Clinical data for patients less than 2 months of age
RAVICTI HCP
Important information
- Of the 16 pediatric patients less than 2 months of age in a 24-month, uncontrolled, open-label study, 5 patients (31%) reported a total of 7 hyperammonemic crises.1
- Of the 17 pediatric patients 2 months to less than 2 years of age in 3 open-label studies, 7 patients (41%) reported a total of 11 hyperammonemic crises.1
- Of the 26 pediatric patients 6 to 17 years of age in two 12-month studies of RAVICTI, 5 patients (19%) reported a total of 5 hyperammonemic crises.1
- Of 51 adult patients in a 12-month study of RAVICTI, 7 patients (14%) reported a total of 10 hyperammonemic crises.1
aIn uncontrolled, open-label, extension clinical trials, mean blood ammonia levels were controlled over at least 12 months in all age groups tested.1
bSix uncontrolled, open-label studies were conducted to assess monthly ammonia control and hyperammonemic crises in patients with urea cycle disorders (UCDs): 16 pediatric patients less than 2 months of age, with 9 patients completing 24 months of treatment; 17 pediatric patients 2 months to less than 2 years of age, with 6 patients completing 12 months of treatment; 26 pediatric patients 6 to 17 years of age over a 12-month period; and 51 adults over a 12-month period.1
RAVICTI: Effective, long-term ammonia control with convenient dosing1,c
- Easy-to-administer oral liquid that is nearly tasteless and odorless1,2
- Approved to treat UCD subtypes except NAGS deficiency1
- No pill or powder preparation1,2
- Easy for patients to make the switch from sodium phenylbutyrate (NaPBA) without any gap in treatment1
- Taken with meals via oral dosing syringe1
- With a simple calculation, dosage can be converted from NaPBA to RAVICTI1
RAVICTI is contraindicated in patients with known hypersensitivity to phenylbutyrate.1
cIn uncontrolled, open-label, extension clinical trials, mean blood ammonia levels were controlled over at least 12 months in all age groups tested.1
Get more information about RAVICTI dosing
Calculate the appropriate starting dose for treatment-naïve patients, quickly convert the dosage from NaPBA to RAVICTI, and optimize the RAVICTI dosage.
Optimize the RAVICTI dosage with a metabolite testing kit at no cost
With this test, you can determine your patient's plasma PAA:PAGN ratio and urinary PAGN level.
Stay informed about RAVICTI® (glycerol phenylbutyrate) Oral Liquid
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References: 1. RAVICTI [package insert]. Lake Forest, IL: Horizon Pharma USA, Inc.; 2018. 2. Diaz GA, Krivitzky LS, Mokhtarani M, et al. Ammonia control and neurocognitive outcome among urea cycle disorder patients treated with glycerol phenylbutyrate. Hepatology 2013;57(6):2171-2179. doi:10.1002/hep.26058.