Grifols launches Niuliva®
Grifols has launched of Niuliva® 250 IU/ml, its human anti-hepatitis B immunoglobulin for intravenous administration, in Spain and Italy.
The manufacturing process of Niuliva® produces a high purity, pasteurized solution with a high titer of specific anti-hepatitis B antibodies.
Niuliva® is approved for the:
- prevention of hepatitis B virus reinfection after liver transplantation for hepatitis B induced liver failure during the maintenance phase in non-replicator patients.
- immunoprophylaxis of hepatitis B
Niuliva® is available in different presentations, in an optimum pharmaceutical form (prefilled syringues or vials) for added convenience.
Niuliva® is the first intravenous human anti-hepatitis B immunoglobulin registered in Spain; Grifols anticipates that Niuliva® will be offered in other countries worldwide in upcoming months where the company commercializes its plasma derivative products.
About Hepatitis B Virus infection
The Hepatitis B Virus is highly infectious. About 350 million people are chronically infected worldwide by Hepatitis B Virus. Hepatitis B is the most frequent cause of chronic liver disease which can lead to cirrhosis or liver cancer (1), these patients often require a liver transplant. However, there is a high risk of reinfection alter transplantation which could have severe consequences, such as loss of transplanted liver and high mortality (2). One of the methods to prevent the reinfection of the transplanted liver is treatment with human anti-hepatitis B immunoglobulin. By combining this treatment with antivirals, the reinfection risk is reduced to a minimum and a these patients have a similar survival rate to those liver patients transplanted due to other reasons (3).
(1) www.who.int
(2) Samuel D. et al. N Engl J Med 1993;16;329(25):1842-7
(3) Terrault N. et al. Liver Transpl 2005 Jul;11(7):716-32
For full prescribing information of Niuliva® in countries where authorized, please see corresponding Prescribing Information.
Prescribing Information Italy
Prescribing Information Spain
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