|Packaging Size||28 TABLETS|
|Composition||DACLATASVIR 60 MG|
Coadministration with strong CYP450 3A inhibitors and certain HIV antiviral agents: 30 mg orally once a day
Coadministration with moderate CYP450 3A inducers and nevirapine: 90 mg orally once a day
Coadministration with strong CYP450 3A inducers: Contraindicated
The dose of this drug should not be reduced for side effects.
If sofosbuvir is permanently discontinued, this drug should also be discontinued.
US BOXED WARNING:
-RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Significant removal via dialysis is not likely (highly protein bound).
-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
-Use in combination with sofosbuvir (with or without ribavirin); do not use alone.
-Before starting this drug and sofosbuvir (with or without ribavirin), consider screening HCV genotype 1a-infected patients with cirrhosis for nonstructural protein 5A (NS5A) polymorphisms at amino acid positions M28, Q30, L31, and Y93.
-May administer without regard to food
-Consult the manufacturer product information regarding missed doses.
-Limitations of use: Sustained virologic response (SVR12) rates were reduced in HCV genotype 3-infected patients with cirrhosis using this drug with sofosbuvir for 12 weeks.
-Before starting therapy, the manufacturer product information for coadministered HCV antiviral drugs should be consulted for additional information.
-Read the US FDA-approved patient labeling (Patient Information).
-Avoid missing doses and complete the entire course of therapy