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FOR US HEALTHCARE PROFESSIONALS ONLY

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Adjust the treatment plan as needed1

Dose can be modified for adverse reaction mitigation

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

  • 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 the severity of these adverse reactions, treatment interruption prior to dosage modification should be considered.
In the EPIDYS clinical trial, 2% of patients on DUVYZAT discontinued treatment due to adverse reactions.
Susan, mother of an actual patient who has been taking DUVYZAT for 4+ years.
Not an actual doctor.
In the EPIDYS clinical trial, 2% of patients on DUVYZAT discontinued treatment due to adverse reactions.

Dosage modification for adverse reactions

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.

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

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

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression. Monitor blood count every 2 weeks for the first 2 months, at month 3, and every 3 months thereafter. Modify the dosage for confirmed thrombocytopenia. Discontinuation may be needed if abnormalities worsen.
  • Increased Triglycerides: DUVYZAT can cause elevations in triglycerides. Monitor triglycerides at 1 month, 3 months, 6 months, and then every 6 months thereafter. Modify the dosage if fasting triglycerides are verified >300 mg/dL. Treatment with DUVYZAT should be discontinued if triglycerides remain elevated despite adequate dietary intervention and dosage adjustment.
  • Gastrointestinal Disturbances: Gastrointestinal disturbances, including diarrhea, nausea/vomiting, and abdominal pain were common adverse reactions in DUVYZAT clinical trials. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Modify the dosage of DUVYZAT in patients with moderate or severe diarrhea and discontinue treatment if significant symptoms persist.
  • QTc Prolongation: DUVYZAT can cause prolongation of the QTc interval. Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias (including torsades de pointes), such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbance or in patients taking concomitant medicinal products known to cause QT prolongation. Obtain ECGs prior to initiating treatment with DUVYZAT in patients with underlying cardiac disease or in patients who are taking concomitant medications that cause QT prolongation.

Adverse Reactions

The most common adverse reactions reported in >5% of patients treated with DUVYZAT are diarrhea (37%), abdominal pain (34%), thrombocytopenia (33%), nausea/vomiting (32%), hypertriglyceridemia (23%), pyrexia (13%), myalgia (9%), rash (9%), arthralgia (8%), fatigue (8%), constipation (7%), and decreased appetite (7%).

Drug Interactions

Closely monitor when DUVYZAT is used in combination with an oral CYP3A4 sensitive substrate or a sensitive substrate of the OCT2 transporter, for which a small change in substrate plasma concentrations may lead to serious toxicities.

Avoid concomitant use with other drugs that prolong the QTc interval; monitor ECG if concomitant use cannot be avoided. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold DUVYZAT if the QTc interval is >500 ms or the change from baseline is >60 ms.

INDICATION

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

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 for additional safety information.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression. Monitor blood count every 2 weeks for the first 2 months, at month 3, and every 3 months thereafter. Modify the dosage for confirmed thrombocytopenia. Discontinuation may be needed if abnormalities worsen.
  • Increased Triglycerides: DUVYZAT can cause elevations in triglycerides. Monitor triglycerides at 1 month, 3 months, 6 months, and then every 6 months thereafter. Modify the dosage if fasting triglycerides are verified >300 mg/dL. Treatment with DUVYZAT should be discontinued if triglycerides remain elevated despite adequate dietary intervention and dosage adjustment.
  • Gastrointestinal Disturbances: Gastrointestinal disturbances, including diarrhea, nausea/vomiting, and abdominal pain were common adverse reactions in DUVYZAT clinical trials. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Modify the dosage of DUVYZAT in patients with moderate or severe diarrhea and discontinue treatment if significant symptoms persist.
  • QTc Prolongation: DUVYZAT can cause prolongation of the QTc interval. Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias (including torsades de pointes), such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbance or in patients taking concomitant medicinal products known to cause QT prolongation. Obtain ECGs prior to initiating treatment with DUVYZAT in patients with underlying cardiac disease or in patients who are taking concomitant medications that cause QT prolongation.

Adverse Reactions

The most common adverse reactions reported in >5% of patients treated with DUVYZAT are diarrhea (37%), abdominal pain (34%), thrombocytopenia (33%), nausea/vomiting (32%), hypertriglyceridemia (23%), pyrexia (13%), myalgia (9%), rash (9%), arthralgia (8%), fatigue (8%), constipation (7%), and decreased appetite (7%).

Drug Interactions

Closely monitor when DUVYZAT is used in combination with an oral CYP3A4 sensitive substrate or a sensitive substrate of the OCT2 transporter, for which a small change in substrate plasma concentrations may lead to serious toxicities.

Avoid concomitant use with other drugs that prolong the QTc interval; monitor ECG if concomitant use cannot be avoided. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold DUVYZAT if the QTc interval is >500 ms or the change from baseline is >60 ms.

INDICATION

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

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 for additional safety information.