MyDekla Adverse Reactions

Daclatasvir in combination with sofosbuvir: The most frequently reported adverse reactions were fatigue, headache, and nausea. Grade 3 adverse reactions were reported in less than 1% of patients, and no patients had a Grade 4 adverse reaction. Four patients discontinued the Daclatasvir regimen for adverse events, only one of which was considered related to study therapy.
Daclatasvir in combination with peginterferon alfa and ribavirin: The most frequently reported adverse reactions were fatigue, headache, pruritus, anaemia, influenza-like illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea and arthralgia. The most frequently reported adverse reactions of at least Grade 3 severity (frequency of 1 % or greater) were neutropenia, anaemia, lymphopenia and thrombocytopenia. The safety profile of daclatasvir in combination with peginterferon alfa and ribavirin was similar to that seen with peginterferon alfa and ribavirin alone, including among patients with cirrhosis.
Tabulated list of adverse reactions: Adverse reactions are listed in Table 13 by regimen, system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) , rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 13.)


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Laboratory abnormalities: In clinical studies of Daclatasvir in combination with sofosbuvir with or without ribavirin, one patient had a Grade 3 haemoglobin decrease; this patient was in a ribavirin treatment group. Laboratory abnormalities among patients treated with Daclatasvir, peginterferon alfa and ribavirin were similar to those among patients treated with placebo, peginterferon and ribavirin.
Description of selected adverse reactions: Cardiac arrhythmias: Cases of severe bradycardia and heart block have been observed when Daclatasvir is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see Precautions and Interactions).
Paediatric population: The safety and efficacy of Daclatasvir in children and adolescents aged <18 years have not yet been established. No data are available.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.