Horizon By Your Side—A Patient Support Program Designed With Your Patient in Mind

Managing your patient’s urea cycle disorder (UCD) can involve a lot of moving parts. Horizon By Your Side is a patient support program with dedicated team members who take a personalized approach to meeting your patient’s unique treatment needs.

As treatment with BUPHENYL® (sodium phenylbutyrate) Tablets or Powder begins, our Horizon By Your Side team is ready to support your patient and their caregivers. Once your patient is enrolled in the program, we’ll partner with them to discuss support options and next steps. Our dedicated team provides ongoing non-medical, logistical assistance so there’s support throughout your patient’s treatment journey.

The Horizon By Your Side team is here to help, so your patient can focus on moving toward the future they deserve.

Together, we will:

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CONNECT: Your patient will be paired with a personal Patient Access Liaison who will support your patient throughout their treatment when they need it

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COORDINATE: The Horizon By Your Side team will work with your patient and healthcare team to make sure non-medical, logistical efforts are coordinated properly

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CHAMPION: The Patient Access Liaison will be the point of contact to work with your patient’s unique needs and help them build confidence throughout their treatment

APPROVED USES and IMPORTANT SAFETY INFORMATION for BUPHENYL®
(sodium phenylbutyrate) Tablets and Powder

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 the following enzyme deficiencies:

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

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.

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).The breakdown of BUPHENYL produces the byproduct phenylacetate (PAA), which may cause nervous system side effects.

  • sleepiness
  • weakness
  • lightheadedness
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet
  • change in taste
  • problems with hearing
  • confusion
  • nausea
  • headache

Who should not take BUPHENYL?

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.

What should I tell my doctor before taking BUPHENYL?

Before taking BUPHENYL, tell your doctor about any 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 safety information I should know about BUPHENYL?

The most common side effects of BUPHENYL include:

  • 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.

For additional important safety information, click here for the Full Prescribing Information and Patient Package Insert and discuss with your doctor.

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.

APPROVED USES and IMPORTANT SAFETY INFORMATION for BUPHENYL®
(sodium phenylbutyrate) Tablets and Powder

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 the following enzyme deficiencies:

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

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.

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).The breakdown of BUPHENYL produces the byproduct phenylacetate (PAA), which may cause nervous system side effects.

  • sleepiness
  • weakness
  • lightheadedness
  • problems with memory
  • worsening of numbness, tingling, or burning in your hands or feet
  • change in taste
  • problems with hearing
  • confusion
  • nausea
  • headache

Who should not take BUPHENYL?

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.

What should I tell my doctor before taking BUPHENYL?

Before taking BUPHENYL, tell your doctor about any 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 safety information I should know about BUPHENYL?

The most common side effects of BUPHENYL include:

  • 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.

For additional important safety information, click here for the Full Prescribing Information and Patient Package Insert and discuss with your doctor.

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.