Should concomitant use of amiodarone be considered necessary, it is recommended that patients undergo cardiac monitoring in an in-patient setting for the first 48 hours of coadministration, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment. Amiodarone should only be used in patients on Epclusa when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated. Bradycardia has generally occurred within hours to days, but cases with a longer time to onset have been observed mostly up to 2 weeks after initiating HCV treatment. Life-threatening cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone. Close monitoring is recommended if this medicinal product is administered with Epclusa. Use only if no other alternative is available. Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown but may result in serious symptomatic bradycardia. In the postmarketing setting, cases of severe bradycardia and heart block have been observed when SOF-containing products are used in combination with amiodarone.
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