In case of accidental paravenous administration of cyclophosphamide, the infusion should be stopped immediately, the extravascular cyclophosphamide solution should be aspirated with the cannula in place, and other measures should be instituted as appropriate. Rituxan is the brand name of the drug rituximab, which is used to treat nonhodgkin lymphoma a type of cancer that starts in the lymphatic system and chronic lymphocytic leukemia a type of. What is the most important information i should know about rituximab rituxan, truxima. Relapsed or refractory, lowgrade or follicular, cd20positive, bcell nhl as a single agent. Rituxan rituximab label food and drug administration. The earliest marketed date recorded in the drug product database. Melted cyclophosphamide is a clear or yellowish viscous liquid.
For other severe or lifethreatening toxicities related to zydelig, withhold drug until toxicity is resolved. Because clinical trials are conducted under very specific conditions, the adverse event rates observed may not refl ect the rates observed in clinical practice. Rituxan rituximab is indicated for the treatment of adult patients with. With the discovery of rituximab, more than 70 percent of patients diagnosed with nonhodgkin lymphoma now live five years past their initial diagnosis. In rheumatoid arthritis, rituximab was infused at a fixed dose of mg on days 1 and 15.
Previously untreated follicular, cd20positive, bcell nhl in combination with first line. What are the possible side effects of rituximab rituxan, truxima. Based on human data, rituximab products can cause adverse developmental outcomes, including lymphoid bcell depletion. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed. Health professional information 1 indications indications have been granted on the basis of similarity between truximatm and the reference biologic drug rituxan. Acetaminophen 650 mg po 30 minutes prior to rituximab diphenhydramine 50 mg po or iv 30 minutes prior to rituximab first infusion. The product monograph is developed by a drug sponsor according to guidelines published by health canada that provide direction on the content and format. Ruxience rituximabpvvr injection is a sterile, preservativefree, clear to slightly opalescent, colorless to pale brownishyellow solution for intravenous infusion. Find out what health conditions may be a health risk when taken with rituximab intravenous. A total of 220 patients were randomized to receive study treatment as assigned. Rituximab drug monograph pediatric care online aap. The recommendations in this online publication do not indicate an exclusive course of treatment or serve as a standard of medical care.
The benefits and risks of treatment with humira should be carefully considered before initiating therapy. Rituximab and ofatumumab have mechanisms of action similar to ocrelizumab, and all 3 agents are being studied for use as diseasemodifying therapy for ms. Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in. Find patient medical information for rituximab intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Wear protective clothing including gloves and face mask. Rituximab can deplete b cells for several months and, as such, could represent an effective therapy for b cellmediated autoimmune diseases.
Circulating b cells depleted within 3 weeks after the first dose in patients with nhl. Used as monotherapy for treatment of relapsed or refractory lowgrade or follicular, antigen cd20positive, bcell nonhodgkins lymphoma nhl. Rituxan rituximab is a cd20directed cytolytic antibody indicated for the treatment of adult patients with. Rituximab abbs has an approximate molecular weight of 145 kd. Us exhibited similar pk profiles following administration of assigned study drug on days 1 and 15. Niosh list of antineoplastic and other hazardous drugs in. Dailymed ruxience rituximabpvvr injection, solution. Rituximab is a monoclonal antibody composed of human and mouse protein. Rituximab in renal transplantation prescribing protocol. Rituximab has therefore been proposed in rheumatoid arthritis and systemic lupus erythematosus. The veterinary labelling is developed by the drug sponsor according to the food and drug regulations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Rituximab rituxan is indicated for the treatment of rheumatoid arthritis in.
Adverse drug reaction overview treatment of wet amd. They treat the various types of nhl and cll by killing cancer cells. Rituximab products may cause fetal harm if used in pregnant women. Rituximab should be administered in a setting where full resuscitation facilities are immediately available, and under the close supervision of someone experienced and capable of dealing with severe infusionrelated reactions. Discovery development of rituximab national cancer institute. Precautions should be taken to avoid extravasation, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and. Apr 29, 2016 a total of 220 patients were randomized to receive study treatment as assigned. Venclexta in combination with rituximab venclexta venetoclax in combination with rituximab is indicated for the treatment of adult. The benefits and risks of treatment with humira should be carefully.
Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. Variations, taking into account individual circumstances, may be appropriate. Pdf the complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered.
See full prescribing information for rituxan hycela. Rituximab abbs is produced by mammalian cell chinese hamster ovary suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Nonhodgkins lymphoma nhl truximatm rituximab for injection is indicated for. Rituxan rituximab administration and infusion information. Discovery development of rituximab national cancer. See important safety including boxed warnings for more information. Relapsed or refractory, lowgrade or follicular, cd20positive, bcell nhl as a single agent previously untreated follicular, cd20positive, bcell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituxan in. Funding available through the ontario public drug programs via the exceptional access program. What should i discuss with my healthcare provider before receiving rituximab rituxan, truxima. This drug should only be used by health professionals experienced in treating nonhodgkins lymphoma nhl and chronic lymphocytic leukemia cll. For details on rituximab subcut administration, refer to rituximab subcut drug monograph. A total of 1824 patients with up to 96 weeks exposure to eylea constituted the safety population in the 2 doubleblind activecontrolled clinical studies view1 and view2.
Rituxan rituximab side effects, dosage, interactions drugs. Ofatumumab arzerra september 2010, updated august 2014. Rituxan hycela rituximab and hyaluronidase human injection, for subcutaneous use initial u. Rituximab injection rituxan is used to treat pemphigus vulgaris a condition that causes painful blisters on the skin and the lining the mouth, nose, throat and genitals. Several adverse reactions are associated with rituxan, some of which are severe and lifethreatening see warnings and precautions. Highlights of prescribing information these highlights do not include all the information needed to use rituxan safely and effectively. Rituximab is a monoclonal antibody that was first approved by the fda as an antineo plastic agent designed to treat bcell malignancies. Previously untreated follicular, cd20positive, bcell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as singleagent maintenance therapy. Truxima fda prescribing information, side effects and uses. Webmd provides common contraindications for rituximab intravenous. Read about rituxan rituximab administration and standard infusion information for nonhodgkins lymphoma and cll. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.
Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. Truximatm rituximab for injection is a biosimilar biologic drug biosimilar to rituxan. Each month, subscribers to the formulary monograph service receive 5 to 6 welldocumented monographs on drugs that are newly released or are in late phase 3 trials. Highlights of prescribing information these highlights do not include all the information needed to use rituxan hycela safely and effectively. Because clinical trials are conducted under very specific conditions, the adverse event rates observed may not reflect the rates observed in clinical practice. Va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Rituxan rituximab dose, indications, adverse effects.
Depletion of circulating b cells lasted for up to 69 months in 83% of patients with nhl in one study. Rituximab is a monoclonal antibody that was first approved by the fda as an antineoplastic agent designed to treat bcell malignancies. Nci funded the development of rituximab, one of the first monoclonal antibody cancer treatments. Adverse events are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials, andor determined to be. Humira product monograph page 8 of 164 date of revision. Rituximabpvvr has an approximate molecular weight of 145 kd. The antilymphocyte monoclonal antibodies cause lysis of b lymphocytes. This drug should only be used by health professionals experienced in treating nonhodgkins lymphoma nhl, chronic lymphocytic leukemia cll, rheumatoid. It is used for nonhodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and epsteinbarr virus. Nov 01, 2019 rituximab abbs is a genetically engineered chimeric murinehuman monoclonal igg 1 kappa antibody directed against the cd20 antigen. Rituximab drug monograph uk paediatric care online. If resuming zydelig after interruption for other severe or lifethreatening toxicities, reduce the dose to. Rituximab sc same antibody, different route of administration contains the same rituximab antibody as currently approved rituxan after maximal concentrating, larger than traditional sc.
Begin at 25mlhour, increasing in 25mlhour increments every 30minutes to maximum rate of 200mlhour. Rituximab is now associated with chemotherapy for the treatment of nonhodgkins lymphoma and should be approved soon in maintenance strategies. Rituxan rituximab side effects, dosage, interactions. Improvement in patient survival or disease related symptoms has not been established.
The following are significant adverse drug reactions identified in clinical trials conducted with venclexta. Rituximab, sold under the brand name rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. Do not use cyclophosphamide vials if there are signs of melting. Sign in or purchase a subscription to access this content. Rituximab injection products are in a class of medications called monoclonal antibodies. It is used for nonhodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and epsteinbarr viruspositive mucocutaneous ulcers. Treanda product monograph page 5 of 40 there are postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling and pain. Rituximabpvvr is produced by mammalian cell chinese hamster ovary suspension culture in a nutrient medium.
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