RAVICTI is approved for babies and toddlers 2 months and older

Learning that your child has a urea cycle disorder (UCD) can be scary. A UCD requires long-term treatment to keep the amount of ammonia in the body at a safe level, and choosing a treatment is an important decision. RAVICTI helped manage ammonia levels in babies and toddlers ages 2 months to younger than 2 years. On this page you’ll find more information, including resources like mentors who can tell you about their own RAVICTI experience and a customizable discussion guide to bring to your next doctor visit.
 

Selected Important Risk Information

RAVICTI is for people with UCDs who are at least 2 months of age and cannot manage their UCD with diet and supplements alone. RAVICTI must be used with a low-protein diet. It should not be used in children younger than 2 months of age.

RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crisis) or for NAGS deficiency.

RAVICTI for babies and toddlers 2 months and older

RAVICTI is a liquid medicine taken as few as 3 times a day

RAVICTI is a liquid medicine that has little to no taste. It is taken by mouth using an oral syringe or a dosing cup. It can also be given through a feeding tube. Babies and toddlers take 3 or more equal doses of RAVICTI each day with food or formula. They must also eat a low-protein diet and, in many cases, take dietary supplements to help manage their ammonia levels.

Your child should take RAVICTI exactly as their doctor has prescribed it. Your child’s doctor may change their dose of RAVICTI if needed, but do not change your child’s dose without their doctor’s permission. If your child takes too much RAVICTI, call their doctor and go to the nearest emergency room right away.

The maximum approved daily dose of RAVICTI is 17.5 mL for both adults and children.

In medical studies, RAVICTI helped to successfully manage ammonia in young children who switched to RAVICTI and young children who were being treated for the first time

17 babies and toddlers took part in the medical studies, and 7 of the 17 young children (41%) who participated reported a total of 11 hyperammonemic crises.

RAVICTI offers long-term* ammonia control in young children ages 2 months to younger than 2 years

*In medical studies that lasted up to 18 months, RAVICTI helped keep ammonia levels in a safe range for young children ages 2 months to younger than 2 years.

Side effects among young children in the study were similar to those in older patients, with a few exceptions

In the medical studies, at least 10% of young children ages 2 months to younger than 2 years who were given RAVICTI had one or more of these side effects:

  • Decreased level of a type of white blood cell
  • Vomiting
  • Diarrhea
  • Fever
  • Decreased appetite
  • Cough
  • Nasal congestion (stuffy nose)
  • Runny nose
  • Rash

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.