Our focus: saving, extending, and improving patients’ lives
Hyperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company committed to advancing science and developing treatments for orphan and hepatic diseases. RAVICTI™ is our first approved product for the treatment of urea cycle disorders (UCDs) and is being developed for a second orphan indication, hepatic encephalopathy.
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Indication and Usage
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (eg, essential amino acids, arginine, citrulline, protein-free calorie supplements).
LIMITATIONS OF USE:
- RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels.
- The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.
- The use of RAVICTI in patients <2 months of age is contraindicated.
Important Safety Information
WARNINGS AND PRECAUTIONS:
- Neurotoxicity: Phenylacetate (PAA), a major metabolite of RAVICTI, may be toxic at levels ≥500 μg/mL. Reduce RAVICTI dosage if symptoms of neurotoxicity, including vomiting, nausea, headache, somnolence, confusion, or sleepiness, are present in the absence of high ammonia or other intercurrent illnesses.
- Reduced Phenylbutyrate Absorption in Pancreatic Insufficiency or Intestinal Malabsorption: Monitor ammonia levels closely.
- The most common adverse reactions (occurring in ≥10% of adult patients) reported during short-term and long-term treatment with RAVICTI were diarrhea, flatulence, and headache; and nausea, vomiting, diarrhea, decreased appetite, hyperammonemia, dizziness, headache and fatigue, respectively.
- Adverse events occurring in ≥10% of pediatric patients during long-term treatment with RAVICTI were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, hyperammonemia, and headache.
- Corticosteroids, valproic acid, or haloperidol: May increase plasma ammonia level. Monitor ammonia levels closely.
- Probenecid: May affect renal excretion of metabolites of RAVICTI, including PAGN and PAA.
- Pregnancy: Based on animal data, may cause fetal harm.
- Nursing Mothers: Discontinue nursing or discontinue the drug.
RAVICTI is a trademark of Hyperion Therapeutics, Inc.