How to Take RAVICTI

RAVICTI® (glycerol phenylbutyrate) Oral Liquid is a liquid medicine that you can take by mouth, as few as 3 times a day. It is odorless, nearly tasteless, and there are no pills to swallow or powders to mix.

  • RAVICTI can be taken by mouth, feeding tube, or G-tube. In patients who can swallow safely, RAVICTI can be taken by mouth, even if the patient has a G-tube
  • Adults and children 2 years and older take RAVICTI as few as 3 times per day
  • Newborns, babies, and toddlers up to 2 years of age take 3 or more equal doses of RAVICTI each day with food or formula
  • In an infant who is breastfeeding, give RAVICTI just before breastfeeding
  • People who take RAVICTI must follow a low-protein diet, and in some cases, take dietary supplements

Easy dosing

Ravicti Dosing Icon Ravicti Dosing Icon Ravicti Dosing Icon

Odorless and nearly tasteless liquid

Ravicti Prepping Icon Ravicti Prepping Icon Ravicti Prepping Icon

Easy to prep

Liquid syringe iconLiquid syringe iconLiquid syringe icon

Take by mouth with meals


Simple steps for taking RAVICTI by mouth

Watch the videos below for step-by-step instructions on how to take RAVICTI by mouth. Or, if you have questions or need more help, you can contact your Patient Access Liaison at 1-855-823-7878 or speak with your doctor.

Shot 1 Shot 1

Getting started: All it takes is 1 twist off and 1 twist on

Remove the childproof cap on the RAVICTI bottle by pushing down on the cap while twisting it to the left. Then, attach the blue AdaptaCap® Bottle Adapter onto the bottle by twisting it to the right.

Shot 2 Shot 2

Fill the syringe: It's as easy as "Hold, flip, pull"

  • Hold the RAVICTI bottle securely as you place the tip of the oral dosing syringe into the AdaptaCap® Bottle Adapter
  • Flip the bottle upside down with the oral dosing syringe still inserted
  • Pull the plunger of the oral dosing syringe back slowly to draw up the amount of RAVICTI prescribed by your doctor. Don’t forget to turn the bottle upright again (Tip: Pulling slowly will help avoid large air bubbles from forming in the medicine.)
shot 3 shot 3

Easy to take: Squirt RAVICTI right into the mouth

Once the oral dosing syringe is ready, place it into the mouth. Push the plunger to squirt all of the medicine directly into the mouth.

shot 4 shot 4

Wash it down: Take RAVICTI with water or food

Ensure the full dose of RAVICTI is swallowed completely by drinking liquid or eating some food. Breakfast, lunch, or dinner, RAVICTI can work with the timing of your meals.

Watch the full videos or download the guides

Child taking RAVICTI by mouth

Download PDF:

Taking by Mouth Guide

Read transcript

Welcome to the RAVICTI® (glycerol phenylbutyrate) Oral Liquid instructional dosing video.

In this video you will see step-by-step instructions for the oral administration of RAVICTI for you or your child.

Use for RAVICTI®  (glycerol phenylbutyrate) Oral Liquid

RAVICTI 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.

Please listen to the RAVICTI Important Safety Information at the end of this video. For additional important safety information, see the Medication Guide at RAVICTI.com and discuss with your doctor.

This video is intended to complement the instructions you have already received from your doctor. Always take RAVICTI exactly as directed by your doctor.

Do not mix RAVICTI with formula or any other liquids.

Now, let’s get started.

Your RAVICTI shipment includes a 25-mL bottle of RAVICTI, a blue AdaptaCap® Bottle Adapter, and an oral dosing syringe.

When dosing RAVICTI, be sure to use the oral dosing syringe provided with the product.

First, remove the childproof cap on the RAVICTI bottle. To do that, push down on the cap while twisting it to the left.

Then, attach the blue AdaptaCap® Bottle Adapter onto the bottle. Put it on top of the bottle and twist it to the right.

Make sure it is secured tightly on the bottle.

While holding the RAVICTI bottle securely, place the tip of the oral dosing syringe into the AdaptaCap® Bottle Adapter.

Turn the bottle upside down with the oral dosing syringe still inserted.

Now you’re ready to fill the oral dosing syringe with RAVICTI.

Get the medicine into the oral dosing syringe by pulling the plunger back slowly. Pulling slowly will help avoid large air bubbles from forming in the medicine.

Pull the plunger back until the first line of the black rubber stopper is even with the dosing mark. The dosing marks are on the barrel of the oral dosing syringe. Match the dosing mark with the amount of medicine prescribed by your doctor.

Then, turn the bottle upright again.

If there are large air bubbles, push the medicine back into the bottle. Do this slowly.

Then draw up the medicine again.

Once you have your oral dosing syringe ready, place it into the mouth. Push the plunger to squirt the medicine directly into the mouth.

Make sure all of the medicine is pushed out of the oral dosing syringe and swallowed.

Put the cap on the oral dosing syringe.

Drink liquid or eat some food right after taking RAVICTI.

This helps ensure that all of the medicine is swallowed.

Close the tab on the AdaptaCap® Bottle Adapter.

Make sure it’s closed tightly.

You can use 1 oral dosing syringe and 1 blue AdaptaCap® Bottle Adapter for all doses each day. You can also choose to use a new oral dosing syringe with each dose. Do not rinse the AdaptaCap® Bottle Adapter or oral dosing syringe between doses.

After the last dose of the day, dispose of the oral dosing syringe.

If you take too much RAVICTI, call your doctor or go to the nearest hospital emergency room right away.

You should consult your physician if you have missed a dose of RAVICTI.

Do not mix RAVICTI with formula or any other liquids.

USE and IMPORTANT SAFETY INFORMATION

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.

Lauren:

I’ve had a lot of experience with living with this. I got diagnosed when I was 2 years old. I’ve been through the process of taking powdered medicine and pills.

The most challenging thing about my previous medication was the amount, of how much I had to take. Pills after each meal was a lot.

When I found out about RAVICTI there was no hesitation from me because I had already been through so much with my other medication. 

I had been on pills for 25 years. So I was ready for a change.

When I first started taking RAVICTI, full-time, I was excited. Because I didn’t have to count out so many pills. 

I just did not realize how much time that took. 

I chose RAVICTI [because] it’s easy for me to take and I can move on to whatever else I need to do. 

It’s different for everyone, but for me my ammonia levels are managed really well.

If you’re nervous about making the switch to RAVICTI, you should talk to your doctor.

And if you ever get scared or feel like you’re unsure whether it is the right choice or not, you can look at me as an example and say, “This girl, she has tried it, and it’s worked for her.” And maybe that will give you some hope and some courage to move on with the choice to try it.

 

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: 
  • sleepiness 
  • lightheadedness 
  • change in taste 
  • problems with hearing 
  • confusion 
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet  
  • headache 
  • feeling very tired (fatigue) 
  • nausea 
  • vomiting 

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:

  • wheezing
  • shortness of breath
  • cough
  • low blood pressure
  • flushing
  • nausea
  • 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:

  • See What is the most important information I should know about RAVICTI?

 The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting
  • tiredness
  • 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
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache 

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)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose
  • runny 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:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • 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)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability
  • agitation

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, see the Medication Guide available at RAVICTI.com and discuss with your doctor.

RAVICTI and the HORIZON logo are trademarks owned by or licensed to Horizon. All other referenced trademarks are the property of their respective owners. © 2020 Horizon Therapeutics plc  P-RVT-00473 05/20
Taking RAVICTI by feeding tube

Download PDF:

Feeding Tube Guide

Read transcript

Welcome to the RAVICTI® (glycerol phenylbutyrate) Oral Liquid instructional dosing video.

In this video, you will see step-by-step instructions for administration of RAVICTI if you or your child have a nasogastric or gastrostomy feeding tube.

If you can swallow liquids, it is recommended you take RAVICTI by mouth.

Use for RAVICTI® (glycerol phenylbutyrate) Oral Liquid

RAVICTI 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.

Please listen to the RAVICTI Important Safety Information at the end of this video. For additional important safety information, see the Medication Guide at RAVICTI.com and discuss with your doctor

This video is intended to complement the instructions you have already received from your doctor. Always take RAVICTI exactly as directed by your doctor.

Do not mix RAVICTI with formula or any other liquids.

Now, let’s get started.

Your RAVICTI shipment includes:

A 25-mL bottle of RAVICTI, a blue AdaptaCap® Bottle Adapter, and an oral dosing syringe.

When dosing RAVICTI, be sure to use the oral dosing syringe provided with the product.

First, remove the childproof cap on the RAVICTI bottle. To do that, push down on the cap while twisting it to the left.

Then, attach the blue AdaptaCap® Bottle Adapter onto the bottle. Put it on top of the bottle and twist it to the right.

Make sure it is secured tightly on the bottle.

While holding the RAVICTI bottle securely: place the tip of the oral dosing syringe into the AdaptaCap® Bottle Adapter.

Turn the bottle upside down with the oral dosing syringe still inserted.

Now you’re ready to fill the oral dosing syringe with RAVICTI.

Get the medicine into the oral dosing syringe by pulling the plunger back slowly. Pulling slowly will help avoid large air bubbles from forming in the medicine.

Pull the plunger back until the first line of the black rubber stopper is even with the dosing mark. The dosing marks are on the barrel of the oral dosing syringe. Match the dosing mark with the amount of medicine prescribed by your doctor.

Then, turn the bottle upright again.

If there are large air bubbles, push the medicine back into the bottle. Do this slowly.

Then draw up the medicine again.

Next, place the tip of the oral dosing syringe into the smaller port of the feeding tube.

The smaller port of the nasogastric or gastrostomy feeding tube is used for medicine.

Ask your doctor if you are not sure which port to use.

Using the plunger of the oral dosing syringe, slowly and carefully push RAVICTI into the feeding tube.

Make sure all of the medicine is pushed out of the oral dosing syringe.

After you have pushed all of the RAVICTI into the feeding tube, remove the oral dosing syringe, put the cap on, and set it aside.

Close the tab on the AdaptaCap® Bottle Adapter. Make sure it’s closed tightly.

Use a separate large syringe to flush water into the feeding tube. A large syringe can be found in the box containing your feeding tube.

Make sure all of the water or formula drains through the feeding tube.

You can use 1 oral dosing syringe and 1 blue AdaptaCap® Bottle Adapter for all doses each day. You can also choose to use a new oral dosing syringe with each dose. Do not rinse the AdaptaCap® Bottle Adapter or oral dosing syringe between doses.

After the last dose of the day, dispose of the oral dosing syringe.

If you take too much RAVICTI, call your doctor or go to the nearest hospital emergency room right away.

You should consult your physician if you have missed a dose of RAVICTI.

For patients who require a volume of less than 1 mL per dose via nasogastric or gastrostomy tube, the delivered dosage may be less than anticipated due to adherence of RAVICTI to the plastic tubing. Therefore, these patients should be closely monitored using ammonia levels following initiation of RAVICTI dosing or dosage adjustments.

USE and IMPORTANT SAFETY INFORMATION

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.

Lauren:

I’ve had a lot of experience with living with this. I got diagnosed when I was 2 years old. I’ve been through the process of taking powdered medicine and pills.

The most challenging thing about my previous medication was the amount, of how much I had to take. Pills after each meal was a lot.

When I found out about RAVICTI there was no hesitation from me because I had already been through so much with my other medication. 

I had been on pills for 25 years. So I was ready for a change.

When I first started taking RAVICTI, full-time, I was excited. Because I didn’t have to count out so many pills. 

I just did not realize how much time that took. 

I chose RAVICTI [because] it’s easy for me to take and I can move on to whatever else I need to do. 

It’s different for everyone, but for me my ammonia levels are managed really well.

If you’re nervous about making the switch to RAVICTI, you should talk to your doctor.

And if you ever get scared or feel like you’re unsure whether it is the right choice or not, you can look at me as an example and say, “This girl, she has tried it, and it’s worked for her.” And maybe that will give you some hope and some courage to move on with the choice to try it.

 

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: 
  • sleepiness 
  • lightheadedness 
  • change in taste 
  • problems with hearing 
  • confusion 
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet  
  • headache 
  • feeling very tired (fatigue) 
  • nausea 
  • vomiting 

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:

  • wheezing
  • shortness of breath
  • cough
  • low blood pressure
  • flushing
  • nausea
  • 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:

  • See What is the most important information I should know about RAVICTI?

 The most common side effects of RAVICTI in adults include:

  • diarrhea
  • gas
  • headache
  • abdomen (stomach) pain
  • vomiting
  • tiredness
  • 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
  • rash
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache 

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)
  • vomiting
  • constipation
  • diarrhea
  • fever
  • reduced food intake
  • cough
  • stuffy nose
  • runny 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:

  • vomiting
  • rash
  • gastroesophageal reflux
  • increased levels of liver enzymes in the blood
  • decreased appetite and reduced food intake
  • low red blood cell count (anemia)
  • cough
  • 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)
  • diarrhea
  • gas
  • constipation
  • fever
  • drowsiness (lethargy)
  • irritability
  • agitation

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, see the Medication Guide available at RAVICTI.com and discuss with your doctor.

RAVICTI and the HORIZON logo are trademarks owned by or licensed to Horizon. All other referenced trademarks are the property of their respective owners. © 2020 Horizon Therapeutics plc  P-RVT-00473 05/20

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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:

  • sleepiness
  • lightheadedness
  • change in taste
  • problems with hearing
  • confusion
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet
  • headache
  • feeling very tired (fatigue)
  • nausea
  • vomiting

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:

  • wheezing
  • shortness of breath
  • cough
  • low blood pressure
  • flushing
  • nausea
  • 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:

        • See "What is the most important information I should know about RAVICTI?"

        The most common side effects of RAVICTI in adults include:

        • diarrhea
        • gas
        • headache
        • abdomen (stomach) pain
        • vomiting
        • tiredness
        • 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
        • rash
        • nausea
        • vomiting
        • diarrhea
        • decreased appetite
        • headache

        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)
        • vomiting
        • constipation
        • diarrhea
        • fever
        • reduced food intake
        • cough
        • 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:

        • vomiting
        • rash
        • gastroesophageal reflux
        • increased levels of liver enzymes in the blood
        • decreased appetite and reduced food intake
        • low red blood cell count (anemia)
        • cough
        • 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)
        • diarrhea
        • gas
        • constipation
        • fever
        • drowsiness (lethargy)
        • irritability
        • agitation

        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.

        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:

        • sleepiness
        • lightheadedness
        • change in taste
        • problems with hearing
        • confusion
        • problems with memory
        • worsening of numbness, tingling, or burning in your hands or feet
        • headache
        • feeling very tired (fatigue)
        • nausea
        • vomiting

        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:

        • wheezing
        • shortness of breath
        • cough
        • low blood pressure
        • flushing
        • nausea
        • 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:

              • See "What is the most important information I should know about RAVICTI?"

              The most common side effects of RAVICTI in adults include:

              • diarrhea
              • gas
              • headache
              • abdomen (stomach) pain
              • vomiting
              • tiredness
              • 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
              • rash
              • nausea
              • vomiting
              • diarrhea
              • decreased appetite
              • headache

              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)
              • vomiting
              • constipation
              • diarrhea
              • fever
              • reduced food intake
              • cough
              • 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:

              • vomiting
              • rash
              • gastroesophageal reflux
              • increased levels of liver enzymes in the blood
              • decreased appetite and reduced food intake
              • low red blood cell count (anemia)
              • cough
              • 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)
              • diarrhea
              • gas
              • constipation
              • fever
              • drowsiness (lethargy)
              • irritability
              • agitation

              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.