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Alexion Pharmaceuticals Inc (Cheshire, Conn) recently received FDA approval for Soliris. The product is the first therapy approved for paroxysmal nocturnal hemoglobinuria (PNH), a rare, disabling, and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is a complement inhibitor indicated for the treatment of patients with PNH to reduce hemolysis. The recommended dose regimen is 600 mg via 35-minute intravenous infusion every 7 days for the first 4 weeks, followed by 900 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 of 10-mg/mL, sterile, preservative-free solution. For more information, visit www.soliris.net, or call 888-SOLIRIS (888-765-4747).
Vidaza (azacitidine for injection)
Pharmion Corp (Boulder, Colo) recently received FDA approval for a supplemental new drug application to add intravenous (IV) use as a new route of administration to the instructions in the approved prescribing information for its DNA-demethylating agent Vidaza. The product is indicated for the treatment of patients with the following subtypes: refractory anemia (RA); RA with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia, or requiring transfusions); RA with excess blasts; RA with excess blasts in transformation; and chronic myelomonocytic leukemia. With this approval, Vidaza may now be administered intravenously over a period of 10 to 40 minutes in a clinic or hospital setting. With IV administration, the dosing for Vidaza remains the same as for the previously approved subcutaneous administration, at 75 mg/m2 daily for 7 days. Patients should be premedicated for nausea and vomiting. Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 cycles. For more information, visit www.vidaza.com.
Cyanokit (hydroxocobalamin for injection)
EMD Pharmaceuticals (Durham, NC) and Dey LP (Napa, Calif) recently received FDA approval for Cyanokit for the treatment of known or suspected cyanide poisoning. Cyanokit's unique mechanism of action makes its use possible in a prehospital or hospital setting. It is the first cyanide antidote to be approved in the United States in several decades. The recommended dose 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 poisoning and the clinical response, a second dose of 5 g may be administered by IV infusion, for a total dose of 10 g. The rate of infusion for the second 5-g dose may range from 15 minutes (for patients in extremis) to 2 hours, based on patient condition. Each Cyanokit carton contains two 250-mL glass vials, each containing lyophilized hydroxocobalamin for injection, 2.5 g; 2 sterile transfer spikes; 1 sterile IV infusion set; a quick reference guide; and a package insert. For more information, visit www.dey.com/Pressroom/Cyanokit_PI.pdf.
Flo Healthcare (Atlanta, Ga) recently introduced the Flo 1800, the newest mobile workstation in its 1000 series. The Flo 1800 provides advanced ergonomics that bring the clinician closer to the patient. The workstation is fully customizable, offering hospitals more choices in fully integrated peripherals, including handheld units, barcode scanners, vitals technology, and a Lifespan Healthcare rail system. The Flo 1800 benefits include a larger, lightweight work space with a full-sized keyboard; improved aesthetics featuring a taller, modular model with a smaller footprint that can go anywhere; and a PC mounting system for easy access for service. The product comes fully assembled and fully integrated. For more information, visit www.flohealthcare.com, or call 877-FLO-4040 (877-356-4040).