Mechanism of Action
Learn about the unique slow release of phenylbutyrate
The following adverse reactions have been identified during postapproval use of RAVICTI1:
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.1
dAssessment of adverse reactions in a randomized, double-blind, active-controlled, crossover study in which 45 adult patients (at least 18 years of age) with UCDs were treated with either RAVICTI or NaPBA for 2 weeks.1
eAssessment of adverse reactions in 2 open-label studies of 26 patients with UCDs 2 to 17 years of age being treated with RAVICTI for 12 months. There were no deaths during these studies.1
fAssessment of adverse reactions in 3 open-label studies of 17 patients with UCDs 2 months to less than 2 years of age (median exposure, 6 months [range, 0.2-20 months]). One patient developed hyperammonemia during dosing and experienced surgical complications (bowel perforation and peritonitis) following jejunal tube placement; this patient developed a hyperammonemic crisis, and subsequently died of sepsis from peritonitis unrelated to drug.1
gAssessment of adverse reactions in 1 open-label study of 16 patients with UCDs who began treatment at less than 2 months of age (median exposure, 10 months [range, 2-20 months]) to assess transition to RAVICTI over a period of 7 days, followed by monthly assessment of ammonia control and hyperammonemic crises over a 24-month period.1
Learn about the unique slow release of phenylbutyrate
Review the patient treatment profile and administration features of RAVICTI
Reference: 1. RAVICTI (glycerol phenylbutyrate) Oral Liquid [prescribing information] Horizon.
RAVICTI (glycerol phenylbutyrate) Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements).
The most common adverse reactions reported in clinical trials (at least 10% of patients) were:
Please see Full Prescribing Information.
RAVICTI (glycerol phenylbutyrate) Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements).
The most common adverse reactions reported in clinical trials (at least 10% of patients) were:
Please see Full Prescribing Information.