GJ Daclatasvir Dihydrochloride Tablets

• Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks

NS5A Resistance Testing In HCV Genotype 1a-Infected Patients With Cirrhosis Consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis who are infected with HCV genotype 1a prior to the initiation of treatment with DAKLINZA and sofosbuvir with or without ribavirin

Tablets:

• 60 mg: 60 mg of daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride), light green, biconvex, pentagonal, and debossed with “BMS” on one side and “215” on the other side.
• 30 mg: 30 mg of daclatasvir (equivalent to 33 mg daclatasvir dihydrochloride), green, biconvex, pentagonal, and debossed with “BMS” on one side and “213” on the other side.
• 90 mg: 90 mg of daclatasvir (equivalent to 99 mg daclatasvir dihydrochloride), light green, biconvex, round, and embossed with “BMS” on one side and “011” on the other side.

• If DAKLINZA and sofosbuvir are administered with ribavirin, refer to the prescribing information for ribavirin regarding ribavirin-associated adverse reactions.
• The following serious adverse reaction is described below and elsewhere in the labeling:
• Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone