{"id":17290,"date":"2022-01-07T10:36:53","date_gmt":"2022-01-07T10:36:53","guid":{"rendered":"https:\/\/zeepedia.com\/?p=17290"},"modified":"2022-01-10T15:32:48","modified_gmt":"2022-01-10T15:32:48","slug":"mabthera","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/mabthera\/","title":{"rendered":"MabThera &#8211; Rituximab uses, dose and side effects"},"content":{"rendered":"\n<p>1400 mg&nbsp;injection&nbsp;, solution for&nbsp;subcutaneous&nbsp;injection<br>rituximab<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What MabThera is and what it is used for<\/h2>\n\n\n\n<p><strong>What MabThera is<\/strong><\/p>\n\n\n\n<p>MabThera contains the active substance rituximab.&nbsp;This is a type of&nbsp;protein&nbsp;called a monoclonal&nbsp;antibody&nbsp;.&nbsp;Rituximab binds to the surface of a type of&nbsp;white blood cell&nbsp;,&nbsp;B lymphocytes&nbsp;.&nbsp;When rituximab binds to the surface of this cell, it causes the cell to die.<\/p>\n\n\n\n<p>MabThera is available as a drip medicine (MabThera 100 mg or MabThera 500 mg, concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;) and as a medicine given as an&nbsp;injection&nbsp;under the skin (MabThera 1400 mg or MabThera 1600 mg&nbsp;solution for injection&nbsp;,&nbsp;subcutaneous&nbsp;injection solution&nbsp;)<\/p>\n\n\n\n<p><strong>What MabThera is used for<\/strong><\/p>\n\n\n\n<p>MabThera 1400 mg is used to treat&nbsp;non-Hodgkin&#8217;s lymphoma&nbsp;in adults.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>This is a disease of the&nbsp;lymphatic system&nbsp;(part of the immune system) that affects a type of white blood cell, the&nbsp;B lymphocytes&nbsp;.<\/li><\/ul>\n\n\n\n<p>MabThera 1400 mg can be given alone or in combination with other medicines called&nbsp;chemotherapy&nbsp;.<\/p>\n\n\n\n<p>You will always receive MabThera as a drip (&nbsp;intravenous&nbsp;infusion&nbsp;) at the beginning of your treatment.<\/p>\n\n\n\n<p>You will then receive MabThera as an&nbsp;injection&nbsp;under the skin.&nbsp;Your doctor will decide when&nbsp;to start your&nbsp;injection&nbsp;of MabThera.<\/p>\n\n\n\n<p>In patients where the treatment works, MabThera can be used as maintenance treatment for 2 years after the initial treatment has been completed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using MabThera<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take MabThera<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to rituximab, other&nbsp;proteins&nbsp;similar to rituximab or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are allergic to hyaluronidase (an&nbsp;enzyme&nbsp;that helps increase the&nbsp;absorption of&nbsp;an injected active substance)<\/li><li>if you have an active, severe&nbsp;infection<\/li><li>if you have a weakened immune system.<\/li><\/ul>\n\n\n\n<p>Do not take MabThera if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor, pharmacist or nurse before receiving MabThera.<\/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 MabThera about:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You think you have&nbsp;infection&nbsp;with&nbsp;hepatitis&nbsp;B now or have had it before.&nbsp;In a few cases, patients with&nbsp;hepatitis&nbsp;B have regained the disease, which can be fatal in very rare cases.&nbsp;Patients who have previously had&nbsp;hepatitis&nbsp;B&nbsp;infection&nbsp;should be checked regularly by their doctor for signs of this&nbsp;infection.<\/li><li>if you have ever had a heart disease (eg&nbsp;angina pectoris&nbsp;), palpitations or&nbsp;heart failure&nbsp;) 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 MabThera.&nbsp;Your doctor may need to monitor you extra closely during treatment with MabThera.<\/p>\n\n\n\n<p>Also talk to a doctor if you think you need a vaccination in the near future, including vaccinations needed to travel to other countries.&nbsp;Some vaccines should not be given at the same time as MabThera or during the months after receiving MabThera.&nbsp;Your doctor will check if you need any vaccinations before receiving MabThera.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist or nurse before you or your child receive this medicine if you or your child are under 18 years of age.&nbsp;This is because there is not much information on the treatment of children and adolescents with MabThera.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and MabThera<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.&nbsp;This is because MabThera may affect the way other medicines work.&nbsp;Other medicines may also affect the way MabThera 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&nbsp;blood pressure&nbsp;.&nbsp;You may be asked not to take your medication for 12 hours before receiving MabThera.&nbsp;This is because some patients experience a drop in blood pressure when they receive MabThera<\/li><li>if you have ever taken medicines that affect your immune system &#8211; such as&nbsp;chemotherapy&nbsp;or 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 MabThera.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>You must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.&nbsp;This is because MabThera can pass through 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 MabThera and for 12 months after the last treatment with MabThera.<\/p>\n\n\n\n<p>MabThera passes into breast milk in small amounts.&nbsp;As the long-term effect on breast-fed infants is not known, it is recommended not to breast-feed during treatment with MabThera 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 MabThera affects your ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Sodium<\/h2>\n\n\n\n<p>MabThera 1400 mg contains less than 1 mmol&nbsp;sodium&nbsp;(the main ingredient in table salt \/ table salt) per&nbsp;dose&nbsp;, ie it is essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to get MabThera<\/h2>\n\n\n\n<p><strong>How it is given<\/strong><\/p>\n\n\n\n<p>MabThera will be given to you by a doctor or nurse who has experience using this treatment.&nbsp;They will monitor you closely when you are treated with this medicine should you experience any&nbsp;side effects&nbsp;.<\/p>\n\n\n\n<p>You will always receive MabThera as a drip (&nbsp;intravenous&nbsp;infusion&nbsp;) at the beginning of your treatment.<\/p>\n\n\n\n<p>You will then receive MabThera as an&nbsp;injection&nbsp;under the skin (&nbsp;subcutaneous&nbsp;injection&nbsp;) for about 5 minutes.&nbsp;The glass vial contains a removable adhesive label with a description of the medicine.&nbsp;Your doctor or nurse will put the sticker on the syringe before&nbsp;injecting&nbsp;one.<\/p>\n\n\n\n<p>Your doctor will decide when&nbsp;to start your&nbsp;injection&nbsp;of MabThera.<\/p>\n\n\n\n<p>When the drug is injected under the skin, it should be given in the stomach area and not elsewhere on the body.&nbsp;It should also not be injected into areas of the abdomen where the skin is red, bruised, tender, hard or where there are birthmarks or scars.<\/p>\n\n\n\n<p><strong>Medicines given before each&nbsp;administration&nbsp;of MabThera<\/strong><\/p>\n\n\n\n<p>Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce any&nbsp;side effects&nbsp;.<\/p>\n\n\n\n<p><strong>How much and how often you will receive your treatment<\/strong><\/p>\n\n\n\n<p>MabThera will be given to you on the same day as your&nbsp;chemotherapy&nbsp;.&nbsp;This is usually given every three weeks up to 8 times.<\/p>\n\n\n\n<p>If you respond well to the treatment, you can receive MabThera as a maintenance treatment every two or three months for two years.<\/p>\n\n\n\n<p>Your doctor may change this depending on how you respond to the medicine.<\/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&nbsp;side effects&nbsp;, 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>Injection site reactions<\/strong><\/p>\n\n\n\n<p>Many patients experience local&nbsp;side effects&nbsp;where MabThera is injected.&nbsp;These include: pain, swelling, bruising, bleeding, reddening of the skin,&nbsp;itching&nbsp;and rash.<\/p>\n\n\n\n<p>Your doctor may decide to stop your treatment with MabThera 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 get 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 loss of vision &#8211; these can be due to a very rare, serious&nbsp;infection&nbsp;in the brain that has had a fatal outcome (&nbsp;progressive&nbsp;multifocal&nbsp;leukoencephalopathy or PML).<\/li><\/ul>\n\n\n\n<p>You can get&nbsp;infection&nbsp;more easily during your treatment with MabThera.&nbsp;There are often colds, but there have been cases of&nbsp;pneumonia&nbsp;or urinary tract infection.&nbsp;These are listed under &#8220;Other side effects&#8221;<\/p>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;include:<\/strong><\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bacterial&nbsp;or viral infection,&nbsp;bronchitis<\/li><li>low number of&nbsp;white blood cells&nbsp;in the blood, with or without fever, low number of&nbsp;platelets&nbsp;in 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&nbsp;antibodies&nbsp;in the blood (&nbsp;immunoglobulins&nbsp;(IgG)) that help protect against&nbsp;infection&nbsp;.<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>infection&nbsp;in the blood (blood poisoning),&nbsp;pneumonia&nbsp;,&nbsp;shingles&nbsp;, colds,&nbsp;bronchitis&nbsp;, fungal infections,&nbsp;infections&nbsp;of unknown origin, sinusitis,&nbsp;hepatitis&nbsp;B<\/li><li>low number of&nbsp;red blood cells&nbsp;in the blood (&nbsp;anemia&nbsp;,&nbsp;anemia&nbsp;), low numbers of all&nbsp;blood&nbsp;s<\/li><li>allergic reactions (hypersensitivity)<\/li><li>elevated blood sugar, weight loss, swelling of the face and body, high levels of&nbsp;enzyme&nbsp;and LDH in the blood, decreased amount of&nbsp;calcium&nbsp;in 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&nbsp;of 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, problems with the tear duct, 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&nbsp;blood pressure&nbsp;(low&nbsp;blood pressure&nbsp;, especially when standing upright)<\/li><li>tension of the muscles of the airways which gives rise to wheezing (&nbsp;bronchospasm&nbsp;),&nbsp;inflammation&nbsp;, irritation of the lungs, throat or sinuses, shortness of breath, runny nose<\/li><li>vomiting, diarrhea, abdominal pain, irritation or sore throat and mouth, difficulty swallowing, constipation, indigestion<\/li><li>eating disorders, decreased appetite which leads 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><strong>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>coagulation disorders in the blood, decrease in the production of&nbsp;red blood cells&nbsp;and increased degradation of&nbsp;red blood cells&nbsp;(aplastic&nbsp;hemolytic anemia&nbsp;), swollen or enlarged&nbsp;lymph nodes<\/li><li>depression and lack of interest in normal activities, nervousness<\/li><li>taste change<\/li><li>heart disease such as decreased heart rate or chest pain (angina)<\/li><li>asthma&nbsp;, too little oxygen reaching the body&#8217;s organs<\/li><li>swollen abdomen.<\/li><\/ul>\n\n\n\n<p><strong>Very rare&nbsp;side effects&nbsp;(may affect up to 1 in 10,000 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>transient increase in different types of&nbsp;antibodies&nbsp;in the blood (&nbsp;immunoglobulins&nbsp;&#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<\/li><li>kidney failure<\/li><li>severe visual impairment (signs of brain nerve damage).<\/li><\/ul>\n\n\n\n<p><strong>No known frequency (it is not known how often these&nbsp;side effects&nbsp;occur):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>delayed decrease in&nbsp;white blood cells<\/li><li>reduction of&nbsp;platelets&nbsp;shortly after&nbsp;infusion&nbsp;one &#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>MabThera may also cause changes in laboratory tests performed by your doctor.<\/p>\n\n\n\n<p>If you are receiving MabThera in combination with other medicines, some of the&nbsp;side effects&nbsp;you may have may be due to the other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store MabThera<\/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;dat.&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 &#8211; 8 \u00b0 C).&nbsp;Do not freeze.&nbsp;Store 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 pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">What MabThera 1400 mg, solution for injection for subcutaneous injection contains<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is rituximab.&nbsp;Each&nbsp;vial&nbsp;contains 1400 mg \/ 11.7 ml rituximab.&nbsp;Each ml contains 120 mg of rituximab.<\/li><li>The other ingredients are&nbsp;recombinant&nbsp;human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, \u03b1, \u03b1-trehalose dihydrate, L-methionine, Polysorbate 80 and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What MabThera 1400 mg, solution for injection, subcutaneous injection solution looks like and contents of the pack<\/h2>\n\n\n\n<p>MabThera is a clear to opalescent, colorless to yellowish solution that is ready to use.&nbsp;It is provided as a solution for&nbsp;subcutaneous&nbsp;injection&nbsp;in a&nbsp;stained glass&nbsp;vial&nbsp;with a butyl rubber stopper with an aluminum seal and a detachable pink plastic seal.<\/p>\n\n\n\n<p>Each&nbsp;vial&nbsp;contains 1400 mg \/ 11.7 ml rituximab.&nbsp;Each pack contains 1&nbsp;vial&nbsp;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Roche Registration GmbH<\/p>\n\n\n\n<p>Emil-Barell-Strasse 1<\/p>\n\n\n\n<p>79639 Grenzach-Wyhlen<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Roche Pharma AG<\/p>\n\n\n\n<p>Emil-Barell-Str.&nbsp;1<\/p>\n\n\n\n<p>D-79639 Grenzach-Wyhlen<\/p>\n\n\n\n<p>Germany<\/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>Sweden<\/strong>Roche ABTel: +46 (0) 8 726 1200<\/td><td><strong>Finland \/ Finland<\/strong>Roche OyPuh \/ Tel: +358 (0) 10 554 500<\/td><\/tr><tr><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>MabThera 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":[2200,15580],"tags":[16755,16750,16751,16754,16746,16749,16752,16747,16753,16748],"class_list":["post-17290","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-benefits-of-mabthera","tag-benefits-of-rituximab","tag-mabthera","tag-mabthera-side-effects","tag-rituximab","tag-rituximab-side-effects","tag-what-is-mabthera","tag-what-is-rituximab","tag-what-mabthera-is-used-for","tag-what-rituximab-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17290","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=17290"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17290\/revisions"}],"predecessor-version":[{"id":17346,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17290\/revisions\/17346"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=17290"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=17290"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=17290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}