Brand Name
Duvyzat
Generic Name
Givinostat
View Brand Information FDA approval date: March 21, 2024
Classification: Histone Deacetylase Inhibitor
Form: Suspension
What is Duvyzat (Givinostat)?
DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older. DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older.
Approved To Treat
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Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy
Summary: This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to \<18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. * Planned screening duration: approximately 4 weeks (±14 days) * Planned treatment duration...
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Brand Information
DUVYZAT (givinostat)
1INDICATIONS AND USAGE
DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
2DOSAGE FORMS AND STRENGTHS
Oral suspension: 8.86 mg/mL givinostat as a white to off-white or faintly pink, peach-cream flavored suspension.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described below and elsewhere in the labeling:
- Hematological Changes
- Increased Triglycerides
- Gastrointestinal Disturbances
- QTc Prolongation
4.1Clinical 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)
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.
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.
5DESCRIPTION
DUVYZAT (givinostat) oral suspension contains givinostat hydrochloride monohydrate, a histone deacetylase inhibitor. Givinostat hydrochloride monohydrate is designated chemically as: [6-(diethylaminomethyl)naphthalen-2-yl]methyl[4(hydroxycarbamoyl) phenyl] carbamate hydrochloride monohydrate. The molecular formula is C
Givinostat hydrochloride monohydrate is a white to off-white, non-hygroscopic, crystalline powder that is very slightly to slightly soluble in aqueous media and slightly soluble in ethanol.
DUVYZAT contains givinostat 8.86 mg/mL (equivalent to givinostat hydrochloride monohydrate 10 mg/mL) and the following inactive ingredients: cream flavor, glycerin, non-crystallizing sorbitol solution, peach flavor, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, tartaric acid, and tragacanth.
6CLINICAL STUDIES
The effectiveness of DUVYZAT for the treatment of Duchenne muscular dystrophy (DMD) was evaluated in a randomized, double-blind, placebo-controlled 18-month study (Study 1; NCT02851797). A total of 179 patients were randomized 2:1 to receive either DUVYZAT (n = 118) or placebo (n = 61). A weight-based dose regimen was applied
The primary endpoint was the change from baseline to Month 18 in 4-stair climb (4SC) time for DUVYZAT compared to placebo. The 4SC is a measure of muscle function that tests the time it takes to climb 4 stairs. A secondary efficacy endpoint was change from baseline to Month 18 in physical function as assessed by the North Star Ambulatory Assessment (NSAA).
The primary analysis population was based on a prespecified range of baseline muscle fat fraction as determined by MR spectroscopy. Patients treated with DUVYZAT showed statistically significant less decline in the 4-stair climb compared to placebo (see
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Administration Instructions
Instruct patients or caregivers to
- Shake DUVYZAT oral suspension well before measuring out each dose.
- Administer using the provided graduated oral syringe to measure the appropriate volume of suspension corresponding to the prescribed dose for the patient.
- Take DUVYZAT with food.
- Discard any unused DUVYZAT oral suspension remaining after 60 days of first opening the bottle.
Hematological Changes
Inform patients and/or caregivers that DUVYZAT can cause hematological changes including a decrease in platelet counts (thrombocytopenia), anemia, and a decrease in neutrophils (neutropenia)
Increased Triglycerides
Inform patients and/or caregivers that DUVYZAT can cause an increase in triglycerides,
Gastrointestinal Disturbances
Inform patients and/or caregivers that DUVYZAT can cause diarrhea and vomiting, which may require medication for treatment
QTc Prolongation
Inform patients and/or caregivers that DUVYZAT can cause prolongation of the QTc interval
Manufactured by:
Distributed by:
DUVYZAT is a trademark owned by Italfarmaco S.p.A.
All rights reserved.
8PRINCIPAL DISPLAY PANEL
NDC 11797-110-01
Rx only
DuvyzatTM
[givinostat]
Oral suspension
[givinostat]
Oral suspension
For Oral Administration Only
Shake bottle for 30 seconds
before use
Shake bottle for 30 seconds
before use
140 mL
Dispense a Medication Guide to each
ITALFARMACO
Distributed by: ITF Therapeutics, LLC
Concord, MA 01742
Concord, MA 01742
9PRINCIPAL DISPLAY PANEL
NDC 11797-110-02
Rx only
DuvyzatTM
[givinostat]
Oral suspension
[givinostat]
Oral suspension
For Oral
Shake bottle for 30 seconds
before use
Shake bottle for 30 seconds
before use
See enclosed Instructions for Use
Dispense a Medication Guide to each patient.
140 mL
