Drug updated on 9/4/2024
Dosage Form | Liquid (oral; 1.1 g/mL) |
Drug Class | Nitrogen-binding agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for chronic management of patients 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.
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Summary
- Ravicti (glycerol phenylbutyrate) is indicated for chronic management of patients 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.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Glycerol phenylbutyrate demonstrated a beneficial effect in reducing hepatic encephalopathy compared to placebo (RR 0.57, 95% CI 0.36 to 0.90; 178 participants) and significantly reduced blood ammonia levels (MD -12.00, 95% CI -23.37 to -0.63; 178 participants).
- Polyethylene glycol was more effective than lactulose in reducing hepatic encephalopathy (RR 0.19, 95% CI 0.08 to 0.44; 190 participants).
- Sodium benzoate, ornithine phenylacetate, and AST-120 showed no beneficial effects on hepatic encephalopathy compared to their respective controls.
- Serious Adverse Events: No significant differences in serious adverse events were observed between glycerol phenylbutyrate and placebo (RR 1.63, 95% CI 0.85 to 3.13; 178 participants) or between other drugs (sodium benzoate, ornithine phenylacetate, AST-120, polyethylene glycol) and their respective controls.
- Non-Serious Adverse Events: No significant differences in non-serious adverse events were reported between glycerol phenylbutyrate and placebo, as well as between other drugs and their respective controls.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ravicti (glycerol phenylbutyrate) Prescribing Information. | 2021 | Horizon Therapeutics USA, Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis. | 2019 | Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Suggested guidelines for the diagnosis and management of urea cycle disorders: first revision. | 2019 | Journal of Inherited Metabolic Disease |