Dear Healthcare Professional Letter on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone
11.05.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform healthcare professionals on the risk of clinically important arrhythmias when Harvoni (sofosbuvir+ledipasvir) or combination of Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are used together with amiodarone
Summary
- There were reports of bradycardia and heart block in patients treated together with amiodarone and Harvoni or amiodarone and combination of Sovaldi and Daklinza.
- Bradycardia has been discovered a few hours up to 2 weeks after beginning of treatment of viral hepatitis C (HCV)
- Patients taking amoidarone should be monitored carefuly when introducing Harvoni or combination of Sovaldi and Daklinza (see further recommendations and information).
- In patients treated with Harvoni or combination of Sovaldi and Daklinza, amiodarone may be introduced only when the treatment with other antiarrhythmic medicines is contraindicated or not tolerated. A corresponding careful monitoring is needed.
- Due to a long amiodarone decay, a corresponding monitoring is also needed in patients having stopped taking amiodarone a few months before and in whom Harvoni or Sovaldi + Daklinza are planned to be taken in combination.
Further information
The mechanism behind this findings has not been established and further cases (including combined use of sofosbuvir with other antiviral medicines with direct action (DAA) except daclatasvir or ledipasvir or cases without amiodarone) is currently being investigated.
Since the number of patients taking smiodarone is not known and they have been treated with Harvoni or combination of Sovaldi and Daklinza, it is not possible to estimate the incidence of these events. The information on these medicines will be renowned according to new findings and recommendations.
Harvoni (sofosbuvir/ledipasvir), Daklinza (daclatasvir) and Sovaldi (sofosbuvir) are authorised in the EU via centralised procedure and may be placed on the Croatian market. So far, Harvoni has been placed on the Croatian market, whereas Daklinza and Sovaldi are not available on the Croatian market. These medicines are currently not listed on the positive list of the Croatian Health Insurance Fund.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
