Healthcare resource utilization with rasburicase in the. Velcade bortezomib for injection, for subcutaneous or intravenous use initial u. The information was verified by the guideline developer on may 30, 2003. Full prescribing information 1 indications and usage fuzeonin combination with other antiretroviral agents is indicated for the treatment of hiv1 infection in treatmentexperienced patientswith evidence of hiv1 replication despite ongoing antiretroviral therapy.
See important safety including boxed warnings for more information. By providing your information and information about your patient on the front of the benefits investigation and enrollment form, you are requesting the services described on this form. Facebook is a vital channel for any business digital marketing. Elitek patient information including if i miss a dose. The limited available data with elitek use in pregnant women are insufficient to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes. Elitek rasburicase for managing uric acid levels when. This summary was updated by ecri on september 8, 2005 following the u. Call your doctor right away if you notice any of these side effects. Highlights of prescribing information urothelial carcinoma.
Elitek rasburicase side effects, images, uses, dosage. Elitek rasburicase for injection for intravenous use prescribing information. Patient support for elitek rasburicase iv infusion. Elitek rasburicase is a recombinant urateoxidase enzyme produced by a genetically modified. Canadian coordinating office for health technology assessment emerging drug list rasburicase and hyperuricemia in cancer patients 11. What should i discuss with my healthcare provider before receiving rasburicase elitek. Llchighlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively.
Please see package insert for additional information and. Addressing fundamental health issues, sanofi us strives to make major therapeutic solutions available for patients. Aarp health insurance plans pdf download medicare replacement pdf download aarp life insurance pdf download medicare benefits pdf download medicare part b pdf download medicare guidelines for rasburicase. Moderate or severe hepatic impairment or severe renal impairment. Indications and usage fluad is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b contained in the vaccine. Repatha evolocumab injection, for subcutaneous use initial u.
The information you provide will only be used by janssen biotech, inc. Dec 01, 2019 elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek rasburicase is a recombinant urateoxidase produced by a genetically modified saccharomyces cerevisiae strain. Keytruda pembrolizumab injection, for intravenous use initial u.
What is the most important information i should know about rasburicase elitek. Elitek rasburicase powder for solution, for intravenous infusion. Seek emergency medical attention or call the poison help line at 1. Elitek prescribing information pdf the official hcp site for elitek rasburicase for the initial management of see trial design, and important safety information, including boxed warning. Rasburicase is a recombinant urate oxidase enzyme approved for use by the food and drug administration in patients who are at risk of developing tumor lysis syndrome or for the management of elevated uric acid levels. Each scored white to off white tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone and purified water.
Highlights of prescribing information an initial dose of 600. Elitek prescribing information pdf keyword found websites. The digital outputs vary from 0 to a maximum of differential analog input. Serious or fatal hemorrhagic eventswith associated prolonged.
Many of these, as well as other sanofi genzyme products, are also approved and marketed in other parts of the world. Our core business is the discovery and development of prescription medicines for diseases and conditions that impact. Rasburicase, a recombinant urate oxidase used to manage hyperuricemia in patients at risk of tumor lysis syndrome, is increasingly being used in outpatient settings, but outcomes with this approach have not been extensively documented. The adverse reaction information from clinical trials does. Vyxeos treatment is not recommended in patients with cardiac function that is less than normal. Prolia denosumab injection, for subcutaneous use initial u. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kda. We comply with the honcode standard for trustworthy health information. Severe local tissue necrosis will occur if there is extravasation during administration. Dec 18, 2019 the limited available data with elitek use in pregnant women are insufficient to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes.
Treatment with this nonrecombinant product had been effective in preventing renal precipitation of uric acid in cancer patients, but was associated. Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. The fda includes pgx information in the labeling of approved drugs to better inform on their safety and effectiveness. Highlights of prescribing information these highlights do not include all the information needed to use besponsa safely and effectively. Taltz ixekizumab injection, for subcutaneous use initial u. These highlights do not include all the information needed to use elitek safely and effectively. A detailed overview of treatment and patient management with elitek. The cdna coding for rasburicase was cloned from a strain of aspergillus flavus. For further information, including about cookie settings, please read our cookie policy.
Detailed information on this product is available on the website of the european. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek to a pregnant woman lactation. Rasburicase is a tetrameric protein with identical subunits. Study of pharmacogenomic information in fdaapproved drug. Elitek rasburicase for injection, for intravenous use. An information sheet for pharmacies about how elitek is supplied. Do not use filters during infusion of reconstituted elitek drug product. Highlights of prescribing information these highlights do not include all the information needed to use infanrix safely and effectively. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Allopurinol fda prescribing information, side effects and uses.
Article information, pdf download for the value of fixed rasburicase dosing versus weightbased. Discontinue vyxeos in patients with impaired cardiac function unless the benefit of continuing treatment. Adriamycin must not be given by the intramuscular or subcutaneous route. We invest billions of research dollars to find medicines that can help improve lives. Orencia abatacept for injection, for intravenous use orencia abatacept injection, for subcutaneous use initial u. Dilution rasburicase elitek for injection intravenous iv standard dilution protocol and. Elitek rasburicase prescribing information package insert new york.
Elitek fda prescribing information, side effects and uses. Itching or hives, swelling in face or hands, swelling or tingling in the mouth or throat, tightness or pain in chest, trouble breathing. Full prescribing information 1 indications and usage rapivab is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days. It is a xanthine oxidase inhibitor which is administered orally. Sanofi us medical information provides healthcare professionals with accurate, unbiased, and balanced evidencebased product information. Recombinant urate oxidase rasburicase is safe and effective in managing hyperuricemia in children and adults. Please see full prescribing information, including boxed warning. See full prescribing information for complete boxed warning. What are the possible side effects of rasburicase elitek. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with elitek and for 2 weeks after the last dose. Identify and provide information on independent support services for patients and caregivers. Guidelines for the management of pediatric and adult tumor lysis syndrome. There may be diodes in places you would think would.
Please see full prescribing information, including boxed warning pdf. Learn about elitek for managing uric acid levels in patients receiving anticancer therapy expected to result in tls. Various sensors like temperature, pressure, force etc. Highlights of prescribing information for psoriatic. Fasturtec, innrasburicase european medicines agency. Our core business is the discovery and development of prescription medicines for diseases and conditions that impact millions of people. Elitek rasburicase for injection, for intravenous use initial u. Serious irreversible myocardial toxicity with delayed congestive. Product information adriamycin solution for injection warnings 1. Highlights of prescribing information these highlights do not include all the information needed to use velcade safely and effectively. Food and drug administration fda advisory on herceptin trastuzumab. Besponsa inotuzumab ozogamicin for injection, for intravenous use initial u. Rasburicase is a medication that helps to clear uric acid from the blood. Rasburicase is produced by a genetically modified saccharomyces cerevisiae strain.
The data is transferred as bytewide 8bit serial data, msb first. The drug product is a sterile, white to offwhite, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Today, merck has more than 50 prescription products in key therapeutic. Careassist patient access specialists are available mondayfriday, 9am 8pm est at 18339302273, option 1. Elitek prescribing information pdf keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested customers on the this website. Please see full prescribing information pdf dupixent dupilumab injection support. Dataseet to make the internal clock to work we have to use a rc circuit.
A total of 362 drugbiomarker pairs dbps were identified. Adacel package insert pdf adacel is an adultadolescent formulation diphtheriatetanusacellular encephalopathy has resulted from the administration of any vaccine product. The updated information was verified by the guideline developer on may 24, 2006. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases. Highlights of prescribing information these highlights do not include all the information needed to use taltz safely and effectively. Highlights of prescribing information hemodialysis. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek to a pregnant woman.
Control of plasma uric acid in adults at risk for tumor lysis syndrome. Tumor lysis syndrome tls in adult patients page 1 of 7. Elitek rasburicase is supplied in 3 ml and 10 ml colorless, glass vials containing rasburicase at a concentration of 1. Highlights of prescribing information an initial dose. We herein present a summary of pgx information found in 261 prescription drug labeling documents by querying the publicly available fdalabel database. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek. Realworld analysis of outpatient rasburicase to prevent. Effectiveness of a single 6mg fixed dose of rasburicase. We assessed the feasibility of using rasburicase in the outpatient setting using anonymized data from electronic medical records of 400 hospitalbased. It is a recombinant version of urate oxidase, an enzyme that metabolizes uric acid to allantoin. Dilution rasburicase elitek for injection globalrph. Elitek rasburicase prescribing information official prescribing information of manufacturer. Please see full prescribing information pdf elitek rasburicase iv infusion support.
Please see full prescribing information pdf cerezyme imiglucerase for injection support. Highlights of prescribing information these highlights do not include all the information needed to use xifaxan safely and effectively. Elitek rasburicase for managing uric acid levels when using. Previously untreated stage iiiiv chl adult patients with previously untreated stage iiiiv classical hodgkin lymphoma chl in combination with doxorubicin, vinblastine, and dacarbazine. The cdna coding for rasburicase was cloned from a strain of aspergillus flavus rasburicase is a tetrameric protein with identical subunits. Urate oxidase is known to be present in many mammals but does not naturally occur in humans. This algorithm has been developed for md anderson using a multidisciplinary approach considering circumstances particular to md andersons specific patient population, services and structure, and clinical information.
Elitek rasburicase is a recombinant urate oxidase developed for the prevention and treatment of hyperuricemia in. Rasburicase trade names elitek in the us and fasturtec in europe is a medication that helps to clear uric acid from the blood. Center for drug evaluation and research list of licensed biological products with 1 reference product exclusivity and 2 biosimilarity or interchangeability evaluations to date. Highlights of prescribing information these highlights do not include all the information needed to use prolia safely and effectively. Several strategies are available for the prevention and treatment of tumor lysis syndrome, with rasburicase being the most recent. Allow the user to program the adc channel selection under software control. Tumor lysis syndrome tls in adult patients page 1 of 7 disclaimer. By continuing to use this site, you consent to the use of cookies.
Full prescribing information 1 indications and usage spinraza is indicated for the treatment of spinal muscular atrophy sma in pediatric and adult patients. Hydrogen peroxide is a byproduct of the conversion of uric acid to allantoin. Highlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively. Aug 29, 2019 elitek rasburicase is a recombinant urateoxidase produced by a genetically modified saccharomyces cerevisiae strain. Serious or fatal hemorrhagic eventswith associated prolonged monitor blood counts regularly until recovery. Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. Advise males with female sexual partners of reproductive potential to use effective contraception during adcetris treatment and for at least 6 months after the final dose of adcetris. Sep 12, 2019 elitek prescribing information pdf posted on september 12, 2019 by admin the official hcp site for elitek rasburicase for the initial management of see trial design, and important safety information, including boxed warning. Sanofi is a leader in the global pharmaceutical market, with an extensive line of prescription medicines. Highlights of prescribing information these highlights do not include all the information needed to use repatha safely and effectively.
Used with clock in pin when internal clock source is used. Prophylaxis of dvt following hip or knee replacement. This will cause the current variety in the collector of v, this various current is amplified by v and controls the be current in of v ib. The value of fixed rasburicase dosing versus weightbased dosing. Call your doctor for instructions if you miss an appointment for your rasburicase injection. Elitek drug and prescription information, side effects, use. Infanrix diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed suspension for intramuscular injection. Bexsero is a vaccine indicated for active immunization to prevent invasive disease caused by. Outpatient and inpatient groupings based on administration of rasburicase after chemotherapy economic effect including longer inpatient length of stay which may impact total cost.
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