Online Pharmacy Training

HARVONI   It is a combination of ledipasvir (90mg), a (HCV) NS5A inhibitor, and sofosbuvir (400mg), an HCV nucleotide analog NS5B polymerase inhibitor. HARVONI was approved by FDA on 10  October  2014, as first Hepatitis C drug combination, that used alone without need to ribavirin or peginterferon alfa, as in case of SOVALDI. Harvoni 15 facts: Used for treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. HARVONI dose is one tablet to be taken once daily regardless of food. Treatment duration varies according to the case and presence of liver cirrhosis. In naive cirrhotic or not, and in experienced non cirrhotic, they treated for 12 weeks. In naive non-cirrhotic patient with PCR < 6million IU/ml, treatment may reduced to 8 weeks. In experienced cirrhotic patients the treatment extends for 24 weeks. Experienced patients who have failed to treat with other medications. HARVONI used alone without the need to peginterferon al...

Serious and Life-Threatening Cases for use Harvoni and Sovaldi with amiodarone Serious and Life-Threatening Cases of Symptomatic Bradycardia, as well as One Case of Fatal Cardiac Arrest, Reported with Coadministration of amiodarone with either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or with Sovaldi® (sofosbuvir) in combination with another direct-acting antiviral. The specific changes to each label are summarized below. Harvoni label changes: WARNINGS AND PRECAUTIONS Serious Symptomatic Bradycardia When Coadministered with Amiodarone Postmarketing cases of symptomatic bradycardia, including fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with HARVONI. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver ...