{"id":22519,"date":"2022-06-30T07:50:25","date_gmt":"2022-06-30T07:50:25","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22519"},"modified":"2022-07-01T10:51:12","modified_gmt":"2022-07-01T10:51:12","slug":"ruxience","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/ruxience\/","title":{"rendered":"Ruxience &#8211; Rituximab uses, dose and side effects"},"content":{"rendered":"\n<p>100 mg or 500 mg&nbsp;concentrate for&nbsp;solution for&nbsp;infusion<br>rituximab<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Ruxience is and what it is used for<\/h2>\n\n\n\n<p><strong>What Ruxience is<\/strong><\/p>\n\n\n\n<p>Ruxience contains the active substance rituximab.\u00a0This is a type of\u00a0protein\u00a0called a monoclonal\u00a0antibody.\u00a0Rituximab binds to the surface of a type of\u00a0white blood cell,\u00a0B lymphocytes.\u00a0When rituximab binds to the surface of this cell, it causes the cell to die.<\/p>\n\n\n\n<p><strong>What Ruxience is used for<\/strong><\/p>\n\n\n\n<p>The audience can be used to treat several different diseases in adults and children.\u00a0Your doctor may prescribe Ruxience for the treatment of:<\/p>\n\n\n\n<p><strong>a)&nbsp;Non-Hodgkin&#8217;s lymphoma<\/strong><\/p>\n\n\n\n<p>This is a disease of the\u00a0lymphatic system\u00a0(part of the immune system) that affects a type of white blood cell,\u00a0the B lymphocytes.<\/p>\n\n\n\n<p>In adults, Ruxience can be given alone or in combination with\u00a0chemotherapy.<\/p>\n\n\n\n<p>In adult patients where the treatment works, Ruxience can be used as maintenance treatment for 2 years after the initial treatment has been completed.<\/p>\n\n\n\n<p>In children and adolescents, Ruxience is given in combination with &#8220;chemotherapy&#8221;.<\/p>\n\n\n\n<p><strong>b)&nbsp;Chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n<p>Chronic lymphocytic leukemia\u00a0(\u00a0CLL\u00a0) is the most common form of\u00a0leukemia\u00a0in adults.\u00a0KLL\u00a0affects a specific\u00a0lymphocyte,\u00a0B-cell\u00a0one, which originates from\u00a0bone marrow\u00a0and develops in\u00a0lymph nodes.\u00a0Patients with\u00a0CLL\u00a0have too many abnormal\u00a0lymphocytes, which accumulate mainly in the\u00a0bone marrow\u00a0and blood.\u00a0The development of these abnormal\u00a0B lymphocytes\u00a0is the cause of the symptoms you may have.\u00a0The audience in combination with\u00a0chemotherapy\u00a0destroys these cells which gradually disappear from the body through biological processes.<\/p>\n\n\n\n<p><strong>c)&nbsp;Rheumatoid arthritis<\/strong><\/p>\n\n\n\n<p>The audience is used to\u00a0treat\u00a0rheumatoid\u00a0arthritis.\u00a0Rheumatoid arthritis\u00a0is a disease of the joints and\u00a0the B lymphocytes\u00a0that causes some of the symptoms you have.\u00a0The audience is usetreatingtreat\u00a0rheumatoid arthritis\u00a0in people who have already tried other medicines, but these have either stopped working, have not worked well enough, or have caused\u00a0side effects.\u00a0Ruxience is usually taken with another medicine called methotrexate.<\/p>\n\n\n\n<p>Ruxience slows down the damage to your joints caused by&nbsp;rheumatoid arthritis&nbsp;and increases your ability to perform your daily chores.<\/p>\n\n\n\n<p>Ruxience has the best effect in patients with rheumatoid factor (RF) and\/or anti-cyclic citrullinated\u00a0peptide\u00a0(anti-CCP).\u00a0This is demonstrated by taking a blood sample.<\/p>\n\n\n\n<p>Both tests are usually positive for\u00a0rheumatoid arthritis\u00a0and aid in diagnosis.<\/p>\n\n\n\n<p><strong>d) Granulomatosis with polyangiitis<\/strong> or microscopic polyangiitis<br>Ruxience is used in combination with\u00a0corticosteroids\u00a0for the treatment of adult patients and children from 2 years of age with granulomatosis with polyangiitis (formerly called\u00a0Wegener&#8217;s granulomatosis\u00a0) or microscopic polyangiitis.<\/p>\n\n\n\n<p>Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of\u00a0inflammation\u00a0in the blood vessels that mainly affect the lungs and kidneys, but which can also affect other organs.\u00a0B lymphocytes\u00a0are a contributing cause of these conditions.<\/p>\n\n\n\n<p><strong>e)\u00a0Pemphigus\u00a0Vulgaris<\/strong><\/p>\n\n\n\n<p>Ruxience is used to treat patients with moderate to severe\u00a0pemphigus\u00a0Vulgaris.\u00a0Pemphigus\u00a0Vulgaris is an\u00a0autoimmune\u00a0disease that causes painful blisters on the skin, mouth, nose, throat, and genitals.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you get Ruxience<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Ruxience<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to rituximab, other\u00a0proteins\u00a0similar to rituximab, or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you currently have a severe active\u00a0infection.<\/li><li>if you have a weakened immune system.<\/li><li>if you have severe\u00a0heart failure\u00a0or severe uncontrolled heart disease and have\u00a0rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or\u00a0pemphigus\u00a0Vulgaris.<\/li><\/ul>\n\n\n\n<p>Do not take Ruxience if any of the above applies to you.\u00a0If you are not sure, talk to your doctor, pharmacist, or nurse before receiving Ruxience.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>You and your doctor must register the name and manufacturing kit number of the medicine.<\/p>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before receiving Ruxience about:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you think you have\u00a0hepatitis B\u00a0infection\u00a0now or have had it before.\u00a0In a few cases, patients who have had\u00a0hepatitis\u00a0B have regained the disease, which can be fatal in very rare cases.\u00a0Patients who have previously had\u00a0hepatitis\u00a0B\u00a0infection\u00a0should be checked regularly by their doctor for signs of this\u00a0infection.<\/li><li>you have ever had heart disease (eg\u00a0angina pectoris\u00a0), palpitations, or\u00a0heart failure\u00a0) or had breathing problems.<\/li><\/ul>\n\n\n\n<p>If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before receiving Ruxience.\u00a0Your doctor may need to monitor you extra closely during treatment with Ruxience.<\/p>\n\n\n\n<p>Also talk to a doctor if you think you need a vaccination shortly, including vaccinations needed to travel to other countries.\u00a0Some vaccines should not be given at the same time as Ruxience or during the months after receiving Ruxience.\u00a0Your doctor will check if you need any vaccinations before receiving Ruxience.<\/p>\n\n\n\n<p><strong>If you have\u00a0rheumatoid arthritis<\/strong>, granulomatosis with polyangiitis, microscopic polyangiitis, or\u00a0pemphigus\u00a0Vulgaris<strong>, you should also tell your doctor<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you think you have an\u00a0infection, even a mild\u00a0infection\u00a0such as a cold.\u00a0The cells that are affected by Ruxience help fight\u00a0infection\u00a0and you should wait until\u00a0the infection\u00a0has passed before you get Ruxience.\u00a0Also, tell your doctor if you have had many\u00a0infections\u00a0in the past or suffer from severe\u00a0infections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p><em>Non-Hodgkin&#8217;s lymphoma<\/em><\/p>\n\n\n\n<p>Ruxience can be used to treat children and adolescents, 6 months of age and older, with\u00a0non-Hodgkin&#8217;s lymphoma, specifically CD20 positive diffuse large cell\u00a0B\u00a0-cell lymphoma (DLBCL\u00a0), Burkitt\u00a0lymphoma\u00a0(BL) \/ Burkitt leukemia\u00a0(mature\u00a0acute\u00a0leukemia\u00a0in\u00a0B cells\u00a0)\u00a0(BAL) or Burkitt-like\u00a0lymphoma\u00a0(BLL).<\/p>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before you or your child receives this medicine if you, or your child, are under 18 years of age.<\/p>\n\n\n\n<p><em>Granulomatosis with polyangiitis<\/em> or microscopic polyangiitis\u00a0<\/p>\n\n\n\n<p>Ruxience can be used to treat children and adolescents from 2 years of age and older who have granulomatosis with polyangiitis (formerly called\u00a0Wegener&#8217;s granulomatosis\u00a0) or microscopic polyangiitis.\u00a0There is not much information on the use of rituximab in children and adolescents with other diseases.<\/p>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before you or your child receives this medicine if you or your child are under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Ruxience<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse if you have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines.\u00a0This is because Ruxience can affect the way other medicines work.\u00a0Other medicines may also affect the way Ruxience works.<\/p>\n\n\n\n<p>Talk to your doctor specifically about:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you are taking medicines for high\u00a0blood pressure.\u00a0You may be asked not to take your medication for 12 hours before receiving Ruxience.\u00a0This is because some patients experience a drop in blood pressure when they receive Ruxience.<\/li><li>if you have ever taken medicines that affect your immune systems &#8211; such as\u00a0chemotherapy\u00a0or immunosuppressive medicines.<\/li><\/ul>\n\n\n\n<p>If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before receiving Ruxience.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>You must tell your doctor or nurse if you are pregnant, think you may be pregnant, or are planning to have a baby.\u00a0This is because Ruxience can pass the placenta and affect your baby.<\/p>\n\n\n\n<p>If you could become pregnant, you and your partner must use an effective contraceptive during treatment with Ruxience and for 12 months after the last treatment with Ruxience.<\/p>\n\n\n\n<p>Ruxience passes into breast milk in small amounts.\u00a0As the long-term effect on breast-fed infants is not known, it is recommended not to breastfeed during treatment with Ruxience and for 12 months after stopping treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>It is not known if rituximab affects your ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ruxience contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0dose, ie essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to get Ruxience<\/h2>\n\n\n\n<p><strong>How it is given<\/strong><\/p>\n\n\n\n<p>Ruxience will be given to you by a doctor or nurse who has experience using this treatment.\u00a0They will monitor you closely when you are being treated with this medicine in case you get any\u00a0side effects.<\/p>\n\n\n\n<p>You will always receive Ruxience as a drip (&nbsp;intravenous&nbsp;infusion&nbsp;).<\/p>\n\n\n\n<p><strong>Medicines are given before each\u00a0administration\u00a0of Ruxience<\/strong><\/p>\n\n\n\n<p>Before you are given Ruxience, you will be given other medicines (pre-medication) to prevent or reduce any\u00a0side effects.<\/p>\n\n\n\n<p><strong>How much and how often you will receive your treatment<\/strong><\/p>\n\n\n\n<p><strong>a) If you are being treated for&nbsp;non-Hodgkin&#8217;s lymphoma<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><em>If you are being treated with Ruxience alone<\/em>Ruxience will be given to you once a week for a total of 4 weeks.\u00a0Repeated treatments with Ruxience are possible.<\/li><li><em>If you are being treated with Ruxience in combination with\u00a0chemotherapy<\/em>Ruxience will be given to you on the same day as your\u00a0chemotherapy.\u00a0This is usually given every three weeks up to 8 times.<\/li><li>If you respond well to the treatment, you can receive Ruxience as maintenance treatment every two or three months for two years.\u00a0Your doctor may change this depending on how you respond to the medicine.<\/li><li>If you are younger than 18 years, you will be given Ruxience in combination with\u00a0chemotherapy.\u00a0You will receive Ruxience up to 6 times over 3.5-5.5 months.<\/li><\/ul>\n\n\n\n<p>Your doctor may change this depending on how you respond to the medicine.<\/p>\n\n\n\n<p><strong>b) If you are being treated for&nbsp;chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n<p>When you are treated with Ruxience in combination with\u00a0chemotherapy, you will receive Ruxience\u00a0infusion\u00a0on day 0 of the first cycle and then on day 1 of each treatment cycle, for a total of 6 cycles.\u00a0Each cycle lasts 28 days.\u00a0The chemotherapy should be given after Ruxience\u00a0infusion.\u00a0Your doctor will decide if you should receive any additional supportive care.<\/p>\n\n\n\n<p><strong>c) If you are being treated for&nbsp;rheumatoid arthritis<\/strong><\/p>\n\n\n\n<p>Each course of treatment consists of two separate&nbsp;infusions&nbsp;given at 2-week intervals.&nbsp;Repeated treatments with Ruxience are possible.&nbsp;Depending on the signs and symptoms of your disease, your doctor will decide when to get more Ruxience.&nbsp;This can take several months.<\/p>\n\n\n\n<p><strong>d) If you are being treated for granulomatosis with polyangiitis<\/strong> or microscopic polyangiitis<br>Treatment with Ruxience consists of four separate\u00a0infusions\u00a0given at one-week intervals.\u00a0Corticosteroids\u00a0will usually be given as an\u00a0injection\u00a0before Ruxience treatment.\u00a0Corticosteroids\u00a0given by mouth can be started at any time by your doctor to treat your condition.<\/p>\n\n\n\n<p>If you are 18 years or older and respond well to the treatment, you can receive Ruxience as maintenance treatment.\u00a0It will be given as 2 separate\u00a0infusions\u00a0at 2-week intervals, followed by 1\u00a0infusion\u00a0every 6 months for at least 2 years.\u00a0Your doctor may decide to treat you longer with Ruxience (up to 5 years) depending on how you respond to the medicine.<\/p>\n\n\n\n<p><strong>e) If you are being treated for\u00a0pemphigus\u00a0Vulgaris<\/strong><\/p>\n\n\n\n<p>Each course of treatment consists of two separate&nbsp;infusions&nbsp;given at 2-week intervals.&nbsp;If you respond well to the treatment, you can get Ruxience as maintenance treatment.&nbsp;It will be given one year after and 18 months after the first treatment and then every six months as needed, or your doctor may change this depending on how you respond to the treatment.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask 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>Most&nbsp;side effects&nbsp;are mild to moderate but some can be serious and require treatment.&nbsp;In rare cases, these&nbsp;side effects&nbsp;have been fatal.<\/p>\n\n\n\n<p><strong>Infusion reactions<\/strong><\/p>\n\n\n\n<p>During or within the first 24 hours after\u00a0infusion\u00a0one, you may experience fever, chills, and tremors.\u00a0Less frequently, some patients may experience infusion site pain, blisters,\u00a0itching, nausea, fatigue, headache, difficulty breathing, high\u00a0blood pressure, wheezing, sore throat, swelling of the tongue and throat, itchy or runny nose, vomiting, reddening of the skin or irregularity. , heart attack or low\u00a0platelet count.\u00a0If you have heart disease or angina, these reactions may worsen.\u00a0Tell the person giving you the\u00a0infusion\u00a0immediately\u00a0if you or your child develops any of these symptoms, as the\u00a0infusion may need to be given more slowly or discontinued.\u00a0You may also need supplements such as\u00a0antihistamines\u00a0or\u00a0paracetamol.\u00a0When the symptoms disappear or improve, the\u00a0infusion\u00a0can be continued.\u00a0These reactions are less likely to occur after the second\u00a0infusion.\u00a0Your doctor may decide to stop your treatment with Ruxience if these reactions are severe.<\/p>\n\n\n\n<p><strong>Infection&nbsp;is<\/strong><\/p>\n\n\n\n<p><strong>Tell your doctor immediately if you or your child develop symptoms of&nbsp;infection&nbsp;such as:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fever, cough, sore throat, burning pain when you urinate, or if you start to feel weak or generally ill<\/li><li>memory loss, difficulty thinking, difficulty walking, or vision loss &#8211; can be due to a very rare, serious\u00a0infection\u00a0in the brain that has had a fatal outcome (\u00a0progressive\u00a0multifocal\u00a0leukoencephalopathy or PML).<\/li><\/ul>\n\n\n\n<p>You can get\u00a0infections\u00a0more easily during your treatment with Ruxience.\u00a0There are often colds, but there have been cases of\u00a0pneumonia\u00a0or urinary tract infections.\u00a0These are listed under &#8220;Other side effects&#8221;.<\/p>\n\n\n\n<p>If you are being treated for\u00a0rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or\u00a0pemphigus\u00a0Vulgaris, you will also find this information in the patient care that you have received from your doctor.\u00a0You must keep this patient card and show it to your partner or caregiver.<\/p>\n\n\n\n<p><strong>Skin reactions<\/strong><br>In very rare cases, severe conditions with skin blisters, which can be life-threatening, can occur.\u00a0Redness, often associated with blisters, can occur on the skin or the mucous membranes, such as in the mouth, around the genitals, or the eyelids, and fever may occur.\u00a0<strong>Tell your doctor immediately if you experience any of these symptoms.<\/strong><\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;include:<\/strong><\/p>\n\n\n\n<p><strong>a) If you or your child are being treated for&nbsp;non-Hodgkin&#8217;s lymphoma&nbsp;or&nbsp;chronic lymphocytic leukemia<\/strong><\/p>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bacterial\u00a0or viral infection,\u00a0bronchitis\u00a0(\u00a0tracheal catarrh\u00a0)<\/li><li>the low number of\u00a0white blood cells\u00a0in the blood, with or without fever, low number of\u00a0platelets\u00a0in the blood<\/li><li>nausea<\/li><li>bald spots on the head, chills, headache<\/li><li>lower immunity due to a decrease in the number of certain specific\u00a0antibodies\u00a0in the blood (\u00a0immunoglobulins\u00a0(IgG)) that help protect against\u00a0infection\u00a0).<\/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>infection\u00a0in the blood (blood poisoning),\u00a0pneumonia,\u00a0shingles, colds, tracheal infections, fungal infections,\u00a0infections\u00a0of unknown origin, sinusitis,\u00a0hepatitis\u00a0B<\/li><li>the low number of\u00a0red blood cells\u00a0in the blood (\u00a0anemia,\u00a0anemia\u00a0), low number of all\u00a0blood\u00a0cells<\/li><li>allergic reactions (hypersensitivity)<\/li><li>elevated blood sugar, weight loss, swelling of the face and body, high levels of\u00a0enzyme\u00a0and LDH in the blood, decreased amount of\u00a0calcium\u00a0in the blood<\/li><li>abnormal sensations such as numbness, tingling, burning sensation, tingling in the skin, decreased sensation<\/li><li>restlessness, insomnia<\/li><li>redness\u00a0of the face and other areas of the skin as a consequence of dilated blood vessels<\/li><li>dizziness, anxiety<\/li><li>increased production of tears and tear secretions, eye inflammation (conjunctivitis)<\/li><li>ringing sounds in the ears, pain in the ears<\/li><li>heart disease such as heart attack, irregular or abnormally high heart rate<\/li><li>high or low\u00a0blood pressure\u00a0(low\u00a0blood pressure\u00a0especially when standing upright)<\/li><li>the tension of the muscles of the airways which gives rise to wheezing (\u00a0bronchospasm\u00a0),\u00a0inflammation, irritation of the lungs, throat, or sinuses, shortness of breath, runny nose<\/li><li>vomiting, diarrhea, abdominal pain, irritation or sore throat, difficulty swallowing, constipation, indigestion<\/li><li>eating disorders, decreased appetite leading to weight loss<\/li><li>hives, increased sweating, night sweats<\/li><li>symptoms in muscles such as tense muscles, joint or muscle pain, back and neck pain<\/li><li>tumor pain<\/li><li>general symptoms of discomfort or feeling of discomfort or tiredness, shaking, flu symptoms<\/li><li>deterioration of several organs.<\/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>coagulation disorders in the blood, reduction of\u00a0red blood cell production\u00a0and increased degradation of\u00a0red blood cells\u00a0(aplastic\u00a0hemolytic anemia\u00a0), swollen or enlarged\u00a0lymph nodes<\/li><li>depression and lack of interest in normal activities, nervousness<\/li><li>taste change<\/li><li>heart diseases such as decreased heart rate or chest pain (angina)<\/li><li>asthma, too little oxygen reaching the body&#8217;s organs<\/li><li>swollen abdomen.<\/li><\/ul>\n\n\n\n<p>Very rare&nbsp;side effects&nbsp;(may affect up to 1 in 10,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>temporary increase in different types of\u00a0antibodies\u00a0in the blood (\u00a0immunoglobulins\u00a0&#8211; IgM), chemical disorders in the blood caused by the breakdown of dying cancer cells<\/li><li>nerve damage in arms and legs, facial paralysis<\/li><li>heart failure<\/li><li>inflamed blood vessels, including those that can cause skin symptoms<\/li><li>respiratory failure<\/li><li>damage to the intestinal wall (perforation)<\/li><li>severe conditions with blisters that can be life-threatening.\u00a0Redness, often associated with blisters, can occur on the skin or the mucous membranes, such as in the mouth, around the genitals, or the eyelids, and fever may occur.<\/li><li>kidney failure<\/li><li>and severe visual impairment.<\/li><\/ul>\n\n\n\n<p>No known frequency (cannot be calculated from the available data):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>delayed decrease in\u00a0white blood cells<\/li><li>reduction of\u00a0platelets\u00a0shortly after\u00a0infusion\u00a0&#8211; may be transient but may in rare cases be fatal<\/li><li>hearing loss, loss of other senses.<\/li><\/ul>\n\n\n\n<p><strong>Children and adolescents with non-Hodgkin&#8217;s lymphoma:<\/strong><\/p>\n\n\n\n<p>In general,\u00a0side effects\u00a0in children and adolescents with\u00a0non-Hodgkin&#8217;s lymphoma\u00a0were similar to those in adults with\u00a0non-Hodgkin&#8217;s lymphoma\u00a0or\u00a0chronic lymphocytic leukemia.\u00a0The most common\u00a0side effects\u00a0observed were fever associated with low levels of a\u00a0white blood cell\u00a0type (\u00a0neutrophils\u00a0),\u00a0inflammation\u00a0or sores in the mouth, and allergic reactions (hypersensitivity).<\/p>\n\n\n\n<p><strong>b) If you are being treated for&nbsp;rheumatoid arthritis<\/strong><\/p>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>infection\u00a0is such as\u00a0pneumonia\u00a0(bacterial)<\/li><li>pain when urinating (urinary tract infection)<\/li><li>allergic reactions that are most likely to occur during an\u00a0infusion\u00a0but may occur up to 24 hours after the\u00a0infusion<\/li><li>changes in\u00a0blood pressure, nausea, rash, fever,\u00a0itching, runny or stuffy nose, as well as sneezing, tremors, palpitations, and fatigue<\/li><li>headache<\/li><li>changes in laboratory tests performed by treating physicians.\u00a0These include a reduction in the number of certain specific\u00a0proteins\u00a0in the blood (\u00a0immunoglobulins\u00a0) that help protect against\u00a0infection.<\/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>infection\u00a0is such as\u00a0bronchitis\u00a0(\u00a0bronchitis\u00a0)<\/li><li>the feeling of tightness or throbbing pain behind the nose, cheeks, and eyes (sinusitis), abdominal pain, vomiting, and diarrhea, difficulty breathing<\/li><li>athlete&#8217;s foot<\/li><li>high cholesterol levels in the blood<\/li><li>abnormal sensations, such as numbness, tingling, burning sensation, skin tingling, sciatica,\u00a0migraine, dizziness<\/li><li>hair loss<\/li><li>anxiety, depression<\/li><li>indigestion, diarrhea, acid regurgitation, irritation and\/or sore throat and mouth<\/li><li>pain in the abdomen, back, muscles, and\/or joints.<\/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>accumulation of fluid on the face and body<\/li><li>inflammation, irritation and\/or feeling of tightness in the lungs and throat, cough<\/li><li>skin reactions including\u00a0hives,\u00a0itching,\u00a0and rash<\/li><li>allergic reactions including wheezing, shortness of breath, swelling of the face and tongue, and collapse.<\/li><\/ul>\n\n\n\n<p>Very rare&nbsp;side effects&nbsp;(may affect up to 1 in 10,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a range of symptoms that occur within a few weeks after rituximab\u00a0infusion\u00a0including allergic reactions such as skin rash,\u00a0itching, joint pain, swollen\u00a0lymph nodes,\u00a0and fever<\/li><li>severe conditions with blisters that can be life-threatening.\u00a0Redness, often associated with blisters, can occur on the skin or mucous membranes such as in the mouth, around the genitals, or the eyelids, and fever may occur.<\/li><\/ul>\n\n\n\n<p>Other rarely reported\u00a0side effects\u00a0caused by rituximab to include a decrease in the number of\u00a0white blood cells\u00a0(\u00a0neutrophils\u00a0) that help fight\u00a0infections.\u00a0Some\u00a0infections\u00a0can be serious (see the information on\u00a0<strong><em>Infections\u00a0in<\/em><\/strong>\u00a0this section).<\/p>\n\n\n\n<p><strong>c) If you or your child are being treated for granulomatosis with polyangiitis<\/strong> or microscopic polyangiitis<\/p>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>infections, such as respiratory\u00a0infections,\u00a0urinary tract infections (pain when urinating), colds,\u00a0and\u00a0herpes\u00a0infections<\/li><li>allergic reactions that are most likely to occur during an\u00a0infusion,\u00a0but may occur up to 24 hours after the\u00a0infusion<\/li><li>diarrhea<\/li><li>cough or shortness of breath<\/li><li>nosebleeds<\/li><li>high\u00a0blood pressure<\/li><li>joint or back pain<\/li><li>muscle twitching and muscle weakness<\/li><li>feeling of dizziness<\/li><li>shaking (often in the hands)<\/li><li>difficulty sleeping (insomnia)<\/li><li>swelling of hands or ankles.<\/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>indigestion<\/li><li>constipation<\/li><li>rash, including\u00a0acne\u00a0or pimples<\/li><li>flare-up or\u00a0redness\u00a0of the skin<\/li><li>fever<\/li><li>nasal congestion or runny nose<\/li><li>tense or aching muscles<\/li><li>pain in muscles or hands or feet<\/li><li>low\u00a0red blood cell count\u00a0(\u00a0anemia\u00a0)<\/li><li>low\u00a0platelet count\u00a0in the blood<\/li><li>an increase in the amount of\u00a0potassium\u00a0in the blood<\/li><li>change in heart rhythm, or that the heart beats faster than usual.<\/li><\/ul>\n\n\n\n<p>Very rare&nbsp;side effects&nbsp;(may affect up to 1 in 10,000 patients):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>severe conditions with blisters that can be life-threatening.\u00a0Redness, often associated with blisters, can occur on the skin or mucous membranes such as in the mouth, around the genitals, or the eyelids, and fever may occur.<\/li><li>reactivation of previous\u00a0hepatitis\u00a0B\u00a0infection.<\/li><\/ul>\n\n\n\n<p><strong>Children and adolescents with\u00a0<\/strong>\u00a0<strong>granulomatosis with polyangiitis<\/strong> or microscopic polyangiitis<\/p>\n\n\n\n<p>In general,\u00a0side effects\u00a0in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis are of the same type as those in adults with granulomatosis with polyangiitis or microscopic polyangiitis.\u00a0The most common\u00a0side effects\u00a0were\u00a0infection, allergic reactions, and nausea.<\/p>\n\n\n\n<p><strong>d) If you are being treated for\u00a0pemphigus\u00a0Vulgaris<\/strong><\/p>\n\n\n\n<p>Very common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions that are most likely to occur during an\u00a0infusion, but may occur up to 24 hours after the\u00a0infusion<\/li><li>headache<\/li><li>infection\u00a0is like\u00a0an infection\u00a0in the airways<\/li><li>prolonged depression<\/li><li>hair loss<\/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>infections\u00a0such as colds, herpes infections,\u00a0eye infections, fungal infections of the mouth, and urinary tract infections (pain when urinating)<\/li><li>mood effects such as irritation and depression<\/li><li>skin effects such as\u00a0itching, hives, and benign lumps<\/li><li>fatigue or dizziness<\/li><li>fever<\/li><li>pain in joints and back<\/li><li>abdominal pain<\/li><li>muscle pain<\/li><li>the heart beats faster than usual<\/li><\/ul>\n\n\n\n<p>Ruxience can also cause changes in laboratory tests performed by your doctor.<\/p>\n\n\n\n<p>If you get Ruxience in combination with other medicines, some of the&nbsp;side effects&nbsp;you may experience are due to the other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Ruxience<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton 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 \u00b0 C-8 \u00b0 C).&nbsp;Store the container in the outer carton.&nbsp;Sensitive to light.<\/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\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance in Ruxience is rituximab.The 10 ml vial contains 100 mg rituximab (10 mg \/ ml).The 50 ml vial contains 500 mg rituximab (10 mg \/ ml).<\/li><li>The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, disodium edetate, polysorbate 80, sucrose, and water for injections.<\/li><\/ul>\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>Ruxience is a clear to slightly cloudy, colorless to light brownish-yellow solution and is available as a concentrate for solution for&nbsp;infusion&nbsp;[sterile concentrate].<\/p>\n\n\n\n<p>10 ml\u00a0vial\u00a0&#8211; pack of 1\u00a0vial.<\/p>\n\n\n\n<p>50 ml\u00a0vial\u00a0&#8211; pack of 1\u00a0vial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Pfizer Europe MA EEIG<\/p>\n\n\n\n<p>Boulevard de la Plaine 17<\/p>\n\n\n\n<p>1050 Brussels<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Pfizer Manufacturing Belgium NV<\/p>\n\n\n\n<p>Rijksweg 12<\/p>\n\n\n\n<p>2870 Puurs<\/p>\n\n\n\n<p>Belgium<\/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><strong>Luxembourg \/ Luxemburg<\/strong>Pfizer NV \/ SATel: +32 (0) 2 554 62 11<\/td><td><strong>\u038e\u03c0\u03c1\u03bf\u03c2<\/strong>Pfizer United AE (Cyprus Branch)T\u03b7\u03bb: +357 22817690<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Pfizer, spol.&nbsp;s roTel: +420 283 004 111<\/td><td><strong>Hungary<\/strong>Pfizer Kft.Tel .: + 36 1 488 37 00<\/td><\/tr><tr><td><strong>Denmark<\/strong>Pfizer ApSTel: +45 44 20 11 00<\/td><td><strong>Malta<\/strong>Vivian Corporation Ltd.Tel: +356 21344610<\/td><\/tr><tr><td><strong>Germany<\/strong>PFIZER PHARMA GmbHTel: +49 (0) 30 550055-51000<\/td><td><strong>The Netherlands<\/strong>Pfizer bvTel: +31 (0) 10 406 43 01<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>The Pfizer Luxembourg XARO,Clone of BulgariaTel: +359 2 970 4333<\/td><td><strong>Norway<\/strong>Pfizer ASTel: +47 67 52 61 00<\/td><\/tr><tr><td><strong>Eesti<\/strong>Pfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500<\/td><td><strong>Austria<\/strong>Pfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0<\/td><\/tr><tr><td><strong>Greece<\/strong>Pfizer \u03bb\u03bb\u03ac\u03c2 AE:\u0397\u03bb: +30 210 6785800<\/td><td><strong>Poland<\/strong>Pfizer Polska Sp.&nbsp;z ooTel .: +48 22 335 61 00<\/td><\/tr><tr><td><strong>Spain<\/strong>Pfizer, SLTel: +34 91 490 99 00<\/td><td><strong>Portugal<\/strong>Pfizer Laboratories, Lda.Tel: +351 21 423 5500<\/td><\/tr><tr><td><strong>France<\/strong>PfizerTel: +33 (0) 1 58 07 34 40<\/td><td><strong>Romania<\/strong>Pfizer Romania SRLTel: +40 (0) 21 207 28 00<\/td><\/tr><tr><td><strong>Croatia<\/strong>Pfizer Croatia dooTel: +385 1 3908 777<\/td><td><strong>Slovenia<\/strong>Pfizer Luxembourg SARLPfizer, for construction and pharmaceutical services, LjubljanaTel: +386 (0) 1 52 11 400<\/td><\/tr><tr><td><strong>Ireland<\/strong>Pfizer Healthcare IrelandTel: +1800 633 363 (toll free)Tel: +44 (0) 1304 616161<\/td><td><strong>Slovak Republic<\/strong>Pfizer Luxembourg SARL, organizerTel: + 421 2 3355 5500<\/td><\/tr><tr><td><strong>Iceland<\/strong>Icepharma hf.Phone: +354 540 8000<\/td><td><strong>Finland \/ Finland<\/strong>Pfizer OyPuh \/ Tel: +358 (0) 9 430 040<\/td><\/tr><tr><td><strong>Italy<\/strong>Pfizer SrlTel: +39 06 33 18 21<\/td><td><strong>Sweden<\/strong>Pfizer ABTel: +46 (0) 8 550 520 00<\/td><\/tr><tr><td><strong>Latvia<\/strong>Pfizer Luxembourg SARL subsidiary Latvij\u0101Tel: + 371 670 35 775<\/td><td><strong>United Kingdom (Northern Ireland)<\/strong>Pfizer LimitedTel: +44 (0) 1304 616161<\/td><\/tr><tr><td><strong>Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel: +370 5 251 4000<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Ruxience contains the active substance rituximab. This is a type of protein called a monoclonal antibody . Rituximab binds to the surface of a type of white blood cell , B lymphocytes . When rituximab binds to the surface of this cell, it causes the cell to die.<\/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":[2200,18529],"tags":[16750,23448,16746,16749,23444,23447,16747,23445,16748,23446],"class_list":["post-22519","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-rituximab","tag-benefits-of-ruxience","tag-rituximab","tag-rituximab-side-effects","tag-ruxience","tag-ruxience-side-effects","tag-what-is-rituximab","tag-what-is-ruxience","tag-what-rituximab-is-used-for","tag-what-ruxience-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22519","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=22519"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22519\/revisions"}],"predecessor-version":[{"id":22542,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22519\/revisions\/22542"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22519"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22519"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22519"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}