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Articles

Safety in Lactation: Drugs for bleeding disorders

18 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Antifibrinolytics & haemostatics Etamsylate is a…
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Lactation Safety Information

Yes
-
Synonym: Recombinant coagulation factor VIIa
No published evidence of safety
Unlikely to enter milk and not absorbed from the infant’s GI tract
Factor VIIa is a normal component of maternal and infant plasma
10 August 2020

New Medicines

NovoSeven Severe post-partum haemorrhage

Information

NovoSeven
Licence extension / variation
Novo Nordisk
Novo Nordisk

Development and Regulatory status

None
Recommended for approval (Positive opinion)
None
Apr 22Recommended for EU approval by CHMP - the extension to the existing indication is for the "treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis [1]".

Category

NovoSeven contains activated recombinant coagulation factor VII. The mechanism of action includes the binding of factor VIIa to exposed tissue factor [2].
Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. The 2011–13 Confidential Enquiries into Maternal Deaths and Morbidity report identified 13 direct deaths due to obstetric haemorrhage in the UK and Ireland [3].
Severe post-partum haemorrhage
Intravenous

HemAryoHaemophilia A and B treatment and prevention of bleeding, and other NovoSeven indications

Information

HemAryo
Biosimilar
UGA Biopharma
UGA Biopharma

Development and Regulatory status

None
Filing withdrawn
None
May 22UGA Biopharma withdraw marketing authorisation application due to major manufacturing issues [1].

Category

Activated recombinant coagulation factor VII. The mechanism of action includes the binding of factor VIIa to exposed tissue factor.
Haemophilia B has a prevalence of around 1 in 30,000 live births; Haemophilia A affects 1 in 4,000 to 1 in 5,000 live male births worldwide [2].
Haemophilia A and B treatment and prevention of bleeding, and other NovoSeven indications
Intravenous