ZSL Behring(King of Prussia,Pa) recently received FDA marketingapproval for an additional indication forRhophylac (RhO[D] Immune GlobulinIntravenous [Human]),an anti-D rhesus(Rh) immunoglobulin,for the treatmentof immune thrombocytopenic purpura(ITP).Administered intravenously,Rhophy-lac is indicated to raise platelet counts inRhO(D)-positive,nonsplenectomized adultpatients with chronic ITP.The product isalso indicated for suppression of Rhisoimmunization in pregnancy andobstetric conditions in nonsensitizedRhO(D)-negative women with an Rh-incompatible pregnancy,including rou-tine antepartum and postpartum Rh pro-phylaxis,and Rh prophylaxis in obstetriccomplications or invasive procedures.The product is indicated as well forincompatible transfusions in RhO(D)-neg-ative individuals transfused with bloodcomponents containing RhO(D)-positivered blood cells.Rhophylac 1500 international units (300 mcg) is supplied in packages of 1 or 10 latex-free, ready-to-use, prefilled syringes, each containing 2 mL of preservative-free liquid. Each syringe is accompanied by a SafetyGlide needle for intravenous or intramuscular use. Visit www.rhophylacusa.com for more information.
Bayer Pharmaceuticals Corp (West Haven, Conn) recently received FDA approval for revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved use to specific situations. Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. The new labeling specifies that Trasylol should be given only to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery when patients undergo cardiopul-monary bypass. The changes also include a warning that Trasylol increases the possible risk for kidney damage, and they suggest ways to manage and reduce the patient’s risk for hypersensitivity reactions. For more information, visit www.trasylol.com.
Astellas Pharma US Inc (Deerfield, Ill) recently received FDA approval for Vaprisol (conivaptan hydrochloride injection), an arginine vasopressin receptor antagonist, for the intravenous (IV) treatment of hypervolemic hypona-tremia in hospitalized patients. The product is also indicated to treat euv-olemic hyponatremia (eg, the syndrome of inappropriate secretion of antidiuret-ic hormone, or in the setting of hypothy-roidism, adrenal insufficiency, pulmonary disorders, etc) in hospitalized patients. Vaprisol is administered as a 20-mg IV loading dose over 30 minutes. It is followed by 20 mg administered as a continuous infusion over 24 hours. Following the initial day of treatment, the product is to be administered for an additional 1 to 3 days as a continuous infusion of 20 mg/day. If serum sodium does not rise at the desired rate, Vaprisol may be titrated upward to a daily dose of 40 mg, again administered in a continuous infusion. For additional information, visit www.vaprisol.com, or call 800-888-7704.
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