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PROTECTION with convenient dosing

DUVYZAT is an oral suspension that is administered twice daily (can be taken with food)1

Taking DUVYZAT

Weight-based dosing with DUVYZAT1

Use the dosing calculator below to find the right dose for your patients.1

SEE FULL DOSING CHART
Syringe Syringe fill
00 mg twice daily

Dosage (mg)

00 mL twice daily

Oral suspension
volume (mL)

*Dose can be as high as 6 mL oral suspension volume.

For illustration purposes. Not actual product or product color.

Dose can be modified for adverse reaction management1

  • Modifications may be needed for decreased platelet count, diarrhea, increased triglycerides, or QTc prolongation1
LEARN MORE ABOUT DOSE MODIFICATIONS

Initial testing and ongoing monitoring1

  • Obtain and evaluate baseline platelet counts and triglycerides prior to initiating treatment with DUVYZAT
    • Do not initiate DUVYZAT in patients with a platelet count of <150 x 109/L
  • In patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs:
    • When initiating treatment with DUVYZAT
    • During concomitant use
    • When clinically indicated
  • After treatment with DUVYZAT has been initiated, ongoing monitoring is required. Please see the DUVYZAT Prescribing Information

Reference: 1. DUVYZAT. Prescribing information. ITF Therapeutics; 2024.

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.