Treating Most Types of UCDs With RAVICTI
For some patients, a low-protein diet and supplements alone are not enough to manage elevated ammonia levels caused by urea cycle disorders (UCDs). These patients may be prescribed a nitrogen-scavenger medicine (sometimes called an ammonia scavenger) to keep their ammonia levels under control. Two such ammonia scavengers are RAVICTI® (glycerol phenylbutyrate) Oral Liquid and BUPHENYL® (sodium phenylbutyrate) Tablets and Powder. Both medicines contain the same active ingredient—phenylbutyrate—and help remove ammonia from the body. But there are some differences. See the chart below to understand more.
RAVICTI is for patients whose UCD cannot be managed by diet and supplements alone. RAVICTI must be used with a low-protein diet and, in some cases, with dietary supplements. In the chart below, you can compare taking RAVICTI with taking BUPHENYL.
Along with a low-protein diet that may include supplements, RAVICTI has been proven to help manage ammonia levels for newborns, babies, children, and adults with urea cycle disorders. RAVICTI is a liquid medicine that is easy to take. It is odorless and nearly tasteless. Watch a video to see how RAVICTI works.
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.
Are you considering RAVICTI?
Answer a few questions to see if RAVICTI may be right for you or your loved one
What are the differences between RAVICTI and BUPHENYL?
Dose
BUPHENYL
up to 40 tablets per day
RAVICTI
up to 17.5 mL per day
People switching from BUPHENYL to RAVICTI should get the dose of RAVICTI that has the same amount of the active ingredient (phenylbutyrate) as their dose of BUPHENYL
Delivery
BUPHENYL
- Tablet or powder form
- Taken by mouth
- Can be taken by feeding tube
RAVICTI
- Liquid form
- Taken by mouth
- Can be taken by feeding tube
Taste
BUPHENYL
- Strong odor
- Salty taste
RAVICTI
- Odorless
- Nearly tasteless
Important Reminders
Take RAVICTI exactly as your doctor has prescribed it. Newborns, babies and toddlers may be prescribed up to 5 doses per day. Do not change your dose of RAVICTI without a doctor's permission. If you take too much RAVICTI, call your doctor or go to the nearest hospital emergency room right away. The maximum approved daily dose of RAVICTI is 17.5 mL for both adults and children.* If you miss a dose, talk to your doctor.
*Total daily RAVICTI dose:
- Adults and children age 2 years and up: given in 3 equally divided doses, each rounded up to the nearest 0.5 mL
- Newborns and babies from birth up to 2 years: given in 3 or more equally divided doses, each rounded up to the nearest 0.1 mL
- In infants who are breastfeeding, RAVICTI should be given just prior to breastfeeding
Switching to RAVICTI: Making a change may be easier than you think
Living with a urea cycle disorder can be stressful. Choosing a medicine that requires little preparation might make it easier. If you are taking BUPHENYL tablets or powder to treat your UCD, you should know that liquid RAVICTI is taken differently.
- You may take RAVICTI as few as 3 times a day with formula or fluid
- RAVICTI is odorless and nearly tasteless
- No pills to swallow or powder to mix
Once you and your doctor decide to switch, your doctor will tell you the right amount of RAVICTI to take. Always take RAVICTI exactly as your doctor prescribes. RAVICTI is for patients with UCDs who have not been able to control their ammonia levels with diet and supplements alone. RAVICTI must be used 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 crises) or N-acetylglutamate synthase (NAGS) deficiency.
How RAVICTI Works
The active ingredient in RAVICTI is released slowly in your body, helping to control your ammonia levels all day.
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.
Starting RAVICTI – Amy and Mya
When Amy's daughter Mya was diagnosed with a UCD at age 6 months, Amy learned to be an advocate for her daughter. Talk to a UCD patient or caregiver
Read transcriptVoiceover:
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.
Amy:
Mya was diagnosed at 6 months old. Our first step was low-protein diet. And she was just on that until about a year. At a year, we added some supplements. At 2 years, we had to add a medication, an ammonia scavenger.
The ammonia scavenger she was on could leave a bad taste in the mouth.
It was challenging to just flat out get her to take it.
And I thought there has to be another treatment. I was willing to try something new.
So I went to the Internet, and I searched and I searched, and I found RAVICTI. And I thought, I have to get my child on this.
I did talk to my doctor about starting RAVICTI.
I had found most of the information online, so I pretty much sent him a link and said, "Here's this information." And he responded, "Great. I support you." RAVICTI may not be a fit for everybody. For Mya specifically, it is convenient because it’s tasteless, it’s odorless. Mya really doesn’t mind taking it.
For us, starting RAVICTI was pretty easy.
It was easy for her to take and the routine was the same, cause she still got the RAVICTI at the same time every day that she got the other one. It was just a different medication.
Every family’s experience is different, but for us Mya has been on RAVICTI for almost 6 years and we continue to like the convenience.
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
View doctor discussion guide
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.