What Is RAVICTI™ (glycerol phenylbutyrate) Oral Liquid?
RAVICTI is a prescription medication that can be used in adults and children 2 years of age and older for the long-term management of high blood levels of ammonia caused by a condition called a UCD. If you or your child has a UCD, consider using RAVICTI to treat it. It is the only FDA- approved liquid medicine that:
- You take by mouth
- Has little-to-no smell
- Has little-to-no taste
Only use RAVICTI if your UCD cannot be managed with a low-protein diet and dietary supplements alone. Read more »
Important Safety Information
RAVICTI Indications and Usage
WHAT IS RAVICTI?
RAVICTI is a prescription medicine used in adults and children 2 years of age and older for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a UCD. RAVICTI should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone. RAVICTI must be used along with a low-protein diet and, in some cases, dietary supplements.
RAVICTI is not used for the treatment of acute hyperammonemia in people with UCDs.
It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
It is not known if RAVICTI is safe and effective in children 2 months to less than 2 years of age.
RAVICTI Important Safety Information
WHO SHOULD NOT TAKE RAVICTI:
- Children less than 2 months of age should not take RAVICTI because it may not be digested in babies less than 2 months of age.
- Do not take RAVICTI if you are allergic to phenylbutyrate.
- RAVICTI is not used for the treatment of acute hyperammonemia in people with UCDs.
- It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
- It is not known if RAVICTI is safe and effective in children 2 months to less than 2 years of age.
RAVICTI MAY CAUSE SERIOUS SIDE EFFECTS
Phenylacetate, a breakdown product of RAVICTI, may cause nervous system side effects. Call your doctor or get medical help right away if you get any of these symptoms while taking RAVICTI:
- sleepiness
- weakness
- lightheadedness
- change in taste
- problems with hearing
- confusion
- problems with memory
- worsening neuropathy (numbness, tingling, or burning in your hands or feet)
- headache
WHAT ARE THE POSSIBLE SIDE EFFECTS OF RAVICTI?
The most common side effects of RAVICTI in adults include:
- diarrhea
- gas
- headache
- nausea
- vomiting
- tiredness
- decreased appetite
- high blood levels of ammonia
- dizziness
The most common side effects of RAVICTI in children include:
- upper abdomen (stomach) pain
- nausea
- vomiting
- diarrhea
- decreased appetite
- high blood levels of ammonia
- headache
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of RAVICTI. Call your doctor for medical advice about side effects.
BEFORE YOU TAKE RAVICTI, TELL YOUR DOCTOR IF YOU:
- Have liver or kidney problems
- Have pancreas or bowel (intestine) problems
- Have any other medical conditions
- Are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. RAVICTI may harm your baby, so you and your doctor should decide if you will take RAVICTI or breastfeed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact the Hyperion Therapeutics Medical Information Department toll-free at 1-855-UCD-SUPT (1-855-823-7878) or drugsafety@hyperiontx.com.
Please see full Prescribing Information (PDF) and Medication Guide (PDF) for RAVICTI.
