The following is an update on supply from Novo Nordisk regarding the availability of NovoSeven® RT, Novoeight®, and Esperoct®

As part of our commitment to sharing timely and transparent information, we want to provide you with an important update about NovoSeven® RT (coagulation Factor VIIa, recombinant) and Novoeight® (antihemophilic factor, recombinant)

We have 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. Additionally, there are no underfilled vials of Novoeight® or Esperoct®.

It is important to note that Novo Nordisk’s medical evaluation concluded that treatment with under-filled doses will still have an effect and the probability of serious adverse health consequences is remote. Because 1 mg and 2 mg vials are commonly used in combination with additional vials for treatment, and that hemostasis is typically achieved with NovoSeven® RT using repeated dosing at 2-3 hour intervals, the likelihood of under-filled vials having an impact on therapeutic dose is extremely low. 

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). 

• We expect NovoSeven® RT 1 mg vials to be back in stock at the NNDC by around June 24, 2024. However, during this time, supply of the 1 mg vial should remain available at some Novo Nordisk Authorized Distributors. The NovoSeven® RT 2 mg vials are expected to be available in the NNDC by Monday, June 17, 2024, and we also expect the supply of the 2 mg vial to be available at some Novo Nordisk Authorized Distributors. We encourage you to contact the Novo Nordisk ordering center to access a list of Authorized Distributors if your primary distributor does not have 1 mg or 2 mg vials on-hand.

• The NovoSeven® RT 5 mg vials are fully available.

• We are awaiting confirmation of the availability of the NovoSeven® RT 8 mg vial and will communicate promptly when we know more.

• Novoeight® 1000 IU and 2000 IU vial sizes are expected to be out of stock until the end of July 2024, and Novoeight® 500 IU and 3000 IU vial sizes are expected to be out of stock at the NNDC from mid-June until the end of July 2024. However, we do expect stock of the 500 IU, 1000 IU, 2000 IU, and 3000 IU vial sizes to be available at authorized specialty distributors. We continue to have an adequate stock of Novoeight® 250 IU and 1500 IU vial sizes.

Patients who have questions about how to make up their dose using the currently available vial sizes should consult their healthcare provider.

Based on our current understanding and inventory levels of NovoSeven® RT and Novoeight®, additional shortages are expected to be intermittent and to continue at least throughout 2024 due to this manufacturing issue, combined with unrelated release delays from the packaging line, and other continued capacity constraints. We will keep you informed if any occur.

We have informed the U.S. Food and Drug Administration (FDA) of the current situation and are proactively engaging in dialog with various stakeholders including healthcare professionals, hemophilia treatment centers, specialty pharmacies as well as professional and patient advocacy groups, to provide updates on our supply situation.

We understand the impact this may have on patients, their families, and physicians, and are dedicated to continuing our support for the community and ensuring the availability of these therapies. In the interim, if you have any questions, please reach out to your Novo Nordisk representative or contact Novo Care customer support at 1-844-668-6732.