Other safety alerts
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| Canada: Amiodarone - Slow Heart Rate in Patients Taking Amiodarone Together with Harvoni or Sovaldi and a Direct Acting Antiviral |
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Gilead Sciences Canada, in consultation with Health Canada, would like to inform healthcare professionals, caregivers and patients of important safety information related to the development of serious symptomatic bradycardia (slow heart rate) in patients who are treated with amiodarone concomitantly with a) Harvoni™ or b) Sovaldi® in combination with another Direct Acting Antiviral (DAA). DAA are drugs that directly target specific steps or encoded proteins vital to the replication of the virus within the Hepatitis C Virus (HCV) life cycle. Nine cases of symptomatic bradycardia have been reported during postmarketing use in patients receiving amiodarone with either Harvoni™, or Sovaldi® in combination with another DAA.
Sovaldi® (sofosbuvir tablets) is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Harvoni™ (ledipasvir and sofosbuvir fixed-dose combination tablets) is indicated for the treatment of chronic hepatitis C genotype 1 infection in adults.
Nine cases of symptomatic bradycardia have been reported during postmarketing in patients receiving amiodarone with either Harvoni™, or Sovaldi® in combination with another DAA. Seven patients were also receiving a beta blocker. Bradycardia was observed within hours to two weeks of starting therapy. Of the nine cases of bradycardia, one resulted in cardiac arrest with a fatal outcome and three cases required pacemaker intervention. Three of the 9 cases were in patients receiving amiodarone and Harvoni™, six cases were in patients receiving amiodarone and Sovaldi® in combination with another DAA. Risk factors for the development of symptomatic bradycardia in patients receiving amiodarone may include co-administration of a beta blocker, or use in those patients with underlying cardiac comorbidities and/or advanced liver disease. The mechanism of this potential drug interaction is unclear at this time.
The co-administration of amiodarone with either Harvoni™ or Sovaldi® in combination with another DAA is not recommended. Healthcare professionals should counsel patients about the risk of serious symptomatic bradycardia when co administering amiodarone with either Harvoni™ or Sovaldi® in combination with another DAA. In cases where concomitant administration of amiodarone and Harvoni™ or Sovaldi® in combination with another DAA is unavoidable as judged by a medical practitioner, it is recommended that heart monitoring within an in-patient setting be conducted in the first 48 hours followed by daily self-monitoring of the heart rate in the first 2 weeks of treatment. Due to amiodarone’s long half-life (15 – 142 days, mean 58 days), patients discontinuing amiodarone less than 3 months before starting Harvoni™ or Sovaldi® in combination with a DAA should also undergo cardiac monitoring as outlined above.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../52801a-eng.php
In Hong Kong, Harvoni is not a registered pharmaceutical product. Meanwhile, there is one registered pharmaceutical product containing sofosbuvir, namely Sovaldi Tablets 400mg (HK-63501). It is a prescription only medicine registered by Gilead Sciences Hong Kong Limited. The company has issued letters to inform local healthacre professionals on the new warnings, and will apply to include the new warnings in the local product information. Related news has been released by the FDA, and was posted on the Drug Office website on 25 March 2015. Letters to healthcare professionals was issued on the same day to draw their attention to the new warning. So far, the Department of Health has received two adverse drug reaction reports on Sovaldi Tablets, and none of them are related to symptomatic bradycardia. As previously reported, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, April 08, 2015
Issued at HKT 13:00
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