Duvyzat
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Duvyzat is a {{{drugClass}}} that is FDA approved for the treatment of DUVYZAT is a histone deacetylase inhibitor that is FDA approved for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.. Common adverse reactions include Most common adverse reactions (≥10% in DUVYZAT-treated patients) are
- diarrhea,
- abdominal pain,
- thrombocytopenia,
- nausea/vomiting,
- hypertriglyceridemia,
- pyrexia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
- 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 10^9/L.
- The dosage of DUVYZAT is based on patient’s body weight.
- Administer orally twice daily with food.
- Dosage modifications may be needed for decreased platelet counts, diarrhea, increased triglycerides, or QTc prolongation.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Duvyzat in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Duvyzat in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Duvyzat FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Duvyzat in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Duvyzat in pediatric patients.
Contraindications
None.
Warnings
- 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.
Adverse Reactions
Clinical Trials Experience
The following clinically significant adverse reactions are described below and elsewhere in the labeling:
- Hematological Changes.
- Increased Triglycerides.
*Gastrointestinal Disturbances. *QTc Prolongation .
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- In controlled and uncontrolled trials in patients with confirmed DMD, 222 male patients aged 6 years and older were treated with DUVYZAT, including 210 patients treated for ≥ 6 months, 187 patients for ≥ 12 months, and 105 patients for ≥ 24 months.
- The safety profile of DUVYZAT is based on a double-blind, placebo-controlled, 18-month study in a total of 179 ambulant DMD patients aged 6 years or older on concomitant steroid treatment (Study 1) . The dosage in Study 1 was weight-based .Patients were excluded from the study if they had the following abnormalities at the screening visit: platelet, white blood cell, or hemoglobin counts less than the lower limit of normal, triglycerides > 300 mg/dL (3.42 mmol/L) in fasting condition, or had a baseline-corrected QT interval, Fridericia’s correction (QTcF) of > 450 msec (mean of 3 consecutive readings 5 minutes apart) or a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome). Overall, 2% of the patients discontinued the study because of adverse reactions.
Adverse reactions reported in >5% of DUVYZAT-treated patients at a frequency at least 5% greater than that of the placebo group are presented in Table 3 below.
Thrombocytopenia includes platelet count decreased and thrombocytopenia.
- Less Common Adverse Reactions in Study 1
Adverse reactions of hypothyroidism and/or thyroid stimulating hormone (TSH) increased occurred in 5% of patients treated with DUVYZAT compared to 2% of patients who received placebo.
Postmarketing Experience
There is limited information regarding Duvyzat Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Duvyzat Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Duvyzat in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Duvyzat in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Duvyzat during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Duvyzat in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Duvyzat in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Duvyzat in geriatric settings.
Gender
There is no FDA guidance on the use of Duvyzat with respect to specific gender populations.
Race
There is no FDA guidance on the use of Duvyzat with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Duvyzat in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Duvyzat in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Duvyzat in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Duvyzat in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Duvyzat Administration in the drug label.
Monitoring
There is limited information regarding Duvyzat Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Duvyzat and IV administrations.
Overdosage
There is limited information regarding Duvyzat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Duvyzat Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Duvyzat Mechanism of Action in the drug label.
Structure
There is limited information regarding Duvyzat Structure in the drug label.
Pharmacodynamics
There is limited information regarding Duvyzat Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Duvyzat Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Duvyzat Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Duvyzat Clinical Studies in the drug label.
How Supplied
There is limited information regarding Duvyzat How Supplied in the drug label.
Storage
There is limited information regarding Duvyzat Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Duvyzat Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Duvyzat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Duvyzat Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Duvyzat Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.