Ravicti Oral Liquid
Generic name:glycerol phenylbutyrate
Dosage form: oral liquid
Drug class:Urea cycle disorder agents
Medically reviewed by Drugs.com. Last updated on Sep 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
Indications and Usage for Ravicti Oral Liquid
RAVICTI 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 amino acid 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).
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.
Ravicti Oral Liquid Dosage and Administration
Important Administration Instructions
RAVICTI should be prescribed by a physician experienced in the management of UCDs.
- Instruct patients to take RAVICTI with food or formula and to administer directly into the mouth via oral syringe.
- Instruct patients to use the RAVICTI bottle and oral syringe as follows:
- Use a new reclosable bottle cap adapter with each new bottle that is opened.
- Open the RAVICTI bottle and twist on the new reclosable bottle cap adapter.
- Use a new and dry oral syringe to withdraw each prescribed dose of RAVICTI.
- Discard the oral syringe after each dose.
- Tightly close the tethered tab on the reclosable bottle cap adapter after each use.
- Do not rinse the reclosable bottle cap adapter.
- Discard bottle and an...