For Healthcare Professionals For Patients and Caregivers Important Safety Information Prescribing Information
FINANCIAL ASSISTANCE

Paying for Treatment Shouldn’t Get in the Way of Your Patient’s Health

The Amgen By Your Side team is committed to exploring all options to help your patient start and continue treatment, as you prescribe, whether your patient has:

Regardless of your patient’s situation, the Patient Access Liaison (PAL) can help them explore their insurance coverage criteria and other financial assistance options (some restrictions and eligibility may apply).

Shared Responsibility

As an industry partner, we have limitations that we must respect. We cannot guarantee access or reimbursement for our medicines; however, we can educate you and your staff about gaining access to the medicine and various patient financial support programs.

Similarly, we cannot provide medical advice to your patient about the medicines you prescribe or act as an extension of—or substitution for—your staff.

Together, we can advocate for your patients to gain access to the medicines you believe will improve their lives.

Patient Advocacy Organizations That May Also Provide Financial Assistance

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The Assistance Fund

The Assistance Fund is an independent charitable patient assistance organization that provides support for adults and children with rare and chronic diseases. The organization may help provide families with cost and travel assistance.
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Good Days

Good Days works to improve the health and quality of life of patients with chronic disease, cancer, or other life-altering conditions. The organization may help provide families with financial and travel assistance.
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National Organization for Rare Disorders (NORD)

NORD is a patient advocacy organization dedicated to people with rare diseases and the groups that help them. NORD provides patients and families with advocacy information, assistance programs, and connections to patient organizations.

NORD also has an Emergency Relief Program. This fund provides financial assistance that can be used to pay for unexpected or emergency non-medical expenses such as utility expenses, cellular or internet service, emergency repairs to car, home or major appliance, and rent or mortgage payment assistance.

Discover valuable resources to help patients understand every aspect of the treatment experience

Familiarize yourself with important forms and downloadable resources that explain the process

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INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

BUPHENYL® (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL® (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration are indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders (UCDs) involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

BUPHENYL is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.

BUPHENYL must be used with dietary protein restriction and, in some cases, essential amino acid supplementation.

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Acute hyperammonemia: BUPHENYL should not be used to manage acute hyperammonemia, which is a medical emergency.

WARNINGS AND PRECAUTIONS

BUPHENYL should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation.

  • Use caution with administering BUPHENYL to patients with:
    • Congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
    • Hepatic or renal insufficiency or inborn errors of beta oxidation.
  • Probenecid may affect renal excretion of the conjugated product of BUPHENYL as well as its metabolite.
  • Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
  • There have been published reports of hyperammonemia being induced by haloperidol and by valproic acid.

ADVERSE REACTIONS

  • The most common adverse reactions (≥3%) reported in BUPHENYL clinical trials were decreased appetite, body odor, bad taste or taste aversion.
  • In female patients, amenorrhea/menstrual dysfunction (irregular menstrual cycles) occurred in 23% of the menstruating patients.
  • Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy.
  • Laboratory adverse events occurring in >2% of UCD patients by body system were:
    • Metabolic: acidosis, alkalosis, hyperchloremia, and hypophosphatemia
    • Nutritional: hypoalbuminemia and decreased total protein
    • Hepatic: increased alkaline phosphatase and increased liver transaminases
    • Hematologic: anemia, leukopenia, leukocytosis, and thrombocytopenia

USE IN SPECIFIC POPULATIONS

  • Pregnancy: BUPHENYL should be used with caution in patients who are pregnant or planning to become pregnant. Animal reproduction studies have not been conducted with BUPHENYL. It is not known whether BUPHENYL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
  • Lactation: breastfeeding is not recommended during treatment with BUPHENYL. There are no data on the presence of BUPHENYL in human milk.

Please see Full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

BUPHENYL® (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL® (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration are indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders (UCDs) involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

BUPHENYL is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.

BUPHENYL must be used with dietary protein restriction and, in some cases, essential amino acid supplementation.

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Acute hyperammonemia: BUPHENYL should not be used to manage acute hyperammonemia, which is a medical emergency.

WARNINGS AND PRECAUTIONS

BUPHENYL should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation.

  • Use caution with administering BUPHENYL to patients with:
    • Congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
    • Hepatic or renal insufficiency or inborn errors of beta oxidation.
  • Probenecid may affect renal excretion of the conjugated product of BUPHENYL as well as its metabolite.
  • Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
  • There have been published reports of hyperammonemia being induced by haloperidol and by valproic acid.

ADVERSE REACTIONS

  • The most common adverse reactions (≥3%) reported in BUPHENYL clinical trials were decreased appetite, body odor, bad taste or taste aversion.
  • In female patients, amenorrhea/menstrual dysfunction (irregular menstrual cycles) occurred in 23% of the menstruating patients.
  • Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy.
  • Laboratory adverse events occurring in >2% of UCD patients by body system were:
    • Metabolic: acidosis, alkalosis, hyperchloremia, and hypophosphatemia
    • Nutritional: hypoalbuminemia and decreased total protein
    • Hepatic: increased alkaline phosphatase and increased liver transaminases
    • Hematologic: anemia, leukopenia, leukocytosis, and thrombocytopenia

USE IN SPECIFIC POPULATIONS

  • Pregnancy: BUPHENYL should be used with caution in patients who are pregnant or planning to become pregnant. Animal reproduction studies have not been conducted with BUPHENYL. It is not known whether BUPHENYL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
  • Lactation: breastfeeding is not recommended during treatment with BUPHENYL. There are no data on the presence of BUPHENYL in human milk.

Please see Full Prescribing Information.