Duvyzat (Givinostat) is a histone deacetylase inhibitor for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years and above. Some side effects may occur during the use of Duvyzat. We should identify and manage these side effects in a timely manner. The following is a detailed introduction.
Duvyzat givinostat side effects
Hematological and digestive system reactions
About 37% of patients experience thrombocytopenia after use, manifested as bleeding symptoms such as nosebleeds and subcutaneous ecchymoses. In clinical trials, 37% of patients reported diarrhea, some of which were severe; 32% of patients experienced nausea or vomiting. It is recommended to test the platelet count before treatment. If it is less than 150×10⁹/L, the medication should be suspended. Gastrointestinal reactions can be alleviated by adjusting the diet structure or using antidiarrheal drugs for a short period of time.
Metabolic abnormalities and cardiac risks
About 25% of patients have serum triglyceride levels exceeding 300mg/dL and need to be intervened by a low-fat diet. Electrocardiogram monitoring shows that some patients have a prolonged QTc interval of more than 60ms, increasing the risk of arrhythmia. For patients with a history of heart disease or taking other QT-prolonging drugs, the electrocardiogram should be evaluated before treatment and retested regularly.
Understanding the manifestation characteristics of common side effects will help early intervention. The following content will explain the specific treatment methods for different adverse reactions.
Treatment methods after side effects of Duvyzat
The side effect management of Duvyzat needs to be combined with laboratory indicators and clinical symptoms, and a graded adjustment strategy should be adopted. Standardized treatment can minimize the risk of treatment interruption.
Thrombocytopenia and dose adjustment
If the platelet count is less than 150×10⁹/L in two tests (one week apart), the dose should be reduced step by step according to body weight. For example, patients weighing more than 60kg are adjusted to 39.9mg/day for the first time and 35.4mg/day for the second time. If the dose cannot be restored after the reduction, the drug should be permanently discontinued and referred to the hematology department.
Intervention for diarrhea and metabolic disorders
Moderate diarrhea (4-6 watery stools per day) can be combined with loperamide and electrolyte solution supplementation. Severe diarrhea requires suspension of medication until symptoms are relieved. For patients with triglycerides that persist >300mg/dL, it is recommended to adopt a low-fat diet and increase omega-3 fatty acid intake, and if necessary, use fibrates to lower lipids.
Scientific response measures can improve patient tolerance. The following will list the medication specifications that require special attention when using Duvyzat.
Duvyzat medication precautions
The efficacy and safety of Duvyzat are highly dependent on standardized medication and regular monitoring. Patients and medical staff need to pay attention to the following core issues.
Pre-treatment evaluation and regular monitoring
Platelet count, triglyceride level and electrocardiogram must be tested before medication. During treatment, platelet and lipid indicators should be reviewed every 4 weeks, and electrocardiograms should be evaluated every 3 months. If the QTc interval exceeds 500ms or increases by ≥60ms from baseline, the drug should be discontinued immediately and the cause should be checked.
Drug combination and restrictions on special populations
It is prohibited to use it in combination with drugs that can prolong the QT interval (such as fluoroquinolone antibiotics, antipsychotics). Patients with renal or hepatic dysfunction need to adjust the dose individually and monitor adverse reactions closely. The specifications of the original drug from Italfarmaco in Spain are 140ml/box, which needs to be refrigerated and used up within 60 days after opening.
Strictly following the doctor's advice and maintaining regular follow-up visits are the basis for ensuring the treatment effect. If the patient has myalgia, rash or persistent fatigue, he should seek medical attention in time. Through doctor-patient collaboration and standardized management, Duvyzat can provide more lasting motor function improvement for DMD patients. For specific indications and professional content in the article, please refer to the original instructions. The content of this article is for reference only.
