"The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing "...
- Patient Information:
Details with Side Effects
Elitek (rasburicase) ® 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 anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
DOSAGE AND ADMINISTRATION
The recommended dose of Elitek (rasburicase) is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.
- Elitek (rasburicase) must be reconstituted with the diluent provided in the carton.
- Reconstitute the 1.5 mg vial of Elitek (rasburicase) with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek (rasburicase) with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
- Inspect reconstituted Elitek (rasburicase) visually for particulate matter and discoloration prior to administration. Discard solution if particulate matter is visible or product is discolored.
Further Dilution and Administration
- Do not administer Elitek (rasburicase) as a bolus injection.
- Inject the calculated dose of reconstituted Elitek (rasburicase) solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
- Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek (rasburicase) infusion.
- Do not use filters during reconstitution or infusion of Elitek (rasburicase) .
- Store reconstituted or diluted solution at 2-8°C.
- Discard unused product solution 24 hours following reconstitution.
Dosage Forms And Strengths
- 1.5 mg powder per single-use vial
- 7.5 mg powder per single-use vial
NDC 0024-5150-10: One carton contains 3 single-use vials each containing 1.5 mg of rasburicase and 3 ampules each containing 1 mL diluent.
NDC 0024-5151-75: One carton contains 1 single-use vial containing 7.5 mg of rasburicase and 1 ampule containing 5 mL diluent.
Storage and Handling
The lyophilized drug product and the diluent for reconstitution should be stored at 2-8°C (36-46°F). Do not freeze. Protect from light.
Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807.
Last reviewed on RxList: 11/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Elitek Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.