MyDekla

Daclatasvir

Combination w/ sofosbuvir w/ or w/o ribavirin for the treatment of chronic HCV genotype 1, 3 & 4 infection in adults; w/ peg IFN/RBV for the treatment of chronic HCV genotype 4 infection in adults.

Recommended dose: 60 mg once daily. Reduce dose to 30 mg once daily when co-administered w/ strong CYP3A4 inhibitors. Increase dose to 90 mg once daily when co-administered w/ moderate CYP3A4 inducers.

May be taken with or without food: Swallow whole, do not chew/crush.

Hypersensitivity. Co-administration w/ strong inducers of CYP3A4 & P-gp transporter eg, phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone & St. John's wort may lead to lower exposure & loss of efficacy.

Not to be administered as monotherapy. Amiodarone should only be used in patients on daclastavir & sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated. Continuously monitor for 48 hr patients at high risk of bradyarrhythmia. Perform screening for current or past HBV infection. Monitor & treat patients w/ serologic evidence of current or past HBV infection. Patients w/ Child-Pugh C liver disease. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not to be used during pregnancy or in women of childbearing potential not using contraception. Discontinue breastfeeding during therapy. Childn & adolescents <18 yr.

Anaemia; headache; nausea; fatigue. Decreased appetite; insomnia, irritability; dizziness, migraine; hot flush; dyspnoea, exertional dyspnoea, cough, nasal congestion; diarrhoea, vomiting, abdominal pain, GERD, constipation, dry mouth, flatulence; rash, alopecia, pruritus, dry skin; arthralgia, myalgia.

May lead to lower exposure & loss of efficacy w/ strong CYP3A4 inducers & P-gp eg, phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort. May decrease plasma level & therapeutic effect w/ CYP3A4, P-gp & organic cation transporter (OCT) 1 substrates. Strong CYP3A4 inhibitors may increase plasma levels of daclastavir. May increase systemic exposure to P-gp, OATP 1B1, OCT1 or BCRP substrates. Not recommended in co-administration w/ darunavir, lopinavir or etravirine or nevirapine, amiodarone. Use w/ caution when co-admistered w/ HMG-CoA reductase inhibitors eg, rosuvastatin. Monitor safely when initiating treatment in patients receiving dabigatran, etexilate or other intestinal P-gp substrates that have a narrow therapeutic range. Increased conc w/ erythromycin. Serious symptomatic bradycardia may occur in patients taking amiodarone w/ sofosbuvir & daclatasvir. May increase digoxin levels. Increased conc w/ Ca channel blockers eg, diltiazem, nifedipine, amlodipine & verapamil.

Antivirals

J05AP07 - daclatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.

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