Risk information for RAVICTI

RAVICTI® (glycerol phenylbutyrate) has been shown to be safe and effective for patients with urea cycle disorders. However, as with all medications, there are risks and benefits to taking RAVICTI. It is important for you to know some of the possible side effects of RAVICTI.

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 or your child 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), and/or headache

Who should not take RAVICTI?

  • Children younger than 2 months should not take RAVICTI because they may not be able to digest it
  • Do not take RAVICTI if you are allergic to phenylbutyrate

Call your doctor or go to the nearest hospital emergency room if you get wheezing, shortness of breath, cough, low blood pressure, flushing, nausea, or a rash while taking RAVICTI.

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, and 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, and headache

Tell your doctor if you or your child experience any bothersome side effects that do not go away. Some of the side effects may be similar to symptoms experienced with elevated ammonia. You should always contact your doctor and/or go to the hospital if you suspect that you are having a hyperammonemic crisis. The side effects listed above are not all of the possible side effects you could experience while on RAVICTI. See the Medication Guide (PDF) for more information.

What to tell your doctor before taking RAVICTI

Medical conditions
Tell your doctor if you have liver or kidney problems, pancreas or bowel (intestine) problems, or any other medical conditions.

Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby because tests have not been conducted. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into breast milk. RAVICTI may harm your baby, so you and your doctor should decide if you will take RAVICTI or breastfeed.

Medicines
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements. It's important to know the medicines you take, so keep a list to show your doctor and pharmacist when you are prescribed a new medicine.

Talk to your doctor about participating in a UCD registry. The purpose of this registry is to collect information about people with UCDs to improve care. For more information about the registry program, call 1-855-823-2595 or visit www.ucdregistry.com.

Important Safety information

Ravicti® (glycerol phenylbutyrate) oral liquid indications and usage

Approved Uses for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

RAVICTI is a prescription medicine used in adults and children 2 months of age and older for long-term management of high levels of ammonia in the blood (hyperammonemia) caused by a condition called a urea cycle disorder (UCD). RAVICTI must be used along with a low-protein diet and, in some cases, dietary supplements. RAVICTI should only be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone.

RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crises) in people with UCDs as they may require rapidly acting medication.

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 for children younger than 2 months.

Detailed Important Safety Information

Who should not take RAVICTI:

Children younger than 2 months should not take RAVICTI because they may not be able to digest it.

Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have symptoms of an allergic reaction, such as wheezing, shortness of breath, cough, low blood pressure, flushing, nausea, or rash while taking RAVICTI.

RAVICTI may cause serious side effects:

The breakdown of RAVICTI produces the byproduct phenylacetate, 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: sleepiness; lightheadedness; change in taste; problems with hearing; confusion; problems with memory; worsening of numbness, tingling, or burning in your hands or feet; headache, tiredness; nausea; or vomiting.

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, and dizziness.

The most common side effects of RAVICTI in children ages 2 to 17 years include stomach pain, nausea, vomiting, diarrhea, decreased appetite, and headache.

The most common side effects of RAVICTI in children ages 2 months to younger than 2 years include decreased level of a type of white blood cell, vomiting, diarrhea, fever, decreased appetite, cough, nasal congestion, runny nose, and rash.

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, pancreas or bowel (intestine) problems, or any other medical conditions. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby. Tell your doctor if you 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.

Talk to your doctor about participating in a UCD registry. The purpose of this registry is to collect information about people with UCDs to improve care. For more information about the registry program, call 1-855-823-2595 or visit www.ucdregistry.com.

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.

This information is not comprehensive. To learn more, talk to your healthcare provider or pharmacist. The FDA-approved product labeling, including the Medication Guide can be found at Ravicti.com.