GIVINOSTAT

Other

Brand names: DUVYZAT

Oral

Mechanism of Action

12.1 Mechanism of Action DUVYZAT is a histone deacetylase inhibitor. The precise mechanism by which DUVYZAT exerts its effect in patients with DMD is unknown.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia
3 ) QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias
One case of abdominal pain was serious
Fluid and electrolytes should be replaced as needed to prevent dehydration [see Warnings and Precautions (5

Known Side Effects

6 documented side effects by frequency

Diarrhea

>10%

Nausea

1-10%

Vomiting

1-10%

Weight Gain

0.1-1%

Fever

0.1-1%

Muscle Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral