For more information about the availability of RAVICTI in Canada, including Horizon's patient support programs, please call 1-844-823-4226.About RAVICTI® Indication and Clinical Use In Canada, RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients >2 years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI should be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, and protein-free calorie supplements).
- Not for treatment of acute hyperammonemia in patients with UCDs.
- Safety and efficacy in patients with N-acetylglutamate synthase (NAGS) deficiency have not been established.
- Safety and efficacy in patients two months to two years of age have not been established.
- Clinical studies did not include sufficient subjects 65 years of age or older to determine response compared to younger subjects.
- RAVICTI should be prescribed by a physician experienced in the management of UCDs.
- Hypersensitive to RAVICTI or its metabolites (phenylbutyric acid [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN])
- Less than two months of age
- Neurologic Risk: Acute Hyperammonemic Encephalopathy may occur even when patient is on therapy. Symptoms of neurotoxicity are associated with the RAVICTI major metabolite, phenylacetic acid (PAA).
- Cardiovascular: Caution should be observed in patients who have conditions that could be worsened by an increase in heart rate such as tachyarrhythmias or ischemic heart disease.
- Hepatic: Caution should be used in patients with hepatic insufficiency.
- Pancreatic: Caution should be used in patients in whom there is inadequate intestinal hydrolysis of RAVICTI as impaired absorption of PBA and hyperammonemia could occur.
- Renal: Caution should be used in patients with renal insufficiency, including those with end-stage renal disease (ESRD) or those on hemodialysis.
- Pregnancy: Caution should be used in patients who are pregnant as the potential risk to the fetus is not known.
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- Summar, Ml, et al. "Diagnosis, Symptoms, Frequency and Mortality of 260 Patients with Urea Cycle Disorders from a 21-Year, Multicentre Study of Acute Hyperammonaemic Episodes." Acta Paediatr. 97.10. (2008): 1420-1425. Web. 31 Oct 2016.
- "Urea Cycle Disorders: What Are Urea Cycle Disorders?" NORD Physician Guides. Web. 31 Oct 2016.
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