FOR US HEALTHCARE PROFESSIONALS ONLY

Dedicated support through ITF ARC

ITF ARC offers support for your patients that helps make insurance coverage navigation easier, helps address your patients' financial concerns, and encourages adherence to therapy.

Here are some of the ways ITF ARC may be able to help your patients:

  • Insurance navigation

    Insurance navigation:

    • Insurance coverage benefits verification
    • Prior authorization and appeal support, as needed
    • Medication deliveries to home or preferred address
  • Education and adherence

    Education and adherence:

    • Personalized pharmacist support
    • Disease and therapy education materials
    • Coordination with families and healthcare providers, including refill reminders
    • Translation services available as needed

ITF ARC provides a variety of financial support options:

  • Copay Program
    • Copay assistance for eligible, commercially insured patients whose health plan covers DUVYZAT
      • Eligible patients may pay as little as $0
  • Education about third-party resources
    • Education about third-party resources
  • Patient Assistance Program
    • Patient assistance program for eligible uninsured and underinsured patients
  • Temporary supply programs
    • Temporary supply programs to help ensure timely start and treatment adherence

Have questions?
Contact a case manager at ITF ARC.

1-855-4 ITF ARC (1-855-448-3272) 8 AM – 8 PM ET, Monday-Friday

Each patient's eligibility for access programs is evaluated on an individual basis. To be eligible, patients must first meet the FDA-approved indication. All programs may be modified or discontinued at any time based on eligibility, state and federal laws, and program availability. Restrictions apply. See full restrictions for ARC Copay Program, Patient Assistance Program, and temporary supply programs here.

DMD, Duchenne muscular dystrophy.

Indication and Important Safety Information

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Important Safety Information

Warnings and precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia. Monitor platelets; dosage adjustment or discontinuation may be needed.
  • Increased Triglycerides: An increase in triglycerides can occur; dosage modification may be needed. Discontinuation may be needed.
  • Gastrointestinal Disturbances: Adjust dosage if moderate or severe diarrhea occurs. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Discontinue DUVYZAT if the symptoms persist.
  • QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias.

Indication

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Important Safety Information

Warnings and precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia. Monitor platelets; dosage adjustment or discontinuation may be needed.
  • Increased Triglycerides: An increase in triglycerides can occur; dosage modification may be needed. Discontinuation may be needed.
  • Gastrointestinal Disturbances: Adjust dosage if moderate or severe diarrhea occurs. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Discontinue DUVYZAT if the symptoms persist.
  • QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias.

Recommended Evaluation and Testing Before Initiation of DUVYZAT:

Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of DUVYZAT. Do not initiate DUVYZAT in patients with a platelet count less than 150 x 109/L. Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed.

In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with DUVYZAT, during concomitant use, and as clinically indicated.

Most Common Adverse Reactions:

Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact ITF Therapeutics LLC at 1-833-582-4312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide.