Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017
FDA (Food and Drug Administration, USA)
• Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with Alphanate should be
discontinued, and emergency treatment should be sought (5.1)
• Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 VWD patients have been occasionally reported in the literature (5.2)
• Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors (5.3)
• Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human) (5.4)
• Rapid administration of a FVIII concentrate may result in vasomotor reactions (5.5)
• Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk (5.6)
The most frequent adverse events reported with Alphanate in > 5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue (6).
Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand
Factor:Ristocetin Cofactor activity in IU VWF:RCo/vial (2).
Hemophilia A: Control and prevention of bleeding episodes (2.1)
• Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
• Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician
von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery (2.2)
• Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed.
• Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.
• Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator.
• Labor and Delivery: No human or animal data. Use only if clearly needed (8.2)
• Nursing Mothers: No human or animal data. Use only if clearly needed (8.3)
• Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo (8.4).
• Geriatric Use: No human or animal data. Use only if clearly needed (8.5)
|Product NDC||68516-4601; 68516-4602; 68516-4603; 68516-4604; 68516-4609|
|Date First Approved||31-01-2007|
|Date Last Revised||19-05-2017|
|Marketing authorisation holder||Grifols Biologicals Inc|