For: Chronic Hepatit Status: Discontinued
Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.These highlights do not include all the information needed to use DAKLINZA safely and effectively. See full prescribing information for DAKLINZA.
DAKLINZA� (daclatasvir) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
See full prescribing information for complete boxed warning.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.1)
INDICATIONS AND USAGE
DAKLINZA is a hepatitis C virus (HCV) NS5A inhibitor indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1 or 3 infection. (1)
Limitations of Use:
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Sustained virologic response (SVR12) rates are reduced in genotype 3 patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks. (14)
DOSAGE AND ADMINISTRATION
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Testing prior to the initiation of therapy:
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Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1)
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HCV genotype 1a with cirrhosis, consider testing for the presence of virus with NS5A resistance-associated polymorphisms. (2.1)
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60 mg taken orally once daily with or without food in combination with sofosbuvir with or without ribavirin. (2.2)
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Recommended treatment duration: 12 weeks. (2.2)
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Dose modification: Reduce dosage to 30 mg once daily with strong CYP3A inhibitors and increase dosage to 90 mg once daily with moderate CYP3A inducers. (2.3)
DOSAGE FORMS AND STRENGTHS
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Tablets: 60 mg, 30 mg, and 90 mg (3)
CONTRAINDICATIONS
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Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin, and St. John�s wort. (4)
WARNINGS AND PRECAUTIONS
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Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. (5.1)
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Bradycardia When Coadministered with Sofosbuvir and Amiodarone: Serious symptomatic bradycardia may occur in patients taking amiodarone with a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers or those with underlying cardiac comorbidities 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. (5.3, 6.2, 7.3)
ADVERSE REACTIONS
Most common adverse reactions (?10%) observed with DAKLINZA in combination with sofosbuvir were headache and fatigue. (6.1)
Most common adverse reactions (?10%) observed with DAKLINZA in combination with sofosbuvir and ribavirin were headache, anemia, fatigue, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Drug Interactions: Coadministration of DAKLINZA can alter the concentration of other drugs and other drugs may alter the concentration of daclatasvir. Consult the full prescribing information before use for contraindicated drugs and other potential drug-drug interactions. (2.3, 4, 5.2, 7, 12.3)
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Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary (7.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2019
