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Adjust the treatment plan as needed

Dose can be modified for adverse reaction management1

In the EPIDYS clinical trial, timely dosage modification helped to mitigate adverse reactions.1,2

DUVYZAT may cause adverse reactions, which may necessitate a dosage modification if any of the following occur1:

  • Platelet count <150 x 109/L verified by 2 assessments 1 week apart
  • Moderate or severe diarrhea
  • Fasting triglycerides >300 mg/dL verified by 2 assessments 1 week apart

Based on severity of those adverse reactions, treatment interruption prior to dosage modification should be considered.

Susan, mother of an actual patient who has been taking DUVYZAT for 4+ years.
Not an actual doctor.

Dosage modification for adverse reactions1

First dosage modification* Second dosage modification†
Body weight Dosage Oral suspension volume Dosage Oral suspension volume
10 kg to <20 kg 17.7 mg twice daily 2 mL twice daily 13.3 mg twice daily 1.5 mL twice daily
20 kg to <40 kg 22.2 mg twice daily 2.5 mL twice daily 17.7 mg twice daily 2 mL twice daily
40 kg to <60 kg 31 mg twice daily 3.5 mL twice daily 26.6 mg twice daily 3 mL twice daily
≥60 kg 39.9 mg twice daily 4.5 mL twice daily 35.4 mg twice daily 4 mL twice daily
First dosage modification*
Body weight Dosage Oral suspension volume
10 kg to <20 kg 17.7 mg twice daily 2 mL twice daily
20 kg to <40 kg 22.2 mg twice daily 2.5 mL twice daily
40 kg to <60 kg 31 mg twice daily 3.5 mL twice daily
≥60 kg 39.9 mg twice daily 4.5 mL twice daily
Second dosage modification†
Body weight Dosage Oral suspension volume
10 kg to <20 kg 13.3 mg twice daily 1.5 mL twice daily
20 kg to <40 kg 17.7 mg twice daily 2 mL twice daily
40 kg to <60 kg 26.6 mg twice daily 3 mL twice daily
≥60 kg 35.4 mg twice daily 4 mL twice daily

* If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification.1

† If the adverse reaction(s) persist after the second dosage modification, DUVYZAT should be discontinued.1

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References: 1. DUVYZAT. Prescribing information. ITF Therapeutics; 2024. 2. Mercuri E, Vilchez JJ, Boespflug-Tanguy O, et al; EPIDYS Study Group. Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2024;23(4):393-403.

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.