What is DUVYZAT used for?

1 INDICATIONS AND USAGE DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. ( 1 )

How does DUVYZAT work?

11 DESCRIPTION DUVYZAT (givinostat) oral suspension contains givinostat hydrochloride monohydrate, a histone deacetylase inhibitor.

What is the active ingredient in DUVYZAT?

Givinostatum (Givinostati hydrochloridum monohydricum)

What pharmaceutical form is DUVYZAT available in?

DUVYZAT: Zawiesina doustna 8,86 mg/ml (doustna)

What are the side effects of DUVYZAT?

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in the labeling: Hematological Changes [see Warnings and Precautions (5.1) ] Increased Triglycerides [see Warnings and Precautions (5.2) ] Gastrointestinal Disturbances [see Warnings and Precautions (5.3) ] QTc Prolongation [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting,

Who should NOT take DUVYZAT?

4 CONTRAINDICATIONS None. None. ( 4 )

Does DUVYZAT interact with other medications?

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 concentration may lead to serious toxicities. ( 7.1 ) Avoid concomitant use with other drugs that prolong the QTc interval; monitor ECG if concomitant use cannot be avoided. ( 7.2 ) 7.1 Effect of DUVYZAT on Other Drugs CYP3A4 Sensitive Substrates Givinostat is a weak intesti

Can DUVYZAT be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Hepatic Impairment: Exposure to givinostat is expected to be increased. ( 8.6 ) 8.1 Pregnancy Risk Summary DUVYZAT is indicated for the treatment of DMD, which is a disease of predominantly young male patients. Therefore, there are no adequate data available to assess the use of DUVYZAT in pregnant women. In animal studies, oral administration of givinostat during organogenesis resulted

What precautions should be taken with DUVYZAT?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

What ATC class does DUVYZAT belong to?

DUVYZAT: ATC M09AX14. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

DUVYZAT

8,86 mg/ml, Zawiesina doustna

INN: Givinostatum

Data updated: 2026-04-13

Available in:

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Form

Zawiesina doustna

Dosage

8,86 mg/ml

Route

doustna

Storage

16.2 Storage and Handling 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) [see USP Controlled Room Temperature]. Do not freeze. Store upright. Discard any unused DUVYZAT remaining after 60 days of first opening of the bottle.

User Reviews

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