All Rights Reserved. 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. Assay plasma samples within 4 hours of collection (, To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or, Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1)] . Immediately immerse plasma samples for uric acid measurement in an ice water bath. It is not known whether patients with deficiency of cytochrome b5 reductase (formerly known as methemoglobin reductase) or of other enzymes with antioxidant activity are at increased risk for methemoglobinemia or hemolytic anemia. Among the 347 patients for whom all adverse reactions regardless of severity were assessed, the most frequently observed adverse reactions (incidence 10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%). Generic name: rasburicase Dosage form: injection Drug class: Antihyperuricemic agents Medically reviewed by Drugs.com. Three single-dose vials Due to cGMP the blood vessels supplying the penis with blood widen and relax. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek therapy (, Methemoglobinemia: Elitek can result in methemoglobinemia in some patients. Following administration of either 0.15 or 0.20 mg/kg rasburicase daily for up to 5 days, plasma uric acid levels decreased within 4 hours and were maintained below 7.5 mg/dL in 98% of adult and 90% of pediatric patients for at least 7 days. Overall incidence 10% in any Elitek arm and the difference between any Elitek arm versus the allopurinol arm 5%. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including serum sampling, timing and methodology, concomitant medications, and underlying disease. Patients in Arm C received oral allopurinol for 5 days (n=91). Levitra prevents phosphodiesterase-5 enzyme from destroying cGMP and in this way helps to support blood flow to the penis. Clinically relevant P450-mediated drug-drug interactions are therefore not anticipated in patients treated with the recommended Elitek dose and dosing schedule. A total of 342 adults with either leukemia, lymphoma, or other hematologic malignancy received Elitek in five studies (one randomized study, Study 4, and four uncontrolled studies). In these studies, Elitek was administered to a total of 434 adult patients (58% male, 42% female; median age 56 years [range 18 years to 89 years]; 52% Caucasian, 7% African, 14% Asian, 28% other/unknown). 16 mg hr/dL) than those age 2 to 17 years (n=222; 108 s.e. Based on findings in animals, Elitek may cause fetal harm when administered to pregnant women. Additional data were obtained from an expanded access program of 356 patients, for whom data collection was limited to serious adverse reactions. Elitek was administered as a 30-minute infusion once (n=251) or twice (n=14) daily at a dose of 0.15 or 0.2 mg/kg/dose (total daily dose 0.20.4 mg/kg/day). Children <2 years of age had a lower rate of achieving normal uric acid concentration by 48 hours (83% [95% CI: 62, 95]) than those 2 to 17 years (93% [95% CI: 89, 95]). Rasburicase is a tetrameric protein with identical subunits. The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance. Manufactured by:sanofi-aventis U.S. LLCBridgewater, NJ 08807U.S. Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Uric acid must be analyzed in plasma. Unlike tablets, Oral Jelly is easy to swallow and is very quickly . Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see Contraindications (4), Warnings and Precautions (5.2)]. Sildenafil (brand name Viagra; see Important Safety Information), tadalafil (brand name Cialis; see Important Safety Information), and vardenafil (brand name Levitra) are all examples of PDE5 inhibitors. Institute appropriate patient monitoring and support measures (e.g., transfusion support). Reconstitution Procedure. Study 4 was a randomized (1:1:1), multi-center, open-label study conducted in patients with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS. Study 4 was a randomized (1:1:1), multi-center, open-label study conducted in patients with leukemia, lymphoma, and solid tumor malignancies at risk for hyperuricemia and TLS. Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria. Clinical manifestations of hypersensitivity included arthralgia, injection site irritation, peripheral edema, and rash. Patients received Elitek at a dose of 0.15 mg/kg/day. Figure 1: Box and Whisker Plot of Uric Acid Concentration at Designated Time Blocks Elitek Administration Began Immediately after Baseline. Advise females not to breastfeed during treatment with Elitek and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2)]. Of the subset of 61 patients whose plasma uric acid level was elevated at baseline (8 mg/dL), plasma uric acid concentration was maintained by 4 hours for 72% of patients (44/61), by 24 hours for 80% of patients (49/61), by 48 hours for 92% of patients (56/61), by 72 hours for 98% of patients (60/61), and by 96 hours for 100% (61/61). Immediately and permanently discontinue Elitek administration in any patient developing clinical evidence of a serious hypersensitivity reaction [see Boxed Warning, Contraindications (4), Adverse Reactions (6.2)]. The medicine allows increase blood flow into your penis to achieve and maintain erection during sexual intercourse. Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. In this stage, you brand Levitra Oral Jelly be really expected to know all them. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see Contraindications (4), Warnings and Precautions (5.3)]. Advise females not to breastfeed during treatment with Elitek and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2)]. Vardenafil's indications and . Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek, Elitek can result in methemoglobinemia in some patients. Of the 261 evaluable patients, plasma uric acid concentration was maintained (see Study 2 for the definition of uric acid concentration maintenance) by 4 hours for 92% of patients (240/261), by 24 hours for 93% of patients (245/261), by 48 hours for 97% of patients (254/261), by 72 hours for 99% of patients (260/261), and by 96 hours for 100% of patients (261/261). In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. being unable to get an erection at any time. The safety and effectiveness of Elitek have been established in pediatric patients ages 1 month to 17 years for initial management of plasma uric acid levels in 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 limited available data with Elitek use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes. Elitek is contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin. The incidence of renal dysfunction was similar in the two study arms; one patient in the allopurinol arm developed acute renal failure. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Must be Reconstituted and Diluted Before Use, Contents: Immediately and permanently discontinue Elitek in patients developing hemolysis. Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1)]. J Code (medical billing code): J2783 (0.5 mg, injection). In preclinical in vivo studies, rasburicase did not affect the activity of isoenzymes CYP1A, CYP2A, CYP2B, CYP2C, CYP2E, and CYP3A, suggesting no induction or inhibition potential. Institute appropriate monitoring and support measures (e.g., transfusion support, methylene-blue administration) [see Boxed Warning, Contraindications (4)]. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Contra-indications Avoid if systolic blood pressure below 90 mmHg; hereditary degenerative retinal disorders; myocardial infarction; patients in whom vasodilation or sexual activity are inadvisable; previous history of non-arteritic anterior ischaemic optic neuropathy; recent stroke; unstable . Blood must be collected into prechilled tubes containing heparin anticoagulant. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Special sample handling procedure must be followed to avoid ex vivo uric acid degradation [see Boxed Warning, Drug Interactions (7)]. As with all therapeutic proteins, there is potential for immunogenicity. Fax: 1-855-411-9689. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek, Elitek can result in methemoglobinemia in some patients. You'll find more details about ELITEK at www.Elitekpro.com and CareASSIST at www.SanofiCareAssist.com/elitek. These included cases of serious hypoxemia requiring intervention with medical support measures. Study 3 was a multi-institutional, single-arm study conducted in 130 pediatric patients and 1 adult patient with hematologic malignancies. Do not freeze. The recommended dose of Elitek is 0.2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days. We comply with the HONcode standard for trustworthy health information. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see Contraindications (4), Warnings and Precautions (5.3)]. Dosing beyond 5 days or administration of more than one course is not recommended. Reconstitute the 1.5-mg vial of ELITEK with 1 mL of diluent OR; Reconstitute the 7.5-mg vial of ELITEK with 5 mL of diluent; Mix by swirling gently. Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. Elitek was administered prior to and concurrent with antitumor therapy, which consisted of either systemic chemotherapy (n=196) or steroids (n=69). Initiation of dosing was permitted at any time between 4 to 48 hours before the start of antitumor therapy and could be continued for 5 to 7 days after initiation of antitumor therapy. No metabolic-based drug interactions are therefore anticipated with these agents in patients. In clinical studies, methemoglobinemia occurred in <1% patients receiving Elitek. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.1), Adverse Reactions (6.2)]. Plasma uric acid levels were used for all uric acid AUC096 hr calculations [see Warnings and Precautions (5.4)]. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.1), Adverse Reactions (6.2)]. Discard solution if particulate matter is visible or product is discolored. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. 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