The US Food and Drug Administration has determined that RAVICTI is safe and effective in adult and pediatric patients (2 months of age and older) with UCDs.1
Selected Important Safety Information
Reduced phenylbutyrate absorption in pancreatic insufficiency or intestinal malabsorption: Low or absent pancreatic enzymes or intestinal disease resulting in fat malabsorption may result in reduced or absent digestion of RAVICTI and/or absorption of phenylbutyrate and reduced control of plasma ammonia. Monitor ammonia levels closely.
RAVICTI is not used for the treatment of acute hyperammonemia in patients with UCDs.
RAVICTI® (glycerol phenylbutyrate) Oral Liquid has a unique mechanism of action designed for a slow release of phenylbutyrate (PBA)1,3-5
An alternate vehicle for waste nitrogen removal can help control ammonia, which can fluctuate daily above the upper limit of normal in patients with urea cycle disorders (UCDs).1,3,4
The absorption of phenylbutyrate is approximately 70% to 75% slower when administered as RAVICTI vs sodium phenylbutyrate.1,5
References: 1. RAVICTI [package insert]. Lake Forest, IL: Horizon Pharma USA, Inc.; 2017. 2. Data on file. Horizon Pharma USA, Inc.; 2015. 3. Lee B, Diaz GA, Rhead W, et al. Genet Med. 2015;17(7):561-568. doi:10.1038/gim.2014.148. 4. Lichter-Konecki U, Diaz GA, Merritt JL II, et al. Mol Genet Metab. 2011;103(4):323-329. doi:10.1016/j.ymgme.2011.04.013. 5. Monteleone JPR, Mokhtarani M, Diaz GA, et al. J Clin Pharmacol. 2013;53(7):699-710. doi:10.1002/jcph.92. 6. The Physician’s Guide to Urea Cycle Disorders. National Organization for Rare Disorders website. 2012. http://nordphysicianguides.org/urea-cycle-disorders/. Accessed May 3, 2017. 7. Braissant O, McLin VA, Cudalbu C. Inherit Metab Dis. 2013;36(4):595-612. doi:10.1007/s10545-012-9546-2. 8. Mokhtarani M, Diaz GA, Rhead W, et al. Mol Genet Metab. 2013;110(4):446-453. doi:10.1016/j.ymgme.2013.09.017. 9. Mokhtarani M, Diaz GA, Rhead W, et al. Mol Genet Metab. 2012;107(3):308-314. doi:10.1016/j.ymgme.2012.08.006. 10. Diaz GA, Krivitzky LS, Mokhtarani M, et al. Hepatology. 2013;57(6):2171-2179. doi:10.1002/hep.26058.
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