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Daklinza Dosage

Generic name: DACLATASVIR DIHYDROCHLORIDE 90mg
Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 Testing Prior to Initiation of Therapy

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 [see Microbiology (12.4), Table 11].

Recommended Dosage

The recommended dosage of DAKLINZA is 60 mg, taken orally, once daily, with or without food [see Clinical Pharmacology (12.3)].

Table 1 provides the recommended DAKLINZA-containing treatment regimens and duration based on HCV genotype and patient population. The optimal duration of DAKLINZA and sofosbuvir with or without ribavirin has not been established for HCV genotype 3 patients with cirrhosis or for HCV genotype 1 patients with Child-Pugh C cirrhosis [see Clinical Studies (14.2, 14.4)].

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies (14)]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

For specific dosage recommendations for sofosbuvir, refer to the prescribing information.

For HCV genotype 1 or 3 patients with Child-Pugh B or C cirrhosis or post-transplantation patients, the starting dose of ribavirin is 600 mg once daily, increasing up to 1000 mg daily as tolerated. The starting dose and on-treatment dose of ribavirin can be decreased based on hemoglobin and creatinine clearance.

For HCV genotype 3 patients with compensated cirrhosis (Child-Pugh A), the recommended dosing of ribavirin is based on weight (1000 mg for patients weighing less than 75 kg and 1200 mg for those weighing at least 75 kg administered orally in two divided doses with food).

Table 1:     Recommended Treatment Regimen and Duration for DAKLINZA in Patients with Genotype 1 or 3 HCV
Patient Population Treatment and Duration

Genotype 1

Without cirrhosis

DAKLINZA + sofosbuvir for 12 weeks

Compensated (Child-Pugh A) cirrhosis

   

Decompensated (Child-Pugh B or C) cirrhosis

DAKLINZA + sofosbuvir + ribavirin
for 12 weeks

 

Post-transplant

   

Genotype 3

Without cirrhosis

DAKLINZA + sofosbuvir for 12 weeks

Compensated (Child-Pugh A) or
decompensated (Child-Pugh B or C) cirrhosis

DAKLINZA + sofosbuvir + ribavirin
for 12 weeks

Post-transplant

Dosage Modification Due to Drug Interactions

Refer to the drug interactions and contraindications sections for other drugs before coadministration with DAKLINZA.

Table 2:     Recommended DAKLINZA Dosage Modification with CYP3A Inhibitors and Inducers
Concomitant Drugs DAKLINZA Dosage

Strong CYP3A inhibitors and certain HIV antiviral agents
[see Drug Interactions (7.3)]

30 mg once daily

Moderate CYP3A inducers and nevirapine
[see Drug Interactions (7.3)]

90 mg once daily

Strong CYP3A inducers
[see Contraindications (4)]

Contraindicated

Dosage reduction of DAKLINZA for adverse reactions is not recommended.

Discontinuation of Therapy

If sofosbuvir is permanently discontinued in a patient receiving DAKLINZA with sofosbuvir, then DAKLINZA should also be discontinued.

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