ADR that result in revision of patient information
|
| |
| The United Kingdom: Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone |
| |
Simeprevir is a direct-acting antiviral medicine licensed to treat hepatitis C in combination with other medicines, including sofosbuvir. Amiodarone is licensed to treat severe heart-rhythm disorders in patients not responding to other treatments or when other treatments cannot be used.
In May’s issue of Drug Safety Update, the MHRA issued advice on the use of some sofosbuvir combination therapy with amiodarone, and is now extending that advice to simeprevir.
MHRA and other EU medicines regulators have reviewed the cardiac safety of simeprevir, after a similar review of bradycardia events with sofosbuvir, daclatasvir, and ledipasvir with amiodarone use. Two EU cases of bradycardia events after the use of simeprevir with sofosbuvir and concomitant amiodarone use were identified.
Healthcare professionals are advised of the following when treating patients with both heart rhythm disorders and hepatitis C:
• closely monitor patients taking amiodarone if they start taking the combination simeprevir and sofosbuvir; sofosbuvir and daclatasvir; and the fixed-dose combination of sofosbuvir and ledipasvir (particularly during the first weeks of treatment)
• only start amiodarone in patients taking any of these antiviral combinations when other antiarrhythmics are not tolerated or contraindicated; monitor closely (particularly during the first weeks of treatment)
• monitor patients at high risk of bradyarrhythmia continuously for 48 hours in an appropriate clinical setting after starting concomitant amiodarone and antiviral treatment
• monitor patients who have stopped amiodarone within the last few months and need to start taking any of these antiviral combinations—this is due to the long half-life of amiodarone
• advise patients taking amiodarone with any of these antiviral combinations to watch out for signs and symptoms of bradycardia and heart block, and to get medical help urgently if they experience any of these symptoms:
- shortness of breath
- light-headedness
- palpitations
- fainting
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/simeprevir-with-sofosbuvir-risk-of-severe-bradycardia-and-heart-block-when-taken-with-amiodarone
In Hong Kong, there is one registered pharmaceutical product containing sofosbuvir, namely Sovaldi Tablets 400mg (HK-63501), and one registered pharmaceutical product containing a combination of sofosbuvir and ledipasvir, namely Harvoni Tablets (HK-63886). Both products are prescription-only medicines registered by Gilead Sciences Hong Kong Limited (Gilead). There are no registered pharmaceutical products containing daclatasvir or simeprevir. Related news has been issued by various overseas health authorities, and was posted on the Drug Office website since 25 March 2015, with the last update posted on 24 June 2015. Letters to healthcare professionals to draw their attention to the new warning were issued on 25 March 2015. Gilead has applied to the Department of Health (DH) to update the package insert of the products to include the new warnings, and the applications are under evaluation. So far, DH has received two cases of adverse drug reaction (ADR) on Sovaldi, and neither of them was related to bradycardia or heart block. No ADR case has been received on Harvoni. As previously reported, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, August 21, 2015
Issued at HKT 13:00
|
| |
|
