Product News

ONGUARD Contained Medication System

B. Braun Medical Inc's (Bethlehem,PA) ONGUARD Contained MedicationSystem is a drug admixture anddelivery system that provides a newlevel of hazard protection and passiveneedle-stick prevention for pharmacistsand nurses at the front line ofchemotherapy preparation and administration.The American Society ofHealth-System Pharmacists, the NationalInstitute for Occupational Safetyand Health, and the United StatesPharmacopeia <797> have each recommendedthe use of protective devicesfor the preparation of hazardousmedications. The system with TEVADAPTORcomponents provides protectionfrom hazardous vapors, particles,and aerosols, by means of a hydrophobic0.2-&#0181;m sterilizing grade membraneand the TOXIGUARD activated charcoaldrug-binding matrix. Independent laboratorystudies using chemotherapymedications demonstrate this systemeffectively prevents hazardous vaporsfrom escaping by binding them withinthe activated charcoal matrix whilealso preventing nonsterile air fromentering the medication vial. TheONGUARD Contained MedicationSystem further protects workers andthe patient care environment fromadmixture to delivery by preventing liquiddroplets from exiting the dispensingunits during use. For more information,visit www.bbraunusa.com, or call800-854-6851.

Thyrogen (thyrotropin alfa for injection)

Genzyme Corp (Cambridge,MA) recently receivedFDA approval fora supplemental indication for Thyrogento be used in combination with radioiodineto ablate, or destroy, the remainingthyroid tissue in patients who havehad their cancerous thyroids removed.The product was initially approved inthe United States in 1998 for use as anadjunctive diagnostic tool for serumthyroglobulin testing with or withoutradioiodine imaging in the follow-up ofpatients with well-differentiated thyroidcancer. A 2-injection regimen isrecommended. The 2-injection regimenis Thyrogen 0.9 mg intramuscularly(IM), followed by a second 0.9-mg IMinjection 24 hours later. After reconstitutionwith 1.2 mL sterile water forinjection, a 1.0-mL solution (0.9 mg thyrotropinalfa) is administered by IMinjection to the buttock. For radioiodineimaging or remnant ablation,radioiodine should be administered 24hours following the final Thyrogeninjection. The product is supplied as asterile, nonpyrogenic, lypophilized product.It is available in a 2- or 4-vial kit.The 2-vial kit contains two 1.1-mg vialsof Thyrogen. The 4-vial kit contains two1.1-mg vials of Thyrogen as well as two10-mL vials of sterile water for injectionUSP. For more information, visitwww.thyrogen.com, or call 88-THYROGEN(888-497-6436).

Paclitaxel Injection USP

Parenta Pharmaceuticals (WestColumbia, SC), the US subsidiary ofAustrian-based Ebewe Pharma, recentlylaunched Paclitaxel Injection USP.The product is the generic equivalentof Bristol-Myers Squibb Co's TaxolInjection. Paclitaxel Injection USP isindicated as first-line and subsequenttherapy for the treatment of advancedcarcinoma of the ovary. As first-linetherapy, the product is indicated incombination with cisplatin. PaclitaxelInjection USP also is indicated for theadjuvant treatment of node-positivebreast cancer administered sequentiallyto standard doxorubicin-containingcombination chemotherapy. The productis AP-rated, bar-coded, and suppliedin latex-free vials in the followingpresentations: 30-mg/5-mL, 100-mg/16.7-mL, and 300-mg/50-mL multidosevials. For more information, visit www.parentarx.com, or call 800-898-9948.

Tysabri (natalizumab)

Elan Pharmaceuticals Inc (SouthSan Francisco, CA) and Biogen IdecInc (Cambridge, MA) recently receivedFDA approval for a supplemental biologicslicense application for Tysabri.The product is now approved for inducingand maintaining clinical responseand remission in adult patients withmoderate-to-severe active Crohn's disease(CD), with evidence of inflammation,who have had an inadequateresponse to, or are unable to tolerate,conventional CD therapies and inhibitorsof tumor necrosis factor-alpha.Tysabri will be available for the treatmentof CD upon the completion of keyimplementation activities related to theapproved risk management plan.Tysabri is prescribed only by physiciansenrolled in the Tysabri Outreach: UnifiedCommitment to Health (TOUCH)Prescribing Program, infused at an infusioncenter that is enrolled in the program,and given to patients who areenrolled in the program. The TOUCHPrescribing Program has been implementedfor patients receiving Tysabritherapy for multiple sclerosis. For moreinformation, visit www.tysabri.com, orcall 800-456-2255.