Molecule
Givinostat is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. It is available as oral suspension. MedsAcross supplies Givinostat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
DUVYZAT is a histone deacetylase inhibitor. The precise mechanism by which DUVYZAT exerts its effect in patients with DMD is unknown.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described below and elsewhere in the labeling: Hematological Changes Increased Triglycerides Gastrointestinal Disturbances QTc Prolongation Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.
Source: US FDA prescribing information
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. Avoid concomitant use with other drugs that prolong the QTc interval, monitor ECG if concomitant use cannot be avoided.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Givinostat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Duvyzat 8.86 mg/mL oral suspensionOral | Italfarmaco | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Givinostat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Givinostat, including Duvyzat.
Yes. The US FDA first approved Givinostat on 21 March 2024, according to Drugs@FDA.
Yes. Givinostat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Givinostat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Givinostat is classified under ATC code M09AX14 (Givinostat).
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