If DAKLINZA and sofosbuvir are administered in a regimen containing ribavirin, the information for ribavirin on carcinogenesis and mutagenesis also applies to this combination regimen see prescribing information for ribavirin. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection.
Previous exposure to NS5A inhibitors was prohibited. Description In this parallel-arm phase 3 trial, 45ea investigators assigned treatment-naive genotype 3 patients and 51 treatment-experienced genotype 3 patients to a week all-oral regimen of daclatasvir 60 mg once daily and sofosbuvir mg once daily. To check for related product names, use your "Back" button to return to previous menus or start a new product search above.
This information is intended for US healthcare professionals Continue to healthcare professional site Go to patient site. Daclatasvir exposures at these doses were approximately 6-fold males and females the human systemic exposure at the therapeutic daily dose of DAKLINZA. Hepatitis C information for health professionals.
Subjects with HCV genotype 1, 2, 3, 4, 5, or 6 infection were eligible to enroll. Daclatasvir can potentially cause serious bradycardia when coadministered with sofosbuvir and amiodarone, particularly if the patient is also taking a beta-blocker. Advise patients to seek medical evaluation immediately for symptoms of bradycardia, such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion or memory problems [ see Warnings and Precautions 5.
Daclatasvir did not have a clinically relevant effect on the exposure of midazolam, a sensitive CYP3A substrate. Pediatric Patients The pharmacokinetics of daclatasvir in pediatric patients has not been evaluated.
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If you miss a dose, call your healthcare provider or pharmacist. Read how regulations may differ by country. Do not start taking a new medicine without telling your healthcare provider. Do not change your dose unless you are told to by your healthcare provider.
Daclatasvir dihydrochloride has the following structural formula:. DAKLINZA 60 mg tablets contain 60 mg daclatasvir equivalent to 66 mg daclatasvir dihydrochloride and the inactive ingredients anhydrous lactose mgmicrocrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and Opadry green.
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Coadministration of daclatasvir, sofosbuvir and amiodarone is therefore not advised. For specific dosage recommendations for sofosbuvir, refer to the prescribing information. Exposure of daclatasvir was similar between healthy and HCV-infected subjects. If DAKLINZA and sofosbuvir are administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.
No subjects discontinued therapy for adverse events. Shipping Information This pharmacy ships to:. The site you are entering is not controlled by Gilead Sciences, Inc.
This difference in daclatasvir AUC is not considered clinically relevant. No local pharmacy pricing found. A food effect was not observed with administration of a daclatasvir 60 mg tablet after a low-fat, low-caloric meal approximately total kcal, 41 kcal from fat, kcal from carbohydrates, 44 kcal from protein compared with fasted conditions [ see Dosage and Administration 2 ].