li><li>headache<\/li><li>numbness or stinging sensation<\/li><li>superficial fungal diseases<\/li><li>boil<\/li><li>bacterial\u00a0infections\u00a0(such as\u00a0cellulite\u00a0)<\/li><li>the low number of\u00a0red blood cells<\/li><li>low\u00a0white blood cell count<\/li><li>positive blood test for lupus<\/li><li>allergic reactions<\/li><li>indigestion<\/li><li>abdominal pain<\/li><li>nausea<\/li><li>influenza<\/li><li>tracheal catarrh<\/li><li>sinusitis<\/li><li>cold sores<\/li><li>high\u00a0blood pressure<\/li><li>fever<\/li><li>asthma, shortness of breath, wheezing<\/li><li>gastrointestinal disorders that include\u00a0inflammation\u00a0of the gastric mucosa and colon, which can cause fever<\/li><li>pain and sores in the mouth<\/li><li>injection site reactions (includes\u00a0redness, hardness, pain, bruising,\u00a0itching, tingling, and irritation)<\/li><li>hair loss<\/li><li>skin rash and\u00a0itching<\/li><li>difficulty sleeping<\/li><li>Depression<\/li><li>feeling weak<\/li><li>fracture<\/li><li>chest discomfort<\/li><\/ul>\n\n\n\n<p>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>kidney infection<\/li><li>cancers, such as skin cancer and other non-cancerous growths or lumps, including skin blemishes<\/li><li>skin blisters<\/li><li>severe\u00a0infection\u00a0of the body (sepsis), sometimes with low\u00a0blood pressure\u00a0(\u00a0septic\u00a0shock\u00a0)<\/li><li>psoriasis\u00a0(also on the palms and\/or soles of the feet and\/or in the form of blisters)<\/li><li>low\u00a0platelet count<\/li><li>combination of low\u00a0platelet counts, red and\u00a0white blood cells<\/li><li>thyroid problems<\/li><li>elevated blood sugar levels<\/li><li>elevated cholesterol levels<\/li><li>balance disorders<\/li><li>visual disturbances<\/li><li>inflammation\u00a0of the eye (\u00a0conjunctivitis\u00a0)<\/li><li>eye allergy<\/li><li>the feeling of the heart beating irregularly<\/li><li>narrowing of the blood vessels in the heart<\/li><li>blood clots<\/li><li>hemorrhage<\/li><li>constipation<\/li><li>chronic\u00a0inflammatory conditions of the lungs<\/li><li>acid reflux<\/li><li>gallstone<\/li><li>liver problems<\/li><li>chest problems<\/li><li>menstrual disorders<\/li><\/ul>\n\n\n\n<p>Rare&nbsp;side effects&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>the inability of\u00a0bone marrow\u00a0to produce\u00a0blood\u00a0cells<\/li><li>severely decreased\u00a0white blood cell count<\/li><li>infection\u00a0in the joints or the\u00a0tissue\u00a0one around them<\/li><li>impaired healing<\/li><li>inflammation\u00a0of blood vessels in internal organs<\/li><li>leukemia<\/li><li>melanoma\u00a0(a type of skin cancer)<\/li><li>Merkel cell carcinoma (a type of skin cancer)<\/li><li>lichenoid reactions (itchy reddish-purple rash and\/or filamentous white-gray lines on mucous membranes)<\/li><li>scaly, flaky skin<\/li><li>immune disorders that can affect the lungs, skin, and\u00a0lymph nodes\u00a0(usually manifests as\u00a0sarcoidosis\u00a0)<\/li><li>pain in and discolored fingers or toes<\/li><li>taste disorders<\/li><li>bladder problems<\/li><li>kidney problems<\/li><li>inflammation\u00a0of the blood vessels of the skin that causes rashes<\/li><\/ul>\n\n\n\n<p>Side effects&nbsp;are where the frequency is not known:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>an unusual blood cancer that mostly affects young people (T-cell lymphoma in the liver and\u00a0spleen\u00a0)<\/li><li>Kaposi&#8217;s sarcoma, rare cancer associated with human herpes virus\u00a0infection\u00a08.\u00a0Kaposi&#8217;s sarcoma\u00a0usually appears as purple spots on the skin<\/li><li>worsening of a condition called\u00a0dermatomyositis\u00a0(which manifests itself as a skin rash accompanied by muscle weakness)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Simponi<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Keep this medicine out of the sight and reach of children.<\/li><li>Do not use this medicine after the expiry date which is stated on the label and the carton after \u201cEXP\u201d.\u00a0The expiration date is the last day of the specified month.<\/li><li>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).\u00a0Do not freeze.<\/li><li>Keep the pre-filled pen in the outer carton.\u00a0Sensitive to light.<\/li><li>This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 \u00b0 C for a single period of no more than 30 days, but without exceeding the original expiry date printed on the carton.\u00a0Write the new expiration date with day\/month\/year on the box (maximum 30 days after removal from the refrigerator).\u00a0After storage at room temperature, this medicine must not be stored in the refrigerator again.\u00a0Discard this medicine if it is not being used by the new expiration date or the expiration date printed on the carton, whichever comes first.<\/li><li>Do not use this medicine if you notice that the solution is not clear to pale yellow, cloudy, or contains foreign particles.<\/li><li>Medicines should not be disposed of via wastewater or household waste.\u00a0Ask your doctor or pharmacist how to dispose of medicines no longer required.\u00a0These measures will help to protect the environment.<\/li><\/ul>\n\n\n\n<p><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\">Content declaration<\/h2>\n\n\n\n<p>The active substance is golimumab.&nbsp;A 0.45 ml pre-filled&nbsp;pen&nbsp;contains 45 mg golimumab.&nbsp;1 ml contains 100 mg golimumab.<\/p>\n\n\n\n<p>The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injections.\u00a0For more information on sorbitol (E420), see section 2.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Simponi is supplied as a\u00a0solution\u00a0for injection\u00a0in a pre-filled\u00a0disposable pen, VarioJect.\u00a0Simponi is available in packs of 1 pre-filled\u00a0pen.\u00a0<\/p>\n\n\n\n<p>The solution is clear to slightly opalescent (has a pearlescent luster), colorless to pale yellow, and may contain a few small transparent or white particles of\u00a0protein.\u00a0Simponi should not be used if the solution is discolored, cloudy, or contains visible foreign particles.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Janssen Biologics BV<\/p>\n\n\n\n<p>Einsteinweg 101<\/p>\n\n\n\n<p>2333 CB Leiden<\/p>\n\n\n\n<p>Netherlands<\/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<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgium \/ Belgique \/ Belgien<\/strong>MSD BelgiumTel: +32 (0) 27766211dpoc_belux@merck.com<\/td><td><strong>Lithuania<\/strong>UAB Merck Sharp &amp; DohmeTel.&nbsp;+ 370 5 278 02 47msd_lietuva@merck.com<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Mark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>MSD BelgiumPhone: (+32 (0) 27766211)dpoc_belux@merck.com<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Merck Sharp &amp; Dohme story: +420 233 010 111dpoc_czechslovak@merck.com<\/td><td><strong>Hungary<\/strong>MSD Pharma Hungary Kft.Tel .: +36 1 888 5300hungary_msd@merck.com<\/td><\/tr><tr><td><strong>Denmark<\/strong>MSD Danmark ApSTel: + 45 4482 4000dkmail@merck.com<\/td><td><strong>Malta<\/strong>Merck Sharp &amp; Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com<\/td><\/tr><tr><td><strong>Germany<\/strong>MSD Sharp &amp; Dohme GmbHTel: 0800 673 673 673 (+49 (0) 89 4561 0)e-mail@msd.de<\/td><td><strong>The Netherlands<\/strong>Merck Sharp &amp; Dohme BVTel: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com<\/td><\/tr><tr><td><strong>Eesti<\/strong>Merck Sharp &amp; Dohme O\u00dcTel .: +372 6144 200msdeesti@merck.com<\/td><td><strong>Norway<\/strong>MSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no<\/td><\/tr><tr><td><strong>Greece<\/strong>MSD \u0391.\u03a6.\u0392.\u0395.\u0395.:\u0397\u03bb: +30 210 98 97 300dpoc_greece@merck.com<\/td><td><strong>Austria<\/strong>Merck Sharp &amp; Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com<\/td><\/tr><tr><td><strong>Spain<\/strong>Merck Sharp &amp; Dohme de Espa\u00f1a, SATel: +34 91 321 06 00msd_info@merck.com<\/td><td><strong>Poland<\/strong>MSD Polska Sp.\u00a0z hotel: +48 22 549 51 00msdpolska@merck.com<\/td><\/tr><tr><td><strong>France<\/strong>MSD FranceTel: + 33 (0) 1 80 46 40 40<\/td><td><strong>Portugal<\/strong>Merck Sharp &amp; Dohme, LdaTel: +351 21 4465700inform_pt@merck.com<\/td><\/tr><tr><td><strong>Croatia<\/strong>Merck Sharp &amp; Dohme doodle: + 385 1 6611 333croatia_info@merck.com<\/td><td><strong>Romania<\/strong>Merck Sharp &amp; Dohme Romania SRLTel: +40 21 529 29 00msdromania@merck.com<\/td><\/tr><tr><td><strong>Ireland<\/strong>Merck Sharp &amp; Dohme Ireland (&nbsp;Human&nbsp;Health) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com<\/td><td><strong>Slovenia<\/strong>Merck Sharp &amp; Dohme, innovative zdravila dooTel: +386 1 5204 201msd.slovenia@merck.com<\/td><\/tr><tr><td><strong>Iceland<\/strong>Vistor hf.Phone: + 354 535 7000<\/td><td><strong>Slovak Republic<\/strong>Merck Sharp &amp; Dohme, story: +421 2 58282010dpoc_czechslovak@merck.com<\/td><\/tr><tr><td><strong>Italy<\/strong>MSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com<\/td><td><strong>Finland \/ Finland<\/strong>MSD Finland OyPuh \/ Tel: +358 (0) 9 804 650info@msd.fi<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Merck Sharp &amp; Dohme Cyprus Limited.:\u0397\u03bb .: 800 00 673 (+357 22866700)cyprus_info@merck.com<\/td><td><strong>Sweden<\/strong>Merck Sharp &amp; Dohme (Sweden) ABTel: +46 77 5700488medicinskinfo@merck.com<\/td><\/tr><tr><td><strong>Latvia<\/strong>SIA Merck Sharp &amp; Dohme LatvijaTel: + 371 67364224msd_lv@merck.com<\/td><td><strong>United Kingdom(Northern Ireland)<\/strong>Merck Sharp &amp; Dohme Ireland (\u00a0Human\u00a0Health) LimitedTel: +35312998700medinfoNI@msd.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Simponi belongs to a group of medicines called &#8220;TNF inhibitors&#8221;. It is used in children 2 years and older for the treatment of polyarticular juvenile idiopathic arthritis .<\/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":[24152,24143,24146,24147,24148,24151,24145,24144,24149,24150],"class_list":["post-23134","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-simponi","tag-golimumab","tag-golimumab-injection","tag-golimumab-side-effects","tag-simponi","tag-simponi-side-effects","tag-what-golimumab-is-used-for","tag-what-is-golimumab","tag-what-is-simponi","tag-what-simponi-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23134","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=23134"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23134\/revisions"}],"predecessor-version":[{"id":23170,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/23134\/revisions\/23170"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=23134"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=23134"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=23134"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}