Duvyzat (Givinostat) | Duchenne Muscular Dystrophy | DengYue Med

Duvyzat (Givinostat) Application Scope

Treatment of Duchenne Muscular Dystrophy (DMD) in patients aged 6 years and older.

Givinostat Characteristics

• Ingredients:

  • Active Ingredient: Givinostat hydrochloride monohydrate (8.86 mg/mL)

  • Inactive Ingredients: Polysorbate 20 (E432), glycerol (E422), tragacanth gum (E413), sodium benzoate (E211), peach flavor, cream flavor, saccharin sodium (E954), liquid sorbitol (E420), tartaric acid (E334), sodium hydroxide (E524), purified water

• Properties:

  • Mechanism of Action: Histone deacetylase (HDAC) inhibitor; the precise mechanism in DMD is unknown

  • Appearance: White to off-white or faintly pink, peach-cream flavored oral suspension

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• Packaging Specification:​ Supplied in a 140 mL amber polyethylene terephthalate bottle with a child-resistant screw cap and a 5 mL graduated oral syringe

• Storage:

  • Before Opening: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze. Store upright.

  • After Opening: Use within 60 days. Discard any unused portion after this period.​

• Expiry Date: ​Refer to the expiration date stated on the carton and bottle after “EXP”

• Executive Standard: ​Unknown

• Approval Number: FDA Approval Date: March 21, 2024

• Date of Revision: ​January 2025

• Manufacturer:

  • Marketing Authorization Holder: Italfarmaco S.p.A., Milan, Italy

  • Manufacturer: Italfarmaco S.A., Madrid, Spain

Guidelines for the Use of Givinostat

• Dosage and Administration:

  • Administer orally twice daily with food. Dosage is weight-based:

    Weight Range	Dosage (mg)	Volume (mL)
    10–<20 kg	22.2 mg	2.5 mL
    20–<40 kg	31 mg	3.5 mL
    40–<60 kg	44.3 mg	5 mL
    ≥60 kg	53.2 mg	6 mL

  • Dosage Modifications: Adjust dosage in cases of thrombocytopenia, diarrhea, or hypertriglyceridemia as per clinical guidelines.​

• Adverse Reactions:

  Common adverse reactions (≥10%):

  • Diarrhea (37%)

  • Abdominal pain (34%)

  • Thrombocytopenia (33%)

  • Nausea/vomiting (32%)

  • Hypertriglyceridemia (23%)

  • Pyrexia (13%)

• Contraindications: Unknown

• Precautions:

  • Hematological Changes: Monitor for thrombocytopenia and other signs of myelosuppression.

  • Increased Triglycerides: Monitor triglyceride levels; adjust dosage as necessary.

  • Gastrointestinal Disturbances: Manage moderate or severe diarrhea with dosage adjustments and supportive care.

  • QTc Prolongation: Avoid use in patients at increased risk for ventricular arrhythmias; monitor ECGs as clinically indicated

Givinostat Interactions

• Drug Interactions:​ None

• CYP3A4 and OCT2 Substrates: Givinostat is a weak inhibitor; monitor when coadministered with sensitive substrates.

• QTc-Prolonging Drugs: Avoid concomitant use; if unavoidable, monitor ECGs closely.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
• This product is a prescription-only drug, meaning it can only be purchased (or sold) with a valid prescription.
  Specifically, DUVYZAT is a drug used to treat Duchenne muscular dystrophy (DMD) in individuals aged 6 years or older and was approved by the FDA in March 2024 based on the positive results of the phase 3 EPIDYS clinical trial (NCT02851797 ).