RAVICTI is approved to treat newborns and babies
From birth to 2 years
RAVICTI is here for your child or teenager
2-17 years old
Adults can take RAVICTI in as few as 3 doses per day
18 years and olderResults with RAVICTI for Urea Cycle Disorders
RAVICTI® (glycerol phenylbutyrate) Oral Liquid is proven to help control ammonia levels for newborns, babies, children, teens, and adults. Find out more about long-term ammonia control with RAVICTI.
RAVICTI is not used to treat extremely high levels of ammonia in the blood (hyperammonemic crises) 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.
My RAVictory
Emily's RAVictory
Hear Emily's story of how she's living life to the fullest!
Read transcriptHanging out with friends is my RAVictory because my friends are a big part of my life and I feel very happy when I get to spend time with them.
To manage my ammonia levels, I eat low-protein diets and I take my vitamins and medicine.
I take RAVICTI three times a day, after breakfast, after lunch and after dinner. And I take it with a cup of juice or water.
She doesn’t worry about having to be refrigerated and the RAVICTI comes in a small bottle. She carries it when we have to go out for the day.
What motivates me to achieve my RAVictories and keep my ammonia levels low is that I don’t want to have my family see me in the hospital.
Emily’s RAVictory would be taking her medicine. Just being a teenager. You know, doing sports.
Playing her flute. Doing personal things that she wants to do. And for me, that’s her RAVictory.
When I think of Emily, I think of someone really strong, beautiful, inside and out. Someone very sincere and brave. And I don’t know what I’d do without you.
When I look to the future, the RAVictories I hope to achieve are going to college, traveling to Hawaii, and cooking more low-protein meals.
USE and IMPORTANT SAFETY INFORMATION
What is the most important information I should know about RAVICTI?
RAVICTI may cause serious side effects, including:
Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of RAVICTI, 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
Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.
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 for the acute treatment of hyperammonemia in people with UCD.
- It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.
Before taking RAVICTI, tell your doctor about all of your medical conditions, including 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. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
- 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:
- 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 may report side effects to FDA at 1-800-FDA-1088.
For additional important safety information, see the Medication Guide available at RAVICTI.com and discuss with your doctor.
RAVICTI is proven to provide 24-hour ammonia control
Four clinical studies were done to find out if RAVICTI helps control ammonia levels as well as the medicine BUPHENYL® (sodium phenylbutyrate). To do this, the doctors measured ammonia levels in patients taking RAVICTI or BUPHENYL over 24 hours. Results showed RAVICTI was similar to BUPHENYL in safely controlling ammonia levels for 24 hours. After using RAVICTI for 2 weeks in the clinical studies, caregivers and patients were asked if they wanted to continue using RAVICTI for up to a year:
of adults chose to continue taking RAVICTI.
of children ages 6 to 17 and their caregivers chose to continue taking RAVICTI.
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, tiredness; nausea; or vomiting.
Managing a UCD
Understanding Urea Cycle Disorders (UCDs) and Your RAVICTI Treatment
See how RAVICTI releases slowly to remove excess ammonia from the body.
Read transcriptHello, today I want to talk to you about Understanding Urea Cycle Disorders and Your RAVICTI Treatment. First, let's talk about Urea Cycle Disorders. What is a Urea Cycle Disorder?
A urea cycle disorder, or UCD, is a rare inherited condition where toxic levels of waste called ammonia build up in the blood and cause damage throughout the body.
Ammonia is released when the body digests protein from food.
Normally, the liver makes enzymes that break down the ammonia into urea. The body then gets rid of urea through urine.
In people with a UCD, these enzymes don’t work right, so ammonia builds up in the blood.
High levels of ammonia in the blood can make you very sick and cause serious health problems. A low-protein diet and supplements can help keep ammonia levels down, but sometimes this isn’t enough.
Adding RAVICTI can help keep ammonia at a safe level in the blood.
RAVICTI is slowly broken down by a naturally-occurring enzyme found in the digestive tract.
RAVICTI passes through the stomach and starts to slowly break down in the intestine. Once it breaks down, it can start getting to work.
A part of RAVICTI then binds to ammonia molecules to form a RAVICTI/ammonia complex that is excreted in the urine.
When taken correctly, RAVICTI works to keep removing extra ammonia throughout the entire day. RAVICTI may cause side effects. The most common side effects of RAVICTI in adults include: diarrhea, gas, headache, abdomen (stomach) pain, vomiting, tiredness, decreased appetite, indigestion or heartburn.
So how do you take RAVICTI? RAVICTI is a liquid that you take by mouth with a syringe or dosing cup 3 or more times a day with a low-protein diet and in some cases dietary supplements.
It’s important to take RAVICTI exactly as your doctor tells you in order to keep the ammonia in your body at a safe level.
Set reminders so you don’t forget to take your dose...and keep track of when you do take it.
A UCD is a lifelong disease that can cause organ damageand other very serious health problems over time without proper treatment. So even if you’re feeling fine, it’s important to continue taking your Ravicti to help prevent toxic buildup of ammonia in the blood. Talk to your doctor for more information and to help create a routine that works for you.
USE and IMPORTANT SAFETY INFORMATION
What is the most important information I should know about RAVICTI?
RAVICTI may cause serious side effects, including:
Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of RAVICTI, 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
Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.
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 for the acute treatment of hyperammonemia in people with UCD.
- It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.
Before taking RAVICTI, tell your doctor about all of your medical conditions, including 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. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
- 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:
- 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 may report side effects to FDA at 1-800-FDA-1088.
For additional important safety information, see the Medication Guide available at RAVICTI.com and discuss with your doctor.
Could RAVICTI Be Right for You?
Answer a few questions to see if RAVICTI may be right for you or your loved one
Take the survey
Real Patients. Real Stories.
"With RAVICTI, it's easy for me to just
take care of my own medication."
– Isaac | Patient
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) Phenylacetate (PAA), a breakdown product of RAVICTI, 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
Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.
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 for the acute treatment of hyperammonemia in people with UCD.
- It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.
Before taking RAVICTI, tell your doctor about all of your medical conditions, including 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. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
- 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 may report side effects to FDA at 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 BUPHENYL?
BUPHENYL may cause serious side effects, including:
Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of BUPHENYL, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking BUPHENYL:
- sleepiness
- weakness
- lightheadedness
- problems with memory
- worsening of numbness, tingling, or burning in your hands or feet
- change in taste
- problems with hearing
- confusion
- headache
What is BUPHENYL?
- BUPHENYL (sodium phenylbutyrate) Tablets is a prescription medicine that can be taken by mouth and BUPHENYL (sodium phenylbutyrate) Powder is a prescription medicine that can be taken by mouth or feeding tube for the long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD).
- BUPHENYL only treats high blood levels of ammonia in patients with carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) and argininosuccinic acid synthetase (AS) deficiencies.
- BUPHENYL can be used in infants up to 28 days old who have a complete enzyme deficiency, and in patients 1 month of age and older who have a partial enzyme deficiency and have a history of brain damage from high blood levels of ammonia.
- BUPHENYL must be used along with a low-protein diet and in some cases, dietary supplements.
- BUPHENYL is not used to treat acute (severe) hyperammonemia, which is a medical emergency.
Do not take BUPHENYL if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you experience an allergic reaction while taking BUPHENYL.
Before taking BUPHENYL, tell your doctor about all of your medical conditions, including if you:
- have heart failure or decreased kidney function, which may lead to retention of the sodium content of BUPHENYL with potentially serious consequences, such as worsening heart failure, high blood pressure, and swelling.
- are pregnant or plan to become pregnant. It is not known if BUPHENYL will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if BUPHENYL passes into your breast milk. Breastfeeding is not recommended during treatment with BUPHENYL. Talk to your doctor about the best way to feed your baby if you take BUPHENYL.
What are possible side effects of BUPHENYL?
BUPHENYL may cause serious side effects, including:
- See “What is the most important information I should know about BUPHENYL?”
- decreased appetite
- body odor
- bad taste
- absent or irregular periods in women
These are not all of the possible side effects of BUPHENYL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For additional Important Safety Information, click here for the Patient Package Insert 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) Phenylacetate (PAA), a breakdown product of RAVICTI, 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
Your doctor may do blood tests to measure the amount of PAA in your blood during your treatment with RAVICTI.
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 for the acute treatment of hyperammonemia in people with UCD.
- It is not known if RAVICTI is safe and effective for the treatment of N-acetylglutamate synthase (NAGS) deficiency.
Do not take RAVICTI if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you have wheezing, shortness of breath, cough, low blood pressure, flushing, nausea or a rash while taking RAVICTI.
Before taking RAVICTI, tell your doctor about all of your medical conditions, including 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. If you become pregnant during treatment with RAVICTI, call Horizon at 1‐866‐479‐6742 to report the pregnancy.
- 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 may report side effects to FDA at 1-800-FDA-1088.
For additional Important Safety Information, click here for the Medication Guide and discuss with your doctor.
APPROVED USES and IMPORTANT SAFETY INFORMATION for
BUPHENYL® (sodium phenylbutyrate) Tablets and Powder
USE and IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about BUPHENYL?
BUPHENYL may cause serious side effects, including:
Nervous system side effects (Neurotoxicity) Phenylacetate (PAA), a breakdown product of BUPHENYL, may cause nervous system side effects. Call your doctor or get medical help right away if you have any of these symptoms while taking BUPHENYL:
- sleepiness
- weakness
- lightheadedness
- problems with memory
- worsening of numbness, tingling, or burning in your hands or feet
- change in taste
- problems with hearing
- confusion
- headache
What is BUPHENYL?
- BUPHENYL (sodium phenylbutyrate) Tablets is a prescription medicine that can be taken by mouth and BUPHENYL (sodium phenylbutyrate) Powder is a prescription medicine that can be taken by mouth or feeding tube for the long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD).
- BUPHENYL only treats high blood levels of ammonia in patients with carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) and argininosuccinic acid synthetase (AS) deficiencies.
- BUPHENYL can be used in infants up to 28 days old who have a complete enzyme deficiency, and in patients 1 month of age and older who have a partial enzyme deficiency and have a history of brain damage from high blood levels of ammonia.
- BUPHENYL must be used along with a low-protein diet and in some cases, dietary supplements.
- BUPHENYL is not used to treat acute (severe) hyperammonemia, which is a medical emergency.
Do not take BUPHENYL if you are allergic to phenylbutyrate. Call your doctor or go to the nearest hospital emergency room if you experience an allergic reaction while taking BUPHENYL.
Before taking BUPHENYL, tell your doctor about all of your medical conditions, including if you:
- have heart failure or decreased kidney function, which may lead to retention of the sodium content of BUPHENYL with potentially serious consequences, such as worsening heart failure, high blood pressure, and swelling.
- are pregnant or plan to become pregnant. It is not known if BUPHENYL will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if BUPHENYL passes into your breast milk. Breastfeeding is not recommended during treatment with BUPHENYL. Talk to your doctor about the best way to feed your baby if you take BUPHENYL.
What are possible side effects of BUPHENYL?
BUPHENYL may cause serious side effects, including:
- See “What is the most important information I should know about BUPHENYL?”
- decreased appetite
- body odor
- bad taste
- absent or irregular periods in women
These are not all of the possible side effects of BUPHENYL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For additional Important Safety Information, click here for the Patient Package Insert and discuss with your doctor.