Daclatasvir is the first drug that has shown safety and efficacy in treatment of genotype 3HCV infections without the need to collectively give interferon [interferon] or Lee ribavirin [ribavirin], FDA's Drug Evaluation and research Center Anti-microbial products Room Director said: " Today's approval offers a new option for patients with genotype 3HCV, including those who cannot tolerate ribavirin. ”
⑴60mg Oral 1 times a day with or without food with the grand Buver.
⑵ Recommended treatment time: 12 weeks.
⑶ dose modification and strong $literal inhibitor reduced dosage to mg 1 times per day and with moderate $literal inducer increased doses to 90mg daily 1 times.
Daklinza and Grand Buver observed the most common adverse reactions (≥10%) were headaches and fatigue. (6.1)
Report suspected adverse reactions, contact Bristol-myers Squibb Tel 1-800-721-5072 or FDA call 1-800-fda-1088 or www. FDA gov/medwatch.
Drug interactions: Daklinza of the common drug may change the concentration of other drugs and other medications that may change daclatasvir concentrations. Consult the complete prescription information prior to the use of contraindications and other potential drugs-drug interactions. (2.2, 4, 5.1, 7, 12.3).
Dosage and Prescription method
2.1 Recommended dosage
The recommended dosage for Daklinza is the Buver mg, oral, 1 times a day with the grand total of 12 weeks. Daklinza may have or have no food to take.
The optimal time for Daklinza Dhaka and Grand Bouvet for patients with sclerosis has not been determined [see Clinical Research (14)].
The recommended dosage of the Bouvette is the reference to the relevant prescription data.
2.2 Dose modification due to drug interactions
The interaction and contraindication of other drug-referenced drugs before drug-daklinza were given.
Cytochrome P450 enzyme 3A (strong inhibitor of $literal: reduced daklinza dose to mg 1 times per day when combined with strong $literal inhibitors, MG tablets [see drug interactions (7)].
Medium $literal Inducer: When common drug and medium $literal inducer increase Daklinza dose to the 1 times per day, using the appropriate combination (three tablets of MG or one piece of mg and one mg tablets) [See Drug interactions (7)].
Strong $literal Inducer: Daklinza is contraindicated with strong $literal inducer [see Contraindication (4)].
It is recommended that the daklinza dose not be reduced in adverse reactions.
2.3 Termination of the treatment
One case of receiving Daklinza and Bouvet patients who permanently terminate the Grand Bouvet and then Daklinza should also be terminated.