health-systems PRODUCT news
Alexion Pharmaceuticals Inc(Cheshire, Conn) recently received FDAapproval for Soliris. The product is thefirst therapy approved for paroxysmalnocturnal hemoglobinuria (PNH), arare, disabling, and life-threateningblood disorder defined by chronic redblood cell destruction, or hemolysis.Soliris is a complement inhibitor indicatedfor the treatment of patientswith PNH to reduce hemolysis. The recommendeddose regimen is 600 mg via35-minute intravenous infusion every 7days for the first 4 weeks, followed by900 mg for the fifth dose 7 days later,and then 900 mg every 14 days thereafter.Soliris is supplied in 300-mg single-use vials, each containing 30 mL of10-mg/mL, sterile, preservative-freesolution. For more information, visitwww.soliris.net, or call 888-SOLIRIS(888-765-4747).
Vidaza (azacitidine for injection)
Pharmion Corp (Boulder, Colo)recently received FDA approval for asupplemental new drug application toadd intravenous (IV) use as a new routeof administration to the instructions inthe approved prescribing informationfor its DNA-demethylating agentVidaza. The product is indicated for thetreatment of patients with the followingsubtypes: refractory anemia (RA);RA with ringed sideroblasts (if accompaniedby neutropenia or thrombocytopenia,or requiring transfusions); RAwith excess blasts; RA with excessblasts in transformation; and chronicmyelomonocytic leukemia. With thisapproval, Vidaza may now be administeredintravenously over a period of 10to 40 minutes in a clinic or hospital setting.With IV administration, the dosingfor Vidaza remains the same as for thepreviously approved subcutaneousadministration, at 75 mg/m2 daily for 7days. Patients should be premedicatedfor nausea and vomiting. Cycles shouldbe repeated every 4 weeks. The dosemay be increased to 100 mg/m2 if nobeneficial effect is seen after 2 treatmentcycles and if no toxicity otherthan nausea and vomiting hasoccurred. It is recommended thatpatients be treated for a minimum of 4cycles. For more information, visitwww.vidaza.com.
Cyanokit (hydroxocobalaminfor injection)
EMD Pharmaceuticals (Durham,NC) and Dey LP (Napa, Calif) recentlyreceived FDA approval for Cyanokit forthe treatment of known or suspectedcyanide poisoning. Cyanokit's uniquemechanism of action makes its usepossible in a prehospital or hospitalsetting. It is the first cyanide antidoteto be approved in the United States inseveral decades. The recommendeddose of Cyanokit for adults is 5 g (two-2.5-g vials) administered by intravenous(IV) infusion over 15 minutes.Depending on the severity of the poisoningand the clinical response, a seconddose of 5 g may be administeredby IV infusion, for a total dose of 10 g.The rate of infusion for the second 5-gdose may range from 15 minutes (forpatients in extremis) to 2 hours, basedon patient condition. Each Cyanokitcarton contains two 250-mL glass vials,each containing lyophilized hydroxocobalaminfor injection, 2.5 g; 2 steriletransfer spikes; 1 sterile IV infusion set;a quick reference guide; and a packageinsert. For more information, visit www.dey.com/Pressroom/Cyanokit_PI.pdf.
Flo Healthcare (Atlanta, Ga) recentlyintroduced the Flo 1800, thenewest mobile workstationin its 1000series. The Flo 1800provides advancedergonomics thatbring the cliniciancloser tothe patient. Theworkstation isfully customizable,offering hospitalsmore choices in fullyintegrated peripherals,including handheldunits, barcodescanners,vitals technology,and a LifespanHealthcare rail system.The Flo 1800 benefits include alarger, lightweight work space with afull-sized keyboard; improved aestheticsfeaturing a taller, modular modelwith a smaller footprint that can goanywhere; and a PC mounting systemfor easy access for service. The productcomes fully assembled and fullyintegrated. For more information, visitwww.flohealthcare.com, or call 877-FLO-4040 (877-356-4040).