RAVICTI for Babies and Children

Learning that your child has a urea cycle disorder (UCD) can be scary. A child with a UCD needs long-term treatment to keep ammonia in the body at a safe level. This is why choosing the right medicine is so important. Take this survey to find out if RAVICTI® (glycerol phenylbutyrate) may be right for your child.

Babies and toddlers

RAVICTI is the Only FDA APPROVED, easy to take UCD therapy for babies 2 months and older

RAVICTI is the only ready-to-use liquid medicine that’s FDA-approved to treat most types of UCDs for babies as young as 2 months old.

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

  • 17 babies and toddlers took part in the medical studies
  • 7 of the 17 babies and toddlers (41%) who took part in the medical studies reported a total of 11 hyperammonemic crises

*Range of 24–48 μmol/L.


RAVICTI is for people with UCDs who are at least 2 months of age and cannot manage their UCD with diet and supplements alone. Babies younger than 2 months of age should not take RAVICTI because they may not be able to digest it.

See how RAVICTI can help control ammonia levels for children 2 months and older.

Young child with a UCD,  playing outside with bubbles
Read transcript

Finding out that your baby or toddler has a urea cycle disorder, also called a UCD, can be scary and overwhelming. There is a lot of information to process and understand.

One thing you’ll learn right away is the importance of managing the amount of ammonia in your child’s blood.

There are several things you can do to help prevent your child’s blood ammonia levels from getting too high, like feeding them a low-protein diet and monitoring their activity.

There are also treatments that can help you keep your child’s ammonia levels under control over a long period of time.

RAVICTI (glycerol phenylbutyrate) is a treatment option for babies and toddlers 2 months and older.

A recent study found that RAVICTI helped manage ammonia levels in babies and toddlers ages 2 months to younger than 2 years.

This study included babies and toddlers who had been using other medicine to treat their UCDs, as well as those who had not been using any medicine at all.

RAVICTI is a prescription medicine, and it is the only FDA-approved liquid medicine of its kind.

Babies and toddlers 2 months and older take RAVICTI 3 or more times a day, in equal doses, with food or formula. It is taken by mouth, and has little to no taste. It can also be given through a feeding tube, if necessary.

Babies and toddlers using RAVICTI must eat a low-protein diet and, in many cases, take dietary supplements to help manage ammonia levels.

RAVICTI should not be used in children younger than 2 months because they may not be able to digest it, and children of any age should not take RAVICTI if they are allergic to phenylbutyrate.

Managing a UCD requires some lifestyle changes, but there are also treatment options available to help to keep your child’s ammonia at a safe level over time. If your baby or toddler has been diagnosed with a UCD, talk to your doctor to learn more about how RAVICTI might help you and your family.

IMPORTANT SAFETY INFORMATION

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.

Children and teens

12 month control icon

In medical studies that lasted 12 months, RAVICTI helped keep ammonia levels within a normal range* in children and teens up to 17 years old.

  • 26 children and teens took part in the medical studies
  • 5 out of 26 children aged 6 to 17 years (19%) reported a total of 5 hyperammonemic crises

*Range of 17–23 μmol/L.

RAVICTI must be used with a low-protein diet, and in some cases, supplements. RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crisis) in people with UCDs, as they may require more rapidly acting treatment. It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.

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Amy, UCD caregiver
Amy, UCD caregiver

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"As the mother of a child with a rare disease, you have to find your own voice, and use it."  – Amy | Caregiver

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Important Safety Information And Approved Uses For RAVICTI® (glycerol phenylbutyrate) Oral Liquid
Who Should Not Take RAVICTI: Children... 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...

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Important Safety Information And Approved Uses For RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid

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.

Approved Uses and Important Safety Information for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

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

Indication for RAVICTI Oral Liquid

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.

Limitations Of Use

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.

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.

Important Safety Information And Approved Uses For RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid

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.

Approved Uses and Important Safety Information for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

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

Indication for RAVICTI Oral Liquid

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.

Limitations Of Use

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.

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.