October 2015October 2015
New Product - Viekira Pak Combination Therapy Pack
Viekira Pak Combination Therapy Pack ((paritaprevir/ritonavir/ombitasvir) and dasabuvir), combines three direct acting hepatitis C virus antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. Paritaprevir is an inhibitor of HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyproteins and is essential for viral replication. Ombitasvir is an inhibitor of HCV NS5A which is necessary for viral replication. Dasabuvir is a non‑nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene. Ritonavir is a pharmacokinetic enhancer that increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure. Viekira Pak is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population. Viekira Pak Combination Therapy Pack is contraindicated in the following: severe hepatic impairment (Child‑Pugh C); use of ethinyloestradiol containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings; drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events; drugs that are moderate or strong inducers of CYP3A and strong inducers of CYP2C8 and may lead to reduced efficacy of Viekira Pak; and drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongations. It is also contraindicated with the following medicines: alfuzosin, amiodarone, quinidine, carbamazepine, phenytoin, phenobarbitone, astemizole, terfenadine, cisapride, colchicine (in renal/ hepatic impairment), gemfibrozil, rifampicin, blonanserin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, St John's wort, lovastatin, simvastatin, salmeterol, pimozide, efavirenz, sildenafil (in PAH), ticagrelor, triazolam, oral midazolam, fusidic acid, mitotane and enzalutamide. Viekira Pak Combination Therapy Pack is available as a composite pack containing 56 tablets of paritaprevir 75 mg/ ritonavir 50 mg/ ombitasvir 12.5 mg and a pack of 56 tablets of dasabuvir 250 mg. Viekira Pak is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs. Each daily dose pack contains four tablets: two paritaprevir 75 mg/ ritonavir 50 mg/ ombitasvir 12.5 mg tablets and two dasabuvir 250 mg tablets, and indicates which tablets need to be taken in the morning and evening.
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