DaclahepÂ is an inhibitor of non-structural protein 5A (NS5A).
Each film-coated tablet contains Daclatasvir equivalent to Daclatasvir 30 mg or 60 mg.
INDICATIONS AND USAGE
Daclahep is indicated in combination with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection.
DOSAGE AND ADMINISTRATION
Treatment with Daclahep should be initiated and monitored by physician experienced in the management of chronic hepatitis C. The recommended dose of Daclahep is 60 mg once daily to be taken orally with or without meals. Daclahep Â Â must be administered in combination with other medical products.The Packeges inserts of the medicinal products in the regimen should also be consulated before initiation of therapy with Daclahep .Recommended reginmens and treatment duration are provided below.
Recommended regimens and treatment duration for Daclahep Â combination therapy
|Â HCV genotype and patient population||Â Treatment||Â Duration|
|Â Genotype 3 without cirrhosis||Â Daclahep + sofosbuvir||Â 12 weeks|
|Â Genotype 3 with cirrhosis||Â Daclahep + sofosbuvir||Â 24 weeks|
Dose modification, interruption and discontinuation
Dose modification of Daclahep to manage adverse reactions is not recommended.There is no virologic treatment stopping rules that apply to the combination ofÂ Daclahep Â with sofosbuvir.
Hypersensitivity to the active substance or to any of the excipients Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daclahep. These active substances include but are not limited to phenytoin, carbamazepine, oxcarbazepine, Phenobarbital, rifampicin, rifapentine, systemic dexamethasone, and the herbal product St Johnâs wort (Hypericum perforatum).
WARNINGS AND PRECAUTIONS
Daclahep must not be administered as monotherapy.Daclahep Â must be administered in combination with other medicinal products for the the treatment of chronic HCV infection.
The safety and efficacy of the combination of Daclahep and sofosbuvir have been evaluated in a limited number of patients with cirrhosis in clinical studies.
Decompensates liver disease
The safety and efficacy of Daclahep in the treatment of HCV infection in patients with decompensated liver disease have not been established.
Retreatment withÂ Daclahep
The efficacy of Daclahep as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.
Pregnancy and contraception requirements
Daclatasvir should not be used during pregnancy or in women of childbearing potential not using contraception.Use of highly effective contraception should be continued for 5 weeks after completion of Daclahep therapy.
Adverse reactions in clinical trials.
The most common adverse reactions(>=10%) were fatigue and headache, aneamia,hot flush,nausea in subjects treated with 8, 12, or 24 weeks of Ledipasvir + Sofosbuvir.
Contraindications of concomitant use
Daclahep is contraindication in combination with medicinal products that strongly induce CYP3A4 and P-gp,e.g. phenytoin,carbamazepine,oxcarbazepine,Phenobarbital,rifampicin,rifabutin,rifapen-tine,systemic dexamethasone, and the herbal product St Johnâs wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daclahep.
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