FOR US HEALTHCARE PROFESSIONALS ONLY

FOR US HEALTHCARE PROFESSIONALS ONLY

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DUVYZAT resources for you and your practice

Patient Start Form

Patient Start Form

Start your patients on DUVYZAT with the help of ITF ARC.

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Sample Medical Necessity Letter

Sample Medical Necessity Letter

A sample letter that highlights information that the patient's insurance plan may require to authorize coverage of DUZYZAT.

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Sample Medical Appeal Letter

Sample Medical Appeal Letter

A sample letter that highlights information that a patient's insurance plan may require to reconsider coverage of DUVYZAT.

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FAQs

ITF ARC Patient Services Brochure

A quick reference guide for how ITF ARC can help your patients access and stay on treatment with DUVYZAT.

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Patient FAQ

Healthcare Professional Brochure

Information about DUVYZAT for healthcare professionals.

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Patient Brochure

Patient Brochure

A comprehensive guide for your patients to learn more about DUVYZAT.

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Patient Monitoring Tool

Patient Monitoring Tool

A quick reference guide for monitoring your patient's first year of treatment with DUVYZAT.

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Frequently asked questions about DUVYZAT

Here are some frequently asked questions to help answer any questions you may have about DUVYZAT.

When was DUVYZAT approved in the United States? View answer View answer

DUVYZAT was approved by the US Food and Drug Administration on March 21, 2024.

Who is eligible for treatment with DUVYZAT? View answer View answer

DUVYZAT is indicated for all patients with DMD 6 years of age and older, regardless of genetic mutation or ambulatory status.1,* *The EPIDYS clinical trial did not include nonambulatory patients.

Does ITF offer a free drug program for DUVYZAT? View answer View answer

We are committed to making treatment with DUVYZAT available to as many appropriate patients in the US as possible by working with payers to enable access. We also offer a variety of programs to help patients access treatment while insurers complete their assessments. These include:

  • A copay assistance program for commercially insured patients, where patients may pay as little as $0
  • A temporary supply program that provides a limited supply of DUVYZAT to help ensure a timely start for appropriate patients facing insurance-related delays
  • A temporary supply program for patients currently on therapy who may be changing insurance providers and might otherwise experience a gap in treatment
  • A patient assistance program providing DUVYZAT at no charge for eligible patients, based on established criteria
For more information about our patient support services, please visit the patient support page or contact ITF ARC at 1-855-4 ITF ARC (1-855-448-3272).

What options are available to patients who are unable to afford DUVYZAT? View answer View answer

We understand that patients may encounter out-of-pocket costs in situations where insurance coverage is insufficient. As a reflection of our commitment to making treatment with DUVYZAT available to as many appropriate patients in the US as possible, we have created a suite of programs to help address potential financial concerns, including:

  • A copay assistance program for commercially insured patients, where patients may pay as little as $0
  • A temporary supply program that provides a limited supply of DUVYZAT to help ensure a timely start for appropriate patients facing insurance-related delays
  • A temporary supply program for patients currently on therapy who may be changing insurance providers and might otherwise experience a gap in treatment
  • A patient assistance program providing DUVYZAT at no charge for eligible patients, based on established criteria
For more information about our patient support services, please visit the patient support page or contact ITF ARC at 1-855-4 ITF ARC (1-855-448-3272).

Will DUVYZAT be available for patients with Becker muscular dystrophy? View answer View answer

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older in the US.1 DUVYZAT is not approved for patients with Becker muscular dystrophy (BMD). We recognize the significant unmet medical needs of people living with BMD and their families. Our program for BMD is in the early stages of clinical development. It is important to note that this question pertains to an unapproved or uncleared use of DUVYZAT. For further details, please contact Medical Information at medinfo@itftherapeutics.com.

Who is ITF Therapeutics? View answer View answer

ITF Therapeutics is the US-based rare disease division of Italfarmaco S.p.A. Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development of many innovative therapeutic products approved for use by patients around the world. The company operates in more than 90 countries on 5 continents and continues to advance promising research to address unmet medical needs in a wide range of therapeutic areas. In January 2024, Italfarmaco launched ITF Therapeutics as a new division in the United States with a focus on the development and commercialization of products to treat rare diseases, including Duchenne muscular dystrophy (DMD). Building on a legacy grounded in collaboration and innovation, ITF Therapeutics strives to partner with leaders from the US patient advocacy and treatment communities to ensure that our programs reflect and support their unique needs and goals. The establishment of ITF Therapeutics also reflects Italfarmaco's goal to build a world-class team of experts who share a passion to make a positive impact for rare disease communities. For more information about ITF Therapeutics, please visit itftherapeutics.com.

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Reference: 1. DUVYZAT. Prescribing information. lTF 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.