Duvyzat® safety
Adverse event reporting information can be found at the bottom of this page.
Click HERE for prescribing information.
Duvyzat® has a well established safety profile1
- The safety profile of Duvyzat® is based on the double-blind, placebo controlled EPIDYS study in 179 ambulant DMD patients aged 6 years or older on steroid treatment
- A high proportion of boys completed the approximately 18-month follow-up in EPIDYS
- In the EPIDYS clinical trial, the most common side effects included diarrhoea, decreased platelet count or thrombocytopenia, vomiting, and hypertriglyceridemia
Adverse reactions reported in >5% of Duvyzat-treated patients and at least 5% greater than placebo in EPIDYS study2
*All patients were also receiving systemic corticosteroids, in a dose and regimen that was to remain unchanged over the follow-up period
(a) Thrombocytopenia includes platelet count decreased and thrombocytopenia
(b) Diarrhoea includes diarrhoea and faeces soft
(c) Abdominal pain includes abdominal pain and abdominal pain upper
(d) Hypertriglyceridaemia includes hypertriglyceridaemia and blood triglycerides increased
Less common adverse events
Adverse reactions of hypothyroidism and/or thyroid stimulating hormone (TSH) increased occurred in 5% of patients treated with Duvyzat® compared to 2% of patients who received placebo
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
Product Quality Complaints should also be reported to ITF Pharma Ltd Medical Information on: 0800 098 4040 or UK.Medical.Information@italfarmacogroup.com
References
- Duvyzat Summary of Product Characteristics. EMA, June 2025. https://www.ema.europa.eu/en/documents/product-information/duvyzat-epar-product-information_en.pdf
- Duvyzat Summary of Product Characteristics, MHRA, https://www.medicines.org.uk/emc/product/100605/smpc
