Mabthera 500 mg concentrate for solution for infusion summary of product characteristics smpc by roche products limited. Mabthera 1400 mg solution for subcutaneous injection rituximab. Assessment report for mabthera rituximab procedure no. Randomized, doubleblind, pharmacokinetic equivalence trial comparing drlrituximab with mabthera in patients with diffuse large bcell lymphoma. Longterm responses seen with rituximab in patients with itp pdf. Mabthera selectively targets bcells and represents a new highly effective therapeutic approach for ra in addition to existing treatments such as dmards and tnfinhibitors. We do not take any responsibility for accessing such information in those circumstances. Roche announced results from its phase iii pemphix trial evaluated mabtherarituxan rituximab compared to mycophenolate mofetil mmf in adults with moderate to severe pemphigus vulgaris pv. Hoffmannla roche ltd hereafter referred to as roche proposes the inclusion of a new formulation for. The fdas action date for a decision is march 28, 2017. Fatal infusionrelated reactions within 24 hours of rituxan infusion.
When rituximab attaches to cd20, it causes the death of blymphocytes, which helps in lymphoma and cll where blymphocytes have become cancerous and in rheumatoid arthritis where blymphocytes are involved in joint. Mabtherarituxan sales performance, data and rankings. Supply, storage and handling of mabthera 1,400 mg solution for subcutaneous injection how mabthera sc is supplied. Extensive blistering can lead to serious, lifethreatening fluid loss, infection andor death. An australian public assessment record auspar provides information about the evaluation of a prescription medicine and the considerations that led the tga to.
In patients with ra, the duration of peripheral b cell depletion was variable. Rheumatoid arthritis granulomatosis with polyangiitis and. Roche clinches eu approval for mabthera in rare autoimmune. Mabthera rituxan is the first fdaapproved treatment for moderate to severe pemphigus vulgaris pv in more than 60 years. Mabthera instructions for use, the rules of treatment. Roche holding ag rhhby free report announced that the european commission ec has approved the subcutaneous sc formulation of mabthera rituximab for the treatment of patients suffering. Fda approves roches mabtherarituxan rituximab for pemphigus vulgaris. Hoffmannla roche ltd 4070 basel switzerland group communications roche group media relations tel.
Rituxan is a sterile, clear, colorless, preservativefree. Rituxan rituximab is indicated for the treatment of patients with previously. Mabthera 500 mg concentrate for solution for infusion. Drug mabthera 100mg 1vial infusion rituximab price. Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve peoples lives. Patients and methods we conducted a doubleblind, parallelgroup study in patients with untreated dlbcl. Mabthera, known as rituxan in the united states, is a leading product for roche, but it faces significant competition from biosimilars and a measurable decline in sales. Fda approves rituxanmabthera for firstline maintenance. Pharmaceutical form mabthera concentrate for solution for intravenous iv infusion is a clear, colourless liquid supplied in sterile, preservative free, nonpyrogenic singledose vials. The combined strengths of pharmaceuticals and diagnostics under one roof have made roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way. Subcutaneous rituximab for the treatment of bcell hematologic. Mabthera 100 mg and 500 mg concentrate for solution for. Roche holdings ag rhhby free report announced that the european commission has approved a label expansion of its rheumatoid arthritis ra drug, mabthera the drug is now approved in europe. It is marked by progressive and painful blistering of the skin and.
Mabthera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients aged. For more than 20 years, roche has been developing medicines that redefine treatment in haematology. Mabthera is the first biologic treatment approved for moderate to severe cases of the rare autoimmune disease pemphigus vulgaris pv, and the first major advancement in the treatment of the disease in more than 60 years. Summary statement of the proposal for inclusion, change or deletion f. If approved, this would be the first paediatric indication for mabtherarituxan. Rituximab, sold under the brand name rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. Rituxanmabthera plus chemotherapy, nearly doubled the likelihood of them living without their disease worsening progressionfree survival. Auspar mabthera sc rituximab roche products pty ltd pm20120445314 final 4 september 2014 page 3 of 52. Mabthera 1400 mg solution for subcutaneous injection. Rituxan rituximab injection is a sterile, preservativefree, clear, colorless solution for intravenous infusion. Mabtherarituxan is the first fdaapproved treatment for moderate to severe pemphigus vulgaris pv in more than 60 years. Approval for a rare autoimmune disorder may help company fight declining sales in face of biosimilar competition.
The use of rituxan in cll is based on an improvement in progression free survival. The active substance in mabthera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called cd20 present on the surface of blymphocytes. To report an adverse event side effect associated with a roche medicinal product, please contact the roche australia drug safety department immediately on australia. Rituximab, sold under the brand name rituxan among others, is a medication used to treat. Analysis of rituximab, a therapeutic monoclonal antibody. It works by turning off a part of the immune system that is not working properly in autoimmune diseases. Application for the addition of mabthera rituximab on the who model. These cells are central to many blood cancers, including common forms of lymphoma and leukaemia. Roche also presented other important clinical results in 2016. Efficacy, pharmacodynamics pds, safety, and immunogenicity were also compared. Cd20 is a hydrophobic transmembrane protein which is present on the cell surface of preb and mature blymphocytes.
European commission approves roches mabthera rituximab for a rare autoimmune disease. European commission approves roches mabthera for rare. Mabthera nao pode ser administrado por via oral ou intramuscular. An overview of roches hematooncology drugs mabthera and. In addition to mabthera and gazyvaro, roches pipeline includes further potential haematology medicines. A duracao do tratamento com mabthera sera estabelecida pelo medico, dependendo da doenca, do seu organismo e da resposta ao tratamento. This product information was approved at the time this auspar was published. Mabthera is a concentrate that is made up into a solution for infusion drip into a vein. Randomized, doubleblind, pharmacokinetic equivalence. Patient fact sheet rituximab rituxan and mabthera is a drug used to treat rheumatoid arthritis, and certain forms of vasculitis, that has not improved with other types of medications.
Rituximab is currently comarketed by biogen and genentech in the u. Mabthera 100mg 1vial infusion rituximab drug information. 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 mabthera sc to their patients with nonhodgkins lymphoma nhl. If you have health insurance coverage for your medicine, you must have already tried other types of patient assistance to qualify for free genentech medicine from. Mabthera is indicated for treatment of patients with stage iiiiv follicular lymphoma who are chemoresistant. Roche is seeking regulatory approval for this medicine in rms and ppms in the us and the eu. In april, roche had to recall nine batches of herceptin after tampered vials were discovered in the uk, finland, and germany. What is in this leaflet this leaflet answers some common questions about mabthera infusion. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.
Mabthera 500 mg concentrate for solution for infusion patient information leaflet pil by roche products limited. Pemphigus vulgaris is a rare, serious and potentially lifethreatening disease. Mabtherarituxan rituximab mabthera is the first therapeutic monoclonal antibody to target cells that have the cd20 marker on their surface. Roches mabthera rituximab blood cancer and inflammatory diseases drug faces cheaper competition for the first time in europe after regulators approved. Detlef krawinkel, mabthera life cycle leader, roche pharma. Mabthera attacks these cells both directly and together with the bodys immune system. Mabthera rituxan rituximab mabthera is the first therapeutic monoclonal antibody to target cells that have the cd20 marker on their surface. Cd20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding. Narrow your search to look for specific document types, including application notes, manuals, protocols, and brochures. Mabthera, also known as rituximab, is a prescription medicine used to treat nonhodgkins lymphoma nhl in indolent nhl, mabthera is registered by medsafe for the treatment of follicular lymphoma patients for induction treatment, in combination with chemotherapy maintenance therapy, as a single treatment for a set number of cycles to help prevent relapse. Mabthera is used to treat nonhodgkins lymphoma nhl and chronic lymphocytic leukaemia cll and was roches.
Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Mabtherarituxan iv in combination with methotrexate is indicated in adult. European commission approves roches mabthera rituximab. Overall survival benefit has not been demonstrated in patients with previous treatment for cll. Roche noted that in this latest investigation, there does not appear to be any evidence that patients have been harmed by counterfeit mabthera. Search for a variety of documents via title or keyword. Fda approves roche s mabthera rituxan rituximab for pemphigus vulgaris. Roche fda approves roches mabtherarituxan rituximab.
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. However, roche is now preparing to face biosimilar competition with a herceptin alternative expected to launch next year, along with soontobe offpatent biologics avastin bevacizumab and mabthera rituximab marketed as rituxan by biogen in the us. Progressionfree survival in patients receiving rituximab sc or iv in a the phase iii sabrina study 44. Mabthera is indicated for the treatment of previously untreated adult patients with stage iiiiv follicular lymphoma in. Illicit copies of mabthera and another of roches cancer drugs called avastin bevacizumab were also discovered in the us and several european markets in 2012 and in china a year earlier. Roche gets approval for label expansion of mabthera in. The use of rituxan in cll is based on an improvement in progressionfree. Staying ahead of biosimilar competition, roches rituxan. That is why the statement of mabthera prescribes preventive measures and strict rules for infusion, which can reduce the risk. Mabthera definition of mabthera by medical dictionary. Monitor patients and discontinue rituxan infusion for severe reactions. Mabthera contains the active substance rituximab rtx which is a chimeric murinehuman monoclonal antibody that binds cd20. Each 10 ml vial of mabthera 100mg concentrate for intravenous iv infusion contains 100. Roches subcutaneous formulation of mabthera gets eu nod.