givinostat
Duvyzat · ATC code M09AX14
- Key facts
- Active substance
- givinostat
- ATC code
- M09AX14
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Duvyzat 8.86 mg/ml oral suspension
- Marketing authorisation holder
- Italfarmaco S.p.A.
- Information as of
- 2026-10-28
Key facts
Givinostat (Duvyzat) is an oral histone deacetylase inhibitor used together with corticosteroids to treat Duchenne muscular dystrophy in ambulant patients aged 6 years and older.
What it is used for
- Treatment of Duchenne muscular dystrophy (DMD) in ambulant patients aged 6 years and older, with concomitant corticosteroid treatment.
Dosing
- Oral suspension twice daily, dosed by actual body weight: 15 to < 20 kg 22.2 mg (2.5 ml); 20 to < 40 kg 31 mg (3.5 ml); 40 to < 60 kg 44.3 mg (5 ml); 60 kg or more 53.2 mg (6 ml).
- Not to be started with a platelet count less than 150 × 10⁹/l; baseline platelets and triglycerides are required.
- Dose is reduced in steps (see the full text for the dose table) for confirmed platelets < 150 × 10⁹/l, moderate or severe diarrhoea (more than 4 stools per day) or fasting triglycerides > 300 mg/dl; treatment is stopped if reactions persist after the second reduction.
- No double or extra dose after a missed dose.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Dose-related thrombocytopenia and other signs of myelosuppression; platelets are checked every 2 weeks for the first 2 months, at month 3 and then every 3 months.
- Increased serum triglycerides; levels are measured at baseline, at months 3 and 6 and then every 6 months.
- Diarrhoea and vomiting are very common, usually in the first weeks; fluids and electrolytes should be replaced to prevent dehydration.
- In patients with heart disease or taking QT-prolonging medicines, an ECG is recommended at the start of treatment.
Side effects
- Most common: diarrhoea (38.1%), abdominal pain (33.9%), thrombocytopenia (32.2%), vomiting (28.8%) and hypertriglyceridaemia (22.9%).
- Gastroenteritis has also been reported.
Interactions
- Caution with QT-prolonging medicines with a risk of torsades de pointes (e.g. amiodarone, sotalol, ondansetron, azithromycin, clarithromycin, fluconazole, risperidone).
- Caution with medicines that raise triglycerides; the effect of antithrombotics on platelet count is unknown.
Pregnancy and breastfeeding
- As a precaution, use during pregnancy is preferably avoided; should not be used during breast-feeding.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- DuvyzatItalfarmaco S.p.A. · EMEA/H/C/006079
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Duvyzat
- Liechtenstein
- Duvyzat
- Norway
- Duvyzat
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Duvyzat – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/duvyzat-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.