dm+d
Unassigned
Lactation Safety Information
-
Synonym: Recombinant coagulation factor VIII, porcine
No published evidence of safety
Unlikely to enter milk and not absorbed from the infant’s GI tract
Factor VIII is a normal component of maternal and infant plasma
20 October 2016
New Medicines
Obizur
Congenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive proceduresInformation
Obizur
Licence extension / variation
Takeda
Takeda
Development and Regulatory status
Discontinued
Discontinued
Discontinued
Yes
Yes
May 21
Removed from pipeline; development discontinued [5].
Feb 21
PIII CHAWI study (NCT02895945) terminated as the benefit/risk profile did not support continuation in this patient population [4]
Category
First recombinant porcine factor VIII (FVIII).
It affects 1:4,000 to 1:5,000 live male births worldwide [1].
Congenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive procedures
Intravenous infusion