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
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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.