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APPROVED USES & IMPORTANT SAFETY INFORMATION for RAVICTI

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APPROVED USES & IMPORTANT SAFETY INFORMATION for BUPHENYL®  (sodium phenylbutyrate)
 

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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 ofN-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
        • 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.

        For additional important safety information, click here for the Full Prescribing Information and Medication Guide and discuss with your doctor.

        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.

        APPROVED USES & IMPORTANT SAFETY INFORMATION for BUPHENYL® (sodium phenylbutyrate)

        APPROVED USES For 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® should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone.

        BUPHENYL® only treats high blood levels of ammonia in patients with the following enzyme deficiencies:

        • Carbamylphosphate synthetase (CPS)
        • Ornithine transcarbamylase (OTC)
        • Argininosuccinic acid synthetase (ASS)

        BUPHENYL® can be used in infants up to 28 days old who have a complete enzyme deficiency (an enzyme in the urea cycle that does not work at all). It can also be used in people 1 month of age and up who have a partial enzyme deficiency (an enzyme in the urea cycle that only works partially) and have a history of brain damage from high blood levels of ammonia (hyperammonemia). It is important to have a healthcare provider diagnose this condition and prescribe a medication as early as possible to improve chance of survival.

        BUPHENYL® must be used along with a low-protein diet and, in some cases, dietary supplements.

        Any episode related to acute hyperammonemia should be treated as a life-threatening emergency.

        IMPORTANT SAFETY INFORMATION

        Do not take BUPHENYL® if you are allergic to phenylbutyrate, or for the treatment of acute hyperammonemia in people with UCDs.

        Use of BUPHENYL® may cause serious side effects to the nervous system due to phenylacetate, a breakdown product of BUPHENYL. Call your doctor or get medical help right away if you experience any of the following symptoms while taking BUPHENYL: sleepiness, weakness, lightheadedness, problems with memory, worsening neuropathy (numbness, tingling, or burning in your hands or feet), change in taste, problems with hearing, confusion, and headache.

        Talk to your doctor before taking BUPHENYL® 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. You and your doctor should decide if you will take BUPHENYL® if you have these medical conditions. Do not take BUPHENYL® if you have liver or kidney problems, have any other medical conditions, if your child is 20kg or less, or if you are planning to become pregnant or breastfeed, as it is unknown if BUPHENYL® will harm your unborn baby or will pass into your breastmilk.

        The most common side effects of BUPHENYL® include absent or irregular periods in women, decreased appetite, body odor, and bad taste.

        The most common side effects of BUPHENYL® seen in a laboratory setting include changes to blood pH and electrolyte levels (such as chloride and phosphate), low protein levels in the blood, high levels of certain bone and liver enzymes (such as alkaline phosphatase and transaminases), and decreased red and white blood cell and platelet count.

        You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

        This information is not intended to replace discussions with your doctor. For additional information about BUPHENYL® , please consult the Full Prescribing Information and the Information for the Patient/Caregiver and talk to your doctor. BUPHENYL® is available by prescription only.

        Please see the Prescribing Information, including Patient Package Insert, for more information.

        APPROVED USES & IMPORTANT SAFETY INFORMATION for RAVICTI

        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.

        + close -

        APPROVED USES & IMPORTANT SAFETY INFORMATION for BUPHENYL®  (sodium phenylbutyrate)
         

        + close -

        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 ofN-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
              • 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.

              For additional important safety information, click here for the Full Prescribing Information and Medication Guide and discuss with your doctor.

              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.

              APPROVED USES & IMPORTANT SAFETY INFORMATION for BUPHENYL® (sodium phenylbutyrate)

              APPROVED USES For 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® should be used if the UCD cannot be managed with a low-protein diet and dietary supplements alone.

              BUPHENYL® only treats high blood levels of ammonia in patients with the following enzyme deficiencies:

              • Carbamylphosphate synthetase (CPS)
              • Ornithine transcarbamylase (OTC)
              • Argininosuccinic acid synthetase (ASS)

              BUPHENYL® can be used in infants up to 28 days old who have a complete enzyme deficiency (an enzyme in the urea cycle that does not work at all). It can also be used in people 1 month of age and up who have a partial enzyme deficiency (an enzyme in the urea cycle that only works partially) and have a history of brain damage from high blood levels of ammonia (hyperammonemia). It is important to have a healthcare provider diagnose this condition and prescribe a medication as early as possible to improve chance of survival.

              BUPHENYL® must be used along with a low-protein diet and, in some cases, dietary supplements.

              Any episode related to acute hyperammonemia should be treated as a life-threatening emergency.

              IMPORTANT SAFETY INFORMATION

              Do not take BUPHENYL® if you are allergic to phenylbutyrate, or for the treatment of acute hyperammonemia in people with UCDs.

              Use of BUPHENYL® may cause serious side effects to the nervous system due to phenylacetate, a breakdown product of BUPHENYL. Call your doctor or get medical help right away if you experience any of the following symptoms while taking BUPHENYL: sleepiness, weakness, lightheadedness, problems with memory, worsening neuropathy (numbness, tingling, or burning in your hands or feet), change in taste, problems with hearing, confusion, and headache.

              Talk to your doctor before taking BUPHENYL® 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. You and your doctor should decide if you will take BUPHENYL® if you have these medical conditions. Do not take BUPHENYL® if you have liver or kidney problems, have any other medical conditions, if your child is 20kg or less, or if you are planning to become pregnant or breastfeed, as it is unknown if BUPHENYL® will harm your unborn baby or will pass into your breastmilk.

              The most common side effects of BUPHENYL® include absent or irregular periods in women, decreased appetite, body odor, and bad taste.

              The most common side effects of BUPHENYL® seen in a laboratory setting include changes to blood pH and electrolyte levels (such as chloride and phosphate), low protein levels in the blood, high levels of certain bone and liver enzymes (such as alkaline phosphatase and transaminases), and decreased red and white blood cell and platelet count.

              You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

              This information is not intended to replace discussions with your doctor. For additional information about BUPHENYL® , please consult the Full Prescribing Information and the Information for the Patient/Caregiver and talk to your doctor. BUPHENYL® is available by prescription only.

              Please see the Prescribing Information, including Patient Package Insert, for more information.