O tratamento com mabthera nao deve ser iniciado em pacientes com infeccoes graves ativas, por. Indications, side effects, contraindications and other prescribing information for mabthera on mims. Mabthera 1400 mg solution for subcutaneous injection rituximab for nhl only guide to supply, storage, handling and administration produced by roche for healthcare professionals who are administering. Phase i trials of rituximab sc maintenance therapy in patients with follicular lymphoma and trastuzumab sc in healthy volunteers and patients with early breast cancer have demonstrated substantially shorter administration times and comparable tolerability and pharmacokinetics compared with iv formulations. See the summary of product characteristics also part of the epar for full details. It means that the antibody is developed from one plasmatic cell predecessor.
Fatal infusion reactions within 24 hours of rituxan infusion occur. Weiner rituximab is a mainstay in the therapy for a broad variety of bcell malignancies. What mabthera is used for mabthera contains the active ingredient rituximab. Mriblinded, singlecenter study to evaluate the effects of rituximab 375 mgm2 weekly for four weeks on gadoliniumenhancing lesions primary objective in patients who had been treated with a standard injectable diseasemodifying agent in the past 18 months but had shown an inadequate response and were then given rituximab as addon therapy. The sponsor initially requested an additional indication for use in methotrexate mtx naive patients based on the image study. Background the licensed dose of rituximab in rheumatoid arthritis ra is two doses of mg given 2 weeks apart. Mabthera 100mg and 500mg concentrate for solution for infusion summary of product characteristics. Your healthcare provider should give you medicines before your infusion of rituxan to decrease your chance of having a severe infusionrelated reaction. Mabthera monotherapy is indicated for treatment of patients with stage iii iv follicular lymphoma who are chemoresistant or are in their second or s ubsequent relapse after chemotherapy. Mabthera rituxan rituximab mabthera is the first therapeutic monoclonal antibody to target cells that have the cd20 marker on their surface. This antigen is located on preb and mature blymphocytes, but not on hemopoietic stem cells, prob cells, normal plasma cells or other normal cells. Mabthera definition of mabthera by the free dictionary.
Mabthera synonyms, mabthera pronunciation, mabthera translation, english dictionary definition of mabthera. Finally, recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of mabthera have been included in the summary of product characteristics. In december 1992, biogen filed an investigational new drug ind application with the us food and drug adminstration fda, which was only about two and a half. Rituximab rituxan and mabthera is a drug used to treat rheumatoid arthritis that has not improved with other types of medications, as well as certain forms of vasculitis. Rituximab protocol for paediatric rheumatology oxford university. Rituximab, also known as mabthera or rituxan is an antibody which is directed against bcells, specifically a marker on certain types of bcells called cd20. Mabthera has been shown to reduce the rate of progression of joint damage as measured by xray, to improve physical function and to induce major clinical response, when given in combination with. Mabthera 100 mg concentrate for solution for infusion summary of product characteristics smpc by roche products limited. Mabthera is available as a concentrate that is made up into the solution for infusion and as a ready made solution for the injection under the skin. Novartis filing for mabthera biosimilar accepted in the eu. Roche registration limited 6 falcon way shire park welwyn. Mabtherarituxan rituximab mabthera is the first therapeutic monoclonal antibody to target cells that have the cd20 marker on their surface.
Injectable mabthera cuts administration time to five minutes. Use of mabthera may be associated with an increased risk for infections. B lymphocytes play a role in the inflammation observed in ra, gpa and mpa. Monitor patients and discontinue rituxan infusion for severe reactions 5. Mabthera should be administered as two 500 mg iv infusions separated by two weeks, followed by a 500 mg iv infusion every 6 months thereafter. On this page about mabthera you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the. Despite its undeniable therapeutic value, we still do not fully understand. Mabthera 500 mg concentrate for solution for infusion.
The use of rituximab is considered in patients with active juvenile onset systemic lupus. Patients reporting signs and symptoms of infection following mabthera therapy should be promptly evaluated and treated appropriately. Article mundipharma and orexo file for eu approval of zubsolv in opioid dependence. Severe mucocutaneous reactions, some with fatal outcomes 5. Rituximab is a genetically engineered chimeric mousehuman monoclonal antibody. Assessment report for mabthera rituximab procedure no. First mabthera biosimilar to launch in eu for cancer. If you have any concerns about being given this medicine, ask your doctor or pharmacist. Relevant identified uses of the substance or mixture and uses advised against. Important information about mabthera medicines authority. These cells are central to many blood cancers, including common forms of lymphoma and leukaemia.
Nhs england has approved funding for a new subcutaneous formulation of roches cancer drug mabthera rituximab which offers patients with follicular lymphoma a more convenient treatment option while potentially saving the national health service a lot of cash. In use product safety assessment report for truxima and rixathon rituximab biosimilars summary of assessment and its findings background two biosimilar versions of mabthera, the originator rituximab product 100 and 500mg have been launched. Mabthera against the benefits they expect it will have for you. Mabthera has been shown to reduce the rate of progression of joint damage as measured by xray, to improve physical function and to induce major clinical response, when given in combination with methotrexate. On this page about mabthera you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. Assessment report for mabthera rituximab procedure. Mabthera 100mg and 500mg concentrate for solution for. Mabthera may be used for the treatment of several different conditions in adults and children.
This is a summary of the european public assessment report epar for mabthera. Rituxan rituximab administration and infusion information. Mabthera is indicated for the treatment of previously untreated adult patients with. Transient hypotension and bronchospasm have occurred in association with mabthera. In addition, the company that markets mabthera will also submit reports from studies on the longterm safety of mabthera. Pdf icon download leaflet view the patient leaflet in pdf format. Mabthera attacks these cells both directly and together with the bodys immune system. Mabthera 1400 mg solution for subcutaneous injection summary of product characteristics. No total, 321 no total, 321 pacientes 162 rcvp, 159 cvp receberam o tratamento e foram analisados quanto a eficacia. Mabthera infusion mabthera intravenous tell your doctor if. Through its combination with a recombinant human enzyme called hyaluronidase, penetrability of the layer of tissue under the skin is temporarily increased, facilitating injection and absorption of mabthera into the body. Mabthera is a clear, colourless solution, supplied as a concentrate for solution for infusion. Mabthera for multiple sclerosis have ms, will travel.
Mabthera 500 mg concentrate for solution for infusion patient. In diabetes, insulin sc has been available for 50 years and is the. A chimeric monoclonal antibody used to treat certain types of nonhodgkin lymphoma, chronic lymphocytic leukemia, and refractory rheumatoid arthritis. In december 1992, biogen filed an investigational new drug ind application with the us food and drug adminstration fda, which was only about two and a half years after the first immunization of mice with cd20 in august 1990, and only about one and a half year after the first quantities of rituximab were produced in a cho cell line. Administration of rituximab and in111ibritumomab tiuxetan should precede rituximab and y90ibritumomab tiuxetan by 7 to 9 days. Nhs england has approved funding for a new subcutaneous formulation of roches cancer drug mabthera rituximab.
Mabthera rituximab is a genetically engineered chimeric murinehuman monoclonal antibody directed against the cd20 antigen found on the surface of normal and malignant b lymphocytes. For the treatment of multiple sclerosis, mabthera is given every 6 months. Read about rituxan rituximab administration and standard infusion information for nonhodgkins lymphoma and cll. Qualitative and quantitative composition 1 singleuse vial contains 100 mg in 10 ml of rituximab.
Identification of the substancemixture and of the companyundertaking 1. It sticks to the surface of a type of white blood cell called blymphocyte. Mabthera spc for full prescribing information indication. Rituximab, sold under the brand name rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. By binding to the protein mabthera reduces the ability of b lymphocytes to cause inflammation. Dec 16, 2019 infuse rituximab 250 mgm2 iv within 4 hours prior to the administration of indium111 in111 ibritumomab tiuxetan and within 4 hours prior to the administration of yttrium90 y90 ibritumomab tiuxetan. This product information was approved at the time this auspar was published. See important safety including boxed warnings for more information. Mabthera maintenanc e therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Evaluation of lowdose rituximab for the retreatment of.
Submission of the primary csr for study wa29330 pemphix in fulfilment of the first part of post approval commitment paes listed in the annex iid of mabthera product information in addition qrd template was adjusted to the latest version qrd 10. Novartis nvs announced that the ema has accepted its generic arm sandozs maa for its proposed biosimilar of roches rhhby mabthera. Mabthera contains the active ingredient rituximab rch. Safety data sheet mabthera sc according to regulation eu nr. It works by turning off a part of the immune system that is not working properly in autoimmune diseases. Qualitative and quantitative composition 1 singleuse vial contains 100 mg in 10. See full prescribing information for complete boxed warning. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. Mabthera 1400 mg solution for subcutaneous injection rituximab. This is a huge deal for me as tysabri, while awesome, sort of hampered on my travel planning. Subcutaneous administration of rituximab mabthera and. Article polish biotech firm signs deal to supply a biosimilar of mabthera to mylan. Rituximab is a monoclonal antibody that works by removing bcells a type of white blood cell.
European commission approves roches mabthera rituximab for a rare autoimmune. Depending on the condition it is used to treat, mabthera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid. Roche registration limited 6 falcon way shire park welwyn garden city al7 1tw united kingdom. Below is a text only representation of the patient information. Mabthera belongs to a group of medicines known as anticancer agents. These cells are central to many blood cancers, including. Mabthera 1400 mg solution for subcutaneous injection. Patients should receive mabthera for at least 24 months after achievement of remission absence of clinical signs and symptoms. Pdf subcutaneous administration of rituximab mabthera and. Dec 11, 2012 mabthera sc represents a significant advance in the way that nhl cancer treatment is delivered. Through its combination with a recombinant human enzyme called hyaluronidase. Mabthera is a part of medicine rituksimab which is the main active ingredient, and a number of auxiliary components. Final recovery is observed approximately in 9 months of use of mabthera. In march 2012, when the serum myoglobin had increased to a level three times above the upper normal level, i started therapy with rituximab and within a month my myoglobin value was more.
Mabthera is contraindicated in patients with known hypersensitivity to any component of this product or to murine proteins. Mriblinded, singlecenter study to evaluate the effects of rituximab 375 mgm2 weekly for four weeks on gadoliniumenhancing lesions primary objective in patients who had been treated with a standard. A chimeric monoclonal antibody used to treat certain types of nonhodgkin lymphoma. Rituksimab who is a part of mabthera represents an antibody which is developed by the immune cells relating to a uniform cellular clone.
A lower dose has never been specifically studied in patients with an. It is used for nonhodgkins lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and epsteinbarr viruspositive mucocutaneous ulcers. Mabthera is the first therapeutic monoclonal antibody to target cells that have the cd20 marker on their surface. Submission of the primary csr for study wa29330 pemphix in fulfilment of the first part of post approval commitment paes listed in the annex iid of mabthera. Mabthera 100mg and 500mg concentrate for solution for infusion summary of product characteristics smpc by roche products limited. Patients who receive mabthera for rheumatoid arthritis must be given a special card that explains the symptoms of certain types of infection that can occur as a side effect of mabthera, instructing patients to seek medical care immediately if they experience them. This is a type of protein called a monoclonal antibody. Mabthera 100 mg concentrate for solution for infusion summary. Before giving a subsequent course of mabthera treatment, patients should be reevaluated for any potential risk for infections. Subcutaneous administration is commonly used in a number of therapy areas. With mabthera, it allows me to be more spontaneous and free. Nov 18, 20 for the treatment of multiple sclerosis, mabthera is given every 6 months.
Mabthera works by binding to a protein on the surface of certain white blood cells known as b lymphocytes. Pripravek mabthera rituximab u revmatoidni artritidy. Your doctor may prescribe mabthera for the treatment of. You are on page 1 of 1 show all entries previous page. In patients with ra, the duration of peripheral b cell depletion was variable. Roches mabthera sc to be funded on nhs pharmatimes. Mabthera sc is indicated in adults for nonhodgkins lymphoma nhl only. Finally, recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of mabthera have been included in the summary of product characteristics and the package leaflet. Podrobne informace viz spc pripravku mabthera indikace pripravek mabthera je v kombinaci s methotrexatem indikovan k lecbe dospelych pacientu s tezkou aktivni. Product identifier product name mabthera sc product code sap101539 1. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Mabthera rituximab is a genetically engineered chimeric mousehuman monoclonal antibody which binds specifically to the transmembrane antigen, cd20.
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