PHEBURANE®P=Price

Now Available through CVS Specialty Pharmacy!

Unik - Logo

Medunik USA offers Pheburane® through its UNIK Support Program - designed to support each unique patient.

Unik Support (pronounced yoo·neek) has specialized services for Prescribers and Patients.

Medunik USA provides Pheburane® and all its added benefits at a cost that is similar to the other NaPB products and significantly less expensive than the most commonly prescribed chronic UCD treatment.

UNIK offers Prescribers:

  • A Physician Ambassador who will be the primary point of contact for physicians that prescribe Pheburane®. The Ambassador will:
    • Place a welcome call to the prescriber, upon receipt of a new Pheburane® prescription
    • Work with the physician to ensure all patient information is captured
    • Guide the prescriber through enrollment in the physician portal
    • Assist with prior authorizations and ensure the prescriber is provided with status updates throughout the entire PA process
  • Online services through a specialized web portal
  • Prior Authorization (PA) and Benefits Management Services
  • Pharmacy Services

UNIK offers Patients:

  • A Patient Care Liaison who will work directly with Pheburane® patients and caregivers by serving as their primary point of contact throughout the treatment journey. The Liaison will:
    • Coordinate therapy initiation and welcome the patient/caregiver to UNIK and its services and explain next steps
    • Provide guidance on the specialty prescription process, reimbursement information, patient access issues, and more
    • Provide regular refill outreach to the patient/caregiver
  • Enrollment in text, email, mobile app, and web-based patient services
  • Proactive Copay Assistance/Foundational Support
  • Education about Urea Cycle Disorders (UCDs) and Pheburane® therapy and the importance of adherence to treatment
  • Proactive dietary support with trained and experienced dieticians
  • Social service support from a licensed clinical social worker
  • Mail-order pharmacy services

The UNIK Support Program for Pheburane® is offered through 2 national specialty pharmacy partners: Accredo Health Group, Inc and CVS Specialty Pharmacy.

Pheburane® Coverage

Pheburane® also covers ~80% of commercially insured US patients.

Now on the Medicaid Drug list in 12 states

Now on the Preferred Drug list in 11 states

Included on the Contract Drug List in California

*certain Managed Medicaid plans

Coverage Map

Patient Access

Patient Access Process
Overview of key steps & needed documentation for patient access and coverage.
Prior Authorization Checklist
Prior Authorization checklist for PA processing
Letter of Medical Necessity Template
Template letter to include with PA submission
Appeal Checklist
Recommended steps when appealing a denied claim.
Appeal Letter Template
Template letter to include when appealing a denied claim.

Contact a Sales Representative

Enrollment Form for US Dept. of Veteran Affairs

Important Safety Information

INDICATION

Pheburane® is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).

 

Limitations of Use

Episodes of acute hyperammonemia may occur in patients while on Pheburane®. Pheburane® is not indicated for the treatment of acute hyperammonemia, which can be a life-threatening medical emergency that requires rapid acting interventions to reduce plasma ammonia levels.

WARNINGS AND PRECAUTIONS

 

Neurotoxicity of Phenylacetate

Increased exposure to phenylacetate, the major metabolite of Pheburane®, may be associated with neurotoxicity in patients with UCDs. If symptoms of vomiting, nausea, headache, somnolence or confusion are present in the absence of high ammonia levels, consider reducing the dose of Pheburane®.

 

Hypokalemia

Renal excretion of phenylacetylglutamine may induce urinary loss of potassium. Monitor serum potassium during therapy, and initiate appropriate treatment when necessary.

 

Conditions Associated with Edema

In order to decide if administration of Pheburane® is appropriate in patients with diseases that involve edema, calculate the total amount of sodium patients will be exposed to, based on their weight or body surface area. If a patient develops new-onset edema or worsening edema while on treatment, discontinue administration of Pheburane® and initiate appropriate therapy.

 

Diabetes Mellitus, Hereditary Fructose Intolerance, Glucose-Galactose Malabsorption or Sucrase-Isomaltase Insufficiency

Avoid use of Pheburane® in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency.

ADVERSE REACTIONS

The most common adverse reactions associated with the use of sodium phenylbutyrate (incidence > 3%) are menstrual dysfunction, decreased appetite, body odor and bad taste or taste aversion.

DRUG INTERACTIONS

  • Valproic acid, Haloperidol, or Corticosteroids: May increase plasma ammonia levels. Monitor ammonia levels closely.
  • Probenicid: May inhibit renal excretion of metabolites of Pheburane® including phenylacetate and phenylacetylglutamine. Monitor patients for potential neurotoxicity.

OVERDOSAGE

Overdoses of Pheburane® exceeding ten-fold the maximum recommended dosage may produce emesis, CNS depression, metabolic acidosis with or without respiratory alkalosis, hypernatremia, hypokalemia, and hypophosphatemia. Symptoms of overdose overlap with those of acute hyperammonemia. If overdose occurs, discontinue Pheburane®, monitor plasma phenylacetate and ammonia levels closely, and institute appropriate emergency management.

To report suspected adverse reactions, contact Medunik USA at 1-844-884-5520 or medicalinfo@medunikusa.com.

Please read the Full Prescribing Information.

References:

  1. Pheburane® (sodium phenylbutyrate) oral pellets [Prescribing Information]. Medunik USA, Inc.
  2. Kibleur Y, Dobbelaere D, Barth M, Brassier A, Guffon N. Results from a Nationwide Cohort Temporary Utilization Authorization (ATU) survey of patients in france treated with Pheburane® (Sodium Phenylbutyrate) taste-masked granules. Paediatr Drugs. 2014.
  3. Kibleur Y, Guffon N. Long-Term Follow-Up on a Cohort Temporary Utilization Authorization (ATU) Survey of Patients Treated with Pheburane (Sodium Phenylbutyrate) Taste-Masked Granules. Paediatr Drugs. 2016 Apr;18(2):139-44. doi: 10.1007/s40272-015-0159-8. PMID: 26747635.
  4. Guffon N, Kibleur Y, Copalu W, Tissen C, Breitkreutz J. Developing a new formulation of sodium phenylbutyrate. Arch Dis Child. 2012 Dec;97(12):1081-5. doi: 10.1136/archdischild-2012-302398. Epub 2012 Aug 31. PMID: 22941860.
  5. Peña-Quintana L, Llarena M, Reyes-Suárez D, Aldámiz-Echevarria L. Profile of sodium phenylbutyrate granules for the treatment of urea-cycle disorders: patient perspectives. Patient Prefer Adherence. 2017 Sep 6;11:1489-1496. doi: 10.2147/PPA.S136754. PMID: 28919721; PMCID: PMC5593420.