Rasburicase (Elitek)

Trade Name : Elitek

Sanofi-Aventis U.S. LLC

KIT

Strength

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rasburicase (Elitek) which is also known as Elitek and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of per ml. Read more

Rasburicase (Elitek) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
  • Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs (, , ).
  • Hemolysis: Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek if hemolysis occurs. 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. Immediately and permanently discontinue Elitek if methemoglobinemia occurs (, ).
  • Interference with uric acid measurements: Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection ().
  • 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.
  • Limitations of Use
  • Elitek is indicated only for a single course of treatment n n
  • 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 receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ()
  • Limitations of use: Elitek is indicated only for a single course of treatment. ()
  • No data
  • Administer at 0.2 mg/kg as an intravenous infusion over 30 minutes daily for up to 5 days. ()
  • Do not administer as an intravenous bolus. ()
  • No data
  • For injection, 1.5 mg, lyophilized powder in single-dose vial ()
  • For injection, 7.5 mg, lyophilized powder in single-dose vial ()
  • Elitek is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase .
  • Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) .
  • History of the following reactions to rasburicase: anaphylaxis, severe hypersensitivity, hemolysis, methemoglobinemia. ()
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency. ()
  • No data
  • The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information:
  • Most common adverse reactions (incidence u226520%), when used concomitantly with anticancer therapy are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Laboratory Test Interference
  • At room temperature, Elitek causes enzymatic degradation of the uric acid in blood/plasma/serum samples potentially resulting in spuriously low plasma uric acid assay readings. The following special sample handling procedure must be followed to avoid ex vivo uric acid degradation.
  • Uric acid must be analyzed in plasma. Blood must be collected into prechilled tubes containing heparin anticoagulant. Immediately immerse plasma samples for uric acid measurement in an ice water bath. Plasma samples must be prepared by centrifugation in a precooled centrifuge (4u00b0C). Finally, the plasma must be maintained in an ice water bath and analyzed for uric acid within four hours of collection .
  • Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. No metabolic-based drug interactions are therefore anticipated with these agents in patients.
  • No data
  • Pregnancy: May cause fetal harm. ()
  • tLactation: Breastfeeding not recommended. ()
  • Of the six reported cases of overdosage, five cases had no adverse events reported; nonserious adverse events in the sixth case (a single dose of 1.3 mg/kg) included decreased levels of blood potassium and blood albumin, and increased levels of carbon dioxide, blood lactate dehydrogenase, blood urea, blood phosphorus, blood sodium, and blood alkaline phosphatase. Monitor patients who receive an overdose and initiate supportive measures if required.
  • Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified strain. The cDNA coding for rasburicase was cloned from a strain of n
  • Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution.
  • Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188).
  • Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).
  • No data
  • Carcinogenicity studies in animals to evaluate tumorigenic potential of rasburicase have not been performed. Rasburicase was not mutagenic in the Ames, unscheduled DNA synthesis, chromosome analysis, mouse lymphoma, and micronucleus tests.
  • Rasburicase did not affect reproductive performance or fertility in male or female rats with an exposure 11-times greater at a dose of 10 mg/kg than the recommended human dose of 0.2 mg/kg.
  • No data
  • No data
  • No data
  • Manufactured by:sanofi-aventis U.S. LLCBridgewater, NJ 08807U.S. License No. 1752
  • u00a92019 sanofi-aventis U.S. LLC
  • NDC 0024-5150-10Rx only
  • ELITEKn rasburicase
  • 1.5 mg
  • FOR INTRAVENOUS INFUSION
  • Reconstitute with Accompanying Diluent Before UseMust be Reconstituted and Diluted Before Use
  • Sterile u2013 Contains No Preservatives
  • Contents:Three single-dose vialsThree diluent ampules
  • SANOFI
  • NDC 0024-5151-75Rx only
  • ELITEKn rasburicase
  • 7.5 mg
  • FOR INTRAVENOUS INFUSION
  • Reconstitute with Accompanying Diluent Before UseMust be Reconstituted and Diluted Before Use
  • Sterile u2013 Contains No Preservatives
  • Contents:One single-dose vialOne diluent ampule
  • SANOFI

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.