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Prescription Benefit Program Changes for Recombinant Clotting Factor Product

October 18, 2016

  It has come to our attention that Helixate FS, a recombinant clotting factor product sold and distributed by CSL Behring, is being removed from prescription benefit programs for a limited number of patients using CVS/Caremark effective January 1, 2017. Patients currently using Helixate FS who have the “Advanced Control Formulary” plan with CVS/Caremark will have the […]

Voluntary Recalls Issued for Additional Lots of Helixate FS Recombinant Clotting Factor Product

August 11, 2016

CSL Behring has announced a voluntary recall of additional lots of Helixate FS with vial adapter. This is an update to the recall that was issued on July 25, 2016. All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are: Product Lot Number Expiration Date Helixate FS 250 IU 270P892 09/15/2016 […]

Voluntary Withdrawals of Helixate FS & Kogenate FS

July 26, 2016

As part of HFA’s ongoing mission to assist and advocate for the bleeding disorders community, this medical news is being issued to keep you informed about product safety. About These Withdrawals CSL Behring is initiating a voluntarily recall of two lots of its hemophilia A drug Helixate FS containing active ingredient manufactured before November 2015. […]

Update #3: NHF’s MASAC Assessment on Inhibitor Studies

December 3, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.  This study suggests that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using Kogenate/Helixate.  The World Hemophilia Federation (WHF) issued a statement on October 6, and another […]

Update #2: FDA will Review Study Suggesting Higher Inhibitor Incidence in PUPS

November 20, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.  This study suggests that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using Kogenate/Helixate. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have […]


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