Are there any other warnings one should know regarding Daklinza?
Bradycardia When Coadministered with Sofosbuvir and Amiodarone
Serious symptomatic bradycardia may occur in patients taking amiodarone with sofosbuvir and Daklinza, particularly in patients also receiving beta blockers or those with underlying cardiac chronic disease and/or advanced liver disease. Coadministration of amiodarone with Daklinza in combination with sofosbuvir is not recommended. In patients with no alternative treatment options, cardiac monitoring is recommended.
Risk of Hepatitis B Reactivation
The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Daklinza, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.
Last Updated: October 2016
FDA Approved Daklinza (Daclatasvir) for the Treatment of Patients with Chronic Hepatitis C Genotype 3. http://news.bms.com/press-release/fda-approves-daklinza-daclatasvir-treatment-patients-chronic-hepatitis-c-genotype-3, Bristol-Myers Squibb Company. Retrieved July 27, 2015.
Financial Help Info for Daklinza (daclatasvir) . http://www.daklinza.bmscustomerconnect.com/support, Bristol-Myers Squibb Company. Retrieved July 27, 2015.
Highlights of Prescribing Information - DAKLINZA. http://packageinserts.bms.com/pi/pi_daklinza.pdf, Bristol-Myers Squibb Company. Retrieved July 27, 2015.
Patient Support Connect. http://www.patientsupportconnect.bmscustomerconnect.com/, Bristol-Myers Squibb Company. Retrieved July 27, 2015.