Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Dose delays, dose modifications and reinitiation of therapy for cll. Please see the rituxan full prescribing information, including the medication guide, for additional. Rituxan rituximab is indicated, in combination with fludarabine and cyclophosphamide fc, for the treatment of patients with previously untreated and previously treated cd20positive cll. If infusion reactions occurred during rituximab infusion on day 1 of treatment, administer rituximab at an. The recommended dose for cll is rituxan hycela1,600 mg26,800 units 1,600 mg rituximab and 26,800 units hyaluronidase human in combination with fc chemotherapy, at a fixed dose, irrespective of patients body surface area. Rituximab is a genetically engineered chimeric mousehuman monoclonal antibody representing a glycosylated immunoglobulin with human igg1 constant regions and murine lightchain and heavychain variable region sequences. Rituxan rituximab, truxima rituximababbs ruxience rituximabpvvr rituximab fep clinical rationale acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from. The recommended dose is 100 mgm2 administered intravenously over 30 minutes on days 1 and 2 of a 28day cycle, up to 6 cycles. Start rituximab administration after the patient has completed the 5week dose rampup schedule with venclexta see table 1 and has received the 400 mg dose of. Rituxan prescribing information pdf download for more information, ask your doctor or pharmacist.
Follicular lymphoma as an initial treatment with chemotherapy and, in patients whose initial treatment was successful, as a singleagent followup therapy. Highlights of prescribing information these highlights do not include all the information needed to use rituxan safely and effectively. The clinical relevance of antirituximab antibody formation in rituxantreated patients is unclear. Highlights of prescribing information these highlights do not include all the information needed to use venclexta safely and effectively. Acrotech biopharma llc zevalin ibritumomab tiuxetan. 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. Learn about rituxan access solutions, a resource that provides reliable, effective access and reimbursement support to assist your patients and practice. See full prescribing information for rituxan hycela. 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. Tls is caused by the fast breakdown of cancer cells. Lcysteine hydrochloride hydrate 10 mg, sodium bisul. Rituximab is a genetically engineered chimeric mousehuman monoclonal antibody.
Zevalin therapy to treat nonhodgkins follicular lymphoma. For more information, please refer to the enclosed full prescribing information for each product. Highlights of prescribing information the dose for ra in. Drugrelated reactions, which may be related to cytokine release, include fever and chillsrigors. Erbitux can cause serious and fatal infusion reactions. Sections or subsections omitted from the full prescribing information are not listed. Serious infusionrelated reactions can happen during your infusion.
Highlights of prescribing information truxima rituximab. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Rituximab, cyclophosphamide, doxorubicin and prednisone therapy toxicity dose modification or delay hematological toxicity grade 3 or higher neutropenia, or a platelet count not at or above 25 109l withhold velcade therapy for up to 2 weeks until the patient has an anc at. The mechanism of action of rituximab is through complementmediated cell lysis and antibodydependent cellular cytotoxicity through. Treatment of patients with gpampa who have achieved disease control with induction treatment gpampa study 2. See what is the most important information i should know about rituxan. See full prescribing information, including boxed warning. Truxima rituximababbs is a cd20directed cytolytic antibody indicated for the treatment of adult patients with. Highlights of prescribing information these highlights do not include all the information needed to use baraclude safely and effectively. Mabthera 500 mg concentrate for solution for infusion. Questions and answers on rituximab added 12192006 fda warns of safety concern regarding rituxan in new patient population. Mabthera 100 mg concentrate for solution for infusion. See full prescribing information including boxed warning on serious infections. Administer rituximab 250 mgm intravenously at an initial rate of 100 mghr.
Screen all patients for hbv infection before treatment initiation, and monitor patients during and after. Previously untreated follicular, cd20positive, bcell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to. Follicular lymphoma fl as a singleagent therapy in patients whose disease recurred or did not respond to initial treatment. Ruxience rituximabpvvr this product information is intended only for residents of the united states. Each bag contains the following inactive ingredients. Increase rate by 100 mghr increments at 30 minute intervals, to a maximum of 400 mghr, as tolerated. Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic ras mutations in exon 2 codons 12 and, exon 3 codons 59 and 61, and exon 4 codons 117 and 146 of either kras or nras and hereafter is referred to as. Infusionrelated reactions are the most common side effect of rituxan treatment. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated.
Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma fl. Rituximab is a chimeric murinehuman monoclonal immunoglobulin g1 antibody that targets cd20, which is a bcell differentiation marker. Relapsed or refractory, lowgrade or follicular, cd20positive, bcell nhl as a single agent. The recommended dose is 100 mgm2 administered intravenously over 10 minutes on days 1 and 2 of a 28day cycle, up to 6 cycles. Rituximab rituxan american journal of neuroradiology. Hepatitis b virus hbv reactivation hbv reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. In combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission. Rituxan rituximab is indicated for the treatment of adult patients with. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. According to its approved package insert, ruxience is indicated for the treatment of certain types of nonhodgkins lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis wegeners granulomatosis, and microscopic polyangiitis. Refer to the zevalin package insert for full prescribing information regarding. Accelerated approval was granted for fl and sll based on. Rituxan is not recommended for use in patients with severe, active infections.
Proleukin, a lymphokine, is produced by recombinant dna technology using a genetically engineered e. Continued approval for this use may depend on the results of an ongoing study to find. Refer to the zevalin package insert for full prescribing information regarding the zevalin therapeutic regimen. Rituximab is used to reduce the number of bcells in your blood and y90 zevalin is given to treat your nonhodgkins lymphoma nhl. Fda approves ruxience, pfizers rituximab biosimilar. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for rituxan rituximab. Please see the rituxan prescribing information and medication guide. Rituximab rituxan, a chimeric anticd20 monoclonal antibody, is a commonly used component of the treatment of various lymphoproliferative and rheumatologic disorders pdf. On july 23, 2019, the fda approved pfizers abla for ruxience rituximabpvvr, a biosimilar of genentechs rituxan. See important safety including boxed warnings for more information. The chemical name is desalanyl1, serine125 human interleukin2.
Rituxan hycela rituximab and hyaluronidase human injection, for subcutaneous use. Each 50 ml vial of mabthera 500mg concentrate for intravenous iv infusion contains 500 mg of rituximab. Find information about rituxan rituximab, a possible treatment for ra, nhl, cll, gpa, mpa, and pv. Rituxan rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with wegeners granulomatosis wg and microscopic polyangiitis mpa. Find information about rituxan rituximab, a possible treatment for ra, nhl, cll. Rituxan rituximab label food and drug administration. Each 10 ml vial of mabthera 100mg concentrate for intravenous iv infusion contains 100 mg of rituximab. Rituxan rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis gpa wegeners granulomatosis and microscopic polyangiitis mpa. Previously untreated follicular, cd20positive, bcell nhl in combination with.
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