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Susoctocog alfa

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Contents
  1. dm+d
  2. Lactation Safety Information
  3. New Medicines
    1. Obizur · Congenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive procedures

dm+d

Unassigned

Lactation Safety Information

Yes
-
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
Safety in Lactation: Drugs for bleeding disorders
20 October 2016
Bibliography

New Medicines

ObizurCongenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive procedures

Information

Obizur
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Yes
Yes
May 21Removed from pipeline; development discontinued [5].
Feb 21PIII 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