Novo Nordisk provided the following update about the NovoSeven® RT (coagulation Factor VIIa, recombinant) 8 mg vial.
Due to supply constraints, Novo Nordisk will be unable to provide the 8 mg vial of NovoSeven® RT from January until mid-2024. Importantly, the overall supply of NovoSeven® RT is expected to remain intact as other vial sizes are available as a solution for those who would otherwise use the 8 mg vial. Patients can use the 1 mg, 2 mg, and 5 mg vials in combination to make the dose they need in absence of the 8 mg vial. Patients who have questions about how to make up their dose should consult their healthcare provider.
This is not a quality issue. Novo Nordisk has decided to temporarily limit supply of the 8 mg vial because it requires the highest amount of Active Pharmaceutical Ingredient (API), which is currently constrained, compared to the other vial sizes. By re-directing the API towards the 1 mg, 2 mg, and 5 mg vial sizes, we can produce more and help ensure the overall supply of NovoSeven® RT remains intact for patients. Again, we don’t expect constraints on supply of the 1 mg, 2 mg, and 5 mg vials that would impact availability for patients.
We recognize the inconvenience this may cause, and we are working hard to restore availability of the 8 mg vial as soon as possible. We are in dialogue with HCPs, advocacy groups, specialty pharmacies, and specialty distributors to minimize the impact this will have on patients.