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The Power of FVIII/VWF ComplexConvenient Room Temperature StorageFirst FVIII/VWF product in the US stable for 3 years, up to the expiration date printed,when stored at or below 77°F (25°C). Do not freeze.Please see brief summary of Alphanate ® Full Prescribing Information below.HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Alphanate AntihemophilicFactor/von Willebrand Factor Complex (Human) safely and effectively. See FullPrescribing Information for Alphanate.ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX [HUMAN])Sterile, lyophilized powder for injectionFor Intravenous Use OnlyInitial U.S. Approval: 1978INDICATIONS AND USAGEAlphanate is an Antihemophilic Factor/von Willebrand Factor Complex (Human) indicatedfor:• Control and prevention of bleeding in patients with hemophilia A.• Surgical and/or invasive procedures in adult and pediatric patients with vonWillebrand Disease in whom desmopressin (DDAVP) is either ineffective orcontraindicated. It is not indicated for patients with severe VWD (Type 3) undergoingmajor surgery.CONTRAINDICATIONS• Patients who have manifested life-threatening immediate hypersensitivity reactions,including anaphylaxis, to the product or its components.WARNINGS AND PRECAUTIONS• Anaphylaxis and severe hypersensitivity reactions are possible. Should symptomsoccur, treatment with Alphanate should be discontinued, and emergency treatmentshould be sought.• Development of activity-neutralizing antibodies has been detected in patients receivingFVIII containing products. Development of alloantibodies to VWF in Type 3 VWD patientshave been occasionally reported in the literature.• Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWDpatients, especially in the setting of known risk factors.• Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWFComplex (Human).• Rapid administration of a FVIII concentrate may result in vasomotor reactions.• Plasma products carry a risk of transmitting infectious agents, such as viruses, andtheoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed toreduce this risk.ADVERSE REACTIONSThe most frequent adverse events reported with Alphanate in > 5% of patients arerespiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills,joint pain and fatigue.To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.USE IN SPECIFIC POPULATIONS• Pregnancy: No human or animal data. Use only if clearly needed.• Labor and Delivery: No human or animal data. Use only if clearly needed.• Nursing Mothers: No human or animal data. Use only if clearly needed.• Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia Apatients have not been conducted. The hemostatic efficacy of Alphanate has beenstudied in 20 pediatric subjects with VWD 18 years of age and under. Based on the datafrom a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo.• Geriatric Use: No human or animal data. Use only if clearly needed.For more information: Grifols Inc.Customer Service: 888 325 8579 Fax: 323 441 7968© 2012 Grifols Biologicals Inc. All rights reserved. Printed in USA. January 2012 A803-0911Grifols Biologicals Inc.5555 Valley Boulevard, Los Angeles, 90032 CA - USA Tel. 888-GRIFOLS (888 474 3657)www.grifolsusa.comASD Healthcare 33