Updated June 21: News from Novo Nordisk, Potential Under-filling of Some Vials on the Market

Please read the latest update on this issue and addendum as of June 21, 2024.

HFA published the original update on June 18, below:

Novo Nordisk provided the following update about NovoSeven® RT, Novoeight®, and Esperoct® [antihemophilic factor (recombinant),glycopegylated-exei].

“Novo Nordisk has identified an issue on a specific production line that is manufacturing NovoSeven® RT, Novoeight®, and Esperoct® [antihemophilic factor (recombinant),glycopegylated-exei]. This issue has resulted in the potential under-filling of some 1 mg and 2 mg NovoSeven® RT vials on the market. However, the likelihood of an underfilled vial reaching the market is very low due to extensive manual inspections during production, which resulted in most under-filled vials being identified and removed before release. 

It is important to note that Novo Nordisk’s medical evaluation concluded that treatment with under-filled doses will still have effect and the probability of serious adverse health consequences is remote. Additionally, there are no underfilled vials of Novoeight® or Esperoct®.

This manufacturing issue has led to a temporary shortage of the NovoSeven® RT 1 mg and 2 mg vials and some strengths of Novoeight® at the Novo Nordisk Distribution Center (NNDC).”

Read the update in its entirety here.