DAKLINZA- daclatasvir tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DACLATASVIR DIHYDROCHLORIDE (UNII: 50ZO25C11D) (DACLATASVIR - UNII:LI2427F9CI)

Available from:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

DACLATASVIR DIHYDROCHLORIDE

Composition:

DACLATASVIR 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DAKLINZA is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection [see Dosage and Administration (2) and Clinical Studies (14) ]. Limitations of Use: Anticonvulsants phenytoin, carbamazepine May lead to loss of virologic response to DAKLINZA Antimycobacterial agents rifampin Herbal products St. John’s wort (Hypericum perforatum )                No adequate human data are available to determine whether or not DAKLINZA poses a risk to pregnancy outcomes. In animal reproduction studies in rats and rabbits, no evidence of fetal harm was observed with oral administration of daclatasvir during organogenesis at doses that produced exposures up to 6 and 22 times, respectively, the recommended human dose (RHD) of 60 mg of DAKLINZA. However, embryofetal toxicity was observed in rats and rabbits at maternally toxic doses that produced exposures of 33 and 98 times the human exposure, respectively, at the RHD of 6

Product summary:

DAKLINZA is packaged in bottles as described in the table. Tablet Strength Tablet Color/Shape Tablet Markings Package Size NDC Code 60 mg Light green, biconvex, pentagonal Debossed with “BMS” on one side and “215” on the other side Bottles of 28 0003-0215-01 30 mg Green, biconvex, pentagonal Debossed with “BMS” on one side and “213” on the other side Bottles of 28 0003-0213-01 90 mg Light green, biconvex, round Embossed with “BMS” on one side and “011” on the other side Bottles of 28 0003-0011-01 Store DAKLINZA tablets at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

DAKLINZA- DACLATASVIR TABLET
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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:
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥10%) observed with DAKLINZA in
combination with sofosbuvir were headache and
Sustained virologic response (SVR12) rates are reduced in genotype 3
patients with cirrhosis receiving DAKLINZA
in combination with sofosbuvir for 12 weeks. (14)
Testing prior to the initiation of therapy:
•
•
Test all patients for HBV infection by measuring HBsAg and anti-HBc.
(2.1)
HCV genotype 1a with cirrhosis, consider testing for the presence of
virus with NS5A resistance-associated
polymorphisms. (2.1)
60 mg taken orally once daily with or without food in combination with
sofosbuvir with or without ribavirin. (2.2)
Recommended treatment duration: 12 weeks. (2.2)
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)
Tablets: 60 mg, 30 mg, and 90 mg (3)
Strong inducers of CYP3A, including phenytoin, carbamazepine,
rifampin, and St. John’s wort. (4)
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence
of cur