USE and IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about RAVICTI? RAVICTI may cause serious side effects, including: Nervous system side effects (Neurotoxicity). The breakdown of RAVICTI produces the byproduct phenylacetate (PAA), which may cause nervous system side effects.
What is RAVICTI?
RAVICTI (glycerol phenylbutyrate) Oral Liquid is a prescription medicine used for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (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 to treat extremely high levels of ammonia in the blood (hyperammonemic crisis) in people with UCDs.
It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about RAVICTI?
RAVICTI may cause serious side effects, including: Nervous system side effects (Neurotoxicity). The breakdown of RAVICTI produces the byproduct phenylacetate (PAA), which may cause nervous system side effects.
Call your doctor or get medical help right away if you have any of these symptoms while taking RAVICTI:
- change in taste
- problems with hearing
- problems with memory
- worsening of numbness, tingling, or burning in your hands or feet
- feeling very tired (fatigue)
Who should not take RAVICTI?
Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you experience any of the following symptoms of an allergic reaction while taking RAVICTI:
- shortness of breath
- low blood pressure
- skin rash
What should I tell my doctor before taking RAVICTI?
Tell your doctor about any medical conditions and if you:
- Have liver or kidney problems.
- Have pancreas or bowel (intestine) problems.
- Are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby.
- Pregnancy Registry: There is a Pregnancy Registry for women who take RAVICTI just before becoming pregnant or who become pregnant during treatment with RAVICTI. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can join the Pregnancy Registry. For more information about this registry, call 1-855-823-2595 or visit www.ucdregistry.com.
- Are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. Breastfeeding is not recommended during treatment with RAVICTI. Talk to your doctor about the best way to feed your baby if you take RAVICTI.
What are possible side effects of RAVICTI?
RAVICTI may cause serious side effects, including:
The most common side effects of RAVICTI in adults include:
- abdomen (stomach) pain
- decreased appetite
- indigestion or heartburn
The most common side effects of RAVICTI in children 2 years to 17 years of age include:
- upper abdomen (stomach) pain
- decreased appetite
The most common side effects of RAVICTI in children 2 months to less than 2 years of age include:
- low white blood cell count (neutropenia)
- reduced food intake
- runny nose
- stuffy nose
- skin rash
- small round bumps on the skin
The most common side effects of RAVICTI in children less than 2 months of age include:
- gastroesophageal reflux
- increased levels of liver enzymes in the blood
- decreased appetite and reduced food intake
- low red blood cell count (anemia)
- loss of too much body fluid (dehydration)
- too much acid in the blood (acidosis)
- high blood platelet count (thrombocytosis)
- low blood platelet count (thrombocytopenia)
- low blood neutrophil count (type of white blood cell) (neutropenia)
- high white blood cell count (lymphocytosis)
- drowsiness (lethargy)
These are not all of the possible side effects of RAVICTI. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional important safety information, click here for the Medication Guide and discuss with your doctor.