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. See full prescribing information for complete boxed warning. Tumor lysis syndrome tls is one of the metabolic oncologic emergencies identified by the oncology nursing society. A guide to assist with filing claims for treatment, including codes. Our portfolio includes more than 25 specialized products aimed at providing innovative treatments for unmet medical needs worldwide. 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 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. Severe local tissue necrosis will occur if there is extravasation during administration. Medscape indicationspecific dosing for elitek rasburicase, frequencybased.
Labeling for biosimilar products guidance for industry. Elitek rasburicase side effects, images, uses, dosage. Prescription drugs state senate district 7, january 2007 2 executive summary prescription drug affordability is increasingly on the minds of americans as the prices for. Read consumers reports best buy drugs for information on effectiveness and safety of drugs according to scientific evidence. Urate oxidase is known to be present in many mammals but does not naturally occur in humans.
Elitek is a recombinant urateoxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are. Highlights of prescribing information these highlights do not include all the information needed to use besponsa safely and effectively. Recombinant urate oxidase rasburicase is safe and effective in managing hyperuricemia in children and adults. The goal of treatment is to normalize serum insulinlike growth factori igfi levels. Elitek rasburicase for managing uric acid levels when using.
An information sheet for pharmacies about how elitek is supplied. Careassist patient access specialists are available mondayfriday, 9am 8pm est at 18339302273, option 1. Llchighlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively. Elitek fda prescribing information, side effects and uses. The cdna coding for rasburicase was cloned from a strain of aspergillus flavus rasburicase is a tetrameric protein with identical subunits. Palivizumab was licensed in june 1998 by the food and drug administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus rsv in children at increased risk of severe disease. This property is applicable for apple devices which do not provide information about the model in the useragent string. The mcg tm care guidelines are proprietary to mcg tm and are not published on this website. The one study the company conducted solely on patients with alzheimers a type of dementia had 194 subjects and. Both the current state of prescription drug pricing and the projections of continued increases.
Medical policies, medical benefit drug policies, and coverage determination guidelines are the property of unitedhealthcare. Unauthorized copying, use and distribution of this information are strictly prohibited. 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. Rasburicase trade names elitek in the us and fasturtec in europe is a medication that helps to clear uric acid from the blood. Both received the required interstate aviation committee aviation register uelicopter, and can be operated commercially. This program is not valid for prescriptions covered by or submitted for. The careassist of the date of treatment copay program. Elitek rasburicase for injection, for intravenous use initial u. Locate a certified geriatric pharmacist for help managing medications. Many of these, as well as other sanofi genzyme products, are.
One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drugs label, also known as the prescribing information or the package insert pi. See table 1 in the full prescribing information for the recommended dosage. Learn about elitek for managing uric acid levels in patients receiving anticancer therapy expected to result in tls. Updated guidance for palivizumab prophylaxis among infants. Sanofi us medical information provides healthcare professionals with accurate, unbiased, and balanced evidencebased product information. Novarel is designed for intramuscular into the muscle injection. Several strategies are available for the prevention and treatment of tumor lysis syndrome, with rasburicase being the most recent. Elitek rasburicase for managing uric acid levels when. One carton contains 1 singledose vial containing 7. Relistor methylnaltrexone bromide injection, solution.
The information you provide will only be used by janssen biotech, inc. Elitek rasburicase for injection, for intravenous use. Rasburicase is produced by a genetically modified saccharomyces cerevisiae strain. Medicare part b step therapy programs page 1 of 5 unitedhealthcare medicare advantage medical benefit injectable policy effective 01012020. The drug product is a sterile, white to offwhite, lyophilized powder intended. Elitek rasburicase is a recombinant urateoxidase produced by a genetically modified saccharomyces cerevisiae strain. Novarel is used to stimulate egg release ovulation in women who are not ovulating and in whom ovarian failure is not the cause of infertility.
See full prescribing information dosage adjustment in renal or hepatic impairment by indication. Nuedexta is being increasingly prescribed in nursing homes even though drugmaker avanir pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients prompting critics to liken its use to an uncontrolled experiment. It is a recombinant version of urate oxidase, an enzyme that metabolizes uric acid to allantoin. Rasburicase is a medication that helps to clear uric acid from the blood. Elitek patient information including if i miss a dose. The ansat light multipurpose helicopter is intended to carry personnel, cargo and equipment inside its cargo compartment or on external sling, as well as perform special tasks in the interests of different customers. Hypolipidemic agents, or antihyperlipidemic agents, are a diverse group of pharmaceuticals that are used in the treatment of high levels of fats lipids, such as cholesterol, in the blood hyperlipidemia. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kda. Aarp life insurance pdf download medicare benefits pdf download medicare part b pdf download. Seek emergency medical attention or call the poison help line at 1.
Adriamycin must not be given by the intramuscular or subcutaneous route. Addressing fundamental health issues, sanofi us strives to make major therapeutic solutions available for patients. Labeling for biosimilar products guidance for industry1 this guidance represents the current thinking of the food and drug administration fda or agency on. Prevnar pneumococcal valent conjugate vaccine diphtheria crm 197 protein suspension for intramuscular injection initial us approval. Tumor lysis syndrome tls in adult patients page 1 of 7. Sanofi is a leader in the global pharmaceutical market, with an extensive line of prescription medicines. Control of plasma uric acid in adults at risk for tumor lysis syndrome. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek. 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. The list below includes our products marketed in the united states. Identify and provide information on independent support services for patients and caregivers. These highlights do not include all the information needed to use elitek safely and effectively. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek to a pregnant woman.
This document has information about the drugs covered by this plan. Please see full prescribing information, including boxed warning pdf. Canadian coordinating office for health technology assessment emerging drug list rasburicase and hyperuricemia in cancer patients 11. Highlights of prescribing information these highlights do not include all the information needed to use prevnar safely and effectively. Besponsa inotuzumab ozogamicin for injection, for intravenous use initial u. Discontinue nursing or elitek taking into account the importance of the drug to the mother 8. Please see accompanying full prescribing information, including serious side effects. Previously untreated stage iiiiv chl adult patients with previously untreated stage iiiiv classical hodgkin lymphoma chl in combination with doxorubicin, vinblastine, and dacarbazine. Tumor lysis syndrome tls in adult patients page 1 of 7 disclaimer. Since that time, the american academy of pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a. Elitek rasburicase dosing, indications, interactions, adverse effects. What caregivers need to know about the use of antipsychotic drugs in nursing homes pdf join aarp today receive access to exclusive information, benefits and discounts yes, my mom had alzheimers, but she wasnt out of it when she went into the nursing home. Elitek rasburicase powder for solution, for intravenous infusion. Cgrp migraine preventive treatment aimovig erenumabaooe.
Call your doctor for instructions if you miss an appointment for your rasburicase injection. Facebook is a vital channel for any business digital marketing. Somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. Prescription drug side effects, medication symptoms. Serious irreversible myocardial toxicity with delayed congestive. Fox news hosts go mum on the covid19 drug they spent weeks promoting at the height of fox newss coverage of a wouldbe treatment for the novel coronavirus, the networks medical correspondent, marc siegel, offered a remarkable testimonial during tucker carlsons show.
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